Sickle Cell Trial, Backed by $2 Million from State of California, Will be Based in Los Gatos

More details emerged today about a $2 million sickle cell award and clinical trial involving the California stem cell agency, including the location of the trial in Los Gatos and the involvement of a Stanford University researcher. 

The award was approved last Friday by the agency. It went to a Canadian firm, ExCellThera, Inc.,  which is partially matching the state award with $857,143. With the addition of ExCell, the stem agency is now involved in 63 clinical trials. 

                                                                                                                  

The company said yesterday that the Phase 1 trial, which involves safety, will use its ECT-001 product, and will be conducted at the Lucile Packard Children's Hospital. It will be led by Sandeep Soni of Stanford University. The safety phase trial is aimed at children and young adults.

Guy Sauvageau, CEO and founder of ExCellThera, said in a news release.

"The current standard of care for severe sickle cell disease is a blood stem cell transplant, which is only available to patients who have a matched donor. 

“However, the unique properties of ECT-001 cell therapy enable patients without a matched donor to receive treatment, with a greatly reduced risk of post-transplant complications. This study introduces a new indication into the ongoing evaluation of our ECT-001 technology, which we hope will make this life-saving therapy available to a far greater number of  severely ill patients."

The trial has not yet been posted on clinicaltrials.gov. It is not clear whether recruitment of patients is  underway.  Here is a link to a summary of  the stem cell agency's review of ExcellThera's application (CLIN2SCD-11674).

California Award Recipient: 'Promising' Results from Chinese Stem Cell Trial for Knee Arthritis

Cellular Biomed has a four-year U.S. history

A Chinese biomedical firm that popped up last month with an award from the $3 billion California stem cell agency is working with the University of Southern California and Children's Hospital in Los Angeles to ready an arthritis therapy for a clinical trial in the United States.

The publicly traded enterprise is Cellular Biomedicine Group, Inc., which has an office in Cupertino, Ca., as well as China. It was awarded $2.3 million from the California Institute for Regenerative Medicine or CIRM, as the state stem cell agency is formally known.

The company said in a press release that the therapy, known as AlloJoin, is already in a phase one clinical trial in China where it is showing "promising interim 3-month safety data." The company described the therapy as an “off-the-shelf, allogeneic, human adipose-derived, mesenchymal stem cell" treatment.

Qing Liu-Michael, USC photo

Thomas Vangsness, USC photo

The company said it is working with C. Thomas Vangsness, Jr., at the Keck School of Medicine at USC, and Qing Liu-Michael of the Broad Center for Regenerative Medicine, also at USC. Vangsness will be principal investigator on the company's phase one U.S. trial.


The company said the CIRM grant is the first step in bringing its arthritis treatment to the United States. It is also contributing $572,993 to the work  being funded by the state agency.

In an interview last week with Javier Hasse of Benzinga, an online financial information site, Tony Liu, chief executive officer of Cellular, said his company is also working on  immune cell therapies involving cancer. He said his company's focus is on China because of the size of the market.

Liu said,

"In China, 57 million people have a knee issue; in the U.S., 27 million [people] have a knee issue. Stem cells can help knees regenerate by doing two things. First, by helping with the pain, providing symptom relief and functional improvements. Secondly, they regenerate the cartilage, which originally caused the knee problem. Nowadays, patients can only opt between pain pills or a knee replacement.

Today, if you do a knee replacement, you are looking at tens of thousands [of dollars]. So, any way you look at it, [it’s a] multi-billion [market] for knee treatments."

Liu continued,

“Our management team was educated in the U.S., and has experience managing large businesses.... “Our chief scientific officer is a former MedImmune/AstraZeneca plc (ADR) (NYSE: AZN) director. Some of our oncology scientists are from there as well. We also have scientists from the National Cancer Institute. We also have a person who is leading our manufacturing capabilities who worked for Harvard for 30 years and a top German company, leading research for seven years total.”

“So, we have this kind of people with skills come to China. Our company has 130 people with PhDs, and more than 30 with post-doctorate studies, so there is a lot of brain power, I believe, and we have a  common vision that is to create the best, first in class, biotech business in China.”

As for the company's finances, Liu said,

"CBMG’s stock is really thinly traded. Much of the stock is owned by those who have been with the company for a long time; so, they don’t sell. Having said this, there are many reasons that drive stocks: the U.S. election, the pricing discussion… Many investors don’t discriminate, and just punish biotech as a whole. However, CBMG is not really subject to most of these pricing pressures. In fact, because we have a different cost structure, I expect CBMG to do extremely well." 

California Stem Cell Agency Up to State Snuff on Cyberspace Security

Highlights

Most state departments deficient

Agency says it's okay

Foreign stem cell collaborations

The California state auditor this week warned that a host of state agencies are poorly secured and vulnerable to intrusion, but the California stem cell agency is apparently not now one of the miscreants.

In a report released yesterday, State Auditor Elaine Howe said that 73 of the 77 state departments answering a recent security standards survey said that they were not in compliance with security standards.

A story by Jon Ortiz and Jim Miller in The Sacramento Bee said that most departments “have not planned for interruptions or disasters” and five departments audited more closely all had “security deficiencies.”

The Bee story said state departments’ databanks are “stuffed with Social Security numbers, medical records, tax return data and other sensitive information.”

The $3 billion California stem cell agency is one of those departments filled with sensitive data, including proprietary information that is submitted as part of applications for the billions that the agency is handing out.

Responding to a query today from the California Stem Cell Report, Kevin McCormack, senior director of communications for the agency, said that the agency was surveyed by the auditor and now meets state standards. He said,

“We were one of those 77 departments.  We did not have security deficiencies as such – in that we put confidential information at risk – but some aspects of our site were not in full compliance with the state standards, for example not having a link to all previous privacy policies and the dates they were in effect. So we put together a plan of action on how to correct the problems, that plan was approved by the state and those changes have been implemented.”

McCormack continued,

“The question of proprietary information was one of the things we had to address, namely showing all the protections we have in place in our Grants Management System which is the only place that any kind of proprietary information is kept. Because that system already requires separate log in and password protections those met the state standards without any changes being necessary.” 

The agency has awarded tens of millions of dollars to a variety of businesses. It also has relationships with researchers in a number of countries, including China. 

Periodically news surfaces about Internet theft of business information by Chinese interests, including in the world of biotech and pharmaceuticals (See here, here and here.)

China is also widely believed to have ambitious stem cell research aspirations, although current specifics are scarce.  In May, however, Reuters skimmed off a quick look at Chinese biotech. Earlier this month, China announced regulations aimed at both clearing the way for human research and regulating rogue stem cell clinics. (See here also.)

The California research involving a Chinese collaborator does not allow the collaborator password access to the stem cell agency’s grant management system, McCormack said.

“None of the collaborative funding partners, foreign or domestic, can access our (grant management system). We explicitly make clear in the rules for these collaborations that we take care of the California portion of the funding and their respective agency/government/institution, etc., takes care of their portion. The California researchers would have access to our (system)  through a protected log in and password but not their collaborative funding partner.” 

The collaboration involving the China research is connected to a $1.5 million grant to Holger Willenbring, associate director of the UCSF Liver Center, who has received a total of $4.7 million from the stem cell agency. 

The latest progress report on his research on the agency’s Web site said,

“The objective of this project is to establish the feasibility of liver cell therapy with human induced hepatocyte-like cells (iHeps). As proposed we established the feasibility of generating iHeps from several expandable, potentially autologous human cell types. We identified transcription factors effective in inducing hepatocyte differentiation as well as further maturation of these cells. We also identified small molecules and culture conditions (extracellular matrix composition and stiffness) that promote proliferation and hepatocyte-specific differentiation. The next steps are to investigate the genomic integrity and therapeutic efficacy of these cells.”

Here is a link to 2014 information about Willenberg’s research.

'Sun Never Sets on CIRM' – California Agency Awards $69 Million to Researchers

The California stem cell agency today awarded $69 million in grants, including the first involving a collaboration with researchers in China, but none of the awards went to California biotech businesses.

The awards were made in the agency's third translational round, which funds projects that are in the initial stage of identifying drugs or cell types that could become drug therapies.

CIRM originally allocated $95 million for the round, but CIRM spokesman Kevin McCormack said that grant reviewers determined that no applications beyond $69 million were worthy of funding.

The CIRM governing board overturned a negative reviewer decision on one grant after the scientist – W. Douglas Boyd of UC Davis -- filed an appeal. The appeals of two other researchers, including one from a San Diego business, were not successful (see here and here).

CIRM did not disclose the number of applications from businesses. The agency has been sharply criticized for failing to fund businesses in a substantial way.

The approved grants involve collaboration with researchers in Australia and Germany as well as China. The collaborations are based on agreements worked out earlier by CIRM with overseas groups, which fund their own countries' researchers. No CIRM cash is involved, according to the agency.

CIRM President Alan Trounson, a native of Australia and researcher there until joining the stem cell agency, said in a press release,

"The sun now never sets on the CIRM collaborative projects..."

The news release also said,

 "The Chinese Ministry of Science and Technology has committed roughly $850,000 in collaboration with a team at UCSF to study liver failure. This is the stem cell agency’s first joint effort with scientists in China, which is home to a fast-growing stem cell research community."

The UCSF liver team is led by Holger Willenbring, whose goal is "to develop a source of autologous therapeutic cells for patients with liver disease who otherwise would require a liver transplant," according to the CIRM review summary. The agency did not spell out the details of how the collaboration would work.

All of the winning applicants, with the exception of a Salk researcher, work for institutions linked to at least one of the 29-members of the CIRM governing board. CIRM directors, however, are barred from voting or even discussing applications in which CIRM attorneys have determined there is a conflict of interest.

You can find the names of all the successful applicants in the CIRM news release.    

Trounson Talks Stem Cells in Qatar

Qatar Conference Center

If our readers in the Middle East are looking for a first-hand assessment of the state of stem cell research, they might want to take in the four-day conference this week in Qatar, which features the president of the $3 billion California stem cell agency.

Alan Trounson is one of a number of international stem cell notables at the session at the new Qatar Conference Center in the tiny nation in the Persian Gulf. The country is putting on the conference as a means of developing its own stem cell research capabilities.

Qatar had a gross national product of $129 billion in 2010, with a per capita income of $138,000, according to the U.S. State Department. The population is about 1.7 million, more than 75 percent of whom are foreigners with temporary residence status.

In addition to Trounson, other California and CIRM-connected researchers are speaking at the conference in the Qatar center, which just opened in December.  They include David Baltimore, Nobel Laureate and a former director of the stem cell agency. A company Baltimore co-founded, Calimmune, of Tucson, Az., is sharing in a $20 million CIRM grant. Other CIRM grant recipients or representatives of recipient companies appearing at the conference are Irv Weissman of Stanford; Deepak Srivastava of the Gladstone Institute, and Ann Tsukamoto Weissman of Stem Cells Inc. of Newark, Ca.

Social activities at the conference include sand dune "bashing" in off-road vehicles, camel tracking along with a look at their "robot jockeys" and a visit to the original Arabic Oryx farm.

CIRM and Aussie Hopes

Earlier today we carried an item about the hope of some Australian stem cell researchers that California would come to their financial aid.

We queried CIRM concerning the news report. Don Gibbons, CIRM's chief communications officer, replied,

“We are in discussion with the the Australian MRC regarding a potential
agreement like the one we have already for the state of Victoria. It would
be bound by the same stipulations as all our other international agreements,
which means California money would only fund Californians. I think the folks
there hope the opportunity to leverage both their monetary and intellectual
capital with ours might encourage more government support there.”

Gibbons also said the reporter on the Australian story, Andrew Trounson, was not related to Alan Trounson, the president of CIRM and former Australian stem cell researcher.

Aussie Stem Cell Scientists Looking for Help From California

Life is not so good for Australian stem cell researchers, and they are hoping that the $3 billion California stem cell agency can make things better.

At least so says a news report from Down Under. According to The Australian newspaper, proposed government funding for stem cell research will be slashed by 50 percent next year.

However, the article said,

“The scientists are hoping negotiations for a potential joint funding deal between the National Health and Medical Research Council and the $3 billion California Institute for Regenerative Medicine will deliver extra cash.

“The California institute, run by Australian stem cell pioneer Alan Trounson, has a joint deal with the Victorian government.

“Speaking from San Francisco, Professor Trounson told The Australian he was hopeful an agreement could be reached.

"'We can fund research together or we can do it independently, but if you do it independently you have to resource these teams adequately,' he said.”

Trounson was director of the Monash Immunology and Stem Cell Laboratories at Monash University prior to joining CIRM in 2008.

It is not clear how California could legally provide meaningfiul financial assistance to Australian stem cell researchers. CIRM is barred from spending research funds out-of-state, which Trounson apparently refers to in his comment about “independently” funding research.

We are querying CIRM regarding The Australian article, including whether the writer, Andrew Trounson, is related to Alan Trounson.

CIRM News Release: More than $250 Million in Disease Team Round, Including International Partners

The California stem cell agency has posted its press release on the largest research round in its history.

The release notes that, with funding from international partners, the total comes to more than $250 million. The release also contains the identities of all the winning researchers and their institutions.

How the Lucky 11 Made Their Way: A $200 Million Tale

Seventy-three pilgrims started out on California's disease team trail last March, looking to share $210 million. Only 11 have finished, unless the men and women who control $3 billion decide differently.

The initial number of stem cell argonauts was substantially less than predicted by Alan Trounson, president of the California stem cell agency, which is financed by $3 billion borrowed by the state.

Last January, Trounson told CIRM directors that he anticipated more than 100 applicants. The prizes were alluring: up to $20 million each.

But only 73 teams filed “pre-applications,” Trounson said in April. Thirty-two of those were invited to submit full applications following CIRM's new grant triage process, which involved scientific specialists from outside California and CIRM staff.

In June, Trounson reported to directors that eight of the 32 invitees had commercial partners or were led by a business. Nine involved international collaborations, down from 18 in preliminary process. (CIRM reported scores on only 31 applications. Presumably one of the 32 did not apply or failed to qualify for some other reason.)

CIRM is ballyhooing the international aspects of the disease team round, whose original California budget was $210 million with up to 12 successful teams. The 11 likely winners account for only $167 million. But funds from the United Kingdom and Canadian teams will boost the combined total to $200 million, according to CIRM.

The results of the disease team round could be an important indicator of CIRM-industry relations. Some businesses have expressed dismay in the past with CIRM after their applications were denied, sometimes appearing at board meetings to vent their concerns. They are generally rebuffed by directors.

Trounson and others, however, have been talking for months about improving ties with the biotech. The updated strategic plan(also up for a final vote this week) calls for closer links. And Trounson has created a new position (yet to be filled), vice president for research and development, to help encourage more amicable relations. He is hoping to attract a candidate with industry experience.

CIRM reviewers rejected 20 disease team applications. Based on our latest look at the agenda, none have sought to overturn the result via the agency's “extraordinary petition” process. But those appeal letters often show up late publicly. Any applicant can also appear before the board and ask for reconsideration of reviewers' decisions for any reason. Few have.

Only four applications received scientific scores above 80. The highest was 90. The other seven ranged in the 70s. Rejected applicants fell below that line, although their scores are not released publicly. The general ranking of the unsuccessful applicants can be determined by examining the listing of the grants. CIRM has made a practice of ordering all the application summaries by their score. For example, application 1480 is the first to fall below the 70 cutoff. If CIRM follows past practice, 1480 has a much higher score than the last application, 1449, listed on the summary.

Sometimes CIRM directors have discussed whether the difference between a score of 70 and 68 has any significance. Those discussions usually come up when they are considering moving an application out of the “not recommended” category. Given that there is more cash available, some directors may move to approve an application just below the cutoff line.

Directors, with the exception of those on the grant review group, do not have access to the full application. Nor are the names of the individuals or institutions disclosed to directors, although considerable information is contained in the review summaries that provide clues to applicants' identities.

Directors also are barred from voting or even discussing applications in which they have a conflict of interest. Usually directors vote on the top-tier grants as a block, officially recording their votes with this language, “Yes, except for those on which I have a conflict.”

Since many of the 29 directors come from institutions that often have applications before CIRM, the votes of the “non-conflicted” board members (mainly patient advocate representatives) are very important in order to complete legal action on the applications.

CIRM has a supermajority quorum requirement – 65 percent – written into state law by Prop. 71, which created the stem cell agency. The quorum is based on those eligible to vote. While quorum and attendance problems have hampered the board with some frequency in the past, we suspect that will not be the case this week. CIRM Chairman Robert Klein has more than once emphasized the importance of the disease team round in terms of producing results that will help CIRM find funding to continue its work beyond the 10 years it can issue bonds.

CIRM Hopes for Big Media Splash on Disease Team Grants

The California stem cell agency today began trumpeting this week's disease team grants to the mainstream media, proclaiming that it means $200 million for researchers in California, the United Kingdom and Canada.

CIRM issued an advisory to news outlets, presumably globally, that a news conference will held at 11 a.m. PDT on Wednesday at the Luxe Hotel on Sunset Boulevard in Los Angeles. Six winning scientists will be available to answer questions, CIRM said, although the awards have not yet been approved by the CIRM board.

That, obviously, is a technicality. Grant reviewers have already made the de facto decisions, approving 11. Legally, however, the CIRM board has final say. It begins a two-day meeting at the Luxe tomorrow.

CIRM has promised the appearance of six government officials, including one each from the UK and Canada. Also on hand will be patients living with diseases targeted by the awards. Those are the folks who are going to be the selling point for TV coverage. They are much more sympathetic and appealing than say, for example, Herb Schultz, a senior adviser to the California governor and one of the six government officials who will be on the scene.

For those of you unfamiliar with PR drum-beating, the CIRM news advisory is the easiest part of the process. Phone calls will be made along with additional emails. Information specific to various areas will be fed to reporters and editors. Promises about exclusive interviews will be tendered. Whatever it takes. And that is as it should be if CIRM is going to make the most out of what it views as a critical round of grants that may have a lot to do with building support for its continued existence.

CIRM is barred from spending money out of state. Cash for the research in the UK and Canada will come from those countries, but the winning scientists have joined together in teams.

The news conference will be webcast at the following link: http://www.cirm.ca.gov/Disease_Team_Press_Conference

It will not be live until shortly before 11 a.m. Reporters not on the scene will be able to email questions to the news conference.

CIRM-China Agreement?

The $3 billion California stem cell agency has reached a collaborative research agreement with China, according to a news report on the Internet.

Here is what Richard Daverman of ChinaBio posted this morning,

“In a story postdated to Monday, October 19, 2009, The California Institute for Regenerative Medicine (CIRM) revealed it has signed an agreement to collaborate on stem cell research with China’s Ministry of Science and Technology.

“The announcement was little more than a headline. Details will most likely be released on Monday.

“CIRM was established in 2004 with a $3 billion budget earmarked for funding research on stem cells. CIRM’s charter required that the money would be spent over a ten-year period, and grants would be given only to California-based institutions, both public and private. It is not clear how CIRM will cooperate with MOST, given the second provision.”

As of this writing, we could find no other reports on the subject. We are querying CIRM concerning the item.

CIRM has a number of collaborative agreements in place that include such countries as Spain, Canada and Germany. The arrangements provide for creation of international teams of researchers who bid jointly for grants. CIRM funds only research in California. The other countries put up their own cash.

Germany Added to CIRM's Stable of Partners

The California stem cell agency today announced its sixth international agreement – this one with Germany – with the hope that it will lead to joint research in stem cell transplantation and immunology.

The agreement is intended to make it easier for researchers in California and Germany to obtain joint funding. As with the other agreements, no California funds are permitted to be spent outside of the state.

CIRM already has agreements with organizations in Canada, the state of Victoria in Australia, Japan, Spain and the United Kingdom.

CIRM's news release quoted California Gov. Arnold Schwarzenegger as saying,

“There are brilliant minds all over the world, especially here in California, and with collaborations like this we can help ensure that potentially life-saving breakthroughs can come more quickly and more often.”

In response to a query, Don Gibbons, chief communications officer for CIRM, said,

“We have over $60 million in commitments from our international collaborative funding partners.... There were a total of nine collaborative applications in the Disease Teams, with Canada, Spain and the UK represented, but of course we won’t know how those nine fared among the 31 until October 28(the next CIRM board meeting). There are a number of Japanese collaborations among the Basic Biology 2 awards that have just come in and are being assessed internally now.”

The only international grants awarded so far came last spring in the early translation research round. Four collaborations were funded for a total of $29 million($24 million California and $5 million Victoria) involving Alzheimer’s disease, Parkinson’s disease and techniques for working with embryonic stem cells.

Snippets: Creation of Stem Cell Argonauts, Klein and Biotech Outsourcing

Klein Farewell, Sort Of – Robert Klein's not-so-imminent departure as chairman of the California stem cell agency has received no major media attention. But the San Francisco Business Times picked up the story, citing both this Web site and Consumer Watchdog. You can read the Times piece here. Here is a link to The Pluripotent blog on which Michael Scott wrote, “Get ready my popcorn and nachos, waiting for the scene when Bob Klein dumps CIRM, CIRM gets all cried out, and begs her man back.”

Is State Stem Cell Funding Necessary? – Yes, is the answer from Susan Solomon, CEO of the New York Stem Cell Foundation. She gave the response in a speech Friday. While she did not talk about the effort in California, some have asked whether CIRM is needed, given President Obama's moves on stem cell research. She said the proposed federal hESC guidelines are likely to be more conservative than many had hoped. And she said federal funding for the most advanced human embryonic stem cell research will remain limited. The text of Solomon's speech was carried on the Huffington Post.

Sending California Biotech Jobs to China? – Or is it business-building international collaboration? Ask Tergegen of San Diego about the experience. Or ask the 46 employees the firm laid off this year. Peter Ulrich, founder and head of Targegen, told Helen Kaiao Chang of the San Diego News Network,

“The trick in biotech is to survive the period of time when you’re not making any money in product sales. Being able to utilize outsourcing to China enables more companies to survive the neo-natal process and grow up to be big companies. Collectively, they will employ a whole lot more people by surviving than not surviving.”

Ulrich was quoted in a piece leading up to Biocom's “CalAsia” conference, which began today in San Diego and runs through Tuesday.

The Stem Cell 'Gold Rush' – Legislation aimed at creating a host of latter-day argonauts for the biotech industry has passed the state Senate and is now before the Assembly. The measure – SB 471 – Sen. Gloria Romero, D-Los Angeles, and Senate President Pro Tem Darrell Steinberg, D-Sacramento, cleared the Senate on a 24-14 vote. The CIRM-backed bill would embed stem cell and biotechnology workforce training in the state's public schools. Mid Valley News quoted Romero as saying,

“California's next Gold Rush will be found in the Petri dishes and laboratories of this great state, but only if we produce the next generation of scientists, technicians and trained professionals capable of translating stem cell research into therapies and cures.”

(The vote in the Mid Valley story was incorrectly reported as 21-12, probably because the roll was held open and more votes were added after the initial approval.)

Monday Deadline for Canadians on CIRM's Big Disease Team Round

Canadian researchers have an urgent deadline to register for the competition for a piece of possibly as much as $210 million in team-funding in an international effort involving the California stem cell agency.

The collaboration is a Canadian-CIRM project (see item below) and is aimed at funding disease teams that will bring "an investigational new drug filing at the end of the four‐to‐five year grant."

Canadian registration is required by Monday Nov. 17.

The Canadians want the names of the PIs in both Canada and California and the following information:

"the scientifically mature opportunity, with strong preclinical proof-of-concept, to use cancer stem cells in the development of a therapy or diagnostic

"key milestones and deliverables required to achieve the objectives envisaged

"the nature of the partnership between the Canadian and Californian participants

"any anticipated commercial partnerships"

Here is a link to the registration document.

Canadian-California Researchers to Compete for Golden State Cash

The California stem cell agency said today that it will officially go international with an ambitious grant program that could run as high as $210 million.

CIRM released an announcement today aimed at alerting the California and Canadian stem cell communities of this "potential opportunity" and to encourage teams to begin work to snag some of the cash.

The collaborative funding effort involves the Canadian Stem Cell Consortium, which also participated in the joint announcement, and CIRM. The effort was ballyhooed last June but had few specifics.

Today's statement said the goal is to fund multi-disciplinary, disease teams of scientist to develop therapies for specific diseases. CIRM said,

"Successful proposals will include a description of milestones on a path to an investigational new drug filing at the end of the four‐to‐five year grant."

Funds are scheduled to be awarded next year. However, the specifics of the program have not yet been approved by CIRM directors, who are scheduled to take it up in December. Full Canadian approval is not yet in place as well. But both approvals are likely to be a formality.

The announcement may raise questions about the use of California dollars in an international research project. However, under the law, CIRM cash can only be spent in California. CIRM officials have repeatedly said that CIRM grants will be only spent on the California side of international collaborative efforts.

The announcement also raises another question about the fairness of the grant approval process in this case. Given the hooha about Canadian-California collaboration, it would seem that an application pegged to that effort would have an edge over competitors who only have a California program. At least, some other applicants might think so. But perhaps we're wrong.

If the grant round totals $210 million, it would be one of the largest rounds ever by CIRM.

UK, CIRM Ink Collaboration Agreement

The California stem cell agency has expanded its international connections once again, this time linking to the United Kingdom with an agreement that potentially will finance scientists working in California with scientists working half-a-world away.

No money, however, has yet been committed. Reporter Bernadette Tansey of the San Francisco Chronicle also reported that the touchy issue of ownership of IP has not yet been worked out.

The agreement was announced earlier this week. It follows similar agreements in June with Australia and Canada.

According to Maggie Shiels of BBC radio, CIRM Chairman Robert Klein said,

"...(O)ne of the diseases the CIRM was likely to focus on in the future would be stem cell therapy for a type of macular degeneration that leads to a blindness that affects 7% of the US population over 75.

"Mr. Klein said the UK was well ahead in animal trials in this field and that the deal could pave the way for earlier than hoped for human trials."

"'We are very hopeful that this collaboration can bring us together in human trials to prove the first global embryonic stem cell therapy. It will hopefully break open this entire field,' he said."

According to Monya Baker, writing on The Niche (the Nature magazine stem cell blog), Lord Paul Drayson, the UK minister of science, said,

"UK’s National Health System made his country particularly able to carry out clinical trials and gather clinical data."

Don Gibbons, chief communications officer for CIRM, was quoted as saying,

"We could do a one-off with an investigator in Paris, but that bogs us down."

Baker said the agreement permits CIRM to accept applications "under the same rules and avoid bureaucracy."

If Klein's optimism is borne out, the "break-through" on the first embryonic stem cell therapy could mean that Great Britain will be the first to see the clinical fruits of research funded at least in part by California taxpayers.

The UK/CIRM announcement received light news coverage. For example, Bernadette Tansey's story was tucked away on page D2 of the Chronicle.

A meeting is scheduled for January 2009 among scientists and others to determine the "most fruitful options" for collaboration.

Stem Cell Watchdog Warns of the Lure of the World Stage

San Diego – The Consumer Watchdog group today sounded a cautionary note on the international agreements involving CIRM (see item below) and warned that they "should be supported so long as they are based on scientific merit, not merely the glamor and glitz of playing on the world stage."

John M. Simpson, stem cell project director for the watchdog group, noted that California law requires that CIRM-funded research be conducted within the state. Prop. 71 also requires that California suppliers be given preference, an issue that is now before the California legislature.

Simpson said in a statement,

"If the collaborations are driven by the science, that’s great. If it’s a matter of saying let’s go international, just to play on the world stage, I would be dubious."

He continued,

"It’s important that applicants for the disease team grants be judged completely on the scientific merit of their proposals,. Decisions cannot be twisted for geographic equity. I would hope that international collaborative efforts would rise to the top, but if they don’t, so be it."

Sweeping Cancer Fight Launched by CIRM and Canada

SAN DIEGO -- Backed by $100 million in Canadian cash, the Canadian government and the California stem cell agency today announced a three-year effort to probe the role of cancer stem cells in developing the disease.

California Gov. Arnold Schwarzenegger said in a statement:

"Entering into collaborations such as this, which bring together leading medical research capabilities, have great potential in improving the lives of not only Californians, but people around the world."

Canadian Minister of Health Tony Clement said his government will contribute more than $100 million to the Cancer Stem Cell Consortium, which will work with CIRM on the effort.

A statement from CIRM said,

"The first potential area for collaboration under consideration is the upcoming CIRM Disease Team grants. These grants will provide an opportunity for researchers in California and Canada to collaborate, broadening the potential pool of expertise that can be applied toward research in a specific area."

CIRM's board of directors next week is scheduled to approve $1 million in planning grants for the disease program, which will run about $122 million. Those grants are expected to be awarded this time next year.

CIRM President Alan Trounson said,

"One of CIRM’s primary goals is to accelerate the field of stem cell research as a whole. In some instances we can do this more effectively through collaborations that involve the best scientific endeavors, regardless of geography. Through this relationship, CIRM money will continue to be earmarked only for research that takes place within California, but our funding can be significantly leveraged to accelerate the clinical benefits for patients. Coordinating our joint efforts in cancer stem cell research through collaborative programs with our colleagues in Canada will enhance the opportunities to contain and to prevent recurrence of certain cancers."

The Canadian/California announcement said the the Canadian partners in stem cell consortium are the Canada Foundation for Innovation, Canadian Institutes of Health Research, Stem Cell Network, Ontario Institute for Cancer Research and Genome Canada. The news release said they "are expected to make an initial investment of more than $100 million Canadian dollars in the collaboration, with Genome Canada, the Canadian Institutes of Health Research and the Ontario Government through the Ontario Institute for Cancer Research, having already confirmed commitments of up to $30 million each for cancer stem cell research. CIRM will support the collaboration through its existing programs."

CIRM also announced another collaborative agreement between the Australian state of Victoria, also utilizing the disease team grant program. The announcement said CIRM and Victoria are "laying the foundation for an arrangement under which they will jointly seek grant applications, evaluate them, and make recommendations for funding research activities." (Trounson is from Australia, moving to California to take the presidency of CIRM in January.)

The announcement did not indicate any funding beyond the $122 million from CIRM.

Both announcements were made at the BIO conference here, which has attracted an estimated 20,000 persons from throughout the world.

Schwarzenegger made a luncheon speech at the conference. Video clips are expected to be mounted on his web site later today. His office also prepared a California biotech fact sheet that highlight CIRM's $1.1 billion lab construction effort and its $530 million in research grants.

Canadian Money and Gladstone/Yamanaka Research

SAN DIEGO – Robert Klein, chairman of the California stem cell agency, and Alan Trounson, its president, are in San Diego for the mammoth biotech industry conference -- BIO -- that has attracted about 20,000 persons.
They are scheduled to hold a news conference later today to announce more developments in the California/Canadian stem cell research partnership. Their event appears to be tied to Ontario Premier Dalton McGuinty's announcement Tuesday that his province will pony up $1 million for new stem cell research linked to California. That's on top of $30 million announced a year ago.

According to CBC News, the research will be conducted by Shinya Yamanaka of the Gladstone Institute in San Francisco. Also part of the research effort are the University of Toronto and the Hospital for Sick Children in Canada.

Rob Ferguson of the Toronto Star reported:

"'Both centers will be collecting patients with various diseases and making (ips) cells,' said Dr. Deepak Srivastava, director of Gladstone and a pediatric cardiologist."

We will have more on the Klein/Trounson news conference later today as well as a report on the biotech industry outlook by Steve Burrill, head of the Burrill & Co. biotech investment firm in San Francisco.

CIRM Releases Cost on International Stem Cell Forum

The California stem cell agency hosted the International Stem Cell Forum in San Francisco last month, which involved representatives of the leading stem cell research organizations in the world.

CIRM ballyhooed the event with a news release, and prior to the meeting, we asked for an estimate of the cost to CIRM. The agency declined to provide an advance estimate and said that the costs would include "paying for the meeting room at the hotel where the meeting is taking place as well as the audio visual set up and possibly some things like copies. We are also paying for 2 dinners (but not alcohol)."

In response to our queries, Don Gibbons, chief communications officer for CIRM, this afternoon reported that the cost totalled $25,912.