Northwestern Is Lead Site for Geron hESC Trial

Northwestern this afternoon confirmed that it is the first site to be ready to accept candidates for hESC clinical trials with Geron, Inc., of Menlo Park, Ca. The Illinois organization is also the lead site for the unprecedented trial.

Northwestern's role surfaced during the weekend in a case involving a severely injured California jockey. See here and here.

Here is Northwestern's press release, which is not yet on its Web site. (The item subsequently was posted here.)

NORTHWESTERN FIRST SITE OPEN FOR SPINAL CORD STEM CELL TRIAL

Northwestern Medicine and RIC ready to enroll first subject in spinal cord injury study

CHICAGO --- Northwestern Medicine is the first site open for enrollment in a national clinical research trial of a human embryonic stem cell-based therapy for participants with a subacute thoracic spinal cord injury. Following the procedure, participants will receive rehabilitation treatment at The Rehabilitation Institute of Chicago (RIC).

Northwestern also is the lead site of the trial, sponsored by Geron Corporation (Nasdaq: GERN). The trial eventually will include up to six other sites and enroll up to 10 participants nationally.

“We are very pleased to be the first participating center in the world’s first human embryonic stem cell clinical trial for spinal cord injury,” said lead national investigator Richard Fessler, M.D., professor of neurological surgery at Northwestern University Feinberg School of Medicine and a surgeon at Northwestern Memorial Hospital.

“Injection of oligodendrocyte progenitor cells directly into the spinal cord lesion is a rational way to attempt to arrest or reverse the structural damage in the spinal cord caused by severe trauma,” Fessler said. “We are eager to begin evaluating the effects of these cells in subjects with severe spinal cord injuries.”

“RIC is a vital member of the research team for this novel stem cell clinical trial,” said David Chen, M.D., medical director of the RIC Spinal Cord Injury Rehabilitation Program. “RIC’s team of spinal cord injury rehabilitation specialists is responsible for customizing the rehabilitation care plan and therapeutic intervention for each participant, which may include robotic walking therapy and other procedures to facilitate the participant’s neurologic repair and recovery. At RIC, restoring the participant’s ability is our objective and the scientific application of embryonic stem cells offers new hope for recovery.”

The primary objective of the phase I trial is to assess the safety and tolerability of special cells called human embryonic stem cell-derived oligodendrocyte progenitor cells when they are injected into the spinal cord injury of paralyzed subjects. The injuries have to have occurred within two weeks for someone to be eligible for the procedure.

In addition to evaluating safety, the secondary aim of the trial is to see if the stem cells improve neuromuscular control or sensation in the trunk or lower extremities.

In previous animal studies, these stem cells have demonstrated the ability to remyelinate or recoat damaged nerve cells that have lost their ability to conduct electrical impulses down the axon. The stem cells also have shown nerve-growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury.

“The trial is supported by positive animal research,” Fessler said. He noted the trial is using the lowest dose possible for a human based on the animal studies.

Subjects eligible for the Phase I trial will have documented evidence of functionally complete (ASIA Impairment Scale grade A) spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between 7 and 14 days after injury.  For more information, go to information pages of Geron’s website at www.geron.com.

Clinical Trial Challenges: The Matter of Michael Martinez

The complexities of finding candidates for clinical trials as ground-breaking as the hESC effort by Geron were touched upon indirectly in news coverage of the case of jockey Michael Martinez.

This morning the San Francisco Chronicle noted that the state workers' compensation department played a negative role in the matter. Earlier, the Daily Racing Form reported that Highland Hospital in Oakland, Ca., initially refused to release Martinez' records because he could not give consent.

Here is what reporter Larry Stumes wrote this morning:

"The decision by Dr. Richard Fessler of Northwestern University came late Monday after a tumultuous day in which Martinez was to be transferred from Highland Hospital in Oakland to UCSF for a high-resolution MRI exam. The transfer was canceled when the state Division of Workers' Compensation refused to authorize it.

"'The doctors at Highland weren't entirely in favor of the transfer and in an e-mail to Dr. Fessler they indicated that they thought that Michael was doubtful as a candidate for the embryonic stem-cell treatments,' said Golden Gate Fields physician Dr. David Seftel, who is advising Martinez's family on his care. 'The family is devastated, but we're regrouping. I don't give up; Michael doesn't give up.'

"Seftel has contacted Dr. Jorge Paz Rodriguez, the medical director of the Stem Cell Institute of Panama - Martinez's native country - regarding adult stem-cell therapy.

"'The benefits of adult stem-cell treatments have been relatively modest, confined to improvement in sensation, bladder control and bowel control,' Seftel said. 'But because it is so soon after the injury, it is possible Michael could get some of his motor control back. The sooner we get him to Panama, the better.'"

Here is what Chuck Dybdal of the Racing Form wrote.

"After initially refusing to release Martinez’s records so that Northwestern University’s physicians could review them, Highland Hospital agreed late Friday to release them. Highland had cited laws that prohibit the release of the records to anyone but Martinez, who has been rendered incapable of responding to specific requests because of the nature of his injuries."

More Info on hESC Treatment of Jockey with Severed Spinal Cord

Benoit & Associates

Jockey Michael Martinez (left), with cousin Alex Solis.

More details are emerging on the possible use of experimental hESC treatments within the next two weeks on a California jockey with a severed spinal cord.

According to an article yesterday by Chuck Dybdal in the Daily Racing Form, which appears to have carried the first account of the possible treatment, it involves neurological specialists at Northwestern University, presumably at the Acute Spinal Cord Injury Center at Northwest Memorial Hospital.

(Subsequently, it appears that the first story may have been in the New York Daily News on Sunday.)

The center is a nationally recognized leader in spinal cord injury treatment, one of only 14 model systems in the country for spinal cord injury treatment. The center's Web site says it is involved in using stem cells to repair damaged spinal cord and is aggressive in placing patients in innovative rehabilitation programs.

Richard Fessler, a professor of neurological surgery at Northwestern, is evaluating the jockey's MRIs, which are being taken at UC San Francisco, according to a story on page B6 of the sports section of the San Francisco Chronicle.

Neither the story in the Racing Form or in the Chronicle mentions whether treatment involves Geron, Inc., of Menlo Park, Ca., which is conducting the only hESC clinical trial in the country.

In response to a query, Anna Krassowska, a spokeswoman for Geron, told the California Stem Cell Report,

“As you know, there is no other hESC-based therapy cleared for clinical
trials. However, I can't shed any light on this story.”

We also have queried Northwestern and Fessler concerning the possible treatment of the jockey.

The Racing Form story said,

“(Jockey Michael) Martinez suffered a severed spinal cord in a Sept. 12 racing accident at Golden Gate Fields. He needs the MRI to determine if there is enough white matter – a component of the central nervous system that carries messages to and from the brain – for the stem cells to have a chance to work in the experimental treatments, according to Golden Gate Fields track physician Dr. David Seftel.”

Dybdal also wrote,

“After initially refusing to release Martinez’s records so that Northwestern University’s physicians could review them, Highland Hospital agreed late Friday to release them. Highland had cited laws that prohibit the release of the records to anyone but Martinez, who has been rendered incapable of responding to specific requests because of the nature of his injuries.

“A hearing was to be conducted Monday in an Alameda County court as Martinez’s parents, who have come to the United States from Panama, seek to become their son’s temporary conservators for health-related issues. If they are named conservators, Martinez’s parents could approve the experimental stem-cell treatments for their son.

“Martinez has shown continued progress from his injuries, Seftel said. He is able to eat soft foods and drink. All IVs except one have been removed.

“'He’s looking better and shows continual neurological improvement,' said Seftel.

“Seftel said the improvement in his condition would allow Martinez to be flown to Chicago on a private jet with a doctor and nurse in attendance, but that he would not need a specially equipped Medi-Vac flight.”

Geron's Clinical Trial: Risk, Front-loading and Costs

The Vatican doesn't particularly care for the idea. "Unacceptable" was the word it used.

Over at Bioworld Today, it was "the dawn of a new era."

A reader of the New York Times warned of the danger of "front-loaded" arguments that can be detrimental to stem cell research.

What they were talking about is Geron and its re-vitalized clinical trial of an hESC therapy for spinal injuries. The FDA late this week lifted its hold on the effort. Andy Pollack of the New York Times said "cysts were discovered in some mice injected with the cells. Geron had to do another mouse study and develop better ways to check the purity of its cells."

Pollack wrote,

"Years of further testing will be required before the therapy would be proven and ready for widespread use, assuming it works."

Among the readers of Pollack's story was a person from Seattle who said,

"As in the case of most things in science, we just do not know enough to say which scientific modalities will bear fruit first if at all and when and hence multi-pronged approaches are needed. And the field of stem cell biology painfully realized a few years ago, some of these discoveries are fads that cannot be replicated by others ( I am referring to Catherine Verfaillie's assertion that adult stem cells can do most of what embryonic stem cells can do, a claim that has since been refuted/ withdrawn or generally agreed to be highly exaggerated at best). The damage done to stem cell biology from that fiasco is still evident. Hence most scientists would agree that front-loaded arguments for and against particular technologies are dangerous and can be detrimental to general scientific progress."

(Verfaillie is a CIRM grant reviewer.)

Over at UC Davis, stem cell researcher Paul Knoepfler, writing on his blog, called it a “milestone,” but noted that while the potential is high, the risk is very high as well.

Donna Young, Washington editor of Bioworld Today carried a detailed account concerning the trial. Her story began,

"The FDA's blessing Friday of the world's first clinical trial of a human embryonic stem cell (hESC) therapy has not only launched what may be 'the dawn of a new era' for medical treatment, but if successful, the therapies could alleviate much of the burdensome costs plaguing the nation's health care system, insisted Geron Corp. CEO Thomas Okarma."

Most of the news reports did not mention the seminal role of UC Irvine in the research leading to the clinical trial. You can find more details about that here on the Califoria Stem Cell Report.

Geron Go-Ahead Rouses Industry and Researchers

Geron Corp. said today that it hopes to begin within the next two months a clinical trial for an hESC therapy for spinal injuries, triggering a wave of ebullience from scientists, investors and patient advocates.

The company disclosed its plans following the lifting by the FDA of a hold on the effort.

Clive Cookson of the Financial Times of London caught the global significance. He wrote,

“The world’s first treatment based on human embryonic stem cells is set to begin a clinical trial within the next two months, in patients with acute spinal cord injury.”

For patient advocate Don Reed of Fremont, Ca., it was an emotional event. Writing on his blog, Reed said,

“The research behind this ground-breaking event was paid for a California law named after my paralyzed son, the Roman Reed Spinal Cord Injury Research Act of 1999.”
Reed continued,

“Christopher 'Superman' Reeve gave us his blessing, saying, 'One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.' Cure did not come in time for our paralyzed champion, but we still believe in that great dream.”

Shares of Geron, a firm in Menlo Park, Ca., shot up 17 percent or 83 cents to $5.63. Analysts predicted skyrocketing share prices if the clinical trial proves successful.

Rob Waters and Molly Peterson of Bloomberg News interviewed Thomas Okarma, CEO of Geron. Bloomberg said,

"The FDA action strengthens Geron’s ability to start similar trials in the future, Okarma said. It also leaves regulators with a better grasp of how to review a completely new type of therapy.

"'It’s helped both of us to get up the learning curve together,' Okarma said. 'We’ve brought the FDA to a higher level of understanding which has been very positive and mutually beneficial. And phew, it’s about time.'"

Peterson and Bloomberg continued:

"Two other U.S. companies are working with embryonic stem cells. Advanced Cell Technology;of Marlborough, Massachusetts(and Los Angeles), is awaiting FDA approval to start a clinical trial in patients with Stargardt’s macular dystrophy, an eye disorder that causes severe vision loss.

"Viacyte, formerly known as Novocell Inc., a closely held San Diego company, is working on methods of turning embryonic stem cells into insulin-secreting cells for the treatment of diabetes."

Paul Knoepfler, a stem cell researcher at UC Davis, had predicted on his blog on July 1 that the FDA hold on Geron would be lifted “very soon.” Today he said,

"The hold was placed because of a 'higher frequency of cysts.' However many of us were wondering why the serious concern (and seemingly long hold) about non-tumorigenic cysts that were somewhat unremarkable in appearance. That remains unclear except that perhaps it was the "higher frequency" part. Despite being a bit puzzled about the length of the hold, I think in the long run caution makes sense."

CIRM President Alan Trounson said in a statement,

“This is an important milestone for the whole field to have an embryonic stem cell therapeutic in clinical trials. We are looking with hope and expectation that the transplant will be safe and effective.”

Geron is expected to be one of three firms (including Advanced Cell Technology) seeking funding from the California stem cell agency in its upcoming $50 million clinical trial round. The RFA was originally scheduled for May but was rescheduled for this month. CIRM appears likely to miss that target.

CIRM and the Stem Cell Industry: A Lobbying Question

The state of the stem cell/biotech biz drew some attention late last week in Business Week along with a piece on Stockpickr.com dealing with Geron.

Business Week reporter Ben Levisohn painted a depressing picture for most "middling" companies. He wrote that Big Pharma is buying Big Biotech – not the smaller companies. He said,

"That's bad news for small biotech companies, who are already facing a spate of problems. A recent study estimated that 50% of the roughly 380 publicly traded biotechs have less than one year of cash remaining. In the past, they would have raised new capital by selling shares, merging, or partnering with a larger outfit. But for publicly traded companies, equity deals are out—none has been brought to market in the last year, and few are expected to see the light of day in 2009. And even if a deal could be brought to market, with the smallest 10% of stocks in the Nasdaq Biotechnology Index trading down 84% from their 52-week high, vs. 21% for the largest 10%, an equity deal wouldn't make financial sense for many companies."

Over on Stockpickr.com, they had this to say,

"Over the last three months, shares of biotechnology firms Geron (GERN) and StemCells (STEM) are up roughly 200%, compared with a decline in the S&P 500 of almost 5% and a decline in the Nasdaq Biotechnology Index of about 3%.

"So why have both names massively outperformed the boarder market?"

Stockpickr laid out Geron's upcoming clinical trial and surrounding hoopla, but concluded:

"There are still several unknown variables that could take the short-term momentum out of both names."

The Business Week and the Stockpickr pieces could be construed as arguments for the $10 billion biotech aid package promoted by CIRM Chairman Robert Klein. However, the question for the stem cell agency is whether it should be in the business of lobbying the federal government on behalf of the industry. Klein would probably put the question another way: Should CIRM support assistance to the biotech biz so that therapies will result and suffering eased?

Rutgers' Young on Geron Trials

Wise Young, the director of Rutgers Center for Collaborative Neuroscience and a grant reviewer for CIRM, has pulled together a fine overview of the science and media coverage of the Geron clinical trial.

In a piece complete with numbered footnotes, Young (see photo) wrote,

"The media response was massive [18]. The story was carried by almost every news source [18-20]. The community response was initially strongly positive. Coming on the 3rd day after President Barack Obama’s inauguration, some thought that the approval of the first HESC trial was due to Obama’s coming to power.

"The exuberance faded as people read the fine print. First, the trial is not for people with chronic spinal cord injury. It is intended to be used within 2 weeks after injury for people with complete thoracic spinal cord injury. Second, the goal of the trial is to show safety and feasibility, not necessarily efficacy. Third, the cells have been differentiated to the point that they are no longer acting as stem cells but only as oligodendroglia."

Young also wrote,

"Geron’s web site and news reports indicate that the trial will treat 8-10 patients who are within 2 weeks after “complete” thoracic spinal cord injury. It will probably start in July 2009. However, many details are unclear. Before the FDA placed a hold on the trial application in May 2008, Geron had said that the cells would be transplanted into the spinal cord of patients undergoing spinal cord decompressive surgery and all the patients will receive a 2-month period of pharmacological immunosuppression . It is not clear that the same regimen will be used.

"In the meantime, the reaction of the spinal cord injury community has ranged from exuberance over the approval of the first HESC trial [22] to deep pessimism over comments by Okarma, who said that people with “complete” spinal cord injury have no chance of recovering any function, or something to this effect. Many people in the spinal cord injury community [23] were disappointed at being excluded from the study which is only for the newly injured."

Geron: Stock Market Star?

The Wall Street Journal reported today that Geron has become a "sudden star" on the options market.

The piece by Rob Curran said,

"On the options market, about 24,500 call contracts giving the right to buy the stock traded against 3,600 put contracts giving the right to sell, according to TrackData.

"At 4 p.m. (Monday) in Nasdaq Stock Market trading, Geron was up 15% at $8.15. That follows Friday's roughly 36% jump.

"Shares of the developer of therapies based on stem-cell research had languished in recent years along with academic and corporate research in its niche of genetic medicine. The shares rallied Friday after the U.S. Food and Drug Administration cleared the way for the first-ever trial of a therapy derived from embryonic stem cells. That sudden swing and the promise of more like it is what drew options traders to the stock Monday, said Frederic Ruffy, options strategist at Whatstrading.com.

"'The volatility in the share price attracts a lot of option traders,' Mr. Ruffy said.

"'One of the themes you can make a lot of money with is if you can ... predict new policies,' said William Lefkowitz, derivatives strategist at vFinance Investments. 'You don't really need results to make lot of money at the beginning of the administration.'"

At the time of this writing Tuesday morning, Geron stock stood at $7.55, down 7 percent.

If you cannot access the WSJ story and would like to see it, send an email to djensen@californiastemcellreport.com and I will send it to you.

Trounson and the California Stem Cell Story

As part of his job, CIRM President Alan Trounson trots around California and elsewhere, telling the story of how and why the state is pumping $3 billion into human embryonic stem cell research.

If you would like to hear one of his talks and see the PowerPoint presentations that he uses, you can do so by going to the web site of the Milken Institute, an economic think-tank in Santa Monica, Ca.

The institute is offering a two-hour video of Trounson, including his responses to questions following his talk last Thursday (Jan. 22). Trounson has an accessible and easy speaking style, and his presentation slides are downloadable.

Some of the highlights:

Trounson almost let the Geron cat out of the bag although by the time of his talk, the information had already been fed to a number of media outlets, including the New York Times and the Wall Street Journal for publication on Friday.

Trounson had high praise for his tiny, 38-person staff. He noted that CIRM operates with a 6 percent administrative budget cap, compared to 10 percent to 12 percent for administrative costs in other similar organizations with some running as high as 25 percent.

He predicted as many as 100 applications in the upcoming $210 million disease team grant round, which is part of the $1 billion that CIRM has already specifically committed to funding. The disease team round is one of the largest given by CIRM.

He said the performance of grant recipients is closely tracked with under-performers being advised to get their "underdone bits" properly done.

In response to a question about the $40 billion California state budget crisis, Trounson said it is having an "impact." But he said, "We are well insulated from the effects of politics and the economy." Trounson said CIRM has enough money to "get through about October." He noted that CIRM Chairman Robert Klein is making contingency plans should California be unable to sell the bonds that provide the funds for CIRM.

The budget deadlock and CIRM's budget is also up for discussion at the CIRM board of directors meeting this Thursday and Friday.

Geron Price Still Moving Smartly Upward

Geron rose sharply again today, closing at $8.15, up 15 percent for the day.

Barrons reported that Needham Research upgraded its recommendation on Geron from hold to buy with a $9 price target. Needham said "significant unmet needs" exist "in the management of spinal-cord injuries."

Needham also said that Geron previously reported it had $165 million available at the end of 2008 with a projected burn rate of $50 million -- "financial resources...sufficient for operations for several years."

Meanwhile Motley Fool reported that a large group of its readers gave Geron a "distressing two-star ranking," meaning that it might lag the market.

Pluses and Minuses in the Geron News Coverage

Media coverage and commentary continued to ripple out today on the Geron clinical trial announcement, generating considerable attention also on California's $3 billion stem cell research effort.

While CIRM has not played a role in the Geron research, the agency's expertise has popped up in many stories with quotes from President Alan Trounson and Chairman Robert Klein along with references to the size of the state effort. All of which helps meet one of the agency's goals of becoming a key media source in all things stem cell.

As usual in such events, the initial coverage on Geron generally tended to be favorable for both the company and for stem cell research. Television news coverage also surfaced, which is rare on stem cell issues. There is no doubt that the Geron announcement is important in establishing a favorable public view of both the science and the business. The expected Obama administration changes in federal stem cell research rules will add to the positive climate and are likely to come in the near future.

But some not-so-ebullient views could be heard as well. The San Francisco Chronicle editorialized this morning that the Geron trials are a "a cautious but unmistakable advance."

The Chronicle continued,

"At this early point, it's mainly about testing the safety of the treatment. That's a key issue because a harmful result or botched trial could set back the stem cell cause immeasurably, a risk that researchers acknowledge."

Reporter Steve Johnson of the San Jose Mercury News wrote,

"California's $3 billion effort to fund such research, launched in 2004, illustrates some of the obstacles federal officials could face in trying to lure companies to begin such studies.

"Aside from being hindered by legal challenges during its first few years, California's program has funneled the vast majority of its money so far for basic research at universities and other nonprofit institutions. And for a variety of reasons — ranging from a lack of investors to skittishness over the ethical debate surrounding the cells — only a handful of companies in the state are experimenting with embryonic stem cells on their own, despite predictions that the effort would quickly bring about a job boom.

"'I would have expected there to be more interest' among businesses, said Alan Trounson, president of the California Institute for Regenerative Medicine, which voters created in November 2004 by passing Proposition 71."

Senior columnist Adam Feuerstein of TheStreet.com had an even bleaker view. He wrote,

"I say don't buy into the hype.

"Geron has a long track record of over-promising and under-delivering. In fact, the company's only real accomplishment after years and years of effort has been to burn through tons of shareholder cash.

"Before you send emails that blast me for spitting on stem-cell therapies, understand that my cynicism is directed at Geron, not the promise of stem cells. Today's news was well orchestrated by Geron -- a splashy story in The New York Times, a conference call and an appearance on CNBC. But let's get real: Geron is starting a small phase I study, and with Friday's run, the stock's market cap now stands around $600 million. And for that, you get very little.

"Sorry, but Geron looks more like a short to me than a long."

Stanford's Christopher Thomas Scott released a statement that said,

"President Obama's intention to lift the restrictions on embryonic stem cell research, Congress' promised actions to legislate funding, and Geron's announcement are three important steps to a long road for cures and treatments. After an eight year drought, patience is needed. The federal government must retool those agencies and institutes bereft of stem cell expertise. The NIH must appropriate funding at a level needed to produce the kinds of results we need to have more encouraging news from the private sector. Finally, the states must enact policies that are in step with the new vision in Washington. This will take time. Once the US is back on track, then it can do what it does best: discover, translate, and develop the science and treatments for its citizens."

Here some links to other interesting stories on the Geron trial and its implications:ABC News, Wired News (Trounson heavily quoted), The Associated Press and the Los Angeles Times.

Geron Stock Finishes Day up 36 Percent

Geron stock closed at $7.09 today, up 36 percent with the biggest one-day gain in five years, according to Bloomberg.com.

Bloomberg said,

"The FDA’s action may help pave the way for other companies to get permission to start their own trials, said Christopher Thomas Scott, director of Stanford University’s Stem Cells in Society program.

"'Geron is a path-breaking company in getting the first stem-cell trial,'Scott said in a telephone interview yesterday. 'The message is that FDA now feels comfortable with the measure of risk the first trial will contain for the first few patients.'

Bloomberg continued,

"Two other U.S. companies, Advanced Cell Technology Inc. of Los Angeles, and closely held Novocell Inc., based in San Diego, are using embryonic stem cells to develop therapies and are working to begin clinical trials.

"Less than one biotechnology drug out of three that enter clinical trials is approved, said Joseph DiMasi, an economist with the Tufts University Center for the Study of Drug Development in Boston. That risk of failure also applies to Geron, which has spent $45 million preparing an FDA submission on the stem-cell treatment."

UCI Touts Role in Geron Trials

The University of California, Irvine was quick today to put out a news release on its role in development of the Geron therapy that is now moving into history-making clinical trials.

The school headlined the release: "UCI behind world's first embryonic stem cell study in humans." And it said,

"A therapy developed at UC Irvine that made paralyzed rats walk again will become the world’s first embryonic stem cell treatment tested in humans."

Specifically mentioned were Hans Kierstad (see lower photo) and Gabriel Nistor, who published their work in 2005, generating considerable international attention. Kierstad's smiling face dominated the entire home page of UCI today. We asked Nistor to send us a photo which is at the top.

The release also noted that UCI has received more than $52 million from the California stem cell agency. It did not mention that Susan Bryant, vce Chancellor for research at the UCI School of Biological Sciences, and Oswald Steward, director of the UCI Reeve-Irvine Research Center at the campus, sit on the agency's board of directors.

Stem Cell Stocks Rising on Geron's Good News

Geron's high-flying coattails are having a sharp impact today on the prices of some of its competitors.

Streetinsider.com reported earlier today that Aastrom Biosciences, Inc., of Ann Arbor, Mi., and StemCells Inc. of Palo Alto, Ca.,, both jumped 30 percent. At that point, Geron was up 50 percent. (StemCells Inc. was founded by Irv Weissman of Stanford, Fred Gage of the Salk Institute and David Anderson of Caltech.)

Meanwhile scientist Hans Kierstad of UC Irvine or one of his associates has emblazoned "a flash" on the website at California Stem Cell Inc. Geron's hESC therapy is based on technology invented and co-developed by Kierstad and Gabriel Nistor, also of UC Irvine. Kierstad is the chairman of the California Stem Cell scientific advisory board, of which Nisor is also a member.

At the time of this writing, Geron's stock price stood at $7.64, up 47 percent.

Magnus: Do We Need More Guidelines?

"Too little, too late." That's what Stanford ethicist David Magnus has to say about the recommendations released last week concerning embryonic stem cell research.

The proposals came from the International Society for Stem Research. But Magnus asked, "Do we really need another set of guidelines."

Writing in the San Jose Mercury News, he said:

"The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

"All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells."

Magnus also said that the "one really novel stand" from the group concerned payment for eggs for research. He continued:

"The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

"Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance."

The recommendations have been praised by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who said:

"We are pleased the international guidelines stress public benefit and we will continue to insist that California's regulations provide affordable access to any discoveries or cures resulting from research funded by the state program. Too often stem cell advocates have hyped the immediate benefit of stem cell research. I'm delighted to see the call for realism. The Scientific Strategic Plan for the California Institute For Regenerative Medicine already reflects that realistic approach."

Reporter Terri Somers of the San Diego Union-Tribune quoted Larry Goldstein, an ESC researcher at UC San Diego and a member of ISSCR task force, as saying.

“Realizing that stem cell research is an international community, we have to be able to share cells and our scientific methods across borders with some confidence that we have been doing our work to some agreed-upon ethical standards.”

The Stem Cell Race: How California is Like the Cobbler's Children...Sort Of

California's stem cell effort, still yet to dispense a single research dollar, has served as lever globally to boost funding for the field in locations ranging from New Jersey to Australia.

That's one of the conclusions of the third article in a three-part series in the San Diego Union-Tribune called "The Stem Cell Race."

Written by reporter Terri Somers, the piece examines California's $3 billion effort, which has been hampered by a legal tussle over its legitimacy. Somers wrote:

"While San Diego's large stem cell research community has been waiting to tap the state funding, the Harvard University area – supported largely by philanthropists – has become the U.S. science cluster best known internationally for embryonic stem cell research.

"Also pushing ahead have been the governments of Singapore, China, Japan and several European nations, which have supported their embryonic stem cell scientists with money and favorable policies.

"'Proposition 71 is supposed to help the economy by creating jobs first, then new tools and treatments, but until it really gets moving it's just an old Jag in the garage," said Tom Okarma, chief executive of Geron, a Menlo Park stem cell research company."

Somers continued:

"New York Gov.-elect Eliot Spitzer plans to push a $1 billion 10-year stem cell initiative that mirror's California's. On Friday, New Jersey's legislature approved borrowing $270 million to fund stem cell research. And Connecticut has floated a $100 million 10-year initiative. Part of the states' impetus was the fear of losing top researchers to California and abroad."

The San Diego article also reported:

"Scientists and government officials from 15 nations have visited the stem cell institute over the past year, said Zach Hall, the institute's president. Delegations from India, Israel, the United Kingdom and China were eager to forge relationships and take home ideas and the possibility of collaborations."

Nonetheless, Somers reported that 30 "notable" scientists have come to California in the last two years because of the state effort. An informational graphic with the story showed that private and federal funds totalling $234 million have poured into the state, boosting research efforts. And she noted that CIRM now has $181 million in hand, ready to dispense on research.

"'With these loans California's funding is now six times the nation's funding through the (National Institutes of Health) and California is squarely in the global leadership of this breakthrough field of medical research,' said Robert Klein, chairman of the California Institute for Regenerative Medicine."