Business Success Rate at Stem Cell Agency: Zero in Latest Round After 14 Fail


California biotech companies chalked up
a zero in the latest funding round by the state's $3 billion stem
cell agency, although 14 tried to run a gauntlet that industry has
complained about for years.

All $69 million in last month's
translational research round went to 21 academic and nonprofit insitutions. No business received an award. One firm, Eclipse
Therapeutics
of San Diego, appealed to the agency's governing board but was not successful despite having a higher scientific score
than at least two winners.
The miniscule amount of funding for
commercial enterprises – less than 4 percent of $1.4 billion handed
out so far – has been a matter of concern for some time for both
industry and some members of the CIRM governing board. Most
recently, industry executives complained at an April hearing of the
Institute of Medicine panel looking into CIRM's operations.
Even a 2010 review commissioned by CIRM said the agency needed to do
better by business.
The question of funding goes beyond a
simple matter of fairness or "good science," as CIRM
describes its funding goal. Without efforts by industry to turn
research into cures, CIRM will not be able to fulfill promises to
voters in 2004 when they approved creation of the stem cell agency.
CIRM last month approved a set of five-year goals that push more
aggressively for development of commercial products, but the goals
lacked such things as a financing round devoted solely to business
applicants.
In last month's translational round,
applicants went through a three-step process, which is conducted
primarily behind closed doors. First came what CIRM calls
pre-applications. Those were reviewed by CIRM staff with the help of
outside advisors if necessary. Applicants who cleared that hurdle were allowed to apply for the full, peer-reviewed round. During that
process, the CIRM Grants Working Group reviews applications,
makes decisions and sends them to the full CIRM board for
ratification and possible changes. The board almost never has
rejected a grant approved by reviewers. But the board has ultimate
authority and sometimes funds applications that reviewers have
rejected. The applicants' names are withheld from the board and the
public during the process, although some of the board discussion and
the final vote is conducted in public. CIRM does not release the
names of rejected applicants unless they appeal.
In the translational round, a total of 42
pre-applications out of 167 were approved by staff, according to
CIRM. Thirty-eight came from nonprofits and academics out of the 153
such institutions that applied. Four out of 14 business
pre-applications advanced to full applications but none made the
final cut. All of the winning applications were linked to
institutions that have representatives on the CIRM governing board.
Those representatives are not allowed to vote on or take part in
discussion involving applications to their institutions.
The primary decision tool used by the
grant review group is a scientific score. In last month's round,
scores of approved grants ranged from 88 to 53. However, eight grants
that were ranked above 53 were rejected by the board. One of those
higher-ranking applications came from San Diego's Eclipse
Therapeutics, which scored 58. The low-ranking grants were approved
for what CIRM describes as "programmatic" reasons.
More than three weeks ago, the
California Stem Cell Report asked CIRM for figures on the
numbers of applications in the translational round, including those
for business. CIRM said the figures had not been compiled and would
not be available until after the awards were made on May 24. The
numbers were finally supplied yesterday.
Our take: The number of applicants, and
their breakdown, is basic information that should be part of board's
decision-making process. The statistics should be routinely available
well in advance of the board's meeting. Indeed, the agency in its
earlier days used to routinely publish the figures. It may be now
that generating them is more time-consuming than necessary. The
recent performance evaluation of the agency said CIRM needs to make
major improvements in how it handles critical information needed for
its top management and board.
Whatever the reason, given CIRM's poor
track record with business, the agency's directors should diligently
track industry's success rate on applications. If proposals ranked as
low as 53 are approved while higher ranking applications from
business are bypassed, it warrants more than cursory examination.

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

Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co
.
to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

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

Scripps CEO Joins Stem Cell Agency Board; Love Leaves


Michael Marletta
Scripps Photo

State Treasurer Bill Lockyer has
appointed Michael Marletta, president and CEO of the Scripps Research
Institute
, to the 29-member board of directors of the $3 billion
California stem cell agency.

Marletta fills the seat of Floyd Bloom,
also a Scripps executive, who resigned last year. Scripps has
received $45.3 million in funding from CIRM.
In a letter yesterday to the stem cell
agency, Lockyer said Marletta is a member of the National Academy of
Science, American Academy of Arts and Sciences
and the Institute of
Medicine.
Marletta joined Scripps in 2011 and became president in
January.
Prior to that, he was at the University
of California, Berkeley
, where he once served as chairman of the
department of chemistry, among other roles. An item on the Scripps
web site said Marletta "focused his research on the intersection
of chemistry and biology. He is acknowledged as a pioneer in
discovering the role of nitric oxide, a critical player in
communication between cells."
The CIRM board has another vacancy to
fill. Ted Love resigned last month after serving on the board since
its inception in December 2004. CIRM said Love, executive vice
president of Onyx Pharmaceuticals, resigned for personal reasons.
State Controller John Chiang is considering a number of candidates to
replace him. Love was the only African-American on the board.

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

International Stem Cell's Q2 Revenues Nearly Triple by Deborah Sterescu

International Stem Cell Corporation (ISCO) (OTCBB:ISCO) reported Wednesday that second quarter sales more than doubled to almost triple, while year-to-date sales jumped a whopping 271%, as the company's operating subsidiaries continue to generate more revenue.
In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that have reflected revenue growth in the meantime, including Lifeline Cell Technology, which sells its cell-culture products to researchers to grow human cells for pre-clinical research, and Lifeline Skin Care, which sells skin care products based on its parent's stem cell technology.
For the three months ending June 30, International Stem Cell saw revenues rise to $1.1 million, from $0.44 million a year earlier.
Year-to-date revenues totaled $2.6 million, versus $0.7 million for the same period in 2010, helped by a $1.7 million contribution from Lifeline Skin Care, and a $0.9 million addition from Lifeline Cell.
In the last quarter, Lifeline Cell gained over 200 new customers due to new product introductions and the development of distribution channels internationally, a strategy ISCO plans to continue.
Meanwhile, the company's skin care business is coming off a highly successful launch at the end of last year, exceeding its plans to sell 1,000 products, with 7,000 products sold initially. Lifeline Skin plans to aggressively kick start major marketing initiatives again in September.
While these two subsidiaries are busy chalking up revenues, ISCO, whose parthenogenetic stem cell technology can be used to derive pluripotent stem cells, meaning they can be transformed into any cell type in the body, has many important advantages at its fingertips.
Regenerative medicine is a market that is set to boom in the coming years, as more and more companies are developing therapies based on stem cell use. International Stem Cell's long-term goal is to be a universal supplier of stem cells for not just one, but a host of therapies.
The company's parthenogenetic stem cells are derived from unfertilized eggs, avoiding the ethical issues behind the destruction of viable human embryos. Like embryonic stem cells, they also have the capacity to become almost any cell type in the body, but have demonstrated they are better in terms of the immune system, as one single stem cell line can be genetically matched to millions of people, reducing the need for immunosuppressants.
Its plan is to establish a US bank of its clinical-grade human parthenogenetic stem cells that will be capable of being immune-matched to millions of patients, so that a physician could call up and request a specific cell type for people. The company, which recently received approvals to enroll around 3 US donors for its bank, already has a collection of ten human parthenogenetic stem cell lines used for research purposes, which were derived outside the US.
These cell lines could potentially be used to cure a number of diseases, including cancer, heart disease, liver disease, among many others. Already, the company has several trials in the works, and has successfully demonstrated in pre-clinical animal studies that its stem cells can be used to create viable liver cells. It has also started pre-clinical animal trials to create neuronal cells in the brain, to potentially cure Parkinson's disease.
Unsurprisingly, all this work to progress the company's technology has increased expenses, contributing to a $2.5 million loss in the second quarter, or a 3 cent loss per share.
Research and development costs grew on account of greater scientific projects, while general and administrative costs leapt on increased headcount as the company bulks up its management team.
International Stem Cell, with $3.6 million in the bank at the end of the quarter, said that it has not ruled out future capital raising, but it already has a facility that allows it to draw equity as necessary to secure its planned growth.

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

Last Public Hearing in California for CIRM Performance Evaluation Scheduled for April


The blue-ribbon Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency will hold its final public hearing within the state on April 10 at UC Irvine.

No details have yet have been posted online about the matters to be discussed or the witnesses to be heard. So far, the panel has not heard publicly from a single independent witness. The panel's final report and recommendations are scheduled to be released this fall, following its only remaining public meeting, scheduled for Washington, D.C.

The IOM has also posted a list of documents provided to the panel during a closed session last month in South San Francisco, its only public hearing in California so far. Virtually all of documents came from the CIRM itself, which is paying the IOM $700,000 for the study.

One exception was the 2009 report by California's good government agency, the Little Hoover Commission.

In its report, the commission concluded,

"CIRM’s governance structure is not adequate to protect taxpayers’ interests or serve its own ambitious goals."

The commission recommended a number of changes to strengthen CIRM's governance structure, improve accountability and reduce conflicts of interest. They included restructuring and reducing the size of the 29-member board and eliminating the controversial dual executive arrangement at CIRM.

CIRM strongly resisted nearly all of the recommendations, some of which would have required legislative or voter approval. As of last week, the IOM panel had not contacted the Little Hoover Commission for testimony.

(Click on the "closed session summary" at this location to find the information about the documents that were provided.)

The IOM also has posted a list of topics discussed by its panel in closed session last month. They included a follow-up on bias and conflicts of interest, committee composition, discussion of the previous day's hearing and discussion of data needs.

The April meeting is being held at the Beckman Center at UC Irvine, which has received $77 million from CIRM. The agency's board of directors includes two top academicians from UC Irvine: Oswald Steward, who serves on the board as a patient advocate and is director of the Reeve-Irvine Research Center for Spinal Cord Injury, and Susan Bryant, associate executive vice chancellor for research at Irvine and who serves on the CIRM board as in her capacity as an executive officer from a UC campus with a medical school.

 

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

Stem Cell Agency Proposes 7 Percent Budget Hike, Seeks $50 Million in Private Funds


The California stem cell agency is proposing an operational budget of $17.8 million for the coming fiscal year, an increase of 7.2 percent over estimated spending for the current year ending June 30.

Financial documents (proposed budget and finance report) prepared for tomorrow's CIRM governing board meeting also showed that CIRM hopes to snag "$50 million in new, outside financial commitment for CIRM programs." This would represent the first major effort in recent years by CIRM to solicit private funds. The "draft goal" is in keeping with the agency's move to build a base of non-governmental funding.

Currently it is financed with cash that the state, which is mired in a financial crisis, must borrow. While CIRM's budget is increasing, the general fund budget for the entire state has plummeted from $103 billion in 2007-2008 to $87 billion this year.

The proposed CIRM budget also disclosed the agency will be facing substantial new costs – $1 million annually – for rent beginning in November 2015. CIRM has been operating rent-free since 2005 because of an $18 million recruitment package put together by the city of San Francisco.

The largest item in the proposed budget is salaries and benefits at $11 million, up from a projected $9.3 million for this year. The agency, which is administering $1.3 billion in grants involving hundreds of researchers, projects an increase in staff to 59. The agency currently has 51 employees, according to the finance report.

Outside contracts are the second largest expense at $3.4 million ($3 million this year) with grant reviews, meetings and workshops at $2.2 million(no comparable figure for this year).

By law, the stem cell agency operates under a budget cap of 6 percent of bond proceeds under the terms of Proposition 71, the ballot initiative that created CIRM.

In addition to tomorrow's review, the budget will be examined by the directors Finance Subcommittee April 2 before coming back for final approval in late May.

(Editor's note: An earlier version of this item incorrectly stated that the rent costs would rise to $1 million beginning in 2016. In fact, the increase will begin in November 2015. CIRM has revised the start date.)

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

Part 3: The Ellis Martin Report with Ken Aldrich of Int Stem Cell Corp (ISCO.OB)


Ellis Martin of The Ellis Martin Report interviews Ken Aldrich of International Stem Cell Corporation (ISCO.OB) on the latest research involving stem cell technology utilizing unfertilized eggs, as a basis for cell generation with a goal toward organ transplants which are immune to rejection by the body...as well as other applications. Mr. Aldrich also discusses neurological applications focusing on reversing Parkinson's disease. Preventing and reversing blindness is another topic covered. 


International Stem cell Corporation is a paid sponsor of The Ellis Martin Report

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

The Ellis Martin Report: Interview with Ken Aldrich of International Stem Cell Corp.

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"Ken Aldrich of International Stem Cell Corp (ISCO.OB) on the Present and Future of Stem Cell Research and Applications"

The Ellis Martin Report: International Stem Cell Corporation trades under the symbol ISCO.OB on the Over the Counter Bulletin Board and is based in Carlsbad, California where I have the pleasure of interviewing Executive Chairman, Kenneth Aldrich. International Stem Cell has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISCO a unique leadership role in the field of regenerative cell therapy. Additionally, Lifeline Cell Technology, a wholly-owned subsidiary of International Stem Cell Corporation (ISCO), develops, manufactures and markets high-quality human primary cells, stem cells, media and reagents for sale to pharmaceutical, academic and government scientists. The company’s management pioneered the development of the normal human cell culture market through the creation of Clonetics® Corporation in the 1980s and has over 20 years combined experience in research, development, manufacturing, quality control, marketing and sales of human cell culture products. Lifeline’s products are distributed in the United States and Europe. Ken Aldrich, welcome to the program.
For the complete text version of this broadcast: http://www.ellismartinreport.com/node/148

Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp.

International Stem Cell Corporation trades under the symbol ISCO.OB on the Over the Counter Bulletin Board and is based in Carlsbad, California where Ellis Martin had the pleasure of interviewing Executive Chairman Kenneth Aldrich. 


International Stem Cell has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISCO a unique leadership role in the field of regenerative cell therapy. Additionally, Lifeline Cell Technology, (a wholly-owned subsidiary of International Stem Cell Corporation (ISCO) develops, manufactures and markets high-quality human primary cells, stem cells, media and reagents for sale to pharmaceutical, academic and government scientists. 

The company's management pioneered the development of the normal human cell culture market through the creation of Clonetics® Corporation in the 1980s and has over 20 years combined experience in research, development, manufacturing, quality control, marketing and sales of human cell culture products. Lifeline's products are distributed in the United States and Europe. http://www.ellismartinreport.comhttp://www.intlstemcell.com contact: martinreports@gmail.com 
International Stem Cell is a paid sponsor of The Ellis Martin Report

International Stem Cell Corporation: A Company with Scores of Potential by Deborah Sterescu

International Stem Cell Corp (OTCBB:ISCO) is a company to watch this year, with several promising developments in store, according to a conference call with investors this morning.


The company, whose parthenogenetic stem cell technology can be used to derive pluripotent stem cells, meaning they can be transformed into any cell type in the body, has many important advantages at its fingertips.


Regenerative medicine is a market that is set to boom in the coming years, as more and more companies are developing therapies based on stem cell use. International Stem Cell's long-term goal is to be a universal supplier of stem cells for not just one, but a host of therapies.


The company's parthenogenetic stem cells are derived from unfertilized eggs, avoiding the ethical issues behind the destruction of viable human embryos, and giving cell-therapy companies one big reason to chose International Stem Cell as their supplier of choice when the time is right.
These parthenogenetic cells, like embryonic cells, also have the capacity to become almost any cell type in the body, but have demonstrated they are better in terms of the immune system, as one single stem cell line can be genetically matched to millions of people, reducing the need for immunosuppressants.


The company holds the world's largest collection of research-grade human parthenogenetic stem cell (hpSC) lines, which it uses along with its partners to investigate cellular therapies for a number of incurable human diseases.


Its plan is to establish a US bank of its clinical-grade human parthenogenetic stem cells that will be capable of being immune-matched to millions of patients, so that a physician could call up and request a specific cell type for people. The company, which recently received approvals to enroll around 3 US donors for its bank, already has a collection of ten human parthenogenetic stem cell lines used for research purposes, which were derived outside the US.


These cell lines could potentially be used to cure a number of diseases, including cancer, heart disease, liver disease, among many others. Already, the company has several trials in the works, and has successfully demonstrated in pre-clinical animal studies that its stem cells can be used to create viable liver cells.


Currently, efficacy tests in rat models are in progress for the liver cells, with results anticipated soon. If successful, the company said it plans on aggressively initiating the FDA process, with the aim of beginning first stage clinical trials sometime in 2012. The hope is that International Stem Cell will attain Fast Track designation, as few alternative options are available to patients suffering from liver disease.


The company also has trials in the works for Parkinson's disease and diseases of the eye, and is actively looking for collaborative or joint venture opportunities, as well as in-licensing and out-licensing arrangements.


In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that are set to generate revenue in the meantime. Lifeline Cell Technology, which saw sales grow by 35% in the first quarter, develops manufactures and markets the Lifeline brand of cell-culture products, which are used by researchers to grow human cells for pre-clinical research.


The subsidiary's products are developed using parent International Stem Cell's technology, and the company expects that as trials for researchers progress into more advanced stages, its technology will be embedded in this progress, potentially generating hundreds of millions of revenue.


In the last quarter, Lifeline Cell gained over 200 new customers due to new product introductions and the development of distribution channels internationally, a strategy it plans to continue.


Lastly, International Stem Cell's Lifeline Skin Care business sells skin care products based on its stem cells, having a very successful launch at the end of last year. The company planned on selling 1,000 products, but sold 7,000 initially, and plans to aggressively kick start major marketing initiatives again in September.


International Stem Cell is a company with scores of upside potential, and though future capital raising has not been ruled out, it has a facility that allows it to draw equity as necessary.
Register here to be notified of future International Stem Cell articles

International Stem Cell Corporation Not Adversely Affected by Stem Cell Research Funding Ban

OCEANSIDE, CA – August 26, 2010 – International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that the recent action of a federal district judge blocking federal funding of embryonic stem cell research is not expected to have negative effects on ISCO’s therapeutic programs using its human parthenogenetic stem cells.

According to ISCO’s Chairman Ken Aldrich, “Because we have never depended on federal or state money to fund our research, the new ruling is simply not applicable to any of our programs in the US or any of our international efforts. Although we believe anything that restricts legitimate scientific research is detrimental to science and our Country and hope the ruling is quickly reversed, the ruling could in a strange way benefit ISCO by creating additional incentives for researchers to use our parthenogenetic stem cell lines.”

Because ISCO’s technology, parthenogenesis, does not destroy or damage a viable human embryo, its parthenogenetic stem cell lines (“hpSC”) offer an alternative way to continue research previously done with embryonic cell lines without raising ethical issues about the destruction of life. Published peer-reviewed papers have shown hpSC to be “pluripotent”, a characteristic shared with embryonic stem cells that allows them to become tissues leading to all the cells found in the human body. Therefore, ISCO’s hpSC lines offer an alternative to the ethical issues that continue to be problematic for embryonic stem cells.

When enacted, legislation prohibiting the creation of a human embryo for research purposes prohibited both successful methods, such as fertilization, as well as less understood methods such as parthenogenesis. Parthenogenetic methods since developed by ISCO do not create human embryos that could become viable human beings, yet can result in pluripotent hpSC lines with potential therapeutic value. “The recent court ruling may cause Congress to revisit its legislation. If so, then ISCO’s research showing its hpSC lines present an alternative to embryonic stem cells, without raising the ethical concerns about the creation or destruction of viable human life, may lead to Congress allowing federal funding of hpSC in future legislation. ISCO would then be free to provide hpSC lines to federally-funded researchers and move more of our work back into the US from foreign jurisdictions”, said Jeffrey Janus, Senior Vice President of ISCO and one of its founders.

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 all 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 across racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, develops a line of cosmeceutical products via its subsidiary Lifeline Skin Care and advances novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics do not. 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

FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological 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," "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
Jeffrey Janus
Sr. Vice President, Operations
760-640-6383
jjanus@intlstemcell.com

International Stem Cell Corporation Announces Completion of Its First Manufacturing Run of Lifeline Skin Care's Stem Cell-Based Skin Rejuvenation…

International Stem Cell Corporation Announces Completion of Its First Manufacturing Run of Lifeline Skin Care's Stem Cell-Based Skin Rejuvenation Products

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that its wholly-owned subsidiary, Lifeline Skin Care, Inc., in partnership with an experienced OTC drug licensed manufacturer of cosmetic products, successfully manufactured its first scaled-up lots of stem cell-based skin creams, confirming that these unique products can be made in larger batch quantities and continue to meet Lifeline's high quality standards. This marks an important milestone in proving that two new technologies, the derivation of human parthenogenetic stem cells, and the packaging and delivery of critical anti-aging ingredients, including those derived from stem cells, can be scaled-up into a level of production suitable to meet commercial levels of demand.

Lifeline Skin Care's product development scientists have combined human parthenogenetic stem cell technology with the latest discoveries in skin rejuvenation to create its unique day and night skin care creams. ISCO's scientists were the first to intentionally create human parthenogenetic stem cells from unfertilized human eggs, thus avoiding the ethical concerns of harming a viable human embryo. ISCO's therapeutic research team discovered that such cells had qualities that made them suitable for skin care products, thus leading to the formation of ISCO's wholly-owned subsidiary, Lifeline Skin Care. Valuable assistance from ISCO's other wholly-owned subsidiary, Lifeline Cell Technology, allowed the rapid transition and scale-up of a research-based discovery into a quality-controlled commercial product. Lifeline Cell Technology is staffed with experts in the manufacture and quality control of cell based products.

According to Dr. Ruslan Semechkin, CEO of Lifeline Skin Care, "Although it will be necessary to continue to develop new technologies to further scale-up the production of our new skin care products, this first successful manufacturing run proves that the team of ISCO's therapeutic research scientists, in combination with Lifeline Skin Care's product development expertise and Lifeline Cell Technology's manufacturing and quality control expertise, has the ability to quickly develop and commercialize new products using stem cell technologies."

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, 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
Lifeline Skin Care, Inc.
Ruslan Semechkin, Ph.D., President & CEO
Vice President, International Stem Cell Corporation
ras@intlstemcell.com

Two recent OA articles

Two articles, with Open Access (OA) to the full text (PDF):

Putative cancer stem cells in malignant pleural mesothelioma show resistance to cisplatin and pemetrexed, Int J Oncol 2010(Aug); 37(2): 437-44. [PubMed citation].

Possible involvement of stem-like populations with elevated ALDH1 in sarcomas for chemotherapeutic drug resistance, Oncol Rep 2010(Aug); 24(2): 501-5. [PubMed citation].

Comment about these journals:

Spandidos Publications publishes six journals. Of these six, two are: International Journal of Oncology (2009 Impact Factor: 2.4) and Oncology Reports (2009 Impact Factor: 1.6). This publisher provides a hybrid open access option. The Information for Authors for all six journals includes, at the bottom of the page, this information: "Should authors prefer or require their article to be freely available as soon as it has been published, they may request open access immediately upon publication for a fee of EUR 450."

Two Open Access reviews

1) Cancer Stem Cells in Pancreatic Cancer by Qi Bao and 6 co-authors, including Karl-Walter Jauch and Christiane J Bruns, Cancers 2010(Aug 19); 2(3): 1629-41. [Full text PDF][Scribd entry][Part of the Special Issue Pancreatic Cancer]. Abstract:

Pancreatic cancer is an aggressive malignant solid tumor well-known by early metastasis, local invasion, resistance to standard chemo- and radiotherapy and poor prognosis. Increasing evidence indicates that pancreatic cancer is initiated and propagated by cancer stem cells (CSCs). Here we review the current research results regarding CSCs in pancreatic cancer and discuss the different markers identifying pancreatic CSCs. This review will focus on metastasis, microRNA regulation and anti-CSC therapy in pancreatic cancer.

2) The Emerging Role of the Phosphatidylinositol 3-Kinase/ Akt/Mammalian Target of Rapamycin Signaling Network in Cancer Stem Cell Biology by Alberto M Martelli and 4 co-authors, including James A McCubrey, Cancers 2010(Aug 18); 2(3): 1576-96. [Part of the Special Issue Cancer Stem Cells].

Comment: Review #2 is the first paper that has been published in the special issue on Cancer Stem Cells. As of August 20, 17 more contributions to this special issue are planned. Review #1, although about CSCs, is a contribution to a separate special issue on Pancreatic Cancer.

Must the last CML cell be killed?

Do we have to kill the last CML cell? DM Ross, TP Hughes and JV Melo, Leukemia 2010(Sep 16) [Epub ahead of print][FriendFeed entry][PubMed citation][Full text]. The abstract of this OA review:

Previous experience in the treatment of chronic myeloid leukaemic (CML) has shown that the achievement of clinical, morphological and cytogenetic remission does not indicate eradication of the disease. A complete molecular response (CMR; no detectable BCR-ABL mRNA) represents a deeper level of response, but even CMR is not a guarantee of elimination of the leukaemic, because the significance of CMR is determined by the detection limit of the assay that is used. Two studies of imatinib cessation in CMR are underway, cumulatively involving over 100 patients. The current estimated rate of stable CMR after stopping imatinib is approximately 40%, but the duration of follow-up is relatively short. The factors that determine relapse risk are yet to be identified. The intrinsic capacity of any residual leukaemic cells to proliferate following the withdrawal of treatment may be important, but there may also be a role for immunological suppression of the leukaemic clone. No currently available test can formally prove that the leukaemic clone is eradicated. Here we discuss the sensitive measurement of minimal residual disease, and speculate on the biology of BCR-ABL-positive cells that may persist after effective therapy of CML.

CSC news links 2010-05-01

For links to recent news items, visit these [Twitter] or [FriendFeed] pages. Examples of two news items that have received attention:?

$95 Million in California Stem Cell Grants: Preview the Spending


For those interested in how the
California stem cell agency is going to spend its next $95 million,
you can check out short digests today of the 19 research grant applications, including reviewer comments, that are virtually certain of receiving the cash. 
The applications came in what CIRM
calls its "early translational III" round, which is
scheduled to be acted on by the CIRM board May 24 in San Francisco.
Digests of reviewer comments are
part of the directors' meeting agenda. They include scientific
scores, a statement from the applicant and a summary of what
reviewers had to say during their closed door sessions. But you won't
find the names of the applicants, their institutions or businesses.
The stem cell agency conceals the names of the winners until after
the board acts. Names of the unlucky ones are not disclosed by CIRM.
The agency says it does not want to embarrass anybody including the
institutions involved.
However, persons familiar with the area
of science involved may well be able to discern at least some of the
names of applicants from the information contained in the summaries.
Scientific scores of the successful
applicants ranged from 88 to 53. Nine grants scored higher than 53
but were rejected by reviewers(the Grants Working Group). The panel
turned down 22 applications overall. The CIRM board has final
authority on applications, but has almost never rejected a positive
decision by reviewers. Sometimes, however, it will overrule a
negative decision.
One successful application that was
scored at 53 involved ALS. The $1.7 million proposal was approved
for "programmatic reasons," according to the summary.
Often, programmatic motions for approval are made by CIRM board
members sitting on the review panel. However, the summary did not
disclose who made the motion or the vote. The summary said,

"The programmatic reasons provided
were that ALS is a devastating disease that is not well-represented
in CIRM's portfolio."

The other successful application that
scored at 53 sought $6.3 million for research involving heart
disease. The summary did not clearly identify the specific reason for
approving the grant on a programmatic motion. But it said,

 "The
GWG (grants working group) ... advised as a condition for funding
that the applicant consult additional vector specialists with
translational and clinical experience to select a more appropriate
vector to move this program towards the clinic." 

Again CIRM withheld the vote on the
motion and the name of the person who made the motion.
Applicants who have been rejected by
reviewers can appeal to the full board. So far no appeals have been
publicly posted by CIRM. The success rate on such appeals is mixed.
The translational round was open to
both academics and businesses, which have received a tiny fraction of
CIRM's $1.3 billion in spending so far. Some businesses have
complained publicly and, as well, to a panel of the Institute of
Medicine
that is evaluating CIRM's performance.
The California Stem Cell Report
yesterday asked CIRM for the number of businesses that applied in the
translational round, including the pre-application process, which is
used to whittle down the total number of applications. The request included total numbers as well. CIRM spokesman
Kevin McCormack declined to produce the figures prior to the CIRM
board meeting, saying they "won't be ready" until after the
session.   

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

Business-friendly Changes Proposed for Revenue Sharing by Stem Cell Agency


The $3 billion California stem cell
agency, which hopes to generate income for the state through the sale
of stem cell therapies, is moving to make its profit-sharing rules
more friendly to business.

The proposed changes will come up Monday morning before the Intellectual Property and Industry Subcommittee of the
CIRM governing board.
No stem cell research funded by CIRM
has yet been commercialized. Its intellectual property regulations,
which determine payback criteria, were developed shortly after CIRM
was created in 2004. Ed Penhoet, one of the founders of
Chiron and now a venture capitalist, chaired the panel that worked
out the rules. He has since left the CIRM board.
A CIRM staff memo described the payment
rules in the case of a "blockbuster" therapy as "uneven"
and "lumpy." The memo said they "could be a
disincentive for the engagement of industry." Other rules were described as creating
"administrative challenges and uncertainty." The proposed changes, the memo said,
would address those issues and ensure a "comparable economic
return to California."
Here are links to the specific changes
-- see here and here.
Public sites where interested parties
can take part in the discussion are located in San Francisco, La
Jolla, Los Angeles and Irvine. Specific addresses can be found on themeeting agenda.
The proposed changes must go before the
full governing board and then into the state's administrative law
process before taking full effect.  

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