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Can Stem Cells Repair Heart Tissue?

By daniellenierenberg

People who suffer from heart failure could someday be able to use their own skin stem cells to regenerate their damaged heart tissue, according to a new Israeli study.

Researchers took stem cells from the skin of two patients with heart failure and genetically programmed them to become new heart muscle cells. They then transplanted the new cells into healthy rats and found that the cells integrated with cardiac tissue that already existed.

The study, published in European Heart Journal, marks the first time ever that scientists could use skin cells from people with heart failure and transform damaged heart tissue this way.

The newly generated cells turned out to be similar to embryonic stem cells, which can potentially be programmed to grow into any type of cell.

"What is new and exciting about our research is that we have shown that it's possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are healthy and young the equivalent to the stage of his heart cells when he was just born," Dr. Lior Gepstein, lead researcher and a senior clinical electrophysiologist at Rambam Medical Center in Haifa, Israel, said in a news release.

The findings open up the possibility, the authors wrote, that people can use their own skin cells to repair their damaged hearts, which could prevent the problems associated with using embryonic stem cells.

"This approach has a number of attractive features," said Dr. Tom Povsic, an interventional cardiologist at Duke University Medical Center. "We can get the cells that you start with from the patient himself or herself. It avoids the ethical dilemma associated with embryonic stem cells and it removes the possibility of rejection of foreign stem cells by the immune system." Povsic was not involved with the Israeli study.

Another advantage of using skin cells is that other types of cells taken from patients themselves, such as bone marrow cells, could potentially lead to the development of unhealthy tissue.

"If a patient is already sick with heart disease, one of the reasons it may develop is that stem cells weren't able to repair the heart the way they should," Povsic added. Skin cells, he explained, are generally healthy.

"It is very exciting and very interesting, but we are far away from taking this to patients," said Dr. Marrick Kukin, director of the Heart Failure Program at St. Luke's-Roosevelt Hospital who was also not involved in the Israeli study.

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Scientists Turn Skin Cells Into Cardiac Cells to Help Failing Hearts

By raymumme

WEDNESDAY, May 23 (HealthDay News) -- In a medical science first, researchers turned skin cells from heart failure patients into heart muscle cells that may then be used to fix damaged cardiac tissue.

The researchers said the achievement -- done initially with rats -- opens up the prospect of using heart failure patients' own stem cells -- a form of cell called human-induced pluripotent stem cells (hiPSCs) -- to repair damaged hearts. And since the reprogrammed stem cells would originate with the patient, their immune systems would not reject the cells as foreign, the researchers explained.

They added, however, that many obstacles must be overcome before it would be possible to use hiPSCs in humans this way, and any clinical trial would be at least five to 10 years away.

"We have shown that it's possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are healthy and young -- the equivalent to the stage of his heart cells when he was just born," study leader Lior Gepstein said in a European Heart Journal news release. The study's findings are scheduled for online publication in the journal May 23.

Gepstein is professor of medicine (cardiology) and physiology at the Sohnis Research Laboratory for Cardiac Electrophysiology and Regenerative Medicine at the Technion Israel Institute of Technology and Rambam Medical Center in Haifa, Israel.

One expert in the United States applauded the achievement.

"The ability to source a patient's own skin cells and transform them into heart muscle is truly revolutionary," said Dr. Gregory Fontana, chairman of cardiothoracic surgery at Lenox Hill Hospital in New York City.

The results are "another step toward the treatment of heart failure with stem cells," he said. "Although further work is needed, this work represents another step closer to the clinic."

In the study, the researchers retrieved skin cells from two male heart failure patients, ages 51 and 61, and then reprogrammed them in the lab to develop into heart muscle tissue, which was then blended with pre-existing heart tissue. Within 24 to 48 hours, the tissues were beating together.

The new tissue was transplanted into healthy rat hearts and started to establish connections with the cells of the rat hearts. Success in animal experiments does not necessarily translate to success in humans, however.

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Skin cells transformed into beating heart tissue, fueling heart failure treatment hopes

By NEVAGiles23

(CBS News) A new study of patients with heart failure found a novel treatment approach might reverse the damage that has long been considered irreversible: Fixing their damaged hearts using stem cells derived by their own skin cells.

Stem cells heal heart attack scars, regrow healthy muscle Stem cells cure heart failure? What "breakthrough" study shows

In what scientists are calling a first, skin cells were taken from heart failure patients and transformed into stem cells, which were then turned into heart muscle cells capable of beating - albeit in a petri dish.

The treatment approach has scientists buzzing because it avoids the risk of possible immune system rejection from transplanting "foreign" stem cells, since the cells came from patients' own bodies.

"What is new and exciting about our research is that we have shown that it's possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are healthy and young - the equivalent to the stage of his heart cells when he was just born," the study's author Professor Lior Gepstein, professor of cardiology and physiology at the Technion-Israel Institute of Technology in Haifa, said in a news release.

Just how do skin cells become heart cells? Researchers took skin cells from two male patients with heart failure, a 51 and 61-year-old, and genetically reprogrammed them by injecting a cocktail of "transcription factors" and a virus into the nucleus of the skin cell, followed by removing the virus and transcription factors that have been linked to cancerous tumor growth. The goal was to reprogram the cells into human-induced pluripotent stem cells (hiPSCs) that could help repair hearts.

"One of the obstacles to using hiPSCs clinically in humans is the potential for the cells to develop out of control and become tumours," explained Prof Gepstein in using the technique.

Once in stem cell-form, the cells differentiated in a petri dish to become heart muscle cells called cardiomyocytes, which the researchers then combined with heart tissue and cultured them into healthy heart muscle tissue. Within 48 hours, the tissues were beating together.

"The tissue was behaving like a tiny microscopic cardiac tissue comprised of approximately 1000 cells in each beating area," Gepstein said in a statement.

The researchers then transplanted the new human tissue into rats, finding it grafted to the rat's host cardiac tissues. Their research is published in the May 22 issue of the European Heart Journal.

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Biostem U.S., Corporation Announces $5,000,000 Financing Agreement Through Private Placement of Stock

By NEVAGiles23

CLEARWATER, FL--(Marketwire -05/24/12)- Biostem U.S., Corporation, (HAIR.PK) (HAIR.PK) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announces a $5,000,000 financing agreement through private placement of stock.

CEO, Dwight Brunoehler, announced today that the company has signed an agreement with a funder to issue 20,000,000 shares of the company's common stock in exchange for $5,000,000 in cash or 25 cents ($.25) per share. No other considerations will be granted to the funder in exchange for the cash payment.

In announcing the funding agreement, Mr. Brunoehler commented, "We consider the eagerness of the funder to acquire Biostem shares at a price above the current market to be a tribute to our proven proprietary technology to enhance hair re-growth using human stem cells. Although we anticipated funding the company through the sale of a convertible debenture, the funder insisted on being able to acquire stock at a set price now, rather than risk having to convert at higher prices later. Although Rule 144 sale restrictions usually cause private placements of stock to be executed at a discount to the market, Biostem feels that its current share price is not truly reflective of the value of its proprietary technology; as well as the fact that the technology is already being employed, and the overall size of the hair replacement marketplace. It was for this reason that the company and the funder were able to come to an agreement to price the private placement above the current share price."

About Biostem U.S., Corporation

Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group 310-974-6821.

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Stem cell drug approved in Canada to treat bone marrow disease

By Sykes24Tracey

Canadian regulators have approved the world's first stem cell drug.

The drug, Prochymal, will be used to treat a deadly side effect of bone marrow transplants called acute graft-versus host disease (GvHD), which occurs in children.

Acute graft-versus host disease kills about 80 percent of children affected.

Prochymal uses stem cells from healthy adult donors, with one donation able to create 10,000 doses of the drug, reported the New York Times.

The manufacturer, Maryland-based Osiris Therapeutics Inc., saw their shares climb 5.5 percent to $5.55 after losing 24 percent in the last year, reported Bloomberg.

In extended trading, stocks rose 14 percent.

The drug was approved, said Reuters, on the condition that further clinical tests are carried out.

There has been debate about the effectiveness of the drug in recent years.

Late stage clinical trials three years ago failed to show results but more recent tests have shown the drug to be relatively effective about a month into therapy.

Osiris says that it plans to seek approval from the US Food and Drug Administration this year.

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World's First Stem Cell Drug From Osiris: Approved

By daniellenierenberg

Editor's Choice Main Category: Pediatrics / Children's Health Also Included In: Stem Cell Research Article Date: 20 May 2012 - 11:00 PDT

Current ratings for: 'World's First Stem Cell Drug From Osiris: Approved'

5 (1 votes)

The decision is a historic one, as it's both the first stem cell drug going into formal use, as well as the first treatment for GvHD. The disease is a devastating breakdown occurring after a bone marrow transplant and kills around 80% of children affected, often within a matter of weeks.

Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal confirmed :

The approval process for Prochymal was implemented under Health Canada's Notice of Compliance with conditions (NOC/c) pathway. The basis of the procedure allows a new drug to come onto the market where there are unmet medical needs. The approval is granted with the provision that the drug has demonstrated risk / reward benefits in previous clinical trials and that the manufacturer agrees to undertake additional confirmatory clinical testing.

C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris confirmed his' companies happiness at being able to help conquer the disease :

Where children with GvHD are not responding to treatment with steroids, which is presumably most of them, the use of Prochymal will now be authorized. Health Canada based it's approval on previous clinical studies of the drug, in which 64% of patients showed results; the survival rate compared to historical data was drastically improved, even in patients with severe cases. Additional clinical evaluation of Prochymal now will be undertaken, including enrolling patients in a registry to discover any long term effects.

Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal

Osiris has 48 patents protecting Prochymal, and Health Canada's have agreed to provide Prochymal with regulatory exclusivity within their territory. Canada affords eight years of exclusivity to Innovative Drugs, such as Prochymal, with an additional six-month extension because it addresses a pediatric disease. Parents, doctors and shareholders can all rest easy.

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Cellectis stem cells today proudly announces the launch of the world’s very first human iPS cell-derived hepatocyte …

By LizaAVILA

GOTHENBURG, Sweden--(BUSINESS WIRE)--

Regulatory News:

Cellectis stem cells, a Business Unit of Cellectis Group (Alternext:ALCLS.PA - News), a premier provider of stem cell derived products and technologies, today announces the launch of a human iPS derived hepatocyte product, hiPS-HEPTM.

The hiPS-HEPTM demonstrate high reproducibility, homogeneity and a long life span of stable CYP activity, making them the ideal platform for various in vitro applications including drug discovery, toxicity testing and vaccine development. The hiPS-HEP are human hepatocyte-like cells derived from human induced Pluripotent Stem (iPS) cells under strict quality controlled and ethically approved procedures.

"Due to their high relevance in various industrial applications it makes the hiPS-HEP a really promising system for research and development," said Johan Hyllner, CSO of Cellectis stem cells. "The pharmaceutical industry has a great need for better and more clinically relevant models early in the drug development process to predict hepatotoxicity, find new drug targets and develop new vaccines."

"This novel product is the fruition of Cellectis strategy to become the global market leader for stem cell-based in vitro models and related technologies. It illustrates our ambitions and the momentum of our future development in this field," said Andr Choulika, Chairman and CEO of Cellectis.

About Cellectis stem cells:

Cellectis stem cells, is a business unit within the Cellectis group and is a global leader in stem cell technology. Cellectis stem cells, created in November 2011 from Cellartis AB and Ectycell SAS, possesses broad expertise in pluripotent stem cells, including iPS cell technology, genetic engineering and specialised cells. Cellectis stem cells is developing stem cell derived products and related services for drug discovery, toxicity testing and regenerative medicine applications.

For more information visit http://www.cellartis.com and http://www.cellectis.com

About Cellectis

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Cellectis stem cells today proudly announces the launch of the world’s very first human iPS cell-derived hepatocyte ...

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Frozen cord could save a life

By Dr. Matthew Watson

Tim and Padma Vellaichamy of Parramatta have had their new born child's umbilical cord stored cryogenically for future treatment. Pictured with their as yet unnamed three week old daughter. Picture: Adam Ward Source: The Daily Telegraph

IT'S current preservation for future regeneration - and now umbilical cord tissue is going on ice in Australia for the first time.

Usually discarded after birth, umbilical tissue from newborn babies is being collected and cryogenically frozen to be used one day for regenerative and stem cell medicine. And it doesn't just have potential for the babies involved, either. Experts say stem cells could also be used for family members who are genetically compatible.

It is hoped the cells will eventually be able to be used to repair damaged tissues and organs, with researchers investigating its uses for treating diseases like multiple sclerosis, cerebral palsy and diabetes, as well as for bone and cartilage repair.

Although cord blood storage has been available for many years, Cell Care Australia has added cord tissue storage in anticipation of new discoveries in the regenerative medicine field.

Cell Care Australia medical director associate professor Mark Kirkland said the storage process - already popular in the US, Europe and Southeast Asia - was long overdue for Australian shores.

"The science is developing around the world and we're really behind the rest of the world in providing parents the option to store these cells and we thought it was about time it was brought here," he said.

"It's finding a way to take what would otherwise be waste tissue and turning it into something of potential future value for not only your child but also potentially for other family members.'

Parramatta couple Tim and Padma Vellaichamy are among the first to use the service in Australia.

Mr Vellaichamy, 31, said he heard of the technology while working as a dentist in India and decided to store their daughter's cord cell tissue after birth three weeks ago.

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Stem cell medicine thrown umbilical rope

By Dr. Matthew Watson

Tim and Padma Vellaichamy of Parramatta have had their new born child's umbilical cord stored cryogenically for future treatment. Pictured with their as yet unnamed three week old daughter. Picture: Adam Ward Source: The Daily Telegraph

IT'S current preservation for the future regeneration - and now umbilical cord tissue is going on ice in Australia for the first time.

Usually discarded after birth, umbilical tissue from newborn babies is being collected and cryogenically frozen to be used one day for regenerative and stem cell medicine. And it doesn't just have potential for the babies involved, either. Experts say stem cells could also be used for family members who are genetically compatible.

It is hoped the cells will eventually be able to be used to repair damaged tissues and organs, with researchers investigating its uses for treating diseases like multiple sclerosis, cerebral palsy and diabetes, as well as for bone and cartilage repair.

Although cord blood storage has been available for many years, Cell Care Australia has added cord tissue storage in anticipation of new discoveries in the regenerative medicine field.

Cell Care Australia medical director associate professor Mark Kirkland said the storage process - already popular in the US, Europe and Southeast Asia - was long overdue for Australian shores.

"The science is developing around the world and we're really behind the rest of the world in providing parents the option to store these cells and we thought it was about time it was brought here," he said.

"It's finding a way to take what would otherwise be waste tissue and turning it into something of potential future value for not only your child but also potentially for other family members.'

Parramatta couple Tim and Padma Vellaichamy are among the first to use the service in Australia.

Mr Vellaichamy, 31, said he heard of the technology while working as a dentist in India and decided to store their daughter's cord cell tissue after birth three weeks ago.

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Medical success or boondoggle?

By LizaAVILA

Indian clinic's stem cell therapy real?

STORY HIGHLIGHTS

For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.

New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.

Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.

After five weeks of treatment, Cash and his parents returned home to the U.S.

That's when Cash began walking with the aid of braces for the first time.

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Family hangs hope for boy on unproven therapy in India

By raymumme

Indian clinic's stem cell therapy real?

STORY HIGHLIGHTS

For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.

New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.

Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.

After five weeks of treatment, Cash and his parents returned home to the U.S.

That's when Cash began walking with the aid of braces for the first time.

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Family hangs hope for boy on unproven therapy in India

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Heart Disease, Diabetes, Depression a Deadly Mix

By Dr. Matthew Watson

(HealthDay News) --
Heart disease, diabetes and depression can be a lethal triple-play -- boosting
a patient's death risk by 20 percent to 30 percent, new research shows.

"We do not know what this increased risk is due to, but it could either be
that depression influences crucial aspects of self-care behaviors needed to
manage diabetes or that a more severe disease process is reflected in more
depressive symptoms," said lead researcher Anastasia Georgiades, a
research associate in the department of psychiatry and behavioral science at Duke
University in Durham, N.C.

Georgiades was expected to present the findings Friday at the American
Psychosomatic Society annual meeting in Budapest, Hungary.

In their study, the Duke team followed 933 heart patients for more than four
years. During that time, there were 135 deaths among patients with type 2
diabetes and/or depression, the researchers found.

Among patients with moderate-to-severe symptoms of depression who were also
diabetics, the researchers observed a significant 30 percent greater risk of
dying over the four-year period compared with patients with either depression
alone or diabetes alone. Read more…

Source:
http://feeds.feedburner.com/integratedmedicine

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Bipolar Kids May Focus on Different Facial Features

By Dr. Matthew Watson

(HealthDay News) --
Children with bipolar disorder and a similar condition called severe mood
dysregulation spend less time looking at the eyes when trying to identify
facial features, compared to children without the psychiatric disorders,
researchers say.

This new study finding may help explain why children with bipolar disorder and
severe mood dysregulation have difficulty determining other people's emotional
expressions, said the U.S. National Institute of Mental Health investigators.

The researchers tracked the eye movements of children with and without
psychiatric disorders as they viewed faces with different emotional
expressions, such as happy, sad, fearful and angry. In general, the children
spent more time looking at the eyes, the facial feature that conveys the most
information about emotion. Read more…

Source:
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Cell-based Cancer Immunotherapies. Some metrics..

By Dr. Matthew Watson

Tweet 


Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics
As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
Commercial:
  • Dendreon's Provenge
    • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
    • Efficacy: prolongs survival
    • Markets: only the United States (approved April 2010)
    • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
    • 2011 Revenue $290,000
    • Projected 2012 Revenue: ~$380,000

Phase III or II/III:

Phase II or I/II

  • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
    • ~10 of these are expected to have readouts yet this year
    • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
    • Expected enrollment of 3,500+
Investment:

The following are notable cash infusions into the sector for 2012 to-date:
  • Bellicum Pharmaceuticals.  $20M series B. 
  • CellMedica. $15M grant from CPRIT in Texas.
  • Argos Therapeutcs. $25M Series D.
  • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  












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Painful Decisions Coming Up at Stem Cell Agency

By Dr. Matthew Watson


The
Sacramento Bee
today ran a piece by yours truly in its California
Forum
section.

Here
is an excerpt. You can find the entire article here.

"They're
talking about pain at the $3 billion 
California stem
cell agency. And mortality. But not the end of life as you and I know
it.

"They're
talking about the pain that comes from cutting off millions of
dollars for scientists. They're talking about what will happen when
the state stops borrowing money to finance 
stem
cell research
 –
a final-breath moment that arrives in about five years....

"CIRM's
changing priorities create 'stark tension,' said one board
member, Michael Friedman, CEO of the City of Hope in the Los Angeles
area, in January. 'We're going to have to make some really
painful and difficult decisions,' he told directors.

"CIRM's
success – or lack of it – will play a critical role in its future
finances, whether they are based on another bond measure or private
support."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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San Diego Biotech Firm Appeals Rejection of Cancer Stem Cell Grant

By Dr. Matthew Watson


A San Diego biotech firm, Eclipse
Therapeutics
, whose multimillion dollar grant application was
rejected by reviewers at the California stem cell agency, is asking
the agency's board to overturn the decision next Thursday.
Eclipse, a spinoff from
Biogen Idec, said it is reducing its request from $3.5 million
because it has raised $2 million since it applied for the grant six
months ago. However, its appeal did not state specifically how much
it was now requesting from CIRM. The research involves cancer stem cells.
The company's appeal said that
during the period following submission of its application, it has accomplished all of the activities that CIRM had identified
as the first milestone in the research project. Eclipse also said it
has accomplished a number of activities in milestones two and three.
The firm said that it is now accelerating its IND filing by one year.
Eclipse was formed in March 2011 with
$2 million in seed funding from City Hill Ventures, also of San
Diego, according to a Bioworld article by Marie Powers. The
co-founders are Peter Chu, now president of Eclipse, and Christopher
Reyes
, chief scientific officer. Chu and Reyes ran Biogen Idec's
cancer stem cell program. They are also the applicants for the CIRM
grant.
Their appeal carried a routine cover
letter to the CIRM board from CIRM President Alan Trounson. He made
no comment on the worthiness of the request. On
an earlier appeal from Stuart Lipton of Sanford-Burnham, Trounson's
cover letter said Lipton's letter was "without merit."
Eclipse said its proposal received a
scientific score of 58 out of 100 from CIRM reviewers. CIRM, however, has not released the company's score. Two other proposals with scores of 53
were approved by reviewers.
For several years, CIRM has been
sharply criticized for its failure to fund businesses in a
significant way. It is currently moving to engage them more closely.
If Eclipse's appeal is successful, it will be one of less than 20
business to be funded without a nonprofit partner. Businesses have
received only about 4 percent of CIRM's $1.3 billion in awards to 494enterprises.
Appeals from rejected applicants
are included in the agenda material presented to the CIRM board, but
the board does not have to act on them or discuss them. Researchers
can also appear before the board to make a case.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: San Diego Biotech Firm Appeals Rejection of Cancer Stem Cell Grant
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Burnham’s Lipton Appeals Rejection of $5 Million Grant Application

By Dr. Matthew Watson


Sanford-Burnham researcher Stuart
Lipton
is seeking to overturn rejection of his application for a $5
million grant from the California stem cell agency, declaring that
reviewers misinterpreted the proposal and relied partly on
"grantsmanship" instead of science.
Lipton's proposal deals with strokes
and is one of 22 rejected by CIRM's reviewers in a $95 million
round that comes before the agency's directors next Thursday.
Lipton's letter to CIRM yesterday said
some of the reviewers' criticism was "completely unfounded,"
"incorrect" or "in error." The two-page letter
went into specific scientific detail.
In a cover letter to the CIRM board,
CIRM President Alan Trounson said Lipton's appeal was "without
merit." He did not go into details but said CIRM staff is
prepared to discuss it next Thursday.
The scientific score on Lipton's grant
was not disclosed by CIRM, but it appears to be between 62 and 53.
Two grants ranked at 53 were approved by reviewers. Appeals from
rejected scientists are included in the agenda material presented by
the board, but the board does not have to act on them or discuss them.
Researchers can also appear before the board to make a case.
Kristiina Vuori, president of
Sanford-Burnham, is a member of the CIRM board. She will be barred
from taking part in any discussion of Lipton's application or voting
on it.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: Burnham’s Lipton Appeals Rejection of $5 Million Grant Application
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CIRM’s Improving Openness

By Dr. Matthew Watson


The California stem cell agency this
week once again posted in a timely fashion important information
dealing with matters to be decided next Thursday by directors of the
$3 billion stem cell agency.
The agency's actions are a marked
improvement in openness and transparency compared to the practices
prior to the election last June of J.T. Thomas as chairman of the
CIRM board. Previously, background material on multimillion dollar
matters was not available much of the time until shortly before the directors meeting, making it virtually impossible for interested
parties or the public to comment or attend the sessions. Even CIRM directors would complain from time to time about the laggard performance.
According to the agenda, next week's meeting in San Francisco
will include approval of $95 million in new grants, consideration of
the first-ever performance audit of  which made 27
recommendations for improvement, action on the first-ever CIRM directors' code of conduct along with conflict of interest rules, changes in its loan policy and consideration of the agency's
strategy for the next five years.
In addition to the meeting site in San
Francisco, a public teleconference location will be available at UC
San Francisco
, two in Los Angeles and one in La Jolla. Specific
addresses can be found on the meeting agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: CIRM’s Improving Openness
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Conflict of Interest: CIRM to End Contract with Consultant Linked to Grant Recipient

By Dr. Matthew Watson


The California stem cell agency will
not renew a contract with a "special advisor" who has been
nominated to the board of directors of a firm that is sharing in a $14.5 million grant from the agency.
She is Saira Ramasastry, managing
partner of LifeSciences Advisory, LLC, of Emerald Lake Hills, Ca.
Ramasastry has worked for CIRM since May of 2010. Last month, she was
nominated to the board of Sangamo BioSciences, Inc., of Richmond, Ca.
Her responsibilities with CIRM have included "industry analysis
and consultation." Sangamo cited her experience with CIRM in its
press release on her nomination. She was also employed as a
consultant by Sangamo, according to the firm.
Ramasastry's dual roles raise obvious
conflict of interest questions. The case highlights the issues
that can arise between CIRM and the biotech industry as the agency
moves to engage industry more closely. CIRM's response additionally
demonstrates a lack of awareness of the potential for serious
mischief or worse when dealing with consultants.
The California Stem Cell Report asked
CIRM on May 6 for comment on the Sangamo-Ramasastry matter. The
questions included whether Ramasastry disclosed to CIRM her work for
Sangamo and whether CIRM took any action per the agency's conflict of
interest code. CIRM did not respond to the question of whether
Ramasastry ever disclosed her ties to Sangamo, which expects to
receive $5.2 million from the CIRM grant if it runs a full four
years.
Here is the text of CIRM's reply today
from spokesman Kevin McCormack.

"Saira Ramasastry was an
independent contractor. As required by law, we do ask independent
consultants to complete Form 700s(statements of economic interests)
if they participate in an agency decision making role. Her role did
not fall into that category - she was identified as a 'special
advisor' in connection with our external review process - and so she
did not have to fill out a Form 700. Her contract with CIRM comes to
an end at the end of June, and she will not be elected to Sangamo's
board of directors until July. Obviously once she is a member of the
Sangamo board she will not be consulting or advising CIRM because of
our strict conflict of interest rules."

(Editor's note: The board election is
June 21, according to the company, not July.)
Our take: CIRM is heavily dependent on
outside contractors. Expenditures for their services are the second
largest item in CIRM's operational budget, exceeded only by salaries
and benefits of regular employees. The responsibilities of outside
contractors cover a wide range of sensitive tasks including computer
system security, development of software that deals with proprietary
information from grant recipients, analysis of confidential business
operations of grant and loan applicants and much more.
The agency needs to know who their
consultants are working for besides CIRM. Whether they make decisions
for CIRM is beside the point. Gathering information that is not
normally accessible to the public can be extremely valuable to
businesses and their competitors as well as applicants for
CIRM's $3 billion. In Ramasastry's case, she was privy to a great
deal of confidential or economically useful information during her work on CIRM's external
review and likely much more.
The use of California's Form 700 is
hardly adequate to assess conflict of interest issues involving
private consultants. The form was developed in the 1970s to deal with
elected officials primarily and provides only the grossest sort of
look at financial holdings and income.
CIRM's current move to embrace industry
requires more scrutiny of conflicting interests – not less. NextThursday the CIRM board will deal with some of its conflict ofinterest rules. It is fine opportunity to ask for a sharper analysis
of conflict issues and consultants with an eye to strengthening CIRM
regulations and ensuring protection of the agency and its grantees'
work – not to mention the interests of the people of California.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: Conflict of Interest: CIRM to End Contract with Consultant Linked to Grant Recipient
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Scripps CEO Joins Stem Cell Agency Board; Love Leaves

By Dr. Matthew Watson


Michael Marletta
Scripps Photo

State Treasurer Bill Lockyer has
appointed Michael Marletta, president and CEO of the Scripps Research
Institute
, to the 29-member board of directors of the $3 billion
California stem cell agency.

Marletta fills the seat of Floyd Bloom,
also a Scripps executive, who resigned last year. Scripps has
received $45.3 million in funding from CIRM.
In a letter yesterday to the stem cell
agency, Lockyer said Marletta is a member of the National Academy of
Science, American Academy of Arts and Sciences
and the Institute of
Medicine.
Marletta joined Scripps in 2011 and became president in
January.
Prior to that, he was at the University
of California, Berkeley
, where he once served as chairman of the
department of chemistry, among other roles. An item on the Scripps
web site said Marletta "focused his research on the intersection
of chemistry and biology. He is acknowledged as a pioneer in
discovering the role of nitric oxide, a critical player in
communication between cells."
The CIRM board has another vacancy to
fill. Ted Love resigned last month after serving on the board since
its inception in December 2004. CIRM said Love, executive vice
president of Onyx Pharmaceuticals, resigned for personal reasons.
State Controller John Chiang is considering a number of candidates to
replace him. Love was the only African-American on the board.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: Scripps CEO Joins Stem Cell Agency Board; Love Leaves
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