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Sickle cell patient is pain free after geneediting trial altered her DNA – The Times

By daniellenierenberg

Sickle cell disease is a genetic condition in which red blood cells, which should be circular, adopt a crescent shape and are sticky and rigidALAMY

The first patients to receive gene-editing treatments for inherited blood diseases will enter the new year free of agonising symptoms.

The experiments suggest that altering DNA could treat sickle cell disease (SCD) and beta thalassemia, conditions both caused by faulty genes that hamper the bloods ability to carry oxygen.

The companies behind the trials said that a patient in the US with SCD had been well since July. A thalassemia patient in Germany had been free of symptoms for nine months. Previously she had 16 blood transfusions a year.

British patients could be offered similar experimental therapies next year. The treatment for both conditions involved a high-precision gene-editing tool called Crispr-Cas9. It was used to alter the DNA of some of the cells of Victoria

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How reindeer might help deliver the gift of scar-free healing to humans – The Globe and Mail

By daniellenierenberg

Almost 30 reindeer live on pastureland on the outskirts of Calgary where Jeff Biernaskie is among the researchers trying to determine if their unique healing abilities can be applied to human skin.

Todd Korol/The Globe and Mail

Kyle Hynes is 27. He likes kayaking, fishing and hiking with his dogs around the Rocky Mountains. He is a project manager at a helicopter company and talks with his hands when he gets excited.

He believes reindeer may hold the secret to making his life even better.

When Mr. Hynes was 5, he survived a house fire that left him with scars over 80 per cent of his body and forced him to endure years of surgeries.

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I do love my scars now, he said. But if I could get rid of my scars, I would be the happiest guy alive.

Mammals scar when serious skin wounds heal. Reindeer, however, are among the few exceptions to the rule, with the velvet on their antlers, specifically, healing flawlessly. Scientists at the University of Calgary believe human skin has the potential to heal with the same reindeer magic.

Almost 30 of the creatures live on pastureland on the outskirts of Calgary. Jeff Biernaskie is among the researchers experimenting on the animals. He is a cell biologist and neurobiologist by training focused on tissue regeneration. His team is trying to figure out how to make human skin respond to injury the way reindeer velvet does. The research has the potential restore both the appearance and function of skin for people such as Mr. Hynes.

Jeff Biernaskie is a cell biologist researching how reindeer velvet heals.

Todd Korol/The Globe and Mail

Reindeer sport velvet on their antlers for three to four months a year. The oily brown fuzz protects the antlers as they grow back each year. Reindeer both male and female depend on antlers for scrounging up food under the snow and for protection from predators. Males also show off their racks in mating season.

Dr. Biernaskie originally wanted to isolate the cells that might be responsible for antler growth, long thought to be stem cells that reside in two bony structures, called pedicles, on either side of the skull. Using anesthetic, his team removed small pieces of skin in order to access the pedicle and noticed that the wounds healed without scarring. Then they made more purposeful wounds and found the velvet regenerated seamlessly. By way of comparison, the scientists inflicted identical wounds elsewhere on the reindeers bodies and noted that the animals scarred at those sample sites.

When mammals are wounded, skin cells around the injury and the immune system rush to seal the site as quickly as possible to prevent infection. The natural response to injury, Dr. Biernaskie believes, is regenerative, but those signals are overwhelmed by scar-forming ones in the race to close the wound.

This, however, does not apply to embryonic cells, which are strictly regenerative. Fetal humans, Dr. Biernaskie says, heal perfectly. He says the cells that make up reindeer velvet exhibit genetic properties similar to those in embryonic cells. So if his team can activate regenerative genes and suppress those that form scars, humans may be able to regrow damaged tissue without flaws.

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It is almost like a circuit breaker," Dr. Biernaskie said. You have some that need to be turned on and others that need to be turned off.

Drugs, administered topically or intravenously, may be able to flip the switch, and Dr. Biernaskies lab is experimenting on mice.

His team has been working on the reindeer project for about five years and expects to reveal its findings next year. (The animals are known as caribou in North America and reindeer in Europe. The Calgary herd comes from European stock, so Dr. Biernaskie is sticking with reindeer in casual conversation. Also, its Christmas.)

Scars can be psychologically and physically disabling. Scars on joints, for example, limit mobility.

That becomes a massive burden on our economy, on our health-care system, but also on their quality of life, Dr. Biernaskie said.

Five years ago, the Calgary Firefighters Burn Treatment Society donated $1-million its largest single charitable contribution to support Dr. Biernaskies work. It put up another $1-million this year after his teams progress exceeded expectations.

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Mr. Hynes recognizes that science moves slowly but remains optimistic that he may benefit from Calgarys reindeer.

I live life to the fullest, but when I see this research come out, I get really excited to know that [there is] a possibility it could work for me, he said. [And] for other children who do get burns, theres something there that might cure them.

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Donor Will gives the gift of life at Christmas – London News Online

By daniellenierenberg

Last Christmas a student received what he says was the best Christmas present ever the chance to save a strangers life with a stem cell donation.

This Christmas, the student found out the patient who received his donation was successful, and that the patient was recovering well.

In December last year, Will Briant, 23, from Kennington, received an email that informed him he had come up as a potential match for a blood cancer patient in desperate need of a stem cell transplant.

Will said: Just a week before Christmas, I got the best Christmas present ever. I was told that I was the best match for the patient, and I would be donating early in the new year.

I was so excited. When you sign up you know that its such a tiny chance that youll be found as the best match for someone, so to actually be chosen felt really exciting.

Also, because it was just before Christmas, it felt quite exciting to know that the patient would find out that they had a match just in time for Christmas.

At the beginning of this year Will donated his stem cells at The London Clinic.

Will said: For four days before the donation I had a course of G-CSF injections to increase the number of stem cells I was producing.

This caused mild flu-like symptoms. I just felt a bit tired and achy really.

The whole way through I kept thinking about the recipient and how in this context I was absolutely delighted to have mild flu-like symptoms.

It was quite strange to be doing it for real, after talking to so many potential donors when I volunteered with Marrow at university.

Will initially joined the Anthony Nolan stem cell register in 2014.

His girlfriend, who volunteered with Edinburgh Universitys Blood, Bone Marrow and Transplant Society, which is part of blood cancer charity Anthony Nolans student volunteer network, called Marrow, suggested that he sign up.

Will said: My girlfriend, Libby, told me this amazing statistic that a quarter of all stem cell donors sign up through Marrow at university, so I couldnt not join.

If it wasnt for Marrow and for Libby, I wouldnt have become a donor and given someone hope of a second chance of life just before Christmas.

Following his donation Will then went back to his studies and his job, barely giving a second thought to what hed just done.

Will recently received a letter from the hospital to say that the donation had been successful and the donor recipient was recovering well.

Will said: It was honestly the best letter Ive ever received. It was especially powerful because it really hit home that not only had I given him a second chance of life, but also I had given his wife, his children, his grandchildren and his friends more precious time with him.

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Leukaemia and lymphoma have a good survival rate – The Star Online

By daniellenierenberg

Of all blood cancers, leukaemia and lymphoma are among the most curable.

However, many people, including doctors, still believe the disease leads to immediate death.

This is no longer true today as they are not fatal.

With optimal treatment, the majority of patients go into remission and are considered cured.

These two cancers have been more extensively studied than other forms of cancer, due to the ease in obtaining samples from blood, bone marrow or lymph nodes, spurring the advent of novel targeted therapies for a cure, says consultant haematologist Dr Ng Soo Chin.

Most blood cancers start in the bone marrow, where blood is produced.

Bone marrow contains stem cells, which mature and develop into red blood cells, white blood cells or platelets.

In most blood cancers, normal cell development is interrupted by the uncontrolled growth of an abnormal type of a particular blood cell.

These abnormal blood cells, which are cancerous, prevent your blood from performing many of its functions, like fighting off infections or preventing serious bleeding.

Leukaemia or white blood is classified into acute and chronic disease, which is then divided further into subtypes: acute lymphocytic leukaemia, acute myeloid leukaemia, chronic lymphocytic leukaemia (CLL) and chronic myeloid leukaemia (CML).

The presentation between acute and chronic leukaemia differs.

The acute person will tell you he was well a week ago and is now down with symptoms such as lethargy, anaemia and recurrent infection.

Suddenly, he may look pale, so we check his blood count for any abnormalities. A bone marrow exam will further confirm whether it is acute.

With chronic leukaemia, the patient can be unwell for a couple of months.

We are increasingly picking up cases early because of blood test availability.

The survival rate has improved tremendously for acute leukaemia, with more than 50% fully cured because bone marrow transplants are easily available in the country.

For CLL and CML, 95% of patients are alive at the 10-year mark, says Dr Ng.

Generally, chronic leukaemia patients belong to the older age group (50 years and above), but acute leukaemia can occur in all ages.

Leukaemia symptoms are often vague and not specific, so its easy to overlook them as they may resemble symptoms of the flu and other common illnesses.

In fact, chronic leukaemia may initially produce no symptoms and can go unnoticed or undiagnosed for years.

Lymphomas, a type of blood cancer that begins in a subset of white blood cells called lymphocytes, can be classified into Hodgkins and non-Hodgkins.

The main difference between Hodgkins and non-Hodgkins lymphoma is the specific lymphocyte each involves.

Lymphocytes are an integral part of your immune system, which protects you from germs.

Five-year survival rates are high with Hodgkins lymphoma at 86% and non-Hodgkins lymphoma at 70%.

You can beat the disease even if it is detected at a late stage.

Multiple myeloma, which is the third kind of blood cancer, forms in a type of white blood cell called a plasma cell.

Patients often complain of bone pain, and unfortunately, this type of cancer has no cure.

Blood cancers typically involve abnormal white blood cells and can affect paople of all ages, depending on the type of cancer. 123rf.com

Fear of treatment

Chemotherapy is a much dreaded word among cancer patients.

But with advances in medicine, newer chemotherapy-free treatments are now available.

Dr Ng says, Traditionally, cancer is treated via surgery or radiation the layman says we fry and poison them, which is not far from the truth!

Radiation means burning the cancerous area, but a lot of times, the cancer can also be present elsewhere, so there is limitation to this treatment.

With chemotherapy, we use cytotoxic (cell-killing) drugs they go in and knock off both cancer and normal cells.

The short-term effects include vomiting, hair loss, appetite loss and weight loss.

But as doctors, we are looking at a different perspective. We are more worried about white cells dropping (neutropenia) because the patient can pick up an infection that can potentially kill him.

Neutropenia is a condition that results when the body does not have enough neutrophils, a type of white blood cell that is an essential first line of defence against infections.

Thats one risk of chemotherapy, although we can now improve neutropenia by giving a growth factor injection.

But for certain cancers, we need to step up the drugs.

He adds: We are scared of neutropenia, but patients are more concerned about bodily changes.

The older ones get upset over losing hair because they cannot take it when others ask them what has happened to their hair.

Young people are not as concerned with hair loss because it can be trendy.

We understand that chemotherapy is less than pleasant and strong doses can impair fertility in young patients, especially women.

Despite current technology, only one-third of patients are successful in freezing their eggs.

What he is concerned about is that chemotherapy can actually increase the patients risk of getting another cancer, especially blood cancer.

It can happen the day after! says Dr Ng.

Most experts believe chemotherapy damages stem cells, so if youre unlucky, you might get acute myeloid leukaemia after undergoing chemotherapy for breast cancer.

Its just like crossing the road there is always a risk of being knocked down.

All our cells have a biological clock and there is an orderly exchange of old and new cells.

But with blood cancers such as leukaemia, there is a clone of abnormal cells.

Cancer cells have an advantage over normal cells because they can survive longer.

Chemotherapy is still needed to treat most acute blood cancers, although if the mutation is known, targeted therapies can be applied.

For chronic blood cancers, there is no need for chemotherapy. Oral drugs are enough to combat the disease.

Eventually, many patients are able to wean off the drugs.

As we may be aware, immunotherapy is the buzzword in cancer treatment today.

Also called biologic therapy, it is a type of cancer treatment that boosts the bodys natural defences to fight cancer.

It uses substances made by the body or in a laboratory to improve or restore immune system function.

One of the latest treatment modalities is the CAR T-cell therapy, a form of immunotherapy that uses specially altered T cells a part of the immune system to fight cancer.

A sample of a patients T cells are collected from the blood, then modified to produce special structures called chimeric antigen receptors (CARs) on their surface.

When these CAR T-cells are reinfused into the patient, the new receptors enable them to latch onto a specific antigen on the patients tumour cells and kill the cells.

At the moment, this intravenous therapy is available in the United States and hasnt reached our shores yet. It has to be properly regulated first, says Dr Ng.

A volunteer is having his head shaved to donate hair to make wigs for cancer patients in this filepic. Hair loss is one of the side effects of chemotherapy that affect patients the most.

Following natural remedies

The consultant haematologist errs on the side of caution when patients ask about natural cancer remedies, or the dos and donts during treatment.

We always believe there should be a scientific approach to the problem.

If patients are doing okay while undergoing treatment and there is no weight loss, I tell them to go ahead and do what they always do.

However, just be particular about food hygiene, as there is a chance you may get food poisoning.

If youre undergoing chemotherapy, then youll land yourself in hospital, and if your luck is bad, you may even land up in the ICU (intensive care unit).

So make sure the food is cooked and not left overnight to reduce your chances of infection.

Eat a balanced diet, he advises.

When it comes to exercise, he says to work out within your limit.

Instead of pushing the body and running marathons or climbing mountains, go for walks.

Dr Ng says, Life should go on, but be sensible.

Dont go to crowded places because you may pick up an infection, but dont be withdrawn either. All humans need social interaction.

With the billion-dollar dietary supplements industry, companies are constantly trying to lure customers into buying their products.

A lot of supplements are just glorified vitamins in different packaging.

The more expensive they are, the more people will buy them, thinking they are good.

There are people with good intentions, but unfortunately, there are also a lot of scammers out there that is life.

For the amount you spend on supplements, why not keep the money aside and go for a trip once your treatment is over? he suggests.

Often, the late diagnosis is due to preference for alternative treatment.

These alternative treatments are like fashion shows, after some time, they go out of trend.

For me, youre wasting valuable time because cancer is not your friend.

Yes, chemotherapy is tough, but with the latest chemo-free regimen, patients are more willing to come forward.

The earlier it is treated, the higher your chances of recovering, he says.

To share his 30-odd years of knowledge and experience in the field, Dr Ng has written his third book titled Understanding Blood Disorders.

Intended for patients, caregivers and healthcare professionals, proceeds from the sales of the 270-page book will go to the newly set-up Faith Hope Love Hospice Care Malaysia in Petaling Jaya, Selangor.

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Little Mila on amazing path to recovery – Croatia Week

By daniellenierenberg

Mila Roncevic (Photo: Private album)

24 December 2019 There has been some great news just before Christmas from America where little Mila Roncevic has been receiving life-saving treatment.

Mila, from Rijeka in Croatia, has been fighting leukaemia (acute myelogenous megakaryocytic leukaemia AML M7) and earlier this year was given just a 1% chance of beating it. A massive fundraising campaign in Croatia and abroad back in April helped raise $5.6 million to get her to the Childrens Hospital of Philadelphia for urgent treatment.

Mila has been at the hospital since 3 April and on Monday her father has shared some incredible news that after a successful bone marrow transplant, the leukemia has receded.

Mila is fine right now. She underwent a bone marrow transplant from a donor on 1/11/2019 and so far its better than okay. It was not a surgery per se, but rather a bone marrow transplant after achieving and maintaining remission for six months. Transplantation is not an operation but a complex procedure which includes preparation of the so-called conditioning, that is, achieving the conditions for receiving donor stem cells and then recovering and waiting for defence cells to be created on their own, in which case she had to remain in complete isolation because there is no immunity. In order to receive the transplant, the disease must recede, which they achieved within a month of arrival and maintained for almost half a year, her father Marin told 24sata.

Marin says that just three weeks after the transplant, Mila was released from hospital and to the amazement and disbelief of all the doctors, she is now running, lifting, eating and drinking alone and does everything that was considered impossible in the early post-transplant period.

She looks and acts like a perfectly healthy baby, even though we know that there are still many potential dangers ahead, Marin said.

Marin says going to Philadelphia was certainly the right decision, which has been confirmed by the successful outcome of the treatment.

In Croatia, the chances for successful treatment were below 1%. It was also the right decision because at that moment we had no alternative, nor enough time to look for it. It is difficult to actually talk about percentages, because as far as we are told, cases with similar diagnoses that have been successfully cured in Croatia and Europe do not exist, he said, before thanking everyone again who helped get Mila to the United States for treatment.

(Photo: Private album)

Thank you people. If it wasnt for your empathy, kindness and intrinsic desire to help, none of this would be possible. Every kuna, every prayer and every good thought saved Mila and will help countless other children for whom funds will be provided for. This action also showed how important it is for all of us to stick together and how much we can do that way. We are incredibly grateful to have genuinely and openly begged for help and received it. Its not just about the money. It is about the love, support and prayers of all people who have felt our affliction and suffering.

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Abington working toward big win – Sports – The Intelligencer

By daniellenierenberg

The Galloping Ghosts are looking beyond the scoreboard to help classmate Juwan Adams battle pediatric cancer.

Khalis Whiting and her Abington girls basketball teammates have a different perspective this holiday season. A perspective that changed when through Kisses for Kyle they were put in touch with two area families who have a child battling pediatric cancer.

One George Hamlin is a student in Upper Dublin High School. The other, Juwan Adams, is a senior at Abington. Both families were on the receiving end of gifts and gift cards at the Abington-Upper Moreland game last week. It is the 10th annual giving back game since coach Dan Marsh initiated the project.

It was an amazing experience, said Whiting, the Ghosts sophomore point guard. I was not familiar with the families, but I have seen (Adams) a few times in school, but I never really knew the story until this came up and I researched him.

He has a powerful story, and hes such a strong young man to be going through this. Every time I see him in the hallways, hes always smiling and so positive. So you know give it to his family.

Adams, who has been battling Hodgkins Lymphoma since April of 2016, is in need of a match for an allogeneic stem cell transplant.

Right now, he is out of options, his mother, Andrea Adams, said. We know for sure that an allo stem cell transplant will cure him, but unfortunately, in order to do that, we need a donor.

We have tested everyone in our family, and no one is a full match, so were relying on the Be the Match registry to locate a donor. Sadly, for minorities theres a very slim chance to actually find a full 10-out-of-10 match because we dont have enough minorities on the registry.

Hes had almost every treatment available for Hodgkins, including an auto stem cell transplant, which is where he gave himself his own cells in February of 2017. He was in remission for about a year, and unfortunately, in May of this year, we found out the cancer is back, and its been spreading consistently since May.

Despite missing more than half of the last three-and-a-half years of school, Juwan maintains a 4.25 GPA and is a member of the National Honor Society.

Abington School District has been really great with accommodating him, giving him tutors, and whenever hes an in-patient, he does hospital school, Andrea said.

Juwan is the drum captain and lieutenant of Abingtons marching band, and since September is Pediatric Cancer Awareness month, for the past four years, the marching band has worn gold ribbons on their uniforms.

Since his diagnosis in eighth grade, Juwan has been active in pediatric cancer awareness events, and for the past four years, he has held toy and book drives that he presents to the children at CHOP on his birthday in July.

Last week, Juwan and his family were on the receiving end.

It was great because Juwan never wants gifts, Andrea said. Having a child with cancer, financially its tough, especially now that we have only have one person working fulltime, and that lifted a tremendous burden, and it was so unexpected.

To have him honored by his school and his peers, he was super excited about it, and he really appreciated it because a lot of kids (battling cancer) have to give up school, or their friends tend to abandon them.

I want to thank the team and the Abington students because it is very easy to turn your back on kids that are going through these things. These kids have really rallied around him. This is one of the reasons he fights so hard to be in school. He sometimes sneaks to school because he feels the love from his school and his peers. That was one thing he definitely wanted to do to finish his senior year with his class. They have really rallied around him, and this kind of thing gives him the extra push he needs to keep fighting.

Statistics say Juwan has a 23 percent chance of finding a perfect match, but the Abington senior has been proactive.

When they told him the odds of finding his match, he said he had to do something about it, Andrea said. He set a goal to register a thousand people on the national registry, half of those being minorities.

We have gone around holding bone marrow drives. Hes now an ambassador for Be the Match, and hes been an ambassador for CHOP for about two years.

Juwan is inviting everyone to join his fight.

"People are starting to wake up and realize kids with cancer more and more are dying each day, and if they have a chance to do something, they should take every step they can," Juwan said earlier this fall. It's been hard sometimes, but I have my friends and family to support me.

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A blood cancer diagnosis helped me find true happiness – The Guardian

By daniellenierenberg

December 2017, and the Christmas party season is in full flow. Everywhere I look are scenes from some hilariously awful Dickens pastiche: revellers squeezed into warm pubs; joyful chatter spilling out on to the street; the sound of carols and the scent of mulled wine in the air. Its as if I am peering in at it all through frosted glass, wishing my own Christmas could be as carefree.

Instead, I have spent a morning turned on my side on a hospital bed while a nervous-looking young doctor works up a sweat attempting to force a long needle into my hipbone. He needs it to go deep enough that he can suck out some of the marrow inside, but my tough bones are making life difficult for him.

I dont feel so tough. My wife and I spend the next fortnight anxiously waiting for the results. Results that should confirm why my body is behaving in unexpected ways: the unusual infections; the crushing fatigue; the old jeans that suddenly slip off my waist.

Christmas is never a nice time to feel alone. Yet, despite the fact I am surrounded by loved ones, that is how I feel: terrifyingly alone. The emotions of the season get warped and amplified. I attempt to go to one party, see a friend who is going through her own hellish time, and we both sob on each others shoulders for five minutes straight. Everything feels raw and heavy. My little girl is not even 18 months old, and I love her more than anything but I find it hard to even be in the same room as her. Its all too much.

If Christmas has lost its religious meaning, then it hasnt for me. I try praying for the first time in about three decades: Er, yes, it has been a while sorry about that but could you just help me out with this one thing? I promise God and Santa Ill be all sorts of good if things turn out OK.

***

My results arrive on 22 December. There is a wait in a hospital corridor that is still too triggering to think about properly. And then a doctor calls me in, sits me down and tells me that I have a rare blood cancer called essential thrombocythemia, which sounds like some cult artist signed to Warp Records in the 90s (the doctor doesnt say that bit). There is no known cure. But dont worry, he says, its manageable. I just need to take some aspirin and keep an eye on it. You will lead a normal life, he says. My wife tells me my face instantly changed colour, the pallid grey lifting for the first time in weeks.

My little girl throws up all over the seat when we pull out of the drive, and it doesnt even feel slightly annoying

Its a strange gift, receiving blood cancer for Christmas. In some ways I preferred the Mr Frosty slushy-making kit I got when I was eight, and maybe even the Scalextric that never quite played out the way you hoped it would from the adverts. And yet what the doctor is telling me you will lead a normal life feels like the biggest and best present I have ever received. Queueing up to be discharged, I let wave after wave of euphoria run through me and think to myself: This has to be the weirdest cancer diagnosis ever.

A day later, we pack up the car and head off to my parents. My little girl throws up all over the back seat as soon as we pull out of the drive, and it doesnt even feel slightly annoying. We laugh. Life is good. That Christmas, for the first time since I can remember, I am truly happy; just living in the moment. The light seems brighter and more beautiful. I notice dew drops on plants and the smell of fresh air. I hug my wife and daughter even more tightly than usual.

***

All this relief is not to last long. In the first week of 2018, I attend a follow-up appointment and am told that, sorry, they hadnt seen all of the bone marrow samples before. My condition is, in fact, developing into a much more serious disease called myelofibrosis, which needs treatment.

A week on from that, I turn up at the hospital, steeled to start chemotherapy. But there is worse news: a team of specialists have discussed my case and they believe I am at high risk of developing acute myeloid leukaemia, a swift and deadly cancer. They recommend you have a stem cell transplant, says the doctor. I ask when. As soon as possible. If I can find a match on the stem cell donor register, then I will be dosed up with drugs so intense that my entire immune system will be wiped out; then a strangers cells will be fed into me and we will all cross our fingers and hope that my body doesnt reject them. The chance of survival and the disease not returning does not seem to me to be all that much better than 50/50. Even if it all succeeds, the recovery process will be long and gruelling.

I spend the next few weeks in a state of catatonic depression. Or do I? Because I am somehow getting things done: I organise a will, I arrange a sperm bank visit (the transplant, even if successful, will leave me infertile), I cry myself senseless writing a letter to my daughter in case the worst should happen. I also drink all the good bottles of wine I had been saving for special occasions. A bottle of Domaine Dujac Morey Saint-Denis 2012 on a Tuesday night with defrosted Quorn chilli not the pairing Id had in mind, but saving it for the future seems silly.

Through all the gloom I see something with startling clarity. I realise that what Im mourning is not so much my old life before all this started a life of pointless anxieties, petty rivalries and overthinking but rather the carefree, optimistic version of life I had briefly glimpsed over Christmas. And yet no sooner have I understood all this than the chance to enact it has been snatched away. I feel like an old professor who has finally unravelled the mysteries of the universe with his dying breath.

***

Over the next few months, something happens that I still find hard to believe. I am transferred to a new hospital with a more specialist team on the case. There are more blood tests and scans, and another long needle is forced into my hip. And then I get another gift, this one in time for Christmas 2018: my condition is not so serious as I was led to believe. It appears to be a peculiar version of a peculiar cancer caught somewhere between the relatively benign essential thrombocythemia and the more concerning myelofibrosis. But it is stable, at least for now, with no signs to suggest it will progress any time soon.

***

I like to think that this year I have made good on my promise to live like I did during the Christmas of 2017. My outlook has certainly changed. When people ask how, I always say the same thing: that its great to get older. The idea of panicking about a milestone such as my imminent 40th seems so ridiculous now. Instead, just think what a privilege it is to be able to get there.

I am more present for my family these days, and less consumed with things I cant control. I have returned to the volunteering role I thought I didnt have time for; I have got fit; I dont let work define my happiness; I am kinder to myself. I have bought lots more nice wine to replace the nice wine I drank with defrosted Quorn chilli.

Do I still get annoyed by delayed trains, lost keys or the fact my daughter is taking half an hour to put on a pink tutu, the only item of clothing in the house that shell wear? It would be a lie to say no. But the second I think: But youre not quite likely to die any more, the problem disappears. I am, undeniably, a happier person.

I still have a malfunction inside me and I still have to think about it every day. Its hard not to my spleen, inflated with excess blood cells, gently nudges against my ribs like an annoying acquaintance who would hate me to forget that all is not quite right. At some point in the future and not even the best doctors can predict exactly when the disease might whirr into life and start scarring my bone marrow, turning it into a barren wasteland that can no longer produce enough blood to keep me alive. Im hopeful that science will find a fix before that time comes. There are encouraging signs on the horizon. And if not? Well, these days I try not to dwell on the future. I am here, instead, for the present. I am alive. I am alive with the spirit of Christmas.

MPN Voice provides information and emotional support to people diagnosed with a myeloproliferative neoplasm

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Stem Cells Market Poised to Expand at a Robust Pace Over 2017 to 2025 – Market Research Sheets

By daniellenierenberg

In theglobalstem cells marketa sizeable proportion of companies are trying to garner investments from organizations based overseas. This is one of the strategies leveraged by them to grow their market share. Further, they are also forging partnerships with pharmaceutical organizations to up revenues.

In addition, companies in the global stem cells market are pouring money into expansion through multidisciplinary and multi-sector collaboration for large scale production of high quality pluripotent and differentiated cells. The market, at present, is characterized by a diverse product portfolio, which is expected to up competition, and eventually growth in the market.

Some of the key players operating in the global stem cells market are STEMCELL Technologies Inc., Astellas Pharma Inc., Cellular Engineering Technologies Inc., BioTime Inc., Takara Bio Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

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As per a report by Transparency Market Research, the global market for stem cells is expected to register a healthy CAGR of 13.8% during the period from 2017 to 2025 to become worth US$270.5 bn by 2025.

Depending upon the type of products, the global stem cell market can be divided into adult stem cells, human embryonic stem cells, induced pluripotent stem cells, etc. Of them, the segment of adult stem cells accounts for a leading share in the market. This is because of their ability to generate trillions of specialized cells which may lower the risks of rejection and repair tissue damage.

Depending upon geography, the key segments of the global stem cells market are North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. At present, North America dominates the market because of the substantial investments in the field, impressive economic growth, rising instances of target chronic diseases, and technological progress. As per the TMR report, the market in North America will likely retain its dominant share in the near future to become worth US$167.33 bn by 2025.

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Investments in Research Drives Market

Constant thrust on research to broaden the utility scope of associated products is at the forefront of driving growth in the global stem cells market. Such research projects have generated various possibilities of different clinical applications of these cells, to usher in new treatments for diseases.Since cellular therapies are considered the next major step in transforming healthcare, companies are expanding their cellular therapy portfolio to include a range of ailments such as Parkinsons disease, type 1 diabetes, spinal cord injury, Alzheimers disease, etc.

The growing prevalence of chronic diseases and increasing investments of pharmaceutical and biopharmaceutical companies in stem cell research are the key driving factors for the stem cells therapeutics market. The growing number of stem cell donors, improved stem cell banking facilities, and increasing research and development are other crucial factors serving to propel the market, explains the lead analyst of the report.

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Five hot topics in autism research in 2019 – Spectrum

By daniellenierenberg

This year, researchers unearthed clues to the causes of autism and how to treat it from a variety of sources.

Advances in tiny models of the human brain bared new details about the biology of autism and provided possible platforms for testing therapies. Studies of heart rate put a spotlight on the autonomic nervous system as a potential wellspring of autism traits. And others forged a controversial connection between the gut microbiome and autism.

A few studies revealed important information about the time points at which different forms of autism are amenable to therapy. This year also saw scrutiny of tests used for screening and diagnosis, revealing gaps and limitations in the system for identifying autistic children.

Here are the years top five topics in autism research.

Brain organoids start as mere clusters of stem cells, which then are coaxed to mature into brain cells. This year, the life span of these brains-in-a-dish grew to one year and then nearly two, enabling them to mature and mimic some aspects of the human brain. In the longest-lived organoids, researchers tracked changes in the expression of autism genes. Organoids derived from the skin cells of autistic people have a shortage of cells that suppress brain activity, they found. The finding supports the signaling imbalance theory of autism, which holds that the brains of autistic people are hyper-excitable.

This year, scientists also built tiny replicas of two brain areas bridged by a long fiber tract that might reveal how long-range connections are altered in the brains of people with autism.

Brain organoids spun from people with fragile X syndrome may help explain why some experimental fragile X drugs work in mice but not in people and generate leads for effective therapies. Organoids could provide a platform for testing treatments, too, as researchers can now churn out hundreds of these brain-like blobs in parallel and make them uniform in shape and composition.

More distant applications include studies of consciousness and the effects of microgravity on the brain. In a fledgling sign of the former, brain organoids showed synchronized neuronal firing patterns, some aspects of which look like those in preterm infants.

New evidence emerged tying autism to the workings of the autonomic nervous system, which controls breathing, heart rate and digestion. Differences in the system could explain a range of autism traits, including social difficulties and sensory sensitivity, as well as heart problems and digestive issues.

Many of these differences show up in the heart rate. Heart rate remains steady in autistic people as they breathe instead of the typical pattern of slowing slightly on exhale and quickening on inhale. This discrepancy arises after 18 months of age, around the same time that the conditions core traits emerge. Children with Rett syndrome also have unusual heart-rate patterns.

These differences may persist beyond childhood. One study showed that autistic adults resting heart rates rarely vary; an even heart rate suggests a lack of flexibility in responding to environmental changes.

Autistic children are unusually prone to gastrointestinal problems. This association may not be a coincidence: Certain genetic mutations or alterations in the microbiome the mix of microbes in the intestines may contribute to both autism and gut problems.

Four mouse studies in 2019 offered up fresh evidence some of it controversial to support this idea. In one study, researchers replaced the gut microbes in mice with those from autistic boys. The mice have repetitive behaviors, make fewer vocalizations and spend less time socializing than controls do, providing the first evidence that gut microbes contribute to autism traits.

But within hours of the studys publication, several experts criticized its small sample size and highly variable results. Others found a possible statistical error.

In an unrelated study, researchers revealed that oral doses of Lactobacillus reuteri, a type of gut bacteria found in yogurt and breast milk, boost social behavior in three mouse models of autism. And two other sets of findings suggested that mutations in NLGN3, a high-confidence autism gene, alter gut function. One of them showed that a mutation in this gene disrupts the mices microbiome.

Drugs for autism may be most effective when given during a critical period of brain development. Researchers delineated the windows for treating autism traits in mouse and rat models of the condition.

One study revealed that by the time mice reach adulthood, they have lost their ability to learn from social experiences. Giving adult mice an injection of 3,4-methylenedioxymethamphetamine (MDMA), the active ingredient in ecstasy, reopens the critical window for learning.

In another study, researchers fed the cholesterol drug lovastatin to rat models of fragile X syndrome. The treatment, if given at 4 weeks of age (the rat equivalent of childhood), prevents cognitive problems, the researchers found.

The timing of treatments may be more important for some forms of autism than for others. A study of mice missing UBE3A, the gene mutated in Angelman syndrome, showed that the earlier in life the gene is restored, the more the mice improve.

By contrast, a mutation in the autism gene SCN2A has many of the same effects on neurons when introduced into adolescent mice as it does when it is present from conception. And unpublished results show that correcting an SCN2A mutation in adulthood reverses these problems.

A series of studies this year called into question the accuracy of early screening and revealed racial disparities in autism diagnoses.

Some studies cast doubt on the utility of a widely used screening tool, the Modified Checklist for Autism in Toddlers: The test identifies less than 40 percent of autistic children, and 85 percent of those it does flag do not have autism.

Of the toddlers the test flags, most do not receive follow-up evaluations. And for those who are seen again, a definitive diagnosis may not be possible right away. Some children who screen negative at age 3 meet the diagnostic criteria for autism only after age 5.

Not all children have equal access to autism evaluations, with black and Hispanic children at a disadvantage in several U.S. states. In New Jersey, black children are half as likely as white children to receive an autism assessment by age 3.

About 9 percent of autistic children may outgrow an autism diagnosis but still have other conditions that require support, highlighting the need for continued observation to adapt to their evolving needs.

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5 Things to Know About Hair loss and Scalp Care Centre Papilla Haircare – Singapore Tatler

By daniellenierenberg

By Gerald Tan December 23, 2019 Tatler Focus

The centre offers the latest scalp innovations that address all your hair thinning woes by getting to the root cause

While you are pampering your skin with the most luxurious creams and lotions, dont forget to show your crowning glory some tender loving care, too. Beautiful tresses require plenty of effort and dedication to upkeep, but when you are faced with unfortunate scalp ailments or hair-loss issues, however, maintaining its volume and healthy shine can seem like anuphill task.

Enter hair loss and scalp care centre Papilla Haircare, which might have the solution for all your hair woes.

From state-of-the-art equipment to medicallybacked technologies, here are five things to know about the brand:

Thankfully, advances in science and technology can help alleviate many hairrelated problems. Papilla Haircare has the latest innovative solutions. Located at Ngee Ann City, it is a one-stop hub that utilises the latest medicallybacked technologies. The centre collaborates with doctors and scientists to concoct serums rich in stem cells in its own Korean laboratory to ensure the highest safety standards.

(Related: 7 Natural Beauty Products Your Skin Will Love You For)

Boasting sleek black and gold accents, Papilla Haircares contemporary interiors are a reflection of its cutting-edge services. Its clinically proven programmes are the result of extensive scientific research, meticulously developed by a group of Korean dermatologists and hair transplant surgeons. Thanks to their efficacies, these remedies have also been adopted for post-procedure use at top hair transplant centres in South Korea.

(Related: 5 Foods To Eat For Healthy Hair And Nails)

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Stem Cell Therapy Market Consumer Outlook 2025 | MEDIPOST Co., Ltd., Osiris Therapeutics, Inc. – Market Research Sheets

By daniellenierenberg

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma – BioSpace

By daniellenierenberg

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID (lenalidomide), in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma (follicular lymphoma or marginal zone lymphoma). REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma (NDMM) who are not eligible for transplant. It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.

This milestone for REVLIMID marks another step in the expansion of our hematology franchise into non-Hodgkins lymphoma (NHL) in China, where significant unmet medical needs remain. Together with the pending approvals of tislelizumab for Hodgkins lymphoma and zanubrutinib for mantle cell lymphoma and chronic lymphocytic leukemia as well as Revlimid for multiple myeloma, Vidaza for myelodysplastic syndromes and acute myeloid leukemia and additional products from the collaboration we have announced with Amgen, we are working to build a market-leading presence in the treatment of hematological cancers in China, said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. We are excited about this opportunity and look forward to working closely with Bristol-Myers Squibb and the NMPA to bring this chemotherapy-free treatment option to patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma in China as soon as possible.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control (CMC) data package, including the results from the pivotal Phase 3 AUGMENT study (NCT01938001) sponsored and conducted by Bristol-Myers Squibb. AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab (R2) or rituximab and placebo. With a median follow-up of 28.3 months (range: 0.1 to 51.3 months), R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival (PFS), evaluated by an independent review committee (IRC), relative to the control arm with a 54% reduction in the risk of progression or death (hazard ratio [HR] = 0.46; 95% confidence interval [CI]: 0.34, 0.62; p < 0.0001). The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate (ORR), a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC. Duration of response (DoR) was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the control arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in the control arm), constipation (26% vs. 14%), cough (23% vs. 17%), and fatigue (22% vs. 18%). Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

About follicular lymphoma (FL) and marginal zone lymphoma (MZL)

FL and MZL are two major types of indolent lymphomas;1 FL is the most common subtype, constituting approximately 20% to 25% of all NHL,2 followed by MZL (approximately 5% to 17% of all NHLs).3 NHL incidence in China is 88,090 according to the World Health Organizations Globocan 2018 database.4 Given the incurable nature of relapsed or refractory FL/MZL, the efficacy and safety limitations of current treatment options, and the fact that patients are typically older and with comorbidities, a high unmet medical need exists for the development of novel treatment options with new differentiated mechanisms of action and a more tolerable safety profile that can improve the quality of response and PFS in the setting of previously treated FL/MZL.

About REVLIMID

In China, REVLIMID was approved in combination with dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are not eligible for transplant in 2018. It received approval in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone in adult patients who have received at least one prior therapy.

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation. REVLIMID as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMID is approved in Europe for the treatment of patients with mantle cell lymphoma (MCL) and in the United States for the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

U.S. Indications for REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus.

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS.

REVLIMID REMS Program: See Boxed WARNINGS. Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require a dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter.

Venous and Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision.

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In patients with MM, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment.

Increased Mortality With Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches.

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion.

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy.

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L).

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

Please see the rituximab full Prescribing Information for Important Safety Information at http://www.rituxan.com.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in the United States, China, Australia, and Europe; BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA (zanubrutinib) and in China, the Company markets ABRAXANE (paclitaxel for injection [albumin bound]), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.5

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for further development and commercialization of REVLIMID in China and the potential implications for patients. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

______________________1 Bello C, Zhang L, Naghashpour M. Follicular lymphoma: current management and future directions. Cancer Control. 2012;19:187-95.

2 Sousou T, Friedberg J. Rituximab in indolent lymphomas. Semin Hematol. 2010; 47(2):133-42.

3 Zinzani, P. L. (2012). The many faces of marginal zone lymphoma. Hematology, 2012(1), 426432.

4 https://gco.iarc.fr/

5 ABRAXANE is registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company; REVLIMID and VIDAZA are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb company.

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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma - BioSpace

To Read More: BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma – BioSpace
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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma – GlobeNewswire

By daniellenierenberg

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID (lenalidomide), in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma (follicular lymphoma or marginal zone lymphoma). REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma (NDMM) who are not eligible for transplant. It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.

This milestone for REVLIMID marks another step in the expansion of our hematology franchise into non-Hodgkins lymphoma (NHL) in China, where significant unmet medical needs remain. Together with the pending approvals of tislelizumab for Hodgkins lymphoma and zanubrutinib for mantle cell lymphoma and chronic lymphocytic leukemia as well as Revlimid for multiple myeloma, Vidaza for myelodysplastic syndromes and acute myeloid leukemia and additional products from the collaboration we have announced with Amgen, we are working to build a market-leading presence in the treatment of hematological cancers in China, said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. We are excited about this opportunity and look forward to working closely with Bristol-Myers Squibb and the NMPA to bring this chemotherapy-free treatment option to patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma in China as soon as possible.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control (CMC) data package, including the results from the pivotal Phase 3 AUGMENT study (NCT01938001) sponsored and conducted by Bristol-Myers Squibb. AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab (R2) or rituximab and placebo. With a median follow-up of 28.3 months (range: 0.1 to 51.3 months), R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival (PFS), evaluated by an independent review committee (IRC), relative to the control arm with a 54% reduction in the risk of progression or death (hazard ratio [HR] = 0.46; 95% confidence interval [CI]: 0.34, 0.62; p < 0.0001). The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate (ORR), a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC. Duration of response (DoR) was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the control arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in the control arm), constipation (26% vs. 14%), cough (23% vs. 17%), and fatigue (22% vs. 18%). Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

About follicular lymphoma (FL) and marginal zone lymphoma (MZL)

FL and MZL are two major types of indolent lymphomas;1 FL is the most common subtype, constituting approximately 20% to 25% of all NHL,2 followed by MZL (approximately 5% to 17% of all NHLs).3 NHL incidence in China is 88,090 according to the World Health Organizations Globocan 2018 database.4 Given the incurable nature of relapsed or refractory FL/MZL, the efficacy and safety limitations of current treatment options, and the fact that patients are typically older and with comorbidities, a high unmet medical need exists for the development of novel treatment options with new differentiated mechanisms of action and a more tolerable safety profile that can improve the quality of response and PFS in the setting of previously treated FL/MZL.

About REVLIMID

In China, REVLIMID was approved in combination with dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are not eligible for transplant in 2018. It received approval in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone in adult patients who have received at least one prior therapy.

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation. REVLIMIDas combination therapy is approved inEurope, inthe United States, inJapanand in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassingEurope, theAmericas, theMiddle-EastandAsia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy inAustralia and New Zealand.

REVLIMIDis also approved inthe United States,Canada,Switzerland,Australia,New Zealandand several Latin American countries, as well asMalaysiaandIsrael, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and inEuropefor the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMIDis approved inEuropefor the treatment of patients with mantle cell lymphoma (MCL) and inthe United Statesfor the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. InSwitzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

U.S. Indications for REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus.

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS.

REVLIMID REMS Program: See Boxed WARNINGS. Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require a dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter.

Venous and Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision.

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In patients with MM, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment.

Increased Mortality With Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches.

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion.

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy.

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L).

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

Please see the rituximab full Prescribing Information for Important Safety Information at http://www.rituxan.com.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in the United States, China, Australia, and Europe; BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA (zanubrutinib) and in China, the Company markets ABRAXANE (paclitaxel for injection [albumin bound]), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.5

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for further development and commercialization of REVLIMID in China and the potential implications for patients. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

______________________1 Bello C, Zhang L, Naghashpour M. Follicular lymphoma: current management and future directions. Cancer Control. 2012;19:187-95.

2 Sousou T, Friedberg J. Rituximab in indolent lymphomas. Semin Hematol. 2010; 47(2):133-42.

3 Zinzani, P. L. (2012). The many faces of marginal zone lymphoma. Hematology, 2012(1), 426432.

4 https://gco.iarc.fr/

5 ABRAXANEis registered trademark ofAbraxis Bioscience LLC, aBristol-Myers Squibb company; REVLIMIDand VIDAZAare registered trademarks ofCelgene Corporation, aBristol-Myers Squibbcompany.

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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma - GlobeNewswire

To Read More: BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma – GlobeNewswire
categoriaCardiac Stem Cells commentoComments Off on BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma – GlobeNewswire | dataDecember 22nd, 2019
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Wisconsin teen diagnosed with cancer while battling rare ‘butterfly skin’ disease: ‘He is resilient’ – Fox News

By daniellenierenberg

At just 13 years old,Charlie Knuth, of Darboy, Wisc., has known more pain than most others do in a lifetime. The teen, who suffers from epidermolysis bullosa, a rare disease that causes his skin to blister incredibly easily, is near-constantly wrapped in bandages to protect his fragile skin. He takes special baths to soothe his sores, which can form from the slightest touch and are lanced before he is covered in fresh dressings.But the so-called butterfly child a name often given to EB sufferers as their skins fragility is similar to that of a butterfly wing has another battle ahead: cancer.

Its unimaginable, Trisha Knuth, Charlies mother, told Fox News. Even as his mom, when I see him taking it in stride, I cant even believe that he can.

BOY, 2, HAS RARE 'SCALE'-LIKE SKIN CONDITION THAT AFFECTS 1 IN 500,000: 'HES OVERCOME SO MUCH'

Charlies biological parents abandoned him at the hospital shortly after his birth. Knuth and her husband, Kevin, had long fostered children with complex medical needs. But just weeks before they received a call about Charlie, they were readying to let their license expire; the tragic cases were simply becoming too much. Even so, Knuth said shecouldnt say no to Charlie she knew to do so was likely a death sentence. They began the lengthy adoption process shortly after bringing him home.

Trisha Knuth and Charlie, 13. (Trisha Knuth/Facebook)

When I went to the children's hospital in Milwaukee, he was slathered from head-to-toe in Vaseline," she recalled."Nobody ever came for him. I worked with the nurses and learned his care but EB is so rare that many hospitals don't know how to care for those with [the condition]. They sent me home with morphine and a few things and it was a learning process from there.

Thirteen years later, Charlie didnt end up dying, he ended up thriving, she said. When he was 5 years old, he underwent an experimental skin grafting procedure at the University of Minnesota in an attempt to make his skin stronger and less prone to blistering. Knuth called it a transformation for her young son, who had two really good years before his body rejected the graft and he began to suffer from aplastic anemia, a potentially deadly condition that occurs when the body doesn't produce enough red blood cells.

In 2012, he underwent a stem cell transplant in an attempt to treat his severe EB. He was hospitalized for six months but eventually pulled through.

Charlie, who suffers from EB, was recently diagnosed with cancer. (Trisha Knuth/Facebook)

Hes done pretty well after that second time. But he is constantly wounded, very fragile, said Knuth.

But in recent months, Charlie began to complain of a sore throat not uncommon for those with EB, as blisters can form on the inside of the body as well on the outside. The mouth and throat are commonly affected.But there were no visible blisters, raising his doctor's suspicions. ACT scan later revealed enlarged lymph nodes in his neck and armpits. A biopsy later confirmed lymphoma, a type of cancer that affects the bodys lymphatic system. Knuth called the diagnosis another hurdle in his very hard life.

The pain was masked by EB. Its hard to tell whats what because EB causes so much pain, she said.

Cancer treatment often consisting of chemotherapy, radiation, and surgery is hard enough on an average persons body. But those with EB face an entirely different battle; Knuth said nurses inserting an IV cant use medical tape to help attach the drip, as the adhesive ripsher sons skin when removed. Oxygen and anesthesia masks are often a struggle as well, as are blood pressure cuffs.

Charlie (R) when he was younger. (Trisha Knuth/Facebook)

How do you treat someone who cant be touched? Knuth questioned, noting she has gone into the operating room with Charlie in times past to ensure he is not injured. You cant even imagine. [Its like] being burned every day, and then bandaged, and nowundergoing cancer treatment it boggles the mind.

When speaking to Fox News, Knuth and Charlie were in Minnesota, where doctors are working to build atreatment plan. The day after Christmas which the pair are celebrating in an Airbnb Charlie is slated to undergo a procedure to remove fluid from his spine and bone marrow from his hips. One of his affected lymph nodes will be taken for further testing.

In the meantime, Kevin is home with the couples 2-year-old adopted daughter, who also suffers from EB.

"He puts on a great outward attitude, but I know there is trauma."

CLICK HERE TO GET THE FOX NEWS APP

He is very brave and resilient and funny, said Knuth of Charlie. But in addition to the physical pain, He does have emotional pain; he puts on a great outward attitude, but I know there is trauma.

When asked how she and Kevin manage it all, Knuth acknowledged theirs is a crazy life. But, she quickly noted, I am very happy with this life. Its hard. But when I die, I'll know my life was fulfilled and great.

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Wisconsin teen diagnosed with cancer while battling rare 'butterfly skin' disease: 'He is resilient' - Fox News

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Essential oil compound may speed the healing of wounds – New Atlas

By daniellenierenberg

Although essential oils are typically associated with aromatherapy, new research indicates that medicines based on them could also help to heal skin wounds when applied topically. It all comes down to a certain substance in some of the oils, that reduces inflammation.

The chemical compound in question is known as beta-carophyllene it's found in the oils of lavender, rosemary and ylang ylang, among other sources. In a study conducted at Indiana University, beta-carophyllene extracted from these plants was applied to superficial wounds on mice.

It was observed that doing so increased cell growth and cell migration to the wound site, causing the injuries to heal faster than similar untreated wounds. Additionally, the scientists noted increased gene expression of hair follicle stem cells in the treated injuries. This suggests that there would ultimately be less scarring.

Based on previous research, it was already known that beta-carophyllene activates a receptor in the body, which in turn produces an anti-inflammatory response. It is this response that is likely the key.

"In the wound healing process, there are several stages, starting from the inflammatory phase, followed by the cell proliferation stage and the remodelling stage," says the lead scientist, Assoc. Prof. Sachiko Koyama. "I thought maybe wound healing would be accelerated if inflammation was suppressed, stimulating an earlier switch from the inflammatory stage to the next stage."

That said, Koyama believes that there may be additional factors at work, which further research should hopefully reveal. She also advises against simply applying essential oils to wounds, as the beta-carophyllene used in the study was of a known purity, and was diluted in a specific concentration.

"There are many things to test before we can start using it clinically, but our results are very promising and exciting," she says. "Someday in the near future we may be able to develop a drug, and drug delivery methods, using the chemical compounds found in essential oils."

A paper on the research was published this week in the journal PLOS ONE.

Source: Indiana University

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Scientists hope MND cure is a step closer after stem cell breakthrough discovery – The National

By daniellenierenberg

SCIENTISTS hope a cure for motor neurone disease (MND) is a step closer after a research breakthrough identified cells key to the degenerative condition.

There is currently no known cure for MND, which causes signals from motor neurone nerve cells in the brain and spinal cord needed to control movement to gradually stop reaching the muscles.

Notable people who have lived with MND include Scottish rugby star Doddie Weir and Stephen Hawking.

Researchers used stem cell technology to identify a type of cell that can cause motor neurones to fail.

Using stem cells from patient skin samples, they found glial cells, which normally support neurones in the brain and spinal cord, become damaging to motor neurones in the patients with the condition.

By testing different combinations of glial cells and motor neurones grown together in the lab, researchers found glial cells from MND patients can cause motor neurones in healthy people to stop producing the electrical signals needed to control muscles.

READ MORE:BBCSports Personality of the Year award to honour Doddie Weir

Gareth Miles, a professor of neuroscience at the University of St Andrews, helped lead the joint project with the University of Edinburgh.

Miles said: We are very excited by these new findings, which clearly point the finger at glial cells as key players in this devastating disease.

Interestingly, the negative influence of glial cells seems to prevent motor neurones from fulfilling their normal roles, even before the motor neurones show signs of dying.

We hope that this new information highlights targets for the development of much-needed treatments and ultimately a cure for MND.

The joint research was published in the scientific journal Glia.

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Boston Stem Cell Center – Bone Marrow Stem Cells in …

By daniellenierenberg

The problem with the embryonic stem cells are the many complications associated with them. Besides the ethical considerations, from a practical point of view, we are still a long way from being able to utilize these cells in a safe and consistent manner.

When using embryonic stem cells, you are inheriting any potential diseases that the baby may have. For instance, the baby may have a gene that increases susceptibility to cancer. In fact, the embryonic cells themselves may act as a tumor since there is no natural check on these cells. Furthermore, these cells are foreign materials to the body, and the body will react and attack these cells in an immune response. This can sometimes cause a serious medical condition called graft versus host disease. In that case, the patient may have to be placed on immunosuppressant drugslike an organ transplant patient. With our present technology, embryonic stem cells are not the answer. For those reasons, the FDA has put significant restrictions on the use of this type of cell in humans.

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National Marrow Donor Program/Be The Match Applauds Congress for Its Support of Patients with Blood Cancers and Other Diseases – Benzinga

By daniellenierenberg

Bipartisan legislation provides record funding for lifesaving cellular transplants and eliminates a Medicare payment barrier for seniors.

Washington, DC, December 20, 2019 --(PR.com)-- National Marrow Donor Program (NMDP)/Be The Match applauds Congress for passing bipartisan legislation that provides record levels of funding to increase access for patients to cellular transplants, which can be the only curative treatments for blood cancers such as leukemia or lymphoma and other blood diseases. The bill also increases access to these same therapies for senior citizens by fixing a Medicare reimbursement issue that can be a barrier for them to these life-saving procedures.

Increasing funding levels for these programs and bringing Medicare payment policies for these procedures up to date represents major victories for the 1.3 million Americans fighting blood cancers, said Brian Lindberg, Chief Legal Officer and General Counsel of NMDP/Be The Match. By increasing funding for life-saving cellular transplants and removing Medicare barriers that inhibit access to care, Congress has given hope to patients in need of these curative treatments.

We are honored to have broad support from members in the House and Senate who stand with us and our mission to find matched donors for every patient in need of these cellular therapies, Lindberg added. Increasing patient access to life-saving bone marrow and cord blood transplant is NMDP/Be The Matchs top priority.

The program works closely with organizations throughout the nation to recruit volunteer donors for the registry and with public and private insurers to ensure that all patients have equal access to treatment.

The $30 million included in the final legislation for the C.W. Bill Young Cell Transplantation Program, an increase of $5.4 million over last year, and the $17.3 million for the National Cord Blood Inventory, an increase of $1.0 million, will help reduce barriers to transplant by:

Advancing new and innovative methods of providing the best possible transplant to every patient in need, regardless of socioeconomic status, age, ethnic ancestry, or any other individually defining characteristic; Continuing to simplify processes and systems to reduce time to transplant, providing the patient and their physician the therapy the patient needs exactly when he/she needs it; and Protecting access to transplant by allowing NMDP to pursue our vision of achieving equal outcomes for all.

In the case of older Americans, inadequate Medicare transplant reimbursement, primarily for donor-related costs, poses a significant barrier to patient access.

Unlike Medicare payment policies for the acquisition of solid organs for transplant, Medicare does not provide separate payments for the cost of acquiring the cells for transplant (which can include the cost of identifying genetically matched donors, collecting the cells, and transporting them to the transplant hospital). As a result, hospitals take substantial financial losses on these life-saving procedures, which often require a 20-to-30-day hospital stay on average, because the reimbursement rate does not come close to covering the true costs of treatment.

NMDP/Be The Match looks forward to working closely with the Centers for Medicare & Medicaid Services (CMS), which operates the Medicare program, to ensure that this critical payment reform is implemented as quickly as possible, so that Medicare beneficiaries are not at risk of being denied the bone marrow, peripheral blood stem cell, or cord blood transplant they need to survive.

About National Marrow Donor Program/Be The MatchFor people with life-threatening blood cancers such as leukemia and lymphoma, a cure exists. National Marrow Donor Program(NMDP)/Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant and works to identify and eliminate financial and other barriers faced by these patients. NMDP also provides patients and their families one-on-one support, education, and guidance before, during and after transplant.

Contact Information:National Marrow Donor ProgramEllen Almond(703) 548-0019Contact via Emailhttps://bethematch.org/

Read the full story here: https://www.pr.com/press-release/802090

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Why Proper Hydration Is Necessary for the Body to Function – Guardian Liberty Voice

By daniellenierenberg

Some people believe that it is impossible to ionize water, others believe the product is too good to be true.

It is important to note that the ionization of water can be tested using scientific measuring devices such as pH and ORP meters. According to The Miraculous Properties of Ionized Water, the changes that ionization produceareradical, immediate, and measurable.

Ionized water is the charging of water by creating negative ions (-OH) and positive ions (+OH). They are created through electrolysis and then the ions are separated through a membrane, so the water is negatively charged.

There has been a considerable amount of research conducted on the effects of ionized water. Most of the research has been conducted by the Japanese. All of the research has arrived at the same conclusion: ionized water benefits everything it comes in contact with as long as its used correctly. There is hard scientific evidence to back up this claim.

There are strong detoxing effects of ionized water, which proves it is not like any other water consumed. These detoxing effects are due to the small water-molecule cluster size. Water-molecule cluster size is measured using a Nuclear Magnetic Resonance device. The change in the surface tension of ionized water can also be determined. It is measured in dynes. The lower the surface tension, the smaller the water-molecule clusters.

Water is the most essential element needed by the body; therefore, health begins with water. It is impossible to be truly healthy without being properly hydrated.

When babies are born, their bones are mostly water. They are more pliable at birth than at any other time in their lives. As people grow older, the bones dry out and become brittle. The body takes the calcium from the bones to distribute it to other parts of the body that need it more.

By the age of 65, the average person is 50-70 percent dehydrated.This is whythe elderly are riddled with disease and constipation.

Bone marrow is critical to the immune system because it contains T-cells, B-cells and other cells that together form the immune system. White blood cells produce antibodies that have a multitude of other immune functions. Red blood cells carry oxygen, produce stem cells and blood platelets that allow the blood to clot.

Stem cells are primitive cells that continue to divide into infinity and form any other cell the body needs. These cells are birthed out of bone marrow, which makes hydration critical to the body. It is imperative to keep bone marrow hydrated, cleansed, and rejuvenated for great health and longevity.

Every single organ in the body requires water to properly function to its full capacity. The body is 69 percent water. The brain is 85 percent water, bones 35 percent water, blood 83 percent water, and the liveris90 percent water.

When the body is dehydrated, it puts ones health in immediate danger. Each day people should drink half their body weight in ounces. However, The Miraculous Properties of Ionized Water recommends people drink much more than half their body weight in water because that amount of water is lost through basic functions of the human body, such as urinating, sweating, breathing, and defecating.

The National Research Council guidelines suggest that the body requires one milliliter of water for every calorie of food consumed, which tends to be half of ones body weight. For example, if one weighs 200 pounds, they should drink 100 ounces of water. According to the official report from the National Research Council states that most of this quantity is contained in prepared foods. This implies that people will get the water they need from the foods they eat and drinking water is not necessary.

These types of misconceptions lead people to believe that water is a choice, not a necessity. Digestion is dehydrating and requires a large amount of water from the bodys reserves. Additionally, the typical American diet consists of dry, cooked and processed foods. Raw foods contain significant amounts of water and are better for ones diet.

There are some who believe that water consumed in raw foods is enough to hydrate the body. This is not true. Even if one could eat enough raw foods to hydrate the body, water would still be required to flush the digestive tract between meals. This is one of the healthiest things one can do. None of the bodys processes will function to capacity if the body is not well hydrated.

By Jeanette Vietti

Source:

The Miraculous Properties of Ionized Water

Image Courtesy of Rubbermaid Products Flickr Page Creative Commons License

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These Cult Beauty Brands Offer The Most Luxurious Spa Experience at Their Boutiques: Sulwhasoo, La Mer, Dior and More – Singapore Tatler

By daniellenierenberg

By Chloe Pek December 20, 2019

How to make the most of your holy grail skincare products at these beauty spas in Singapore

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We all have our favourite beauty brandsit could be a holy grail skincare product or a go-to beauty routine you rely on for a clear, radiant complexion. But are you truly making the most out of your skincare products? Only the experts will knowwhich is why there's no better way to experience your cult favourites than at their boutiques, where assistants are at hand to offer tips and tricks.

These beauty brands below do it better: with a complete spa experience that will leave your skin glowing and your mind, relaxed.

(Related: Biohack Your Way To Beauty And Health Using Your DNA And Stem Cells At These Wellness Retreats Around The World)

Want to harness the full benefits of SK-IIs miracle water? Then the SK-II Boutique Spa by Senze Salus is the place to go. Operating under an exclusive license by SK-II, the spa offers a selection of facials that last between 60 minutes to 105 minutes, catering to a myriad of skincare concerns like hydration, uneven skin tone, and clogged pores.

Besides their trademark miracle water, pure water is also the secret to their holistic spa experience. A four-stage water filtration system ensures that all water used in treatments are free of impurities, and only 100 per cent pure distilled water is used for facial steaming. Theres even a lot of thought put into the water that they serveonly alkaline water for hydration and antioxidant properties.

(Related: Why Water Is The Essence Of SK-II's Spa Treatments)

Currently exclusive to CldePeauBeauts Diamond tier members, the beauty brands SoindeBeaut offers the ultimate experience of their signature skincare ranges. Treatments available include the 60-minute Intensive Brightening Facial Treatment using CldePeauBeauts Key Radiance Care and targeted Brightening range for a radiant, glowing complexion, as well as the 60-minute Firming Supreme Facial Treatment that helps to firm and lift contours while enhancing your glow with the brands Supreme skincare range.

These services are available at CldePeauBeauts Mandarin Gallery flagship and department store counters.

(Related: Cl de Peau Beaut Revamps Its Signature La Crme Face Cream For Spring 2020)

Touted as the temple of Dior beauty, Dior Institut strives to offer a unique sensory experience for every guest. Each treatment begins with a consultation and examination of the skin with a Dior Skincare Expert to address skincare concerns. Then, a massage using Dior Instituts exclusive tissue massage techniques help to soothe customers and relieve muscle tensions.

The wide suite of services include the Brightening and Radiance-Activating Treatment, Age-Delay and Beautifying Treatment, the Dior Homme Treatment for men, and also sculpting treatments for facial contours and around the eyes. Youll also return home with tips and techniques to maximise your beauty routine. Dior Institut can be found at Dior Beauty's The Shoppes at Marina Bay Sands flagship, Robinsons The Heeren, and Tangs at Tang Plaza.

(Related: Dior Makeup's Peter Philips Reveals Why The Brand's New Lipsticks Are Infused With Flower Oil)

Available in Sulwhasoo boutiques at Capitol Building, Ion Orchard, Westgate and the Sulwhasoo Facial Treatment Studio at Tangs, Sulwhasoo offers a suite of facial treatments to address various skin concerns, from the moisturising Essential Treatment to the rejuvenating Timetreasure Renovating Treatment.

A specialised anti-ageing facial for men is also available. Creating a holistic experience for consumers, each treatment begins with a meridian point massage using a fragrance of the customers choice, followed by a foot bath using ginseng peels and red ginseng water. Traditional applicators like jade, amber and white porcelain are also used to enhance the efficacy of the treatments.

(Related: A Holistic Approach To Beauty At The Sulwhasoo Beauty Lounge)

Previously only available at the Ritz-Carlton Spa, fans of La Mer can now indulge in the full pampering experience with the recent opening of La Mers flagship at The Shoppes at Marina Bay Sands, an experiential space complete with a VIP consultation area and a facial suite. On top of the complimentary services available, the flagship also offers a menu of facial services, including the 75-minute Miracle Broth Facial, which harnesses the healing energies of La Mers signature ingredient, the Miracle Broth.

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