Category Archives: Stem Cell Therapy

Directors of the California stem cell agency today approved a $30 million program that could generate "disease-in-a-dish models" that "have the potential to make drug discovery faster, more efficient and more personalized to individual patients."

The "human pluripotent stem cell (hPSC) initiative" is aimed at generating high quality stem cell-based tools for use by the researchers and drug developers.

The proposal includes four elements, one of which is a $300,000 collaboration with the NIH to develop cell lines from patients with Huntington’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. The plan includes a $4 million disease line award round, a $16 million core hiPSC derivation round and a $10 million stem cell bank round. The RFAs would go out in May of next year with funding expected early in 2013.

The initial staff memo on the initiative did not mention human embryonic stem cells, but a spokeswoman for the agency said they were not excluded from the effort.

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Efforts to speed development of stem cell therapies received a $27 million boost today from directors of the $3 billion California stem cell agency.

They approved two initiatives that grew out of recommendations from a blue-ribbon panel that CIRM organized last year to review its operations.

One element in the plan is a $12 million "bridging fund" that would apply only to current CIRM-funded projects in three areas: disease team grants, some early translational projects and clinical development projects. The bridging fund would provide up to $3 million for up to one year for each recipient.

As originally proposed by CIRM staff, CIRM President Alan Trounson would have been authorized to approve each project. However, the board altered that process to require board approval with "peer review input."

Director Shlomo Melmed, a senior vice president at Cedars-Sinai in Los Angeles, argued that leaving the decision to Trounson and staff could place Trounson in an "untenable" position and lead to second-guessing. Melmed and others also said that process could open the agency to public criticism.

Trounson and other staff members said that biotech firms often need speedier action than can be provided by a more extended process. Director Jonathan Shestack, a Hollywood producer, agreed, but he was the lone vote to oppose removing the authority from Trounson.

No biotech companies spoke out at the meeting concerning the proposal (see here for an earlier version of the plan).

The second part of the response to the review panel's finding is a $15 million "external innovation initiative" to support collaborative efforts of CIRM grantees to work with teams that CIRM said are "making extraordinary progress outside California."

The $15 million program would provide awards as often as two times a year. The maximum amount on each award was not specified. The program was approved on a unanimous voice vote.

Ellen Feigal, CIRM's vice president of research and development, said in a memo to directors that examples of potential projects included collaborative efforts with the NIH and work with the Harvard Stem Cell Institute and its disease-focused programs. CIRM is planning to spend $300,000 over two years in work with the NIH.

Some of the latest CIRM initiatives are open to biotech businesses. Others are open only to non-profit or academic researchers.

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The California stem cell agency said the audiocast today of its directors meeting in Los Angeles is down but that the service provider is working to restore service.

As of this writing, the broadcast has been interrupted for nearly one hour. We will resume coverage if the audiocast is restored.

A footnote on the vagaries of the Internet: Here in Panama the government provides free WiFi to many areas. However, it also limits what can be seen or read. For example, YouTube is banned, also Internet broadcasts of college football games by CBS. If you look up odds on football games, those sites are barred as well. Certain information from cellular phone companies that compete with the firm that is financially backed by the government also cannot be accessed. And this morning, the government's WiFi network blocked the audiocast of the CIRM board meeting.  We picked it up after we found a private WiFi network about an hour after the meeting started.

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Directors of the California stem cell agency today approved a $5.6 million grant to bring a star researcher to California -- a Harvard scientist currently collaborating with a director of the stem cell agency.

The recipient is Zhigang He, who is negotiating with UC Berkeley, which also has a representative on the CIRM board, one who did not vote on the grant or speak during the discussion.

Responding to a query from the California Stem Cell Report, the researcher later said, "I am still talking to Berkeley about the details of my move."

Zhigang He Harvard Photo

CIRM governing board Oswald Steward, director of the Reeve-Irvine Research Center, Anatomy & Neurobiology at the UC Irvine School of Medicine , was also disqualified from voting or participating in the discussion. He left the room, saying that he has been "directly collaborating with this person."

The name of the Harvard researcher was not mentioned prior to the vote on the grant, although a member of the public, patient advocate Don Reed, told directors he knew the applicant and recommended him highly.

The grant is part of a $44 million recruitment effort by CIRM. It has awarded about $11 million to bring two researchers to California institutions, both of which have representatives on the CIRM board.

(An earlier version of this item said Zhigang He "is slated to go to work" at UC Berkeley, based on comments at the CIRM board meeting.)

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The Los Angeles Times, California's largest circulation newspaper with more than 900,000 subscribers, today said the "Geron fiasco" raises questions about the conduct of business at the California stem cell agency and whether it "does a disservice to patients and taxpayers."

The comments came in a column by Pulitzer Prize-winning journalist and author Michael Hiltzik, who wrote about Geron's abandonment of its hESC trial only five months after the firm was awarded a $25 million loan by the stem cell agency. Hiltzik said,

"So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. (CIRM Chairman Jonathan) Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

"The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers."

Hiltzik's column contained brief remarks from Thomas. The columnist wrote,

"'There are going to be fits and starts,' its chairman, Jonathan Thomas, told me last week. Even so, he maintained, 'we remain unwavering in our commitment to pursuing the science.'"

Hiltzik has followed CIRM since the 2004 ballot initiative campaign that created the $3 billion enterprise. The effort was headed by real estate investment banker Robert Klein, who later served as CIRM's chairman for seven years. Hiltzik wrote,

"CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

"These two goals have always been ethically and scientifically incompatible, and the Geron case points to why."

Hiltzik said evidence exists to show that CIRM "downplayed legitimate questions about the state of Geron's science and the design of the clinical trial" in its efforts to fulfill the excessive promises of the electoral campaign. The issues, he said, included over-promising results, questions by other researchers about the trial and whether a spinal cord injury was the best subject for the first tests of stem cell therapies on humans.

Hiltzik continued,

"None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

"CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using 'new criteria' and thus the public might not find the result 'meaningful.' Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant."

Hiltzik concluded,

"Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: 'CIRM is turning stem cells into cures.'

"Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer."

The California Stem Cell Report has asked CIRM Chairman Thomas if he would like to respond in more detail to the Los Angeles Times column, with a commitment to carry his remarks verbatim.

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The Los Angeles Times, California's largest circulation newspaper with more than 900,000 subscribers, today said the "Geron fiasco" raises questions about the conduct of business at the California stem cell agency and whether it "does a disservice to patients and taxpayers."

The comments came in a column by Pulitzer Prize-winning journalist and author Michael Hiltzik, who wrote about Geron's abandonment of its hESC trial only five months after the firm was awarded a $25 million loan by the stem cell agency. Hiltzik said,

"So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. (CIRM Chairman Jonathan) Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

"The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers."

Hiltzik's column contained brief remarks from Thomas. The columnist wrote,

"'There are going to be fits and starts,' its chairman, Jonathan Thomas, told me last week. Even so, he maintained, 'we remain unwavering in our commitment to pursuing the science.'"

Hiltzik has followed CIRM since the 2004 ballot initiative campaign that created the $3 billion enterprise. The effort was headed by real estate investment banker Robert Klein, who later served as CIRM's chairman for seven years. Hiltzik wrote,

"CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

"These two goals have always been ethically and scientifically incompatible, and the Geron case points to why."

Hiltzik said evidence exists to show that CIRM "downplayed legitimate questions about the state of Geron's science and the design of the clinical trial" in its efforts to fulfill the excessive promises of the electoral campaign. The issues, he said, included over-promising results, questions by other researchers about the trial and whether a spinal cord injury was the best subject for the first tests of stem cell therapies on humans.

Hiltzik continued,

"None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

"CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using 'new criteria' and thus the public might not find the result 'meaningful.' Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant."

Hiltzik concluded,

"Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: 'CIRM is turning stem cells into cures.'

"Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer."

The California Stem Cell Report has asked CIRM Chairman Thomas if he would like to respond in more detail to the Los Angeles Times column, with a commitment to carry his remarks verbatim.

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