Third Researcher Appealing Grant Rejection to Stem Cell Agency Board


The director of robotics and biosurgery
at UC Davis is appealing rejection of his application for a
$4.9 million grant from the California stem cell agency.

The scientist, W. Douglas Boyd,
noted that his proposal was given a scientific score of 67, which was
one point below the cutoff for most grants approved by CIRM's
Grants Working Group
. Thirteen grants fell in the 68 to 53
range, including Boyd's. Reviewers approved four in that range,
including two with scores of 53.
Boyd's letter was brief, focusing on a
letter of support from an Indiana firm, Cook Biotech, Inc.,
that would supply the "material and technical expertise to
create a new bioengineered cardiac patch
material."
The appeal letter, along with other
appeals(see here and here), will be given to CIRM directors in the agenda material for their meeting tomorrow in San Francisco. The
board does not have to act on the petitions or discuss them.
Researchers can also appear before the board to make a case.

Claire Pomeroy, CEO of the UC
Davis Health
Systems, is a member of the CIRM board. She
will be barred from taking part in any discussion of Boyd's
application or voting on it.

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

California Stem Cell Directors Open Meeting


Today's session of the governing board of the $3 billion California stem cell agency has begun. The major item on the agenda is a $243 million grant round that has triggered a record pace for appeals by rejected applicants. At the request of the California Stem Cell Report, the agency has provided the conflict of interest list used by the agency to determine which directors will not be allowed today to vote or participate in the discussion of specific applications.  The list can be found below. Conflict of Interest List  -- CIRM Directors Meeting 7-26-12ound below.  

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

Researcher Alert: First Look at Proposed Rules for California's Stem Cell Bank


The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.

The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."

The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.

To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,

"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine
which is also creating a repository for iPSC lines and
derived materials."

Baum also said,

"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."

Baum provided the
following summary of the $30 million banking initiative:

"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses
for the public meeting locations can be found on the agenda.

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

Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure


A key panel of directors of the $3
billion California stem cell agency yesterday voted unanimously to
retain full public disclosure of the financial interests of its
directors and top executives.
The director's Governance Subcommittee
bypassed a proposal that would have substantially weakened disclosure at a time when the agency is moving closer to industry in an effort
to develop cures.
"Because of CIRM's unique mission
and the agency's longstanding commitment to transparency," said
Kevin McCormack, the agency's spokesman, "they believed that
CIRM should continue to set an example by requiring the broadest
disclosure of members of the board and high level staff."
Currently CIRM board members and top
executives must disclose all their investments and income – in a
general way – along with California real property that they hold.
Under the rejected changes, disclosures would have instead been
required only "if the business entity or source of income is of
the type to receive grants or other monies from or through
the California Institute for Regenerative Medicine." 
The proposed changes would also have
relieved CIRM officials of reporting investment in or income from
venture capital or other firms that may be engaged in financing
biotech or stem cell enterprises, since the firms do not receive cash
from CIRM or engage in biomedical research.

The subcommittee's action will go before the full CIRM board later this month, where it is expected to be ratified. 

Our take? The Governance Subcommittee
took the right action and is to be commended for going beyond the
letter of the law. The integrity and credibility of CIRM are
paramount. As the California Stem Cell Report wrote last week, narrowing disclosure would only have engendered suspicion and
unnecessarily raised questions about the conduct of the agency as it
embarks on an aggressive push for stem cell cures.

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

LA Times: Deck Stacked at the IOM Hearing


The Los Angeles Times web site today carried a sharply worded piece about the upcoming Institute of Medicine hearing on the performance of the $3 billion California stem cell agency.

Written by Pulitzer-prize winning columnist Michael Hiltzik, the item was headlined,

"Stacking the deck on the stem cell program."

The piece referred to Tuesday's meeting of the Institute of Medicine panel looking into the stem cell agency's affairs. The Times article was based largely on a piece yesterday on the California Stem Cell Report that reported that six of the 11 witnesses at the IOM hearing were coming from institutions that had received $418 million from CIRM. The item also reported that the only other witnesses were either CIRM employees or on its governing board.

Hiltzik wrote,

"The insular character of the stem-cell research community always has made objective evaluations of CIRM difficult -- most of the experts in the field are in a position to seek grants from the program or work with it on grant review. The IOM study could have been a counterbalance to that. But that doesn't look like it's about to happen."

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

Conflict of Interest: Chair of California Stem Cell Agency Grant Review Group Resigns


A conflict of interest on a grant application before the $3 billion California stem cell agency last year led to the resignation of the grant review committee's longstanding chairman, John Sladek of the University of Colorado.

The incident occurred last April but was not publicly disclosed by CIRM until the California Stem Cell Report (CSCR) raised a question earlier this month.

Sladek is professor of neurology, pediatrics and neuroscience at the University of Colorado in Denver and a former president of Cal Lutheran University in the Los Angeles area. He had served on the stem cell agency's grant review group since 2005 and as its chairman from 2009 until April of last year.

Responding to an email from CSCR, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., outside counsel to the stem cell agency, said that CIRM's staff uncovered the conflict in April after the grant review session was concluded on March 17. Harrison described it as a "technical violation."

He said,

"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application."

Harrison said,

"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window."

Harrison said Sladek's conflict did not violate the state's political reform act nor did he have a financial interest in the application.

Harrison continued,

"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."

Asked for comment, Sladek said that Harrison's account was accurate and that he had nothing to add. (Both Harrison's and Sladek's verbatim comments can be found here.)

In December, the CIRM board of directors approved, on a unanimous voice vote of the 21 directors present out of 29, a resolution commending Sladek for serving in "exemplary fashion."

The stem cell agency disclosed specifics of the conflict of interest violation after the California Stem Cell Report discovered a vague reference to it in the transcript of the January meeting of the Citizens Financial Oversight and Accountability Committee, the only state entity specifically charged with oversight of the agency and its directors.

Members of the committee had raised questions about conflicts of interests at CIRM. At one point, Harrison said,

"We have also had occasion where we have had a conflict of a very technical nature on the grants working group which we addressed pursuant to our procedure and reported to the legislature."

It was that remark that triggered the request for more details.

Asked about the report to the legislature, Harrison said CIRM wrote a letter to the legislative leadership about the incident. We have asked for a copy of the letter, which we will carry when we receive it.

As of this writing, the review summary for the grant application (RB3-02119) in question was not available on the CIRM web. Normally all the summaries are posted. We have queried the agency concerning its absence.

Harrison also said that in the seven-year history of CIRM no other instances exist of grant review committee members having been determined to be in a conflict of interest after participation in a review.

Our comment: CIRM is to be commended for taking care of this situation quickly last April. Sladek correctly resigned promptly. However, failure to disclose the incident at the time does not reflect well on the California stem cell agency nor does it inspire confidence in the agency's now improving openness and transparency.

CIRM is an enterprise that has substantial built-in conflicts of interests – all legal courtesy of Prop. 71, the ballot initiative that created CIRM. Institutions linked to CIRM directors have received $1.1 billion of the $1.2 billion the agency has given away. A display of reticence in this conflict-of-interest case does little to quell the suspicions of those who have criticized the agency for "cronyism," including the journal Nature and some in the biotech business community and elsewhere. As for the description of the incident as a "very technical" violation, that amounts to a bit of PR. Either it is a violation or it isn't.

Sladek's violation is the sort of thing not well understood by the public. Most public attention is focused on financial conflicts of interest in science. However, professional conflicts of interest involving scientists are among the most invidious. The California Stem Cell Report regularly hears complaints and suspicions about such dealings at CIRM: Big-name scientists receiving favored treatment, academic researchers unfairly evaluating applications from business researchers, younger researchers being shunted to background and more. All this as a billion dollars worth of applications have been evaluated behind closed doors with no public disclosure of the economic or professional interests of the reviewers. The stem cell agency would do well to improve its openness and transparency, particularly as it moves into ticklish and expensive relationships with industry. The first step would be to post on its web site the disclosure forms filed by its grant reviewers but withheld from the public by CIRM.

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

Conflict of Interest: California Stem Cell Agency Releases More Documents in Sladek Violation


The California stem cell agency today released its letter to leaders of the California legislature concerning the conflict of interest violation by the scientist who was then chairman of the panel that makes the de facto decisions on hundreds of millions of dollars in research grants.

The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.

The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.

Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."

The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.

The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,

"While preparing the public summary for Basic Biology III Awards Application No. RB3-02119, CIRM staff discovered that Dr. Sladek had co-authored two papers in the last three years with a researcher on the application. Although the researcher’s name was included on the CIRM conflict of interest form, Dr. Sladek did not disclose these publications to CIRM."

As reported earlier, Sladek's participation did not affect the outcome on the application, which was not recommended for funding.

As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.

The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."

The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership

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

International Stem Cell Corporation Launches New Marketing Campaign for Lifeline Skin CareTM Products

International Stem Cell Corporation (OTCBB: ISCO) today announced the Company's near-term marketing plans for products manufactured by its Lifeline Skin Care™ (Lifeline) subsidiary. Following the highly successful launch in late 2010 of Lifeline's first two products with sales that greatly exceeded expectations, Lifeline has now commenced a new phase in the marketing plan for its skin care products.

The first step in these initiatives is a series of briefings being conducted in New York City this week with editors at beauty magazines whose readership reflects the target user base for Lifeline's anti-aging skin care products. This will be followed by a series of targeted email offerings developed by Lifeline's marketing partner, The Mauldin Companies, culminating in a larger offering in June.

Lifeline's anti-aging products were developed by ISCO's scientific research team in collaboration with internationally recognized cosmetic experts. The first two products, a Day Serum and a Night Serum, both contain an extract from ISCO's proprietary human parthenogenetic stem cells which, in combination with vitamin complexes, provides major rejuvenating effects, including improvement in skin tone and elasticity, and improvement in the appearance of fine lines and wrinkles. These effects have been substantiated by clinical studies performed at industry-leading independent testing organizations.

Lifeline's premium product line includes the Recovery Night Moisture Serum and the Defensive Day Moisture Serum/SPF-15. These products are most commonly ordered together in a 2-pack, and can be purchased by visiting Lifeline's website athttp://www.lifelineskincare.com. The products are also available at selected luxury spas and physician's offices in the United States.

Dr. Ruslan Semechkin, President and CEO of Lifeline Skin Care, added that Lifeline plans to launch additional skin care products later this year, including an eye cream formulated with a proprietary stem cell derivative and a cleanser.

Lifeline is focusing its marketing on direct-to-consumer channels to highly targeted audiences with traditional print and media promotions planned for later in the year. The Company's goal is to generate favorable word-of-mouth through a network of satisfied customers, thereby building a community of users based on their shared experience of success with Lifeline's proprietary anti-aging products.

Ken Aldrich, Co-founder and Chairman of Lifeline's parent company, International Stem Cell Corporation, said, "The success of Lifeline Skin Care demonstrates that we can make a positive difference in people's lives today, while also providing an important source of revenue to support ISCO's development of stem cell therapies that may in the future result in treatment for many widespread human diseases."

About International Stem Cell Corporation

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

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

Forward-looking Statements

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

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20110512005363r1&sid=14230&distro=ftp

International Stem Cell Corporation
Kenneth C Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com

or
Lifeline Skin Care, Inc.
Ruslan Semechkin, Ph.D., President & CEO
Vice President, ISCO
ras@intlstemcell.com
or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
dm
arkley@lhai.com

State Controller to Hold Hearing on Stem Cell Agency Finances


The only state body specifically charged with oversight of the $3 billion California stem cell agency and its board will meet next Friday in Los Angeles for a look at the enterprise's financial affairs.

The group is the Citizens Financial Accountability and Oversight Committee, chaired by the state's top fiscal officer, Controller John Chiang. It was created by Proposition 71, the ballot initiative that established the stem cell research effort.

The agenda is a tad shy of details on what is likely to be brought up although it does mention a briefing by CIRM on "CIRM’s financial performance, current budget,update of grants awarded and grant process."

CIRM Chairman Jonathan Thomas is expected to attend along with the agency's new and first chief financial officer, Matt Plunkett.

Source:
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"A Little Egg On the Face" – LifeLine Skin Care Stem Cell Cream Article

"A Little Egg On the Face" by Rebecca Tolin (read San Diego Magazine article here )

Women have been known to slather their faces with fruit, fish oil, foreskin (uh huh, the target of circumcision) and even the neurotoxin that causes botulism?—?all in the name of looking pretty. Now an Oceanside biotech has another novel ingredient for the aging-averse: stem cells from unfertilized human eggs.

“It’s not like a woman donated eggs in Encinitas and three months later it’s in someone’s skin in L.A.,” explains Brian Lundstrom, president of International Stem Cell Corporation (ISSC) in Oceanside, parent company of Lifeline Skin Care. It’s more like this: Women go to in-vitro fertilization clinics to get pregnant. There are often leftover eggs from that process. Researchers select stem cells, grow billions of them, and extract the bits that skin loves, such as growth factors?—?with permission from the donors, of course. Scientists then whip ’em up with antioxidants and sell the stuff in a slick plastic tube for about the cost of a month’s supply of Frappuccinos.

Is this a noncaffeinated fountain of youth? Ruslan Semechkin, the CEO of Lifeline and a biologist by training, says an eight-week study showed the day-and-night serum combo reduced the number and depth of wrinkles and made skin brighter, tighter and moister?—?though he wouldn’t say by how much. (Semechkin is 25, has the olive-tinged skin of a baby and admits a complexion of his variety doesn’t need this heavy hitter.)
Even in the stem cell world, youth is coveted. Lundstrom says stem cells taken from unfertilized eggs?—?the very seeds of life?—?are the youngest around and can become any cell in the human body. This is the first time such stem cell fragments have found their way into beauty cream, he explains. And because the eggs aren’t fertilized, they bypass the embryo controversy.

Someday, movement in the paralyzed and memory in the aged could be restored by using such cells; ISSC has already grown a human cornea that could cure blindness in people with eye damage. These breakthroughs may be dec­ades away, but ISSC’s “cosmeceuticals” are just the beginning. Profits from pocketbooks of the age-obsessed will fund the biotech’s research for other therapeutic drugs. So if you’re considering spending a small fortune to plump things up, you could call it a contribution to science.

Lifeline Defensive Day Moisture Serum sells for $155 and Lifeline Recovery Night Moisture Serum costs $185. It’s available at lifelineskincare.com.

Prostate CSCs sensitive to gamma-tocotrienol?

Gamma-Tocotrienol Kills Prostate Cancer Stem Cells, PRNewswire, July 25, 2010. Excerpt:

The scientists found that low doses of gamma-tocotrienol cause apoptosis in the prostate cancer stem cells and suppress their colony formation capability. This results in a lower prostate cancer stem cell population (as defined by the protein markers CD133 and CD44). Further tests in mice models were conducted, where mice implanted with hormonal refractory prostate cancer cells were given gamma-tocotrienol orally. The results showed that gamma- tocotrienol not only reduced tumour size formed, but also decreased the incidence rate of tumour formation by 75%, as compared to the control group of mice, which had 100% tumour formation. These results strongly suggest that gamma-tocotrienol could be developed for prostate cancer prevention and treatment.

The news release by Davos Life Science is based on the publication:

Gamma-tocotrienol as an effective agent in targeting prostate cancer stem cell-like population by Sze Ue Luk and 11 co-authors, including Ming-Tat Ling, Int J Cancer 2010(Jul 8) [Epub ahead of print][PubMed citation].

Comment:

See also a relevant patent application: (WO/2010/047663) Use of Tocotrienol Composition for the Prevention of Cancer.
Publication Date: 29.04.2010
Applicants: DAVOS LIFE SCIENCE PTE. LTD. [SG/SG]; 16 Tuas South Street 5 Singapore 637795 (SG) (All Except US).
LING, Ming Tat [CN/AU]; (AU) (US Only).
YAP, Wei Ney [MY/SG]; (SG) (US Only).
WONG, Yong Chuan [MY/CN]; (CN) (US Only).
YAP, Yee Leng, Daniel [MY/SG]; (SG) (US Only).

International Stem Cell Corporation and Sristi Biosciences Enter Distribution Agreement for Lifeline Cell Technology's Brand of Human Cell Culture…

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, via its wholly-owned subsidiary, Lifeline Cell Technology® (Lifeline) http://www.lifelinecelltech.com, and Sristi Biosciences, http://www.sristibio.com, have entered into a distribution agreement for the Lifeline® brand of human cell culture products in India.

Lifeline specializes in development, manufacture and distribution of primary human cells and media and growth factors for optimized culturing of cells, including stem cells. These products are being requested by customers internationally, including in India, which represents one of the fastest growing markets for products of this kind.

According to Lifeline's CEO and SVP of Operations at ISCO, Jeffrey Janus, 'Sristi Biosciences is part of one of the most experienced biotechnology companies in India and the first to advance cell therapy into human trials in that country. Their network among academic and corporate researchers and experience and capacity to import and handle primary cell cultures, media and growth factors in India will be highly valuable for Lifeline to continue the international commercial expansion of its brand.'

Lifeline's scientists have over 20 years of experience developing products for the culture of human cells. The company has made significant contributions to the creation and standardization of human cell systems used today for clinical applications and in academic, government and pharmaceutical research laboratories. The group sells over 75 standardized products directly and via its distributors in the US and abroad. It also engages in customized product development for its largest customers.

Dr. Sudhir Reddy, Sristi Biosciences' CEO adds, 'We are pleased to be the first company to introduce the Lifeline products to the growing Indian research market. Our cell culture experience and broad market reach in India will benefit the brand and help Sristi Biosciences further accelerate its commercialization and corporate growth in the biomedical field.'

ISCO recently announced the beginning of a collaboration on its human corneal tissue, CytoCor™, with leading Indian eye hospital and research center, Sankara Nethralaya, and Letter of Intent with Insight Bioventures India (IBVI) to seek funding and establishment of development and manufacturing operations for ISCO's research and pharmaceutical products in India (ISCO India), including the Lifeline products and CytoCor.

'The Lifeline distribution agreement with Sristi Biosciences is central to ISCO's international expansion. Besides facilitating commercialization of the Lifeline products in India, Sristi Biosciences' cell therapy development, regulatory and manufacturing expertise will be important as ISCO and IBVI seek to establish ISCO India with cost-efficient development and manufacturing of research and pharmaceutical products for the Indian and broader Asian markets,' says Brian Lundstrom, ISCO's President.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website.

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

ABOUT SRISTI BIOSCIENCES

Sristi Biosciences Private Limited is a result of twelve years of research and corporate development in the therapeutic space and is the healthcare component of leading biotechnology group, SRI Biotech, in India. Sristi Biosciences' two main divisions include Tissue Engineering and Cell Therapy that has pioneered chondrocytes-based cell therapy in India and Drug Discoverythat covers the Indian research product market with natural compound libraries, molecular diagnostics and markers, informatics and cell-based products. Sristi's integrated research and development facility in Hyderabad is state-of-the-art and the company has wide collaborative and commercial presence across the research market in India, including 23 leading biotech institutes and major corporate bodies.

FORWARD-LOOKING STATEMENTS

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

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

International Stem Cell Corporation Announces Launch Plans for New Skin Care Products

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, and a new firm to be formed by John Mauldin announced today the formation of a new joint marketing venture to launch a line of skin care products developed by ISCO's wholly owned subsidiary, Lifeline Skin Care, Inc. ('LSC'). Mauldin, a significant marketing talent, is president of Millennium Wave Investments and author of an economic letter that goes to over 1.5 million readers.

Lifeline Skin Care's products have been in active development for well over a year and involve a unique high-technology, patent pending formulation for skin rejuvenation crèmes, developed using ISCO's proprietary 'parthenogenetic' stem cells that do not require the use of fertilized embryos. The product was discovered during ISCO's therapeutic stem cell research that revealed the stem cell's potential applications in skin cell rejuvenation. Part of the discovery included developing a way to surround the proteins from the stem cells with a nanovesicle allowing for extended shelf life and enhanced delivery of the product to the skin. Independent third party testing indicates that the crèmes (one for day and one for nighttime application) have significant positive effects on the look and feel of the skin.

'This represents an amazing leap forward in the combination of a variety of cutting edge technologies to yield products that have the potential to find significant consumer acceptance. The anti-aging market is extremely large, and Lifeline Skin Care is offering something completely new and different. We are excited about the prospects,' said Kenneth Aldrich, Chairman of ISCO.

Because the LSC products involve a unique extract from living parthenogenetic stem cells, rather than 'off the shelf' ingredients used by most skin care products, it takes additional time to manufacture the products. Building inventory in advance of demand is critical to avoid disappointing customers.

ISCO and LSC believe the collaboration with Mauldin will provide a much broader potential customer base and a much lower market cost per customer than the alternative marketing programs previously considered. As a result, LSC has revised its previously announced marketing launch plans to be certain that it will have adequate product on hand to meet initial demand.

The initial product offering will be to ISCO's own database of investors and followers, originally set to launch October and now scheduled for November to coordinate with Mauldin's timetable. That will be followed with an offering to Mauldin's extensive subscription base and to a select market of other potential purchasers.

Only after these initial offerings have been completed, involving a total of over 1.5 million potential customers, will more broad scale product offerings be made. 'This will enable us to measure probable future demand, assure our loyal investors and Mauldin's subscribers and affiliates that they will be able to purchase all the products they require while allowing LSC to build an inventory of the unique stem cell extract that is at the heart of this new product,' said Dr. Ruslan Semechkin, CEO of Lifeline Skin Care.

'We are extraordinarily excited to be able to offer LSC's products to our loyal client base in a way that assures they will be able to obtain the product they want, plus monthly refills as required, in spite of the fact that LSC's products are unique and require time and care by many people to bring to market,' said John Mauldin, founder and Chairman of Millennium. 'This is a truly revolutionary approach to skin care. Early test results are very promising and I am excited to be associated with a company of the scientific reputation of International Stem Cell Corporation and their world-renowned staff.'

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website, http://www.internationalstemcell.com.

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

FORWARD-LOOKING STATEMENTS

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

Key Words: Stem cells, parthenogenesis, biotechnology, skin care

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
1-760-940-6383
kaldrich@intlstemcell.com
or
Lifeine Skin Care, Inc.
Ruslan Semechkin, Ph.D., President & CEO
Vice President, ISCO
ras@intlstemcell.com

International Stem Cell Corporation Signs Financing Agreement

OCEANSIDE, CA –May 5, 2010 – International Stem Cell Corporation (ISCO.OB), http://www.intlstemcell.com, today announced it has entered into a definitive agreement dated May 4, 2010 (‘the Agreement”) with Socius CG II, Ltd. (“Socius”), pursuant to which Socius has committed to purchase a single tranche of up to $10 million in non-convertible Series F Preferred Stock (the "Preferred Stock") from ISCO. The Company issued a warrant to purchase $13,500,000 worth of the Company’s Common Stock, the exercise price of the warrant being determined by the closing bid price for the Company’s Common Stock on the trading day immediately preceding the date the Company initiates the sale of the Series F Preferred.

The Company anticipates that the Closing of the Preferred Stock sale will take place 20 business days after the issuance of the Warrants. Proceeds from these sales will be used to provide general working capital and to fund additional development of the Company's proprietary Parthenogenetic Stem Cell Lines, development of commercial research products, and other research and development programs and related business activities.

Additional details on the transaction are contained in the Company's Form 8-K filed today with the Securities and Exchange Commission.

A prospectus relating to this offering is available from:
Investor Relations
International Stem Cell Corporation
2595 Jason Court
Oceanside, CA 92056

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology.

FORWARD-LOOKING STATEMENTS:
Statements pertaining to anticipated future events, including the anticipated closing of the sale of Preferred Stock, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in satisfying the conditions to closing. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-940-6383
bl@intlstemcell.com
WEST\21949392.1

International Stem Cell Corporation – Excerpt from Agora Financial's Breakthrough Technology Alert by Patrick Cox



The following is an excerpt from the June 29, 2010 Breakthrough Technology Alert, published by Agora Financial. Agora Financial is a fully independent publisher and has no financial connections to companies listed below. Breakthrough Technology Alert’s editor is industry expert Patrick Cox. Patrick is renowned for his innovative forecasts and keeping readers “ahead of the story”.



For more information about Patrick Cox and Breakthrough Technology Alert please visit http://www.agorafinancial.com

Q&A with ISCO



International Stem Cell Corp. (OTCBB: ISCO) has also been the target of rumor campaigns. ISCO, incidentally, recently announced further positive IP news. Specifically, Advanced Cell Technology, Inc. (ACT) was just issued U.S. Patent Number 7736896 covering a method for producing retinal pigment epithelial cells. ISCO, however, had previously acquired rights to this technology from ACT, so the award solidifies their position in stem cell eye therapies.

ISCO's corneal research also got an unexpected boost last week, though it's not clear how many people know it yet. A stem cell breakthrough from Italy made quite a few headlines. The article that provoked the coverage was in the June 23 online version of The New England Journal of Medicine (NEJM). Specifically, it featured clinical research from professor Graziella Pellegrini et al. titled "Limbal Stem-Cell Therapy and Long-Term Corneal Regeneration." A helpful video by ABC News can be viewed here.



The coverage of the journal article is, however, incomplete. So let me put it in perspective.

The procedure made use of the well-established practice of extracting and cultivating limbal stem cells. Each of the patients, in effect, had stem cells removed from at least one eye. Once the adult stem cells were multiplied in the lab, they were applied to the cornea. There, they regenerated the corneal epithelium (the outermost thin layer of the cornea), restoring sight.

This is wonderful proof of the power of stem cells, but it doesn't represent a breakthrough in terms of basic science or investment possibilities. This is because the cost of extracting these surviving stem cells is very high. So is multiplying and reattaching them. The only reason the experiments were even allowed to proceed is that all the cell materials come from the subjects of the procedures. They would not have been allowed if, for example, scientists wanted to use the stem cells from one patient to treat another patient. Nor is it clear to what extent, if any, a company can patent these procedures.

On the other hand, the Italian procedures were most successful when they were combined with the implantation of replacement corneal structures. Those replacement corneas cannot be regenerated from limbal stem cells. In fact, they came from cadavers.

ISCO, however, is now able to grow them in the lab to produce cheaper, safer corneas. ISCO is involved in discussions with various companies to commercialize those parthenogenic corneal structures.

For most patients, who have enough of their own stem cells to regenerate the corneal epithelium, ISCO's corneas are all that are required to recover sight. Eventually, in fact, I suspect that ISCO will also have off-the-shelf limbal stem cells that will regenerate the corneal epithelial too. These cells would be from each of ISCO's cell bank lines. Now being established, it will include 50-100 cell lines that immune match most of the world's population. No other company has this ability to provide inexpensive stem cells for the masses.

Now allow me to debunk some of the rumors currently being spread about ISCO. Normally, as you know, I don't like to dignify these attacks, but I do make exceptions when it's important. I'm doing this, by the way, in a question-and-answer format that board chairman Ken Aldrich was kind enough to answer. The questions deal with some of the unfounded rumors circulating. If these don't concern you, feel free to skip them. Q1. Did ISCO close its financing?



A1. Yes, they did a $10 million financing, and then used $2.5 million as part of a balance sheet cleanup that removed approximately $15 million of 10% preferred stock and still left them with an additional $7.5 million in cash on the balance sheet, in addition to whatever cash was already there.

Q2. Doesn't Socius hold a lot of preferred stock that will be a future burden to ISCO?



A2. No, all of that has been retired as part of the capital restructuring announced in an 8-K filed June 11, 2010. As a result, Socius and its predecessor company, Optimus, hold no preferred shares of ISCO at all.

Q3. Is the company running out of money?



A3. Based on the monthly "burn" rate of about $550,000 for the last 15 months ($562,000 for the last quarter), the proceeds of the company's most recent financing of $7.5 million after the repayment of the outstanding preferred stock of Socius and Optimus would give the company at least 12 months of "runway," even without any additional revenues from operations, licensing or partnerships.



I could go on, but this is pretty long. Next week, I'll have more updates.

For transformational profits,

Patrick Cox

To learn more about Patrick Cox and Breakthrough Technology Alert please click here. © 2010 by Agora Financial, LLC. 808 St. Paul Street, Baltimore, MD 21202. All rights reserved. No part of this report may be reproduced by any means or for any reason without the consent of the publisher. The information contained herein is obtained from sources believed to be reliable; however, its accuracy cannot be guaranteed.

Pay-For-Eggs Legislation Draws More Media Attention

California legislation to allow women
to be paid for their eggs for scientific research generated several news articles this week as the measure neared final legislative
approval.
The coverage included both pro and con
but did not amount to major attention from the mainstream media. And,
with one exception, the articles failed to report that the
legislation did not apply to research funded by the $3 billion
California stem cell agency, which bans compensation for egg
providers.
The proposal (AB926) is now on the
state Senate floor with a vote possibly coming as early as next
Thursday. A spokesman for the American Society for Reproductive
Medicine
in Birmingham, Ala., an industry group sponsoring the bill,
said unequivocally that the Gov. Jerry Brown is expected to sign the
measure. (See the Senate floor bill analysis here and a press release on the bill here.)
Assemblywoman Susan Bonilla
Photo Source -- Bonilla's office
The articles about the legislation by
Assemblywoman Susan Bonilla, D-Concord, have appeared in the journal
Nature, the San Francisco Chronicle and the Huffington Post over the
past few days.
Alice Crisci, a California patient
advocate writing on the Huffington Post, yesterday remarked that
women egg providers should be treated the same as men involved in
scientific experiments.

“After all, aren't we past the days
when we treat women like they are less capable than men of making
sound decisions for their own well-being? It's my body and my choice
if I want to donate a dozen of my eggs to science. Who knows -- maybe
it's my egg that will be used to find a cure for cancer.”

Debra Saunders, writing a column in the
Chronicle on Sunday, said,

“That sperm-egg parity argument is so
bogus. When men donate sperm, they risk second thoughts about
unknown, random offspring, but they do not risk serious medical side
effects. Egg donation, on the other hand, can be hazardous to your
health. The New York Times reports, "Egg donors can suffer
serious side effects from the powerful hormones needed to generate
multiple eggs." And: "The most significant risk is ovarian
hyper-stimulation syndrome, which can cause bloating, abdominal pain
and, rarely, blood clots, kidney failure and other life-threatening
ailments."

Charlotte Schubert, writing in Nature
on Tuesday, said,

“In practical terms, the bill would
bump up payments from hundreds to thousands of dollars. In Oregon —
which, like most states, does not have regulations governing egg
donation — women recently received $3,000–7,000 each for eggs
used in a study that created stem-cell
lines from cloned human embryos
.”

Prices for eggs can run substantially higher depending on the characteristics of the supplier.
Bonilla's office said the bill did not
come up for a vote during today's Senate floor session but could come
up next Thursday.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/O3i-n3NxdnA/pay-for-eggs-legislation-draws-more.html

California’s $70 Million ‘Alpha’ Stem Cell Clinic Plan Headed for Approval Next Week

Alpha clinic organizational diagram
Graphic by CIRM
California's stem cell agency next week
is likely to approve a $70 million plan to build a taxpayer-financed
chain of  “Alpha” stem cell clinics in what could be a major step
towards making California the stem cell capital of the world,
The proposal would create five centers
at existing institutions or businesses to be funded at up to $11
million each over five years. Also proposed is a coordination and
information center that would receive $15 million over five years.
A story in Nature Medicine said that
the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”
The clinics are expected to draw stem
cell projects from the around the world as well as those
funded by the $3 billion California stem cell agency. The proposal
would be one of the largest single research efforts funded by the
agency, formally known as the California Institute for Regenerative
Medicine (CIRM)
and use about 10 percent of its remaining cash.
The Alpha clinics are aimed at creation
of a sturdy foundation for the stem cell industry in California,
capitalizing on the burgeoning, international lure of stem cell
treatments. Indeed, one of the objectives of the information center
is to divert people from dubious treatments elsewhere.
The plan would fill a “profound gap”
in quality information about stem cell treatments, according to a CIRM document, which said,

“By providing this resource, the public and potential patients
would be better educated and informed, whether or not they should opt
to enroll in clinical trials or approved treatments at any of the
Alpha clinics.”

The Alpha concept was first broached two years ago publicly by
CIRM President Alan Trounson, a pioneer in IVF research and the IVF
business. His proposal has received early and heavy
attention on the CIRM website with a video, blog items and a white paper.
The plan has received little critical
attention although a researcher from an institution that could be a
candidate for an Alpha clinic commented harshly in May on the California
Stem Cell Report,
calling the proposal “an irresponsible waste”and a “boondoggle for some medical schools.” The researcher, who
asked that he/she not be identified, said,

“CIRM will pay for an unneeded
infrastructure that will be empty space and staff sitting on their
hands 99 percent of the time.  Or worse yet, CIRM will pay but
the space will be used for other things, other clinic procedures paid
for by insurance.”  

Elie Dolgin's July 8 piece in Nature
Medicine quoted Mahendra Rao, director of the Center for Regenerative
Medicine
at the US National Institutes of Health (NIH), as applauding the concept. However, Rao said he doesn't
anticipate the approach being tried nationally soon.
Dolgin wrote,

“Rao regularly asks researchers
hoping to advance promising stem cell therapies whether they require
additional clinical infrastructure. 'So far, what they've told us is
they'll let us know if they need anything more than (the) programs
that we have already established,' he says.”

The question of the size of the demand
for Alpha clinics is not addressed in the CIRM concept plan. Also
absent is much discussion of the business aspects of the proposal. It
does mention “corporate sponsors” in passing. In a CIRM blog item
yesterday, Natalie DeWitt, special project director at the agency,
touched on business elements, declaring,

“(The proprosal) will yield better
clinical trial design, accelerated approval of high quality
treatments, and data and know-how to inform regulatory and
reimbursement decisions.”

Reimbursement is the industry euphemism
for creating ways to generate profits for stem cell firms.
The proposal said applicants would have
to bring substantial support from their own institutions and
“demonstrate the potential to bring in a pipeline of additional
stem cell-based therapeutic trials as well as future funding streams
to sustain the clinic.” Applicants would also be “evaluated in
their ability to create a positive 'brand' that would attract
clinical trials.”
Also up in the air was whether grant
reviewers, all of whom come from out-of-state, would have special
expertise to evaluate the business aspects of each applicant's
proposal along with their business track record.
What is before the CIRM directors July
25 at their meeting in Burlingame, Ca., is a request for approval of the concept, which
would be fleshed out for the RFA. The governing board almost always
approves staff concepts, although they may modify them slightly. A
number of directors come from institutions that are likely to be
applicants in the program. They can participate in voting on the
concept plan but would be barred from voting on any applications that
come in later. The two RFAs could go out as early as October with
approval of funding of applications one year from now.
In addition to the Burlingame meeting
site, members of the public can participate from two teleconference
locations in the Los Angeles area. The specific locations can be
found on the meeting agenda.
The California Stem Cell Report will
provide live coverage of the entire meeting, filing reports as
warranted based on the Internet audiocast.
Here are excerpts from CIRM's staff
document on the plan.

“To accelerate therapeutic
development and delivery of stem cell therapies, CIRM proposes
establishing the CIRM Alpha Stem Cell Clinics Network (CASC Network).
The network will be designed to support projects emanating from
CIRM’s funding pipeline, as well as scientifically outstanding stem
cell products being developed worldwide and brought to California.
Conceptually, the CASC Network is intended to be a sustainable
infrastructure designed to support academic- and industry-initiated
clinical trials, and delivery of therapies proven safe and
effective.”

“The major thrusts (of the overall
plan) will be:

• Development of clinical capacity
and associated resources designed to support the effective
implementation and execution of clinical trials and delivery of
registered stem cell therapies

• Compilation of data and
information concerning clinical trial experience and therapy outcomes
to further inform the research, regulatory, and general community
about the status of investigational stem cell interventions and
long-term outcomes

• Dissemination of information to
the public and counseling of patients and potential trial subjects
about therapeutic options and clinical trials involving stem cells in
the network and elsewhere.”

“The long-term vision is for the
Alpha Clinics to expand and accommodate a broad array of stem
cell-based clinical trials, where the trial meets the scientific,
clinical trial design and ethical standards set forth by the Alpha
Clinics Network, as well as FDA approved treatments.”

The coordinating and information center
would be expected to :
“Build relationships with
Accountable Care Organizations, and participate in initiatives for
informing coverage and payment decisions

“Design strategies to attract
investors and philanthropists to CASC network

“Create business plans, and marketing
and branding strategies for financial sustainability of the Alpha
Clinics Sites and (the coordination/information center)”.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VhnrrutbBC0/californias-70-million-alpha-stem-cell.html

$20 Million in Stem Cell Irony


A bit of irony popped up this
week in the wake of approval of $151 million in awards by the
California stem cell agency.

One of the awards was $20 million to
StemCells, Inc., of Newark, Ca., which is also fighting hard for
another $20 million from the state research enterprise.
However, back in 2008, Kenneth
Stratton
, general counsel for the firm, put some distance between his
company and the agency, which is handing out $3 billion in toto.
Stratton said,

"We will take CIRM money last. We
don't want to be in a position where, years from now, we are actually
forced to sell [our products] in California at a loss."

But last week, Martin McGlynn, CEO of
StemCells, said in a press release,

“We are extremely grateful to CIRM
for its support.”

Times have changed for both the company
and CIRM, which is in the process of altering the intellectual
property rules that offended Stratton in 2008. The changes were due
to be approved last Thursday, but action was put off by the CIRM
board. It was overwhelmed as it dealt with the record pace of appeals
by researchers who were scrambling to overturn negative decisions by
grant reviewers.
StemCells' application for another $20
million is one of those being appealed. The board will take it up
again in either September or late October, after it undergoes
additional scrutiny by the agency.
CIRM is touting its IP changes as being
more friendly to business. They also can be made retroactive to cover
awards to business made in the past. CIRM directors expect to meet by
telephone, probably in August, to approve the new IP rules.

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

ACT and CIRM Together on Eye Research Webinar


Executives of Advanced Cell Technology,
which has been repeatedly rejected for funding by the $3 billion
California stem cell agency, will participate this week in the agency's Internet "webinar" on research involving the human eye.
ACT, which is engaged in the only hESC
clinical trial in the nation, was held up earlier this month (see
here and here) at an Institute of Medicine hearing as a prime example
of the California's agency's failure to fund the stem cell industry
in any significant way.
Gary Rabin, CEO of ACT
Nonetheless, three ACT execs are scheduled to be online for the CIRM session on Wednesday: Gary Rabin, the CEO of
ACT; Matthew Vincent, director of business development, and Edmund
Mickunas
, vice president of regulatory affairs. The webinar will deal with regulatory issues
with the FDA and clinical trials involving the eye.
Also on the panel are Samuel Barone,
medical officer with the FDA, and Mark Humayun, professor of
opthamology at USC, who is the PI on a $16 million macular
degeneration grant from CIRM.
So what is the significance of ACT's
participation in the CIRM event? If the relationship between ACT and
CIRM has been touchy, this sort of cooperation is probably a good
sign for both. For one, CIRM could have hardly staged the webinar
without ACT, given the subject matter. But if the agency did not
want to engage ACT, it could have simply done nothing about setting
up a webinar in which the firm would participate.
Does this mean that ACT is going to
receive a handsome grant or loan from CIRM? CIRM has established
procedures (RFAs, peer review, etc.) for approval of funding, and ACT
would have to go through that process unless CIRM does something very
unusual.
Wednesday's event is aimed at researchers and
is likely to be technical. Persons interested in taking part must
register in advance.

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