Geron has two interested potential buyers for its human embryonic stem cell business, the president of the California stem cell agency said today.

Alan Trounson told CIRM directors that at one point four parties had expressed interest  but two have backed out. He did not disclose the names of any of the parties.

Last fall, Geron announced it was giving up its hESC work because of financial concerns about what once was the first clinical trial of a human embryonic stem therapy. Last summer CIRM loaned Geron $25 million for the trial, which has been repaid with interest.  Following Geron's announcement, Trounson said he was working to help find a buyer for Geron's hESC business.

However, today he said he was "suddenly distanced" from the process a few days ago. CIRM director Sherry Lansing, who once headed a Hollywood film studio, asked Trounson whether there was anything that directors could do to help find a buyer for Geron's hESC business. She asked about the amount of money needed by Geron and whether patient advocates could help generate other momentum.

Trounson suggested that the discussion should  be continued privately. He did say that CIRM has prepared a document that outlines what would  be necessary for the agency to resume funding of the hESC trial.

Trounson told directors that Geron's departure from hESC research has had "a very strong negative influence internationally."

Geron, which is based in Menlo Park in California, said last week it has hired Stifel Nicolaus & Co. to help sell the hESC business. . 

Source:
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The $3 billion California stem cell agency, which is expected to run out of cash in five years, is backing away from an attempt to win voter approval of another multibillion dollar bond measure to finance its research efforts.

The agency disclosed its new position in a document posted in connection with the meeting tomorrow of its governing board in San Diego. CIRM said,

"Although additional funding could be a possibility in the future, it would be premature even to consider another bond measure at this time. Instead, CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work."

The statement is a sharp departure from previous discussion of mounting a ballot campaign for a $4 billion to $5 billion bond measure on behalf of CIRM.

The only significant source of cash for the agency currently is the $3 billion in bonds approved by voters in 2004. Nearly half of that is committed. The latest financial report from CIRM shows its funding of research peaking in 2017-18.

During the last year or so, former CIRM Chairman Robert Klein has repeatedly discussed another bond measure and has even more recently expressed his desire to raise funds for a new electoral campaign. Klein resigned from his post last June. The CIRM board elected Jonathan Thomas, a Los Angeles bond financier, to replace Klein, who was the agency's first chairman and who led the 2004 ballot campaign.

In 2010, the CIRM board approved spending $700,000 for an Institute of Medicine study of CIRM with the expectation that its findings would enhance the likelihood of approval of more bond funding.

The IOM study is currently underway. The blue-ribbon panel is scheduled to hold a two-day public meeting in San Francisco Jan. 24-25 as part of its assessment of CIRM performance.

CIRM largely functions below the news media's radar, but talk of a new pitch for money has triggered negative commentary. Last month, the San Jose Mercury News said in an editorial that the agency should close its doors when its cash runs out because another bond measure would siphon off much-needed money for education and other critical services already "starved" by state budget cuts.

Backing away from another bond measure could benefit CIRM by helping to remove the likelihood that its actions will be judged in the context of an electoral campaign. But the action also raises the possibility that some of CIRM's best employees may leave for better prospects given that they may not have much of a future at an agency that would appear to be going out of business – at least at its current robust level.

The CIRM document dealing with the bond measure is dubbed a "transition plan" and is required by state law.

Instead of seeking to borrow more billions, the document said,

"CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work. Through its funding of state of the art research facilities, collaborative funding agreements, and industry engagement, CIRM has already made progress in creating this platform."

The document also raised the possibility of creation of a nonprofit organization to carry on CIRM's stem cell research, a proposal that has floated quietly for some years. Such an effort could involve raising funds from the biotech industry, which CIRM is currently trying to engage in a more friendly way.

At the top of CIRM's list of transition plan activities is creation -- both nationally and internationally -- of "Alpha Stem Cell Clinics" for delivery of therapies to patients. The clinics also would foster clinical trials and evaluate cell therapies. Additionally included are efforts to drive "follow-on funding" for CIRM projects and strengthened efforts to support industry.

Directors could alter the CIRM transition plan at their meeting tomorrow. But it was placed on the agenda by Chairman Thomas and is unlikely to see major revisions.

Source:
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Via Scoop.it – inPharma

Drug makers are now asking their sales representatives to switch from making forceful, tightly scripted sales pitches to acting more like a resource supporting physicians’ treatment.
Via online.wsj.com

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A British heart surgeon has issued a call for a ban on butter, citing excessive consumption of saturated fats which he believes has rapidly increased the number of heart disease cases in the Great Britain. Dr. Shyam Kolvekar expressed concern that people as young as 30 years old are now getting heart bypass surgery, an issue that he believes could be remedied by switching from butter to margarine or other "healthy" spreads.

Roughly 90 percent of British children eat too much saturated fat according to a U.K. diet survey. Eighty-eight percent of adult men and 83 percent of adult women also consume too much, averaging 20 percent over the recommended maximum. Some researchers believe that saturated fat contributes to high cholesterol and artery blockage. Read more...

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Q: THESE RESULTS FLY IN THE FACE OF WHAT FACT RESPONSES HAVE INDICATED. ANY COMMENT? DAVID J. KRIZMAN, MD

http://www.everydayhealth.com/heart-health/how-low-should-cholesterol-go.aspx?xid=nl_EverydayHealthDietandNutrition_20081221

Cholesterol—How Low Should It Go?
Bringing your cholesterol numbers down is an important part of improving your heart health.

By Arthur Agatston, MD, Everyday Health heart expert If you have established heart disease or are at high risk, aggressive cholesterol lowering is beneficial no matter what cholesterol levels you start with. There are a number of studies that demonstrate this.
The 1998 Air Force/Texas Atherosclerosis Coronary Prevention Study was different from prior statin investigations. In this study, the participants started with normal levels of total and LDL ("bad") cholesterol and no obvious signs of cardiovascular disease. Understandably, many people thought that giving statins to people with normal LDL cholesterol was "overkill." In truth, it turned out to be lifesaving. Compared to people who were given a sugar pill (placebo), those who took a statin had a 37 percent lower risk of having a heart attack, unstable angina, or sudden cardiac death. Read more...

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The California stem cell agency plans to hand out $370 million this year, including a whopping $240 million in what it calls its disease team round.

That amounts to $42,237 every hour of every day of 2012.

Amy Adams, CIRM's communications manager, reported the $370 million figure in the CIRM research blog, which she edits. The other rounds of funding for 2012, Adams wrote, include $95 million for early translational research, $35 million for basic biology and $2.2 million for stem cell research by high school students. Those funds would be routed through universities.

So far CIRM has handed out $1.2 billion to 454 recipients in the seven years it has been in business. It is expected to run out of its $3 billion in about 2017 unless it secures voter approval of more bond funding or some other source of revenue.

Adams' item on the funding expected to be approved this year is part of CIRM's efforts to make its research blog more lively and newsy. Indeed, unless we are mistaken, it is the first time in the history of the agency that it has laid out its funding plans for a forthcoming year in a single public document.

In her item, Adams also pointed to various locations on the CIRM web site where interested parties can track the agency's affairs.

The changes in the blog are a step in the right direction, laying out not only more information but also racheting up the interest level.

Source:
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The California stem cell agency is proposing a $40 million program to set up two stem cell genomic research centers, including possibly one at a for-profit research enterprise.

The plan would augment an existing program in genomics or bioinformatics, according to a CIRM document. The goal is to rapidly build "an effective stem cell genomics infrastructure that will provide a new platform for the application of genomics tools to stem cell biology and regenerative medicine."

The proposal is scheduled to be considered at a meeting of the CIRM directors Science Subcommittee next Wednesday. It will then go to the full CIRM board at its Jan. 17 meeting.

The stem cell agency's proposal said,

"Genomics technologies and the data sets they yield are fast becoming the currency of biology and medicine. The cost of genome sequencing is dropping exponentially, a trend that will soon make genome-scale characterization a practical tool for fundamental studies of stem cell biology and for advancing therapeutic applications. Meanwhile, cell therapeutics are advancing toward clinical trials, and hES and hiPS cells have become the gold standard for studying human cell biology, tissue and organ development and repair, and disease. Combining genomic technologies with stem cell research will accelerate fundamental understanding of human biology, disease mechanisms, tissue engineering and cell therapies...."

The RFA for the proposal would be released in May with board approval of applications in the winter of 2013.

Interested parties can participate in the meeting at locations in San Francisco, Irvine, Oakland, Pleasanton, Duarte, Los Angeles (2), Stanford, Healdsburg and Irvine. Addresses can be found on the agenda for the meeting.

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The California Stem Cell Report will be mostly dark during the next two weeks since its editor, yours truly, will be out of Internet range sailing in the Perlas islands south of Panama.

However, we want to let you know that a meeting of the governing board of the California stem cell agency is scheduled for Jan. 17 in San Diego. Also, the Institute of Medicine later this month will hold one of its two public sessions in California to assess the performance of the $3 billion stem cell research effort. The agenda for the Jan. 24-25 meeting in San Francisco had not been posted at the time of this writing. But the IOM said it will be available at least 10 days ahead of the meeting.

The IOM also has not yet filled the spot on the CIRM study panel vacated by David Scadden of Harvard when he resigned last month because of a conflict of interest involving Fate Therapeutics of San Diego.

If you are eager to delve into the details of what the CIRM governing board is up to, you can find the agenda and perhaps additional background information at this location on the CIRM web site when it is posted, probably by Jan. 7. While the meeting is scheduled for San Diego, usually one or two remote locations around the state are available where interested parties can participate. The California Stem Cell Report does plan to cover the meeting live via the Internet audiocast and file reports as warranted.

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

The $3 billion California stem cell agency has handed out 454 grants since its inception in 2004 but what does it all mean?

Stem cell researcher Paul Knoepfler took a crack at an unusual analysis a couple of days ago, generating a word cloud from the titles of all the CIRM grants.

Writing on his blog, the UC Davis scientist and CIRM grant recipient said he was surprised by some of the results, including how small the word "induced" was in the cloud considering the hooha over induced pluripotent cells. Knoepfler also wrote,

"I found it fascinating that the next top word was 'differentiation.' As much as we all focus on stem cells in their native state, clearly the differentiation of stem cells is critically important."

Knoepfler used a free, word-cloud forming utility(Wordle) to generate the results, which Amy Adams, CIRM's communications manager, called "cool."

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

(HealthDay News) -- Using the biomarker molecule known as brain natriuretic peptide (BNP) to guide treatment for older people with chronic heart failure did not improve the clinical outcome in most cases in a Swiss study.

There have been conflicting reports about the value of monitoring blood levels of BNP, a protein produced by stressed heart cells, for better management of heart failure. For example, a French study reported in 2007 found that BNP monitoring reduced deaths and hospitalizations in a 115-participant trial.

But the new study, published in the Jan. 28 issue of the Journal of the American Medical Association by physicians at University Hospital Basel, found that BNP-monitored therapy guidance generally did not improve 18-month survival or quality of life over conventional symptom-guided therapy.

All the people in the trial were 60 or older. All were hospitalized for heart failure, and all had BNP blood levels at least double the normal readings. Read more...

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25-12-2011 12:17 http://www.adult-stemcells-blog.com Zannos Grekos MD,Interventional Cardiologist, tells how your OWN adult stem cells help repair hearts and how adult stem cells released from the bone marrow travel to the heart to Renew and repair cardiac problems. Review all your adult stem cell options to repair and renew your body ,including the world's first patented adult stem cell enhancer capsules.

Go here to see the original:
Adult Stem Cells Help Repair Hearts / Cardiologist explains Bone Marrow Stem Cells - Video

05-11-2011 22:57 This video is 1 of 2 videos on the day I was to receive radiation during the preparation to receive donor stem cells from my brother. This video is poated to help people see some of the steps they may need to do in order to receive a bone marrow transplant

Read the original:
Radiation Stem Cell Half Match Transplant 1 - Video

01-12-2011 21:21 VOILA! Skin Care offers a premium anti-aging stem cell serum, formulated with malus domestica cells, rich in proteins, phyto-nutrients, and long-living cells to combat the signs of aging.

Read more from the original source:
Anti-Aging Apple Stem Cell Serum - Video

24-12-2011 23:08 Many of our patients travel to Guangzhou from all over the world for medical treatment and tourism.

Go here to see the original:
China medical tourism--Ataxia Multiple System Atrophy--stem cell therapy - Video

(HealthDay News) -- Many older Americans get screened for colon, breast, prostate and cervical cancer even though guidelines recommend against routinely screening the elderly, a new study finds.

As the population of the United States continues to age, balancing good health care with costs will be a continuing battle, experts say. "In an era of escalating health care utilization and expenditures in the United States, identifying areas for cost containment while concurrently improving quality of care in our health care system is increasingly paramount," said lead researcher Keith Bellizzi, an assistant professor of human development and family studies at the University of Connecticut in Storrs.

"Perhaps this area of health care warrants further attention," Bellizzi added.

Currently, nearly 37 million people in the United States are 65 and older, and that number will probably double by 2030. Historically, older adults have been excluded from cancer clinical trials, so what is known about the effectiveness of screening in seniors is limited, he said.

The U.S. Preventive Services Task Force recommends against routine screening for breast, colorectal, and prostate cancer at age 75 and beyond, and advises against cervical cancer testing after 65, according to the study. Read more...

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What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". 


In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.


I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date.  I'll post an update here when I have something useful.
______


In January, the following product was classified as a tissue engineered product - not combined:

• Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions

In April, the following product was classified as a tissue engineered product, combined: 

• Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology

In May, the following product was classified as a somatic cell therapy medicinal product: 

• Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis

In July, the following product was classified as a Tissue Engineered Product, non-combined:

• Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures. 

In September, the following product was classified as a Tissue Engineered Product, non-combined:

• Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy

     and the following product was not classified as an ATMP: 

• Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)

In October, the following product was classified as a somatic cell therapy medicinal product: 

• Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma

In November, the following products were classified as tissue-engineered products:

• Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
• CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI

In December, the following product was classified as somatic cell therapy medicinal product:

• Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Inevitably, year-end lists invite plenty of debate and criticism, and Scientific American 's is no exception. Certainly, we could have included the discovery of new worlds beyond our solar system, including Kepler 22 b, an exoplanet in the "Goldilocks" zone of habitability, as well as the first known Earth-size exoplanets . Or noted the accumulating evidence suggesting that hydraulic fracturing, or fracking, to retrieve natural gas is likely to contaminate water supplies. (Final New York State regulations, expected in mid-2012, could determine the future of fracking in the U.S.)

[More]

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(HealthDay News) -- Men are less willing than women to be screened for cancer, even though men have higher cancer death rates, a new study shows.

Researchers conducted a telephone survey of nearly 1,150 adults in New York City, Baltimore, and San Juan, Puerto Rico, who answered questions from the Cancer Screening Questionnaire. Most of the participants were aged 30 to 59, and 35 percent of them were men.

"This study examined beliefs and attitudes held by men and women about cancer screening. Our aim was to gain insight for improving existing cancer health promotion practices," study corresponding author Jenna Davis, of the department of health outcomes and behavior at the Moffitt Cancer Center in Tampa, Fla., said in a center news release.

"Our findings indicate that there is a need for better health and cancer screening promotion among men," she said.

The researchers suggested several reasons why men are less willing than women to undergo cancer screening: most cancer awareness campaigns in the media are for women's breast cancer; there is a lack of government-sponsored men's cancer awareness campaigns; and studies indicate that women see their primary care doctor more often than men. Read more...

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The $3 billion California stem cell agency should shut its doors when its cash runs out in about six years and turn over development of stem cell therapies to industry and academe, the San Jose Mercury News said in an editorial on Saturday.

The piece in the leading newspaper in California's Silicon Valley was headlined, "Stem Cell Institute Should Take a Bow (Out)."

The newspaper wrote,

"This state is in financial crisis with no full recovery in sight. Bankrolling the next phase of research would come at the expense of other critical state services, including public education, that are state government's core mission and already are starved by budget cuts. It would be a mistake to pile more debt onto the state's already heavy bond obligations, which are paid off from the same general fund that pays for schools and other services. Medical research is important, but it is not at the heart of state government's mission. Bond measures now need to deal with water supplies and other looming crises."

The editorial said CIRM has provided a "strong foundation from which universities and companies can move toward cures."

But the newspaper concluded,

"Cures remain elusive -- there is never a guarantee with scientific research -- but the 10-year start voters approved was meant to be just that. The promise of stem cell treatments now must be kept alive with funding from industry, academic institutions and private foundations and philanthropists."

The editorial comes as the seven-year-old agency is driving to turn research into therapies that can actually be used in treatments. At the same time, CIRM is considering asking California voters to approve another multibillion bond measure in the next few years, a proposal that seems to be fresh news to many in the media.

The San Jose newspaper covered the stem cell agency with some detail in its first year of operation. In the last few years, however, the paper's coverage has been all but non-existent, like most of the news media in California.

Earlier this month, the paper published an overview of the agency, which highlighted the discussions by former CIRM Chairman Bob Klein about another bond issue, along with the fact that the cures promised by the campaign of 2004 have not materialized. The proposed bond issue is old news for most persons who have followed CIRM; the plan has been around publicly for more than a year. But the call for more cash comes a surprise to many of in the media. And to the public. So it is likely to pop up again as other news outlets re-visit the agency from time to time.

The presence of another electoral campaign also imposes a different sort of burden on CIRM – something quite removed from such matters as the basic biology of stem cells. It means that the stem cell agency's endeavors are being evaluated in a political context, which involves such questions as whether its actions are designed to generate the millions in campaign contributions necessary to win a statewide election or whether it is neglecting valuable research for something that will instead generate a high profile result for the benefit of the campaign but not add much to the science.

It is all part of tactics and strategy involved in the "communications war" that CIRM Chairman Jonathan Thomas discussed with CIRM board members last June in his bid to win election to his post.

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

Advanced Cell Technology, which has unsuccessfully sought funding several times from the $3 billion California stem cell agency, drew some attention today in a piece in a Massachusetts newspaper.

The Worcester Telegram took a look at the firm, headquartered in Santa Monica, Ca., with labs in Marlboro, Mass., in the wake of Geron's departure from hESC research. The move left ACT as the only firm in the country with an hESC trial and perhaps with a better shot at CIRM funding.

Reporter Lisa Eckelbecker wrote,

"Advanced Cell, publicly traded since 2005, has spent years developing its technologies. The company brings in little revenue and has an accumulated deficit of $180.9 million. About 1.6 billion shares of Advanced Cell common stock is outstanding, a result of numerous financings over the years. It trades for about 10 cents a share on the Over-the-Counter Bulletin Board, an electronic exchange for small companies. No analysts from major Wall Street banks report on the company.

"The company's treatment for Stargardt's macular dystrophy and dry age-related macular degeneration — the treatment that required (a) mountain of paperwork before the FDA — first went into the eyes of patients in July in Los Angeles. The retinal pigment epithelial cells, generated from embryonic stem cells, were developed to slow the progression of the eye disorders, which can lead to blindness."

ACT moved its headquarters to California following the passage of Prop. 71 in 2004, the ballot initiative that created the California stem cell agency. The company said at the time it expected to "gain significant momentum by being able to take advantage of a favorable environment for funding."

ACT initially landed in Alameda, Ca., but has since moved to Southern California. Its official opening in 2006 in Alameda was attended by the state treasurer and at least one CIRM official, according to the company. The firm has never secured funding from the stem cell agency, which does not release the names of rejected applicants. However, the California Stem Cell Report carried an item in 2008 that pointed out that a researcher for ACT complained publicly about a reviewer's conflict of interest in connection with an ACT application(see here and here). At the time, Robert Klein, then CIRM chairman, brushed off the complaint. The journal Nature has also reported that ACT has applied unsuccessfully several times for CIRM awards.

It is a fair bet that ACT was an initial applicant in the round that provided funding to Geron last spring. However, by the time Geron's application went to the full CIRM board, the other applicants had withdrawn – the first time such an event had occurred at CIRM.

Since Geron pulled out of the hESC business last month, it is likely that ACT and CIRM have opened fresh discussions, given their mutual interest in producing a stem cell therapy. CIRM also has a new chairman who is familiar with ACT. After Geron was awarded its $25 million loan from CIRM last May, the agency's board elected as chairman a Los Angeles bond financier, Jonathan Thomas, who led an early round of financing for ACT in 2000. Thomas last summer sold his remaining 17,046 shares in ACT for $3,239. Thomas said he had a "significant loss" on the sale but did not disclose the amount.

Geron's flight from hESC and ACT's perserverance come as the stem cell agency is pushing aggressively to drive research into the clinic. Plus CIRM needs tangible results that voters can understand if CIRM is win ballot-box approval for continued funding in the next few years. The agency will run out of cash in about 2017 and is considering mounting a campaign for another multibillion bond issue.

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