StemCells, Inc., and Capricor Stave Off Rejection from Stem Cell Agency


Two California stem cell firms today
won a reprieve from rejection in their bids for $40 million in
funding from the California stem cell agency.

They are StemCells, Inc., of Newark
and Capricor, Inc. of Beverly Hills. StemCells was founded by
Stanford researcher Irv Weissman. Capricor was formed to
commercialize research at Cedars of Sinai that had been previously
financed in part by the state's $3 billion enterprise. Frank
Litvack
, who unsuccessfully vied for the chairmanship of the stem
cell agency in June 2011, is the recently appointed executive
chairman of Capricor.
The CIRM board sent the firms' bids back for more scientific review based on
their appeals of reviewers' negative decisions as well as testimony
at the board meeting today. The board will take up the applications, which seek $20 million each, again in early September.

Robert Klein, who was the first
chairman of the stem cell agency, appeared before his old board as a
member of the public on behalf of the StemCells appeal. He said new
evidence will be published soon in a scientific journal that supports
the StemCells approach. Klein also said that he was personally
involved in three CIRM grant reviews in which scientists affirmed the
company's approach. (Here are links to the appeal and to grant reviewer comments.)
The other application also involved new
information. Litvack, former CEO of Conor Medsystem, told the board
the firm has made considerable progress since CIRM's closed-door
review of applications last April, both in terms of management and
science. The firm's appeal said Litvack's appointment is part of the
management improvements at the firm.
Sherry Lansing, a member of the CIRM
board and former CEO of a Hollywood film studio, enthusiastically
recalled a presentation last year before the board about the results
of the initial research. She the firm has solved the problems cited by reviewers. She said,

“We have a fiduciary responsibility
to select the best science.”

Source:
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$18 Million Cedars Sinai ALS Proposal Headed for Approval


The California stem cell agency today
cleared the way for approval of
an $18 million grant to develop a new
cell-based therapy for treatment of ALS.

The agency's governing board moved the
application into a category that is expected to approved later today.
The action came on an appeal by
researcher Clive Svendsen of Cedars Sinai. Also supporting the
application were a number of persons with ALS.

Source:
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Harvard's McMahon on His Way to USC


Andy McMahon
Harvard photo

The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.

The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.

McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”

Source:
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ACT's Top Scientist Sells $1.5 Million in Company Stock


The mainstream media waxed enthusiastic last month when a California hESC clinical trial reported positive results dealing with blindness.

The report was first published account of a human trial of embryonic stem cell based therapy and involved Advanced Cell Technology, which is headquartered in Santa Monica, Ca. Despite a glowing reception of the trial's results, the firm is years away from being able to market the therapy at a profit – if it ever can do so.

The firm's chief scientific officer, Robert Lanza, moved quickly, however, to capture some monetary gain from the news, which was announced in a press release Jan. 23 by ACT.

On Jan. 23 and 24, Lanza sold 7.7 million shares in ACT for $1.5 million, according to SEC documents. He sold the stock at 18 and 19 cents a share. That compares to an ACT price of about 8 cents at the end of 2011. Lanza still holds 26 million shares in the firm. The acquisition price of the stocks is unknown.

There is nothing to suggest anything untoward about Lanza's sale. But it is a reminder that creating a successful stem cell therapy is about making money. Without a profit, there will be no therapy, as Geron reminded everyone last November when it dropped its longstanding hESC trial.

The California Stem Cell Report has asked Lanza if he has any comments about the sale of the stock. We will carry his remarks verbatim when we receive them.

The Seeking Alpha web site appears to have been the first to report the sale. Here is their complete item.

"Advanced Cell Technology, Inc. (ACTC.OB): ACTC is a development-stage biotech focused on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. On Wednesday, Chief Science Officer Robert Lanza filed SEC Form 4 indicating that he sold 7.7 million shares for $1.5 million, ending with 26.0 million shares after that sale. ACTC shares have rallied strongly since the beginning of the year, up from 8.2 cents at the end of last year to currently in 14-15c range after rising above 20c just earlier this week."

Source:
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Text of IOM Statement on Efforts at Soliciting Comment on CIRM


Here is the text of the questions submitted Feb. 12 by the California Stem Cell Report to the Institute of Medicine concerning its attempts to secure comments on the operation of the $3 billion California stem cell agency along with the IOM response.

The response from Christine Stencel, a spokeswoman for the IOM, follows these questions from the California Stem Cell Report.

"I will be writing a piece on Wednesday dealing with the online surveys that IOM has posted. For that piece, please tell me very, very  specifically what the IOM is doing to generate responses. For example, is the IOM buying ads in newspapers or online, asking the public to fill out the forms? Is it hiring a polling firm to call households for responses?  Also please tell me exactly what is being done to generate responses on all the other surveys that have been posted.

"Additionally, please tell me how many responses that the IOM has received so far in each category on the survey forms for CIRM grantees, industry partners and leadership. Thank you."

The IOM response on Feb. 15:

"The IOM has been obtaining and compiling lists of organizations and people to circulate the questionnaires as widely as possible among target groups. For example, IOM has sent a notice to some 300 stakeholder groups encouraging participation. We do not have the resources to hire a polling firm or place ads.

"The purpose of these questionnaires is to extend the committee's information gathering beyond in-person meetings and the standard listing of an email address or phone number for the study on the project website. Not all people who might have useful experiences or perspectives on CIRM may be able to attend the in-person meetings and not all may visit the project website and find the study contact information. This is a proactive effort to reach more people.

"Anyone who knows of individuals or organizations with information on CIRM that would be useful for the committee's knowledge can share the links to the questionnaires with them. This will help spread the word and get the committee insights they need.

"I don't have information on the number of responses so far. Ultimately, as noted at the top of each survey, the responses will be aggregated and de-identified and placed in the public access file in addition to being shared with the committee.

"I trust this will be useful for your readers."

The California Stem Cell Report then asked the following questions on Feb. 15.

"Thank you for your response. A few follow-up questions:
Regarding the 300 stakeholder groups, how are those defined? Please give me a few examples.

"Based on your response, is it correct to say that the IOM is not sending out questionnaires directly to all CIRM grant applicants, including those who were rejected?

"Is it correct to say that no special effort -- other than that described in your response -- is being made to seek responses from stem cell businesses?

"The failure to provide numbers on the responses so far would indicate that the numbers are so small that the IOM is choosing not to disclose them. If that is not the case, please email me the numbers. Thank you."

The IOM had not responded to the follow-up questions as of this writing on Feb. 21.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Source:
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Trounson, Parthenotes and International Stem Cell


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

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

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

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

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

The Scientific American article said,

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

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

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

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

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

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

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

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

Searching for Facts About Cash: CIRM to Treasurer to Finance


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

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

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

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

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

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

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

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

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

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

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

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

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

The response said,

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

Cooney also said,

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

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

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

International Stem Cell Corporation Comments on WSJ Article “Hope for Stem-Cell Treatment of Parkinson's”

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

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

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


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

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Stem Cell Agency's Lobbyist Now Ranked No. 1 in California


The $3 billion California stem cell agency likes to align itself with the very best science. And as of today it is also hooked up with the best lobbyist in California – at least based on earnings.

CIRM hires many firms to perform work, given its unusual needs, rather than building a large and relatively permanent staff. The tasks of the outside contractors range from publishing the annual report to grant review matters. Today Laurel Rosenhall of The Sacramento Bee reported that one of the firms that CIRM has hired now ranks as the No. 1 lobbyist in California, based on its earnings.

The firm of Nielsen, Merksamer, Parrinello, Gross & Leoni pulled down nearly $5 million during the first three quarters of this year. The firm knocked KP Public Affairs out of the top spot, which it had held for at least the last 10 years.

Nielsen has had a contract with CIRM since its earliest days in 2005, but it doesn't amount to much in the scope of Nielsen's business. According to the latest CIRM report on outside contracting, Nielsen was paid $79,984 during the fiscal year 2010-2011 for services that also extended into the current fiscal year. The report did not list payments for earlier years, but it is our recollection that Nielsen was paid about $50,000 every year since 2005. It is not known whether the firm continues to hold a contract for the current fiscal year.

One of Nielsen's partners, Gene Erbin, was one of the drafters of Prop. 71, the ballot initiative that created the California stem cell agency in 2004. Merck and Pfizer, in addition to CIRM, are among the firm's clients.

Source:
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Seeking Alpha Article: 3 Contenders To Be The First Profitable Stem Cell Company by Ryan Pollock


Seeking Alpha is a "stock market news and financial analysis website, including free earnings call transcripts, investment ideas and ETF & stock research written by finance experts". Ryan Pollock recently initiated coverage on International Stem Cell Corporation (ISCO).  Although the views and opinions are Mr. Pollock’s own and not necessarily those of ISCO, we thought you would be interested in his insights about our company.
To read the complete article 3 Contenders To Be The First Profitable Stem Cell Company, please click HERE

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IOM and California Stem Cell Agency: Study Lacks Key Perspective


The prestigious Institute of Medicine earlier this month kicked off its $700,000 study of the California stem cell agency minus an important perspective – the view directly from California.

None of the persons on the 13-member panel evaluating the performance of the $3 billion enterprise comes from California. The reasons for that are not clear. The IOM is all but mum on the matter.

One could argue that it is not necessary to be geographically located in California to determine whether CIRM is working at peak performance. However, some conditions do exist in California that are difficult for many others to grasp. They include its state budget crisis that has now placed the once Golden State at the bottom of the heap in terms of its credit. Some even liken it to Greece. Obviously that situation can be understood in the abstract by reading The Sacramento Bee and the Los Angeles Times. But the intensity and emotion surrounding that issue and others are difficult to comprehend for many folks living in more blessed states.

Count among the other volatile issues the cutbacks in the state's once vaunted higher education system, including the University of California, which showed its back to students by increasing tuition by nearly 18 percent this fall. Couple that with a visceral antipathy -- and that is putting it mildly -- among some Californians to what they regard as execessive state salaries, including those at the stem cell agency.

What does all this have to with financing stem cell research through an agency that was supposed to have a guaranteed stream of income isolated from mischief that could be wreaked by the governor or legislature. It turns out that CIRM's cash flow is not as guaranteed as its backers believed. Instead of issuing bonds, the state is going to finance the agency over the next 18 months with commercial paper, if necessary. That's because Gov. Jerry Brown wants to reduce the interest costs on state borrowing, which have risen sharply and now consume 8 percent of the state budget along with funds that could otherwise go to educate California's children, among other things.

Brown's parsimony is famous. During his first term in office, he denied pay raises to state college professors, saying they are amply rewarded through "psychic income." More recently, he objected to out-of-state travel by CIRM staff. Too much "lollygagging in London on the taxpayer's dime," a Brown spokesman said. CIRM Chairman Jonathan Thomas promptly cut travel in the chairman's office by 50 percent and asked CIRM President Alan Trounson to do the same for the rest of the staff.

It is an environment that can be difficult to navigate under the best of circumstances. It places limitations on the stem cell agency and tends to focus its operations and funding in different directions than might be the case if California's economic climate were rosier.

The IOM has no real response to the question of why no Californian is on the panel. The California Stem Cell Report last week asked the institute whether an overt decision had been made to exclude persons from California. The IOM did not answer directly. Instead it referred to a generic description of how panel members are selected. The institute's unwillingness to address the specific question does not speak well for the openness and transparency of the IOM examination of CIRM.

Currently the IOM does have a comment period available on the selection of the panel members, who will not become official for another three days. Interested parties can make their views known to the IOM by using this link.

A Californian or two on the IOM panel would help to bring a valuable, broader perspective to this important study, which is sure to affect the future of the state's stem cell research and voter approval of another possible multibillion dollar bond issue in the next few years.

Source:
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OncoMed Has 'Wnt' in its Sails

OncoMed Has 'Wnt' in its Sails; Bayer Deal Adds $40M Up Front by Jennifer Boggs, Bioworld, June 18, 2010. Excerpts:

[OncoMed's] latest accomplishment is another early stage deal, this time with Bayer Schering Pharma AG, to develop drugs targeting the Wnt signaling pathway. It's an agreement that brings $40 million up front, with the potential for more than $1 billion in future milestones.

.....

The Wnt pathway is believed to be a key target in halting cancer stem cell activity. But only a few other firms - Avalon Pharmaceuticals Inc. (now part of Clinical Data Inc.) and 2008 start-up Wintherix LLC, for example - have entered that space, largely because Wnt is not an easily druggable target.

News release from Bayer: Bayer Schering Pharma and OncoMed Pharmaceuticals Enter Strategic Alliance to Develop Anti-Cancer Stem Cell Therapeutics, June 17, 2010. Excerpt:

Bayer Schering Pharma AG, Germany, and OncoMed Pharmaceuticals, Inc., today announced a global strategic alliance to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. Cancer stem cells are a subset of tumor cells believed to play a significant role in the establishment, metastasis and recurrence of cancer and agents targeting the Wnt pathway have the potential to be developed as pan-tumor drugs.

Comment: The Bayer-OncoMed strategic alliance has received attention via the social media. See, for example, the results of this FriendFeed search.

International Stem Cell Corporation and The Automation Partnership Enter into Strategic Alliance to Automate Cornea Tissue Production

OCEANSIDE, CA – May 18, 2010 – International Stem Cell Corporation (ISCO.OB), http://www.intlstemcell.com, announced today that it had entered into a strategic alliance with The Automation Partnership (TAP), http://www.automationpartnership.com, to automate and scale up the production of stem cell-derived human corneal tissue. The alliance has been formed to create instrumentation for ISCO and its partners and affiliates to produce development and commercial volumes of donor tissue for cornea transplantation and to reduce the use of animals and animal eyes in safety testing of drugs, chemicals and consumer products.

Cornea-related loss or reduction of vision can be caused by physical injury, infections and degenerative diseases. In cases where cornea replacement is indicated, current medical practice typically involves a one-two hour outpatient procedure under local anesthesia using full or partial corneas from healthy human cadavers. 10 million people worldwide are candidates for such treatment, primarily in Asia and Europe where there is significant quantitative and qualitative shortage of human cornea donation.

Global efforts are underway to transition from the use of live animals and excised animal eyes to test drugs, chemicals and consumer products. For example, Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) estimates a need to spend €270M and use 160,000 animals for eye safety testing alone to catch up with the back-log of insufficiently tested agents. In the US, the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA) have launched a five-year program dedicated to finding new, non-animal technologies for toxicity testing of chemical compounds.

ISCO has discovered and filed for patents on a cell culture process for the synthesis of standardized, human, corneal tissue using stem cells. Histology, permeability and optical testing has demonstrated compatibility with natural corneas. Efforts are ongoing to further characterize this tissue and standardize and scale up its synthesis. Automation is necessary to produce sufficient, reproducible tissue for development and commercialization of the therapeutic and toxicity testing applications.

Brian Lundstrom, ISCO’s President, says: “Given the substantial unmet therapeutic and toxicology testing needs for human corneal tissue, ISCO has embarked on a focused effort to advance this technology with international investors, eye clinics, and development and commercialization partners. After reviewing a range of potential cell culture automation companies, we are very pleased that TAP has agreed to contribute their over twenty years of experience towards this goal.”

David Newble, TAP’s CEO says: “TAP has successfully installed and supported over 160 automated cell culture systems worldwide and continues to design new and customize existing equipment for cell culture and other emerging life science applications. The opportunity to join forces with ISCO in the cornea tissue area will enable us to contribute solutions for clear biomedical needs while also creating new technology and knowhow that will be useful in other applications downstream.”

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 (hpSCs) 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 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. More information is available at 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.

About The Automation Partnership
The Automation Partnership (TAP) provides advanced automation systems and services to improve productivity in life science research, development and production.


For over 20 years TAP has been the leader in the design and development of automated cell culture and processing systems with applications in regenerative medicine, discovery research, bioprocess development and biologics production. Systems include SelecT, CompacT SelecT and Cellmate.

In addition, TAP has a strong track record in providing a range of custom automation solutions for biobanking, biological sample management, compound management and advanced high throughput screening applications.

TAP is a privately-owned company with headquarters near Cambridge, UK and a sales and support facility near Wilmington, Delaware, USA.

FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, 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," "should," "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, 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 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
Or
The Automation Partnership
Matthew Walker
Head of Communications
+44 1763 227 200
Matthew.walker@automationpartnership.com

Phase I clinical trial of ICT-107

Immune response correlation with progression-free survival in glioblastoma following dendritic cell immunotherapy (ICT-107) by Surasak Phuphanich and 9 co-authors, including Manish Singh, Keith Black and John Wu, J Clin Oncol 28:7s, 2010 (suppl; abstr 2097). To be presented at the 2010 ASCO Annual Meeting, June 06, 2010.

Related news releases:

ImmunoCellular Therapeutics Ltd. (IMUC) to Present Cancer Vaccine Candidate, International Business Times, June 02, 2010. Excerpt:

Data from the company’s recent clinical trial of ICT-107, the company’s dendritic cell-based cancer vaccine candidate, will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) June 4-8 in Chicago.

See also: Immunocellular brain cancer vaccine shows promise, Reuters, June 02, 2010. Excerpt:

"We are targeting specific antigens that are on cancer stem cells ... the only population of cells that can really propagate a tumor," said Dr. John Yu, director of surgical neuro-oncology at Cedars-Sinai Medical Center in Los Angeles and ImmunoCellular's chief scientific officer.

Another related news release: Immunocellular Therapeutics Enters into Research Agreement with University of Pennsylvania to Support Phase II Clinical Trial of ICT-107, Business Wire, April 21, 2010.

Putative tumor-initiating progenitor cells predict poor lung cancer prognosis

Adult lung stem cells, vital to injury repair, associated with poor cancer prognosis, News release, UCLA Newsroom, August 17, 2010. Excerpts:

Adult stem cells that are vital for airway repair in the lung but that persist in areas where pre-cancerous lesions are found are associated with a poor prognosis in patients who develop cancer, even those with early-stage disease, researchers at UCLA's Jonsson Comprehensive Cancer Center have found.

.....

In this study, Gomperts and her team screened around 900 tumors removed from patients with non-small cell lung cancer at UCLA and the University of Texas' MD Anderson Cancer Center, looking to see whether the adult stem cells could be found in the tumor. In her lab, Gomperts is now studying the pre-cancerous lesions where the adult stem cells persist in an attempt to uncover the cascade of molecular events that may transform these cells into lung cancer stem cells.

The news release is based on this publication: Presence of a Putative Tumor-Initiating Progenitor Cell Population Predicts Poor Prognosis in Smokers with Non–Small Cell Lung Cancer by Aik T Ooi and 19 co-authors, including Brigitte N Gomperts, Cancer Res 2010(Aug 15); 70(16): 6639-48. [PubMed citation][Full text]. Abstract:

Smoking is the most important known risk factor for the development of lung cancer. Tobacco exposure results in chronic inflammation, tissue injury, and repair. A recent hypothesis argues for a stem/progenitor cell involved in airway epithelial repair that may be a tumor-initiating cell in lung cancer and which may be associated with recurrence and metastasis. We used immunostaining, quantitative real-time PCR, Western blots, and lung cancer tissue microarrays to identify subpopulations of airway epithelial stem/progenitor cells under steady-state conditions, normal repair, aberrant repair with premalignant lesions and lung cancer, and their correlation with injury and prognosis. We identified a population of keratin 14 (K14)-expressing progenitor epithelial cells that was involved in repair after injury. Dysregulated repair resulted in the persistence of K14+ cells in the airway epithelium in potentially premalignant lesions. The presence of K14+ progenitor airway epithelial cells in NSCLC predicted a poor prognosis, and this predictive value was strongest in smokers, in which it also correlated with metastasis. This suggests that reparative K14+ progenitor cells may be tumor-initiating cells in this subgroup of smokers with NSCLC.

On the low frequency of tumor-initiating cells

Tumor-Initiating Cells Are Rare in Many Human Tumors by Kota Ishizawa and 16 co-authors, including Benjamin G Neel and William Matsui, Cell Stem Cell 2010(Sep 3); 7(3): 279-282. [FriendFeed entry][PubMed citation]. Abstract:

Tumor-initiating cells (TICs) are defined by their ability to form tumors after xenotransplantation in immunodeficient mice and appear to be relatively rare in most human cancers. Recent data in melanoma indicate that the frequency of TICs increases dramatically via more permissive xenotransplantation conditions, raising the possibility that the true frequency of TICs has been greatly underestimated in most human tumors. We compared the growth of human pancreatic, non-small cell lung, and head and neck carcinomas in NOD/SCID and NSG mice. Although TIC frequency was detected up to 10-fold higher in NSG mice, it remained low (<1 in 2500 cells) in all cases. Moreover, aldehyde dehydrogenase-positive (ALDH(+)) and CD44(+)CD24(+) cells, phenotypically distinct cells enriched in TICs, were equally tumorigenic in NOD/SCID and NSG mice. Our findings demonstrate that TICs are rare in these cancers and that the identification of TICs and their frequency in other human malignancies should be validated via primary tumors and highly permissive xenotransplantation conditions.

International Stem Cell Corporation Announces Commercial Sales to General Public of Its Breakthrough Stem Cell-Based Lines of Skin Care Products


International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that the first new topical skin care products of its subsidiary, Lifeline Skin Care, are now available to the general public within the United States at http://www.lifelineskincare.com. Lifeline Skin Care's first two products consist of a Defensive Day Moisture Serum and Recovery Night Moisture Serum. Previously, these breakthrough serums, containing extracts from "parthenogenetic" stem cells, were available only to individuals and organizations formerly identified and selected for their interest in innovative approaches to skin care.

According to Lifeline Skin Care CEO, Dr. Ruslan Semechkin, "Because the quality products Lifeline Skin Care offers are experiencing strong demand and the human stem cell extracts require innovative manufacturing processes, we chose to develop our sales channels gradually and incrementally. We are very pleased with the customer feedback from our first limited launch and are delighted to now be able to expand production and make the products available to the general public within the US."

Purchases that could previously be made only by phone, can now be made directly through the company's website,http://www.lifelineskincare.com. "Enabling electronic order processing though our website provides the benefit of both lowering our transaction costs and increasing our scalability, while simultaneously simplifying the ordering process for our customers," said ISCO VP, Dr. Simon Craw.

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, product introduction plans and related support, the potential benefits of planned products, anticipated sales growth for recently introduced 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.

Key Words: Stem cells, parthenogenesis, biotechnology, skin care, anti-aging

International Stem Cell Corporation

Kenneth C. Aldrich, Chairman

1-760-940-6383

kaldrich@intlstemcell.com

or

Lifeline Skin Care, Inc.

Ruslan Semechkin, PhD, President & CEO Vice President, ISCO

ras@intlstemcell.com

Two More Disease Team Applications Sent Back for More Review


Directors of the California stem cell agency today referred two additional research applications for $37 million in disease team funding back to reviewers for further consideration.

Both were the subjects of appeals by researchers whose proposals were rejected by grant reviewers.

One was from Timothy Hoey of OncoMed Pharmaceuticals in Redwood City, who sought $20 million.  The other was from Henry Klassen of UC Irvine, who sought $17 million. (See here and here for their appeals.)

The  board began the day by directing staff to come back to the board in early September. But with the large number of grants to be reassessed, it was acknowledged some might not be acted on until the board's meeting in late October.

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