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Possible Buyers for Geron’s Stem Cell Business: BioTime, Pfizer, Celgene

By Dr. Matthew Watson


The mainstream media is climbing all over the Geron story today with more analysis and a  discussion of firms that might snag the San Francisco area firm's orphan stem cell business.

Reporter Peter Loftus of the Wall Street Journal mentioned Pfizer, which is involved an hESC project with researcher Peter Coffey, who was lured from the UK this fall to UC Santa Barbara. Among the incentives was a $4.9 million grant from the California stem cell agency, which also financed Geron to the tune of $25 million.

Matthew Perrone of The Associated Press had this to say about buyers:

"Analysts say Geron's stem cell business could be acquired by Alameda, Calif.-based BioTime, a company founded by former Geron scientists. Other potential acquirers could include larger pharmaceutical companies like Celgene Corp., Pfizer Inc. and Teva Pharmaceuticals, which have dabbled in stem cells without making major investments."

BioTime's shares were up 7 percent today, closing at $4.52. Geron's shares were down as much as 28 percent and hit a five-year low. It closed at $1.71, down 22 percent.

The AP also wrote,

"Joseph Pantginis, an analyst with Roth Capital Partners, said it would have taken five to ten years before Geron's lead stem cell product reached the market.

"'This is still very much a fledgling space and some people would even consider stem cells to be a science experiment, so there's still a long way to go,' said Pantginis.

"University of Wisconsin professor Alta Charo said Geron's move 'may suggest that a different business model is needed, one with a longer timeline for return on investment.'"

Charo had close ties early on with the $3 billion California stem cell agency, which loaned $25 million to Geron just six months ago. The loan was part of an aggressive effort to produce clinical results that will help extend the agency's life beyond 2017, when funds are expected to run out. Currently CIRM is financed through California state bonds, which will need to be approved by voters again if CIRM is to continue.

Here are more excerpts from today's coverage.

Gretchen Vogel of Science magazine wrote,

"Some observers had reservations about the trial from the start, worrying that the animal results were not strong enough to justify a human trial. But many had been pulling for the company nonetheless. 'It's with a sense of loss that I see this news,' says Roger Pedersen of the University of Cambridge in the United Kingdom, who was one of the researchers to receive funding from Geron in the mid-1990s to attempt to derive hES cells. He says the company may be reacting not only to the long timeline to bring cell therapies to the clinic, but also to a possible weakening of its intellectual property portfolio. The development of induced pluripotent stem (iPS) cells, which are adult cells genetically reprogrammed to resemble embryonic ones, means that Geron's exclusive licenses may be worth less. 'Advances in the stem cell field are disruptive innovations that have the potential to supercede earlier innovations, hES cells being one of those. I don't know if Geron looks at it that way, but I do,' Pedersen says."

Ben Hirschler and Kate Kelland of Reuters reported:

"A decision by one of the biggest names in stem cell research to throw in the towel will not stop other pioneering work that could yet produce cures for blindness and help mend broken hearts.

Scientists were shocked by U.S. biotech company Geron Corp's decision on Monday to quit embryonic stem cell research -- a move it blamed on a lack of money and the complexities of getting regulatory approval....

"Robert Lanza, chief scientific officer of ACT, is not giving up hope on the embryonic front but said Geron's exit put more pressure on his firm to succeed.

"'Of course, it's the second mouse that often gets the cheese,' he said."

Sarah Boseley of The Guardian in the UK wrote:

"The dream of Superman actor Christopher Reeve and others of paralysed people being able to walk again after injections of stem cells has receded, following the announcement by biotech company Geron in the US that it is to abandon the first-ever human trial of its kind."

Jef Akst of The Scientist magazine wrote:

"'It’s certainly going to have a very chilling effect,' said Robert Lanza, chief scientific officer at Advanced Cell Technology, the only other company currently engaged in clinical trials involving hESCs. 'There’s a lot of exciting potential here in this field, and it would just be a real shame for this not to move ahead full steam.'...

"One thing working in the field’s favor is the fact that Geron helped pave the regulatory way for other stem cell therapies, said Sheng Ding, a stem cell biologist at the Gladstone Institutes and the University of California, San Francisco. 'Geron’s past efforts had cleared out a FDA path for pluripotent stem cells,” he wrote in an email to The Scientist."

The Financial Times of London altered its original story by Andrew Jack without notifying its readers that the story was changed or why. The old version began.

"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."

The new version, posted at least 12 hours later, begins:

"Geron, the Californian biotech company, is abandoning its pioneering embryonic stem cell work, after concluding that the costs and length of further development were too great."

Matthew Herper of Forbes published a comment from Jamie Thomson of the University of Wisconsin, whose hESC discoveries were financed in part by Geron. Thomson wrote,

"Geron’s decision to discontinue their stem cell work reflects how genuinely difficult it is to build a business around embryonic stem cell-based transplantation therapies. They also chose a particularly challenging target for the first therapeutic application. They are to be commended, however, for blazing a trail that others can follow in getting the first clinical trial approved by the FDA, as such approvals should be easier in the future."

Herper continued,

"Thomson initially shied away from the idea of building businesses around embryonic stem cells or their successors, induced pluripotent stem cells, which don’t involve destroying embryos. (He told me three years ago, 'I really believe personally that the value of these cells is not in transplantation,' and that '90% of the value of these cells will be in things that don’t make the front pages.') When Thomson did decide to become an entrepreneur, it was through a Madison, Wisconsin-based startup called Cellular Dynamics International, which uses the cells to create better ways of testing the safety and effectiveness of experimental drugs. Drug giants including Roche, Pfizer, and AstraZeneca have taken their own steps toward embracing stem-cell-based research. This field is slowly gaining steam just as the one Geron is abandoning its own attempts to heal the lame."

Brian Orelli on the MotleyFool investment web site wrote,

"Geron is giving up on stem cells. That's like Krispy Kreme Doughnuts without glazed treats, or Apple without Macintosh."

Adam Feuerstein on thestreet.com wrote:

"Geron's  decision to shut down its embryonic stem cell research programs is a blow to the controversial research field and a painful reminder that only dreamers and fools invest in embryonic stem cell stocks....But does anyone believe that Geron would jettison stem-cell research if the ongoing clinical trial in spinal cord injury were helping patient recover neurological or motor function?"

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Geron Flight from hESC Research is ‘Powerful Blow’

By Dr. Matthew Watson


The news about Geron's abrupt departure from hESC research is rippling around the world this morning, casting a pall over the entire field.

The Financial Times of London, in a story by Andrew Jacksaid,

"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."

Ron Leuty at the San Francisco Business Times said in an analysis,

"Just why would I want to invest in a space where one of the most promising companies just called it quits."

In a Washington Post article by Rob Stein, a patient advocate expressed bitterness.

"'I’m disgusted. It makes me sick,' said Daniel Heumann, who is on the board of the Christopher and Dana Reeve Foundation. 'To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.'"

Geron, based in the San Francisco peninsula city of Menlo Park, cited financial problems when it announced yesterday that it was giving up on its stem cell efforts in favor of its cancer drug program. Geron is laying off 38 percent of its staff and says it will try to find a buyer for the stem cell program. Geron also settled its accounts with the California stem cell agency, which loaned it $25 million last May amidst considerable publicity.

The stem cell agency and other advocates expressed optimism about the long term potential of the field and noted the difficulties of bringing any therapy to production. Geron produced 21,000 pages of material over a years-long period to get FDA permission to begin only the first step in the long clinical trial process.

But the dominant tone of the news stories was negative. Heidi Ledford of Nature said Geron is "walking out on the field." Steve Johnson of the San Jose Mercury News said the decision casts "a cloud over the commercial viability of stem cell treatments."

Here are other excerpts:

San Francisco Business Times:

"What does this mean for companies that the California Institute for Regenerative Medicine, the state’s stem cell research funding agency, is pushing toward clinical trials? Will they only get so far before they, too, exit the business?" 

Fergus Walsh, medical correspondent for the BBC(see here), wrote:

"The decision does seem to be extraordinary given the huge investment of time and resources. When I visited Geron nearly three years ago, the then chief executive claimed the technology had an incredible future. 

"John Martin, professor of cardiovascular medicine at University College London said: 'The Geron trial had no real chance of success because of the design and the disease targeted. It was an intrinsically flawed study. And for that reasons we should not be describing this as a set back. 

"The first trials of stem cell that will give an answer are our own in the heart. The heart is an organ that can give quantitative data of quality.'"

Ryan Flinn of Business Week wrote,

"Geron fell 16 percent to $1.86 in extended trading. The shares have declined 58 percent this year.  

Robert Lanza, chief scientific officer of Advanced Cell Technology Inc.(of Santa Monica, Ca.), the second company to win permission from the U.S. Food and Drug Administration to test human embryonic stem cells in people, said the news wasn’t surprising, given the small patient population affected with spinal cord injuries. 

"'It was a very difficult choice to go in and treat spinal cord injury,' Lanza said in an interview. 'There was considerable concern in the scientific community that that might not have been the ideal first indication."

As first reported by the California Stem Cell Report, Geron's loan application was scored as a 66 on a scale 100 last May by scientific reviewers for the California stem cell agency. The score was not disclosed publicly at the time CIRM directors approved the award as has been the practice for all the other 400-plus awards that the agency has granted. The Geron approval process departed radically from the agency's regular procedures.

The news coverage in California of the Geron decision was marked by the absence of a story in the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle carried only a brief story buried on page 6 of its business section. The California stem cell agency is based in San Francisco and the Bay Area contains one of the larger and more important biotech business and academic research communities in the world.

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Geron Quits Stem Cell Research; Move Deemed Setback to the Field

By Dr. Matthew Watson


In a surprise move, Geron today said it was terminating its stem cell business and what was the first-ever clinical trial of an hESC therapy, a potential product backed by a $25 million loan made by the California stem cell agency only six months ago.

Geron's move has "stark implications" for development of stem cell therapies in the United States, The Associated Press said. Andrew Pollack of the New York Times reported,

"The move is expected to be widely seen as a setback for the field, because of Geron’s central role."

The Menlo Park, Ca., company said it will fire 66 employees, 38 percent of its workforce, and will try to find buyers for its stem cell business.

The company's CEO, John Scarlett, cited the need to "focus our resources" given the "current environment of capital scarcity and uncertain economic conditions." The clinical trial of its spinal cord treatment will be closed to further enrollment, although it will continue to follow all four enrolled patients. The company said it now plans to focus on cancer drugs.

The company did not mention CIRM or the $25 million loan in its statement. The stem cell agency issued a press release that said,

"Geron had received $6.42 million of their loan, which the company today repaid in full with accrued interest."

In the news release, CIRM's Ellen Feigal, senior vice president for research and development, did not comment directly on Geron's move. She said CIRM remained optimistic about "many exciting stem cell programs in California." She said moving a therapy into the clinic is a "highly complicated process."

Absent from CIRM's press release were any comments from its new chairman, Jonathan Thomas, and CIRM President Alan Trounson.

Dropping stem cell research will improve Geron's cash situation. The New York Times' Pollack said,

"Geron will be able to last without needing to raise new money until it receives results of clinical trials of its cancer drugs over the next 18 months. By contrast, Dr. Scarlett said, given all the precautions in the stem cell field, he did not think there would be results from the stem cell trial until 2014."

The AP quoted stock analyst Steve Brozak of WBB Securities as saying Geron had encountered difficulty in finding partners for its stem cell program. He said potential partners wanted to see "later stage results." Of the clinical trial, Brozak said,

"It could be outsourced to a place like China very easily. In that case, this would be the de facto abdication of U.S. leadership in biotechnology."

With Geron's departure, Advanced Cell Technology of Santa Monica, Ca., is the only company with a clinical trial involving hESC, one targeting macular degeneration. ACT has never received an award from the California stem cell agency although it relocated its headquarters to California in the wake of the passage of Prop. 71, which created the state's $3 billion research program.

ACT was widely believed to have applied in CIRM's financing round last spring involving Geron.

CIRM directors approved the loan to Geron last May in a meeting that departed radically from its normal awards process.

As reported by the California Stem Cell Report in August,

"The Geron application was not given a public scientific score, standard practice for all the other 433 applications that the agency has approved over the last six years. The usual summary of grant reviewer comments was not provided to the public or the board. The three other applicants in the $50 million round all withdrew prior to presentation to the CIRM board – another first in CIRM's grant program. And no public explanation was provided at the time for the departures from long-established procedures." 

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$127 Million in ‘Good News’ for San Diego Stem Cell Researchers

By Dr. Matthew Watson


Earlier today, an anonymous reader posted a comment on the California Stem Cell Report wondering where the "good news" was about the stem cell agency. We are not sure whether the reader was wondering about the content of this site or the mainstream media or both.

Sanford Consortium lab from live Webcam shot this weekend
on the Sanford web site. 

But the comment came less than 24 hours after a San Diego area newspaper published a glowing piece about the opening of a new stem cell research building under the auspices of five powerful research organizations – Salk, Scripps, Sanford Burnham, UC San Diego and the La Jolla Institute for Allergy and Immunology, a recent addition to the consortium.

Bradley Fikes of the North County Times wrote the story. He may be the last reporter in California to regularly, albeit infrequently, cover California stem cell issues for a mainstream newspaper.

Fikes' story heralded the $127 million structure. (The cost includes equipment.) He wrote,

"San Diego County's bid for supremacy in the fast-growing field of stem cell research will gain an iconic new image Nov. 29, when a gleaming headquarters for some of San Diego County's top stem cell researchers officially opens.

"The 132,000 square-foot building off in La Jolla will become the headquarters of the Sanford Consortium for Regenerative Medicine...."

The consortium was formed in the wake of voter approval of Prop. 71, which created California's $3 billion stem cell program and provided hundreds of millions of dollars for new labs. Edward Holmes, formerly vice chancellor at UC San Diego, is president and CEO of the consortium. Holmes is also chairman of the National Medical Research Council in Singapore. (For Holmes perspective on the consortium, see this 2010 interview.)

The building was financed with $43 million from the California stem cell agency, $65 million in bonds guaranteed by the University of California and $19 million from T. Denny Sanford, a South Dakota billionaire banker.

After CIRM approved funding for the building in May 2008, the consortium struggled with finding cash beyond what CIRM provided. The roadblocks delayed work on the facility, which was supposed to be completed by May 2010 at a cost of $155 million, according to the stem cell agency.

Like the other new labs assisted by $271 million in stem cell agency construction funds, the San Diego building is touted as conducive to bringing scientists together. Indeed, it has been dubbed a "collaboratory."

Fikes wrote,

"Even the staircases have been designed in keeping with the goal of making as much space as possible serve collaboration. The Sanford Consortium's staircases are wide, open and airy. They connect multiple 'laboratory neighborhoods' on different levels, so that scientists from different labs and floors will inevitably pass each other on their way to work."

Fikes said that at each level the staircases include areas with tables and chairs for quick chats. He quoted Louis Coffman, chief operating officer of the consortium, as saying,

"It's a lively interlude between floors. It creates an interesting space. More than that, it connects the physical locations of two different floors. So whereas people on different floors, who would otherwise be as disconnected as they would be in different buildings, hopefully they're going to make connections."

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Dr. Jordan Pomeroy discusses xeno-Free Derivation and Maintenance of Pluripotent Cell Lines – Video

By Dr. Matthew Watson

Dr. Jordan Pomeroy, from the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at the Keck School of Medicine of the University of Southern California, presents his work on the derivation and characterization of new pluripotent stem cell lines for clinical applications.

Follow this link:
Dr. Jordan Pomeroy discusses xeno-Free Derivation and Maintenance of Pluripotent Cell Lines - Video

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Getting Stem Cell Therapies Approved: Ann Tsukamoto – CIRM Science Writer’s Seminar – Video

By Dr. Matthew Watson

(Part 7 of 9) Ann Tsukamoto, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Tsukamoto is the Chief Operating Officer at Stem Cells, Inc., a Palo Alto based company that has begun a stem cell based human clinical trial for the treatment of Batten disease.

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Getting Stem Cell Therapies Approved: Ann Tsukamoto - CIRM Science Writer's Seminar - Video

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StemCellTV – From National Geographic – The Skin Gun – Healing Burns with Stem Cells – Video

By Dr. Matthew Watson

Courtesy of National Geographic TV, StemCellTV reports on the skin gun. McGowan Institute of Regenerative Medicine takes a burn victims stem cells from his skin and regenerates skin to heal him in 4 days.

Original post:
StemCellTV - From National Geographic - The Skin Gun - Healing Burns with Stem Cells - Video

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Beating Cardiomyocytes in Cell Culture – Video

By Dr. Matthew Watson

The cells shown are beating cardiomyocytes derived from human induced pluripotent stem cells.

See original here:
Beating Cardiomyocytes in Cell Culture - Video

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Beating iCell® Cardiomyocytes – Video

By Dr. Matthew Watson

A synchronously beating monolayer of cardiomyocytes (heart cells) derived from induced pluripotent stem cells.

Read more here:
Beating iCell® Cardiomyocytes - Video

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Kids of Deployed Soldiers Vulnerable to Stress

By Dr. Matthew Watson

(HealthDay News) -- About one-third of children of deployed U.S. Army soldiers are at high risk for psychosocial problems, mainly due to high levels of stress experienced by the parent who is still at home, a new study shows.

The research included the spouses (mainly wives) of 101 deployed Army personnel. Participants completed a series of questionnaires and provided information about their children, aged 5 to 12.

The researchers concluded that 32 percent of the children were at high risk for psychosocial problems. This doesn't mean they had psychological problems, but that they were more vulnerable to developing such disorders. That rate is 2.5 times higher than among children in the general population.

The study also found that children of parents with high stress levels were about seven times more likely to be at high risk for psychosocial problems. Psychosocial problems were less likely among children whose parents received support from military organizations and among children of college-educated parents. Read more...

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Commercializing Cell-based Regenerative Medicines

By Dr. Matthew Watson

Tweet 

When introducing a regenerative medicine cell based product to a commercial setting, there are a host of things to take into consideration to ensure a commercially viable and safe product for patient use.

In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some teasers into a few of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

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Calendar: MIND Events in November and December

By Dr. Matthew Watson

NOVEMBER

4–5 According to the World Health Organization, one in four of us will develop at least one mental illness or behavioral disorder in our lifetime. Depression alone affects an estimated 121 million people worldwide. At the two-day EMBO/EMBL Science and Society Conference , biologists, psychologists and neuroscientists will explore the ethical and social implications of major mental illnesses as well as their causes and treatment. Attendees will debate the definitions of mental disorders, financial interests in the refinement of both diagnoses and drugs, and controversial new therapies, among other topics. [More]

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Did Alternative Medicine Extend or Abbreviate Steve Jobs’s Life?

By Dr. Matthew Watson

Exact details of the alternative natural and traditional therapies tried by Steve Jobs before he underwent surgery in 2004 and eventually died of pancreatic cancer earlier this month have not been disclosed. (A representative from Apple declined to comment on any aspect of the Apple co-founder's illness.) He reportedly restricted his diet to just fruits or just fruits and vegetables, tried out something called hydrotherapy and consulted psychics. In any case, a mounting body of scientific and anecdotal reports provides compelling evidence about the potential impact, both positive and negative, of so-called complementary practices on the health and longevity of cancer patients following their diagnosis. And, although Jobs's unconventional early-treatment choices may not have done much to stave off the spread of deadly cancer cells in his case, they provide an opportunity to discuss what makes cancer grow and how to stop it.

Jobs had a rare form of pancreatic cancer known as pancreatic neuroendocrine tumor (pNET). Accounting for about 1 percent of all pancreatic cancers, pNET is a cancer of the endocrine cells, known clinically as the islets of Langerhans, which exist in small clusters throughout the pancreas. These cells produce hormones such as insulin, which lowers blood sugar, and glucagon, which increases it.

[More]

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The Puzzle of Pancreatic Cancer: How Steve Jobs Did Not Beat the Odds—but Nobel Winner Ralph Steinman Did

By Dr. Matthew Watson

Steve Jobs was a rare case, right down to his death. Announced Wednesday, Jobs's death from "complications of pancreatic cancer" only hints at the vast complexity of the disease to which he succumbed at the age of 56. [More]

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Studying Mental Illness in a Dish

By Dr. Matthew Watson

No organ in the human body is as resistant to study as the brain. Whereas researchers can examine living cells from the liver, lung and heart, taking a biopsy of the brain is, for many reasons, more problematic.

The inability to watch living human brain cells in action has hampered scientists in their efforts to understand psychiatric disorders. But researchers have identified a promising new approach that may revolutionize the study and treatment of conditions such as schizophrenia, autism and bipolar dis­order. A team led by researchers at the Salk Institute for Biological Studies in La Jolla, Calif., took skin cells from a patient with schizophrenia, turned them into adult stem cells and then grew those stem cells into neurons. The resulting tangle of brain cells gave neuroscientists their first real-time glimpse of human schizophrenia at the cellular level. Another team, from Stanford University, converted human skin cells directly into neurons without first stopping at the stem cell stage, potentially making the process more efficient. The groups published their results recently in Nature ( Scientific American is part of Nature Publishing Group).

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Source:
http://rss.sciam.com/sciam/topic/gene-therapy

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California Stem Cell Report Article: “Trounson, Parthenotes and International Stem Cell”

By Dr. Matthew Watson

Source: http://californiastemcellreport.blogspot.com/2011/11/trounson-parthenotes-and-international.html

The president of the California Stem Cell Agency, Alan Trounson, popped up in a recent article in Scientific American dealing with a method for creating pluripotent stem cells from unfertilized human eggs. 

The piece by Julia Galef said that "many investigators remain frustrated" that the method "remains offlimits" for federal funding, a barrier that does not apply to financing from the $3 billion California stem cell agency. 

Galef wrote that one California firm, International Stem Cell Corp., of Carlsbad, is using the method to develop products. She said the firm's work involves "a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg—called a parthenote—behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus." 

To read the complete article on "California Stem Cell Report", please click here  

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

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International Stem Cell Corporation Announces the Launch of Two New International Sales Initiatives for Lifeline Skin Care

By Dr. Matthew Watson

International Stem Cell Corporation (OTCBB:ISCO) today announced two new international marketing initiatives. The first is the successful conclusion of an agreement in principle to distribute its Lifeline Skin Care product line in the United Arab Emirates via a strategic relationship with noted facial plastic surgeon, Dr. Gregory S. Keller MD of Los Angeles and Santa Barbara, CA. The second is the engagement of Dr. K. McIsaac who will distribute Lifeline's products in Australia and New Zealand under Lifeline's own brand name. These agreements mark the first time that Lifeline Skin Care has distributed its products overseas. Currently, Lifeline Skin Care products are sold in the United States through the Company's website http://www.lifelineskincare.com.

The UAE represents an attractive market of some 4.3 million people, of which nearly 75% are expatriates. This cosmopolitan market is one of the most urbanized nations in the world with about 88% of its population living in cities. It has one of the highest per capita incomes in the world and an annual GDP growth rate at 8.8%.

"I am excited to introduce Lifeline Skin Care products to the UAE, and I am confident that our customers there will enjoy the same kind of satisfaction with the products as many of my patients in the United States report," said Dr. Keller. "Many of my American patients have been using these products since they were introduced on the market earlier this year, and the results they've seen are amazing."
Dr. Ruslan Semechkin, CEO of Lifeline Skin Care commented: "Dr. Keller has been a faithful supporter of our developmental and commercial efforts in the United States, and he has witnessed the dramatic benefits enjoyed by our customers. We are pleased that he has offered to bring the benefits of Lifeline to the people of UAE.

"In choosing Dr. McIsaac and his marketing team, we believe we will be able to rapidly grow sales and better serve the Australia and New Zealand markets. Dr. McIsaac brings a wealth of experience in direct to consumer sales and marketing. Together these agreements are a key part of our strategy to internationalize our brand."

Lifeline® Skin Care is the only skin care line that is based on human parthenogenetic stem cells that stimulate your skin's own abilities to repair itself. Lifeline products are sold in pairs, including a day cream and a night cream. A complete set is sufficient for one month of regular use.

About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

Forward-looking Statements
Statements pertaining to anticipated developments, potential sales growth and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20111110005408r1&sid=14230&distro=ftp
International Stem Cell Corporation
Kenneth C. Aldrich, Co-Chairman
760-940-6383
kaldrich@intlstemcell.com

or
International Stem Cell Corporation
Donna Queen, Vice President of Marketing and Business Development
760-710-3295
dqueen@lifelineskincare.com
or
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com

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

To Read More: International Stem Cell Corporation Announces the Launch of Two New International Sales Initiatives for Lifeline Skin Care
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International Stem Cell Corporation Comments on WSJ Article “Hope for Stem-Cell Treatment of Parkinson’s”

By Dr. Matthew Watson

“Researchers have used stem cells obtained from human embryos to successfully treat Parkinson's disease in mice and rats, a key step in the quest to develop a similar approach for people.
In a study published Sunday in the journal Nature, scientists described how they converted human embryonic stem cells into nerve cells that produced the brain chemical dopamine. When these nerve cells were transplanted into the brains of mice and rats, they released dopamine and got rid of the animals' Parkinson's symptoms. The cells were also successfully transplanted into rhesus monkeys, whose biology is closer to that of humans.”
SOURCE - To read the complete article on The Wall Street Journal HEALTH site, please click HERE
Comments from International Stem Cell Corporation:

International Stem Cell Corporation (ISCO) announced in July 2011 the initiation of a series of preclinical animal studies of neuronal cells derived from ISCO’s proprietary pluripotent stem cells. The studies will evaluate the in vivo safety and tumorigenicity of neuronal cells derived from ISCO's proprietary human parthenogenetic stem cells (hpSCs), as well as their ability to develop into functioning dopaminergic neuron–like cells, a key milestone towards creating a cell-based therapy for Parkinson's Disease (PD).

Dr. Andrey Semechkin, Co-Chairman and CEO of ISCO, comments: “The ability of neuronal cells to become a specific type of neuron is one of the most important properties that these cells must have to be used in cell-based therapy of neurological disorders. These studies will bring us one step closer to our goal of being able to treat PD.”


Forward-looking Statements
Statements pertaining to anticipated developments, research and development goals and related potential therapeutic treatments, the potential benefits of products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward- looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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

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Searching for Facts About Cash: CIRM to Treasurer to Finance

By Dr. Matthew Watson


"Even if your mother says it is true, check it out," an old saying goes. So we did.

The case in point was the new financial arrangement for the $3 billion California stem cell agency.

CIRM Chairman Jonathan Thomas laid out the plan last month for the California Stem Cell Report in the wake of a state bond issue that provided only $51 million for the agency, which fell far short of its needs over the next year or so. He said, however, a new arrangement was in place that amounted to a win-win for the state and the stem cell agency. The plan minimizes the amount of state bond borrowing immediately needed and instead provides, if necessary, short-term commercial paper, also backed by the state, but at less interest cost.

Thomas said both the state treasurer and the Brown Administration, through its state Department of Finance, were on board.

But -- keeping the admonition about mothers in mind -- we routinely asked the Finance Department and the state treasurer's office about the arrangement. What happened then provides some insight into how difficult it is sometimes to verify even what appear to be simple facts. It also tells a story about the responsiveness of state agencies and their dedication to openness and transparency.

Let's start with CIRM and Thomas. After we raised questions by email following the state bond sale Oct. 19, he offered a telephone interview about the situation and persisted despite dropped cellular signals and several callbacks from our post here in the bay off Panama City.

After we filed our item on the interview, we queried on Oct. 24 the other two agencies involved. The state treasurer's office responded quickly. The state Department of Finance, on the other hand, has remained silent on the subject to this day, despite three emailed queries.

Unfortunately, the state treasurer office's initial response was off the mark. "We haven’t seen any agreement.  We were not aware of the reported agreement until we read about it in your blog.  So, we have no comment about the reported agreement," the treasurer's office said initially.

That raised eyebrows a bit. So we renewed our queries to the Finance Department, even suggesting that a failure to respond could be construed as an indication that the Brown Administration is not fully behind CIRM.

Ten days after our initial query to the two agencies, we sent an email to Thomas briefly describing what we had planned to write and asking him if he would like to comment. He did not respond. But the next day, Steve Cooney, chief deputy state treasurer, said in an email that the earlier comment from the treasurer's office was incorrect. Cooney said,

"Our office DOES (Cooney's capitalization) and DID know that CIRM and the Department of Finance reached an understanding about future funding.

"The Treasurer’s Office has been aware since before last month’s sale of GO (general obligation) bonds that the Department of Finance and CIRM are in general agreement that the state will take necessary action to ensure that CIRM has adequate funds to meet its operational, grant funding and reserve needs, including the use of the state’s commercial paper line in the event the state cannot timely access the bond market.  It is neither necessary nor usual for our office to be informed of the specifics, if any, of any future commitment made by the Administration to any other state agency, including CIRM, and this case is no exception."

Cooney additionally re-affirmed the commercial paper arrangements for CIRM as laid out in the initial response from the treasurer's office.

The response said,

"The issuance of commercial paper has always been a part of our bond financing program.  The size of the CP line is about $1.5 billion, and it is available for use by all infrastructure programs, including stem cell research.  When we issue commercial paper to finance infrastructure projects, including CIRM, the paper is repaid with bond-sale proceeds.  So, if CIRM received funds from the issuance of commercial paper, the 'loan' would be retired not by CIRM, but by the proceeds of a subsequent bond sale."

Cooney also said,

"If you still need further clarification on the issue of future CIRM funding beyond the proceeds of the recent bond sale, the best place to get that information continues to be the Department of Finance."

Silence, however, has only been heard from the state Department of Finance.

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

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Trounson, Parthenotes and International Stem Cell

By Dr. Matthew Watson


The president of the California stem cell agency, Alan Trounson, popped up in a recent article in Scientific American dealing with a method for creating pluripotent stem cells from unfertilized human eggs.

The piece by Julia Galef said that "many investigators remain frustrated" that the method "remains offlimits" for federal funding, a barrier that does not apply to financing from the $3 billion California stem cell agency.

Galef wrote that one California firm, International Stem Cell Corp., of Carlsbad, is using the method to develop products. She said the firm's work involves "a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg—called a parthenote—behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus."

Trounson was quoted as saying, nonetheless, that "proving that unfertilized eggs will produce stable tissues in humans remains an obstacle." He said other labs need to replicate the work.

International Stem Cell has applied unsuccessfully several times for research funding from the California stem cell agency.

The Scientific American article said,

"International Stem Cell scientists have converted them into liver cells and plan to convert them into neurons for treating Parkinson’s disease, pancreatic cells for diabetes, and other tissues. Meanwhile teams at the Massachusetts-based Bedford Stem Cell Research Foundation are working to improve the efficiency of methods of deriving stem cells from parthenotes."

As researcher interest in parthenotes gains attention, the NIH is being urged to change its negative position. Late last year, Teresa Woodruff, founder and director of the Institute for Women's Health Research at Northwestern University Feinberg School of Medicine, and others called for a lifting of the NIH ban on funding for parthenotes.

California is not constrained by NIH limitations. One of the key reasons, if not the only reason, that voters approved in 2004 the ballot initiative that created the $3 billion stem cell agency was to fund research that the federal government did not. At the time, the focus was on the Bush ban on financing hESC research.

Ken Aldrich, co-chairman of International Stem Cell, circulated the Scientific American article, touting its significance.

We found this posting on the Stem Cell Pioneers web site in which Aldrich said,

“We at International Stem Cell Corporation (ISCO.OB) are finding it increasingly gratifying that mainstream and highly respected publications like Scientific American are now beginning to take notice of the fact that our parthenogenetic stem cells may well turn out to be a viable alternative to the embryonic stem cells that have dominated research and headlines for the last 10 years.

"Like embryonic stem cells, our parthenogenetic stem cells can be converted into almost any kind of cell that might ever be needed for therapy, but can also provide a solution to the two biggest issues that have surrounded embryonic stem cell research: 1) the ethics of destroying a fertilized embryo, which our process never does, and 2) the problem of immune rejection by the patient. We hope you enjoy the attached article." 

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

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