The Search for Stem Cell Cures: Can California's $3 Billion Agency Move Audaciously?


IRVINE, Ca.-- California's unprecedented stem cell research effort faces a tight timetable for making major progress in fulfilling promises to voters seven years ago, complicated by potential conflicts of interest, a blue-ribbon panel was told this morning.

David Jensen, editor of the California Stem Cell Report, made the comments to the Institute of Medicine panel looking into the performance of the $3 billion California Institute of Regenerative Medicine.

The panel's inquiry comes as the agency is re-evaluating its strategies as it faces loss of funding in about 2017.

Here is the full text of Jensen's statement.
Statement to IOM-CIRM Panel by California Stem Cell Report April 9, 2012

"

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

Center for Genetics and Society: 'Wrong' to Ask for More Billions for Stem Cell Agency


IRVINE, Ca. – The Center for Genetics and Society today said it would "wrong" to ask the people of California for more money to continue financing stem cell research at state expense.

Marcy Darnovsky, associate executive director of the Berkeley, Ca., non-profit group, addressed a blue-ribbon Institute of Medicine panel evaluating the performance of the $3 billion California stem cell agency, which is financed by money borrowed by the state. The agency is expected to run out of cash in about five years.

Darnovsky said,

"In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding 'would be premature at this time,' but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important."

Representatives of the stem cell agency were present at today's hearing on the UC Irvine campus, but did not speak publicly at today's session. CIRM officials, however, have testified before the panel on two other days of public hearings. The agency is paying the IOM $700,000 to conduct the study. Its results and recommendations are expected to be published in November.

Darnovsky and others testifying at the morning session were critical of the agency's lack of accountability, built-in conflicts of interest and immunity from normal government oversight (see here and here).

Darnovsky said, "

The requirement for 70% super-majorities (to change the law regarding CIRM) means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

"Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues."

Here is the full text of Darnovsky's comments.
Center for Genetics and Society statement to IOM-CIRM panel, April 10 2012

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

Stem Cell Agency Budget Up for Review on Monday: 7 Percent Increase Proposed


The proposed $17.8 million operational budget for the California stem cell agency will receive more public scrutiny at a meeting next week in San Francisco, with additional public participation sites ranging from Boston to La Jolla.

The spending plan for 2012-13 is 7.2 percent higher than the estimated expenditures for the current year. By law, CIRM's budget is not subject to cuts by the legislature or the governor, who are trying to find solutions to the state's ongoing financial crisis.

Next week's hearing will be the last before approval of the budget in late May by the directors of the $3 billion research program. No significant changes are expected from the document to be presented on Monday.

Public sites where the public can participate in the CIRM directors' Finance Subcommittee meeting include South San Francisco, Stanford, Berkeley and Boston. You can find more information about the specific locations on the meeting agenda, but if you are interested in attending you need even more details from CIRM prior to the actual meeting. Email a request to info@cirm.ca.gov.

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

Front Page Coverage of CIRM-backed Research


SAN FRANCISCO -- The California stem cell agency scored during the weekend in a front page story in the San Francisco Chronicle that heralded a possible cancer treatment involving a "don't-eat-me-molecule."

The piece by Victoria Colliver said,

"In a potential breakthrough for cancer research, Stanford immunologists discovered they can shrink or even get rid of a wide range of human cancers by treating them with a single antibody."

The story was played prominently on the Chronicle front page on Saturday. However, the stem cell agency and its funding role was not mentioned until the last paragraph of the story. Nonetheless, on Saturday night, the Chronicle website reported that it was the most read and most emailed story on its site at that time.

When we looked at the story that evening, the article had 84 comments from readers, including several which praised the agency for its work. One reader noted, however, that other funding agencies were involved besides the California stem cell agency. The reader quoted from the Stanford press release, which said,

"This work was supported by the Joseph & Laurie Lacob Gynecologic/Ovarian Cancer Fund, the Jim & Carolyn Pride Fund, the Virginia & D.K. Ludwig Fund for Cancer Research, the Weston Havens Foundation, the National Cancer Institute, the Department of Defense, the California Institute for Regenerative Medicine and anonymous donors."

Stanford's news release said,

"It is the first antibody treatment shown to be broadly effective against a variety of human solid tumors, and the dramatic response — including some overt cures in the laboratory animals — has the investigators eager to begin phase-1 and –2 human clinical trials within the next two years."

The Los Angeles Times also carried a story last week on the research, but did not mention CIRM. The agency itself wrote about the research on its blog.

CIRM Chairman J.T. Thomas and other CIRM directors have been concerned about the lack of coverage in the mainstream media – particularly favorable coverage – of the agency's work. When this writer was at a meeting yesterday afternoon at CIRM headquarters in San Francisco, Thomas pointedly presented a copy of the Chronicle front page, suggesting the article was worthy of note. Thomas is correct; the piece can certainly be counted as a favorable mention of the $3 billion research effort. Now it is up to CIRM and its new communications director, Kevin McCormack, who began work on Monday, to multiply the Chronicle piece many times over.

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

Consumer Watchdog Says 'Serious Consideration' Needed on Continued Cash for State Stem Cell Agency


IRVINE, Ca. – The Consumer Watchdog organization says that serious consideration should be given to whether the state should halt borrowing money to finance the $3 billion California stem cell agency.

The statement was prepared for delivery tomorrow here to a blue-ribbon Institute of Medicine panel evaluating the performance of the research effort, which was created by a ballot initiative in 2004. The agency's only real source of cash is bonds issued by the state, which means the agency will cost $6 billion including interest by end of its grant-making life in about 2017.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said that the political and scientific environment has changed substantially since 2004. The Bush Administration had restricted federal funding of hESC research then, causing an uproar in the scientific community. Funding has since been restored.

Simpson said the stem cell measure "made sense" seven years ago. He said the stem cell agency and its governing board "must recognize that the political, scientific and economic environment have dramatically altered since the passage of Proposition 71."

His statement continued,

"It is also appropriate to consider seriously whether issuing all $3 billion in authorized bonds is the correct policy in light of the new environment and economic realties facing the state."

Simpson was invited make his statement to the IOM panel, which is midway through its public process of looking into CIRM's operations. It is doing so at the behest of CIRM, which is paying the prestigious organization $700,000 to perform the work.

Simpson also made a number of recommendations for changes at CIRM, many of which would require a change in state law or passage of another ballot measure. Proposition 71, which created CIRM and altered the state Constitution, requires a super, super-majority vote (70 percent) by the legislature to make changes at CIRM.

The Consumer Watchdog proposals (full text below) include reducing the size of the 29-member board to 15, including public members on the board, reducing the super-majority requirement on board quorums to a majority, eliminating the controversial dual executive arrangement at CIRM, conducting grant reviews in public and publicly disclosing the financial interests of reviewers.Consumer Watchdog Statement to IOM-CIRM Panel April 9, 2012

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

CIRM Hires New PR Chief


The $3 billion California stem cell agency announced today that it has hired Kevin McCormack, currently media relations manager at California Pacific Medical Center in San Francisco, as its new director of communications.

CIRM Chairman Jonathan Thomas told the agency's directors at their meeting this morning in Sacramento that the appointment comes "not a moment too soon." Thomas told directors last June that the agency was engaged in a "communications war." Directors have been concerned about the lack of media coverage of the agency, which is largely below the radar of the mainstream media.

Thomas said that McCormack has "lots of experience" in media crisis management and "pressure cooker situations."

McCormack also served as media relations manager, Division of Research at Kaiser Permanente, and was a health/medical producer at KRON-TV in San Francisco.

The agency did not immediately release McCormack's salary. He will begin work April 2.

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

Stem Cell Scientist Impressed by CIRM Oversight Over Huge Grants


A California stem cell researcher, who must remain anonymous, made the following emailed comment today on the progress report on the $230 million in disease team grants from the California stem cell agency and termination of a $19 million grant.

"I'm impressed that CIRM is following through on monitoring the huge disease team grants and has actually curtailed the funding of one that didn't meet a key milestone. I hope that makes the other grant holders nervous! Too many scientists (in my humble opinion) forget that they need to do what they said they'd do- or - if the first plan fails, have the expertise and desire to adapt and find another way to reach the goals."

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

International Stem Cell Corporation Chairman Ken Aldrich Interviewed by Ellis Martin

"The Ellis Martin Report features interviews with exciting, potentially undervalued small and mid-cap publicly traded companies, showcased to an audience of potential retail investors during market hours throughout the United States."

Ellis Martin with Ken Aldrich of International Stem Cell Corporation (ISCO.OB)
Listen to full interview here: http://www.youtube.com/watch?v=WUyFYSGhNjc&feature=share or you can read a Transcript of the conversation here: http://www.ellismartinreport.com/node/148
(Scroll down to view this week's Radio Schedule for ISCO.)
“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 Cell Tech’s products are distributed in the United States and Europe.”


Monday, August 1st at 1:00pm

WVNJ-NY/NJ - AM1160      

Tuesday, August 2nd at 10:00am
KCEO - AM1000    
San Diego/Orange County/LA Beach Cities

Tuesday, August 2nd at 9:30am and Friday, August 5th at 3:30pm
WSBR-AM - 740 FM 95.5  
Boca Raton, West Palm Beach, Ft. Lauderdale, Miami

Mondays and Wednesdays at 1:00pm
WBNM-AM 1120
Boston and New England through: WESO AM 970 and WCRN AM 830
Ellis Martin Report
International Stem Cell Corporation
International Stem Cell Corporation is a paid sponsor of The Ellis Martin Report

Click here to listen to the entire interview: http://www.youtube.com/watch?v=WUyFYSGhNjc&feature=share

California Stem Cell Agency Pulls $19 Million Grant


The California stem cell agency has terminated a $19 million grant to a UC San Francisco researcher involved in the agency's ambitious attempts to push stem cell therapies into clinics.

The agency said the research effort led by Mitchel Berger, chairman of the department of neurological surgery at UCSF, "did not meet a go/no-go milestone" stipulated in the grant. His research was funded in 2010 to treat brain tumors with genetically modified neural brain cells. No further explanation for the termination was provided by CIRM in a report prepared for tomorrow's meeting of the CIRM governing board. The agency estimated the cancellation would save $13 million.

The California Stem Cell Report has asked Berger and his co-PIs for comment on the CIRM action. The other researchers are Evan Snyder of Sanford-Burnham and Webster Cavanee of the Ludwig Cancer Institute. Their remarks will be carried verbatim when they are received.

The CIRM action was disclosed in the progress report on the $230 million disease team effort launched by the agency in 2009. The amount climbed to more than $250 million with contributions from partnering countries. Three of the 14 funded applicants – Irv Weissman and Gary Steinberg, both of Stanford, and Karen Aboody of the City of Hope – were approved only after they appealed to the CIRM board to overturn rejections by grant reviewers. (See  here , here and here for their written appeals. See here and here for coverage of the 2009 board action.)

One other disease team grant was modified to limit its scope and revise its funding. No savings were announced by CIRM. The PI on the $20 million project is Dennis Carson of UC San Diego. Co-PIs are Catriona Jamieson, also of UC San Diego, and John Dick of the University Health Network of Canada. The research is aimed at leukemia.

The actions on the disease team grants were not entirely unexpected. From their inception, CIRM directors have been told not to expect all the grants to finish successfully.

Ellen Feigal, senior vice president for research and development at CIRM, prepared the 19-page update on the disease team efforts. The grants are aimed at generating an investigational new drug application with the FDA within the four-year term of the grant.

She said that the funding decisions were made following evaluation of the projects by panels of clinical development advisors. Their recommendations were then considered by CIRM staff.

Feigal's report laid out accomplishments of the research so far and discussed changes in direction.

She said two companies have been formed since the grants were awarded to commercialize the hoped-for products. She said that in June 2011 Aboody founded TheraBiologics Inc., Newport Beach, Ca., of which she is chief scientific officer and director. Another company, Regenerative Patch Technologies, Glendale, Ca., was created by the team working on an hESC treatment for age-related macular degeneration. That $16 million grant involves Mark Humayan and David Hinton of USC, Dennis Clegg of UC Santa Barbara and Peter Coffey, formerly with University College, London, but now at UC Santa Barbara. The effort has generated seven patent filings.

The Feigal update also discussed the efforts of companies involved in other disease team grants. The lack of CIRM funding for biotech firms has been a bone of contention with industry and troublesome for some CIRM directors.

CIRM indicated the projects involving the firms were moving on schedule with no major difficulties reported. The companies involved are ViaCyte of San Diego, Calimmune of Tucson, Az., and Sangamo Inc. of Richmond, Ca.

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

The OTC Investor Article – International Stem Cell (ISCO) Aims to Become the “Intel(tm) of the Stem Cell World” By Justin Kuepper

International Stem Cell Corp (OTCBB: ISCO), a biotechnology company focused on therapeutic biomedical research and cosmeceutical products, operating in the same industry as companies like Geron Corporation (Nasdaq: GERN) and Advanced Cell Technology Inc. (OTCBB: ACTC), aims to become the premier supplier of human cells and cell based products to the rapidly growing regenerative medicine industry.
International Stem Cell Corp (OTCBB: ISCO) specializes in manufacturing pluripotent human “partheno-genetic” stem cells that can be converted into any of the many specific types of cells that will be needed as regenerative medicine moves from the laboratory to the hospital or physician’s office.  ISCO’s cells have the same kind of ability to become any specific cell that might be needed for therapy as do the cells used by competitors like Geron Corporation (Nasdaq: GERN) and Advanced Cell Technology Inc. (OTCBB: ACTC). Unlike the cells used by these competitors, however, ISCO’s cells are not obtained from fertilized embryos that might otherwise mature into a human child. Instead, they are derived from un-fertilized human eggs that would otherwise be destroyed and have no capacity to become a human child. Thus, ISCO’s parthenogenetic stem cells have removed a major ethical barrier to the use of the most prolific class of stem cells available to science today. With its patent on using the parthenogenesis process to make the stem cells, the company plans to establish partnerships, collaborations and licensing agreements with larger pharmaceutical companies to eventually unlock significant shareholder value.
Please read the complete article at The OTC Investor here

International Stem Cell Corporation to Hold Business Update Conference Call on August 10

International Stem Cell Corporation (OTCBB: ISCO) today announced that it will hold a conference call and webcast on Wednesday, August 10, 2011 at 11:00 a.m. Eastern (8:00 a.m. Pacific). Chairman Ken Aldrich will provide an update on the business, including plans for the future development of the skin care line; animal and potential clinical trials for Parkinson's and liver diseases; and the Company's business strategy for 2011 and longer term.
Individuals interested in listening to the conference call may do so by dialing 877-407-8033 for domestic callers, or 201-689-8033 for international callers, or from the webcast on the investor relations section of the Company's Web site athttp://www.intlstemcell.com.
A telephone replay will be available approximately one hour after the conclusion of the call by dialing 877-660-6853 for domestic callers, or 201-612-7415 for international callers, and entering the account code: 286 and the Conference ID: 376367. The webcast will be available on the Company's Web site for 60 days following the completion of the call.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com

or
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com

International Stem Cell Corporation Starts Series of Preclinical Animal Studies of Neuronal Cells Derived From Human Parthenogenetic Stem Cells

CARLSBAD, Calif. (July 20, 2011) – International Stem Cell Corporation (OTCBB: ISCO) announced today 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 (hpSC), 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).

ISCO uses unfertilized oocytes to create human parthenogenetic stem cells, an approach that offers a number of distinct advantages over other types of human stem cells. Like human embryonic stem cells (hESCs), hpSCs are pluripotent, and thus have the capacity to become almost any cell type in the body. 

However, unlike hESCs, hpSCs can be created in a form such that cells from a single donor can be immunologically matched to millions of individuals.


Because no human embryos are ever damaged or destroyed in creating ISCO’s cells, they also avoid the ethical issues associated with embryonic hESC cells. ISCO maintains the world’s largest collection of research-grade hpSC lines.
Dr. Andrey Semechkin, the 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.”
Parkinson’s disease is a disease of the central nervous system that affects millions of people worldwide.
PD patients present a range of possible symptoms, some of which are known to be as a result of the loss of dopaminergic neurons in the mid brain. ISCO’s approach is first to derive neuronal cells successfully from hpSC and, second, to evaluate their safety, functionality and efficacy using a series of in-house in vitro and in vivo models.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com .
To subscribe to receive ongoing corporate communications, please click on the following link: http://
Forward-looking Statements
Statements pertaining to anticipated developments, the potential production and benefits of stem cell
lines, 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.
Contacts:
International Stem Cell Corporation
760-940-6383
Ruslan Semechkin, Ph.D.
Vice President
or:
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
# # #

Partnership Pays Off

Northern Exposure by Emmet Pierce, San Diego Business Journal, August 16, 2010. Excerpt:

An example of San Diegans collaborating with Canadians is the work that has taken place at the UC San Diego Moores Cancer Center in cooperation with research at the University of Toronto. The partnership has enabled San Diego researchers to acquire a $20 million grant to develop drugs to be used against leukemia stem cells, Barr says.Dr. Catriona Jamieson, director of the stem cell research program at the Moores center, said scientists from Toronto and San Diego share "a deep and abiding interest in cancer stem cell biology." The Canadian consulate in San Diego was instrumental in helping to create a relationship in which both institutions would benefit, sharing information and applying for funds to support their research.

"The idea was to establish a Canada-California cancer stem cell initiative and obtain connections with Canadian funding agencies, particularly Genome Canada and the Ministry of Health," she said.

Jamieson added, "The most important thing is it allows people with disparate abilities and backgrounds to work together on the same problem."

Barr said the University of Toronto also was able to secure a $20 million research grant because of the collaboration, "so the team is greater than the sum of its parts."

Two new initiatives from the CSCC

The Cancer Stem Cell Consortium (CSCC) has announced the launch of two new initiatives for 2011-2012. Information about these initiatives is available via the websites of the CSCC and Genome Canada.

The two initiatives are:

1. C4Resource: The Canada-California Collaborative Cancer Stem Cell Resource and Technology Platform Network or C4Resource, which would coordinate cancer stem cell research resources and platform technologies more efficiently and effectively to advance research and discovery and accelerate clinical translation of new findings; and,

2. Partnership with CIRM: A second funding partnership with the California Institute for Regenerative Medicine (CIRM) through the CIRM's Disease Team Therapy Development Research Awards.

Information about the CIRM Disease Team Therapy Development Research Award RFA is available at: http://www.cirm.ca.gov/RFA_10-05

US Patent: Isolation and use of solid tumor stem cells

Isolation and use of solid tumor stem cells, United States Patent 7,713,710. [FreePatentsOnline][PatentStorm].
Publication Date: May 11, 2010.
Inventors: Clarke; Michael F. (Ann Arbor, MI), Morrison; Sean J. (Ann Arbor, MI), Wicha; Max S. (Ann Arbor, MI), Al-Hajj; Muhammad (Ann Arbor, MI).
Assignee: The Regents of the University of Michigan (Ann Arbor, MI) .
Appl. No.: 11/753,191
Filed: May 24, 2007
Abstract:

A small percentage of cells within an established tumor have the properties of stem cells. These solid tumor stem cells give rise both to more tumor stem cells and to the majority of cells in the tumor that have lost the capacity for extensive proliferation and the ability to give rise to new tumors. The solid tumor heterogeneity reflects the presence of tumor cell progeny arising from a solid tumor stem cell. This discovery is the basis for solid tumor stem cell compositions, methods for distinguishing functionally different populations of tumor cells, methods for using these tumor cell populations for studying the effects of therapeutic agents on tumor growth, and methods for identifying and testing novel anti-cancer therapies directed to solid tumor stem cells.

Parent Case Text:

CLAIM OF PRIORITY
This application is a Continuation of U.S. patent application Ser. No. 11/150,073, filed Jun. 10, 2005, which is a Continuation of U.S. patent application Ser. No. 09/920,517, filed Aug. 1, 2001, now U.S. Pat. No. 6,984,522, which claims priority to U.S. provisional applications Ser. No. 60/222,794, filed Aug. 3, 2000, and Ser. No. 60/240,317, filed Oct. 13, 2000, all of which are herein incorporated by reference in their entireties.

Google patents entry for Application Number 11/753,191 (The application that led to patent 7,713,710. The filing date was 24 May 2007).

Google patents entry for Application Number 11/150,073 (See Parent Case Text above: the filing date was 10 June 2005).

Google patents entry for Patent Number 6,984.522 (See Parent Case Text above: the filing date was 1 August, 2001 and the issue date was 10 Jan 2006). [FreePatentsOnline][PatentStorm].

Comment:

Not mentioned in the Parent Case Text above is United States Patent 7,115,360. [FreePatentsOnline][PatentStorm]. This patent was issued October 3, 2006 and filed on August 2, 2001.

The Parent Case Text for patent 7,115,360:

CLAIM OF PRIORITY
This patent is the United States national stage of PCT patent application PCT/US01/24243, published Feb. 14, 2002 as WO 02/12447, which is a continuation of U.S. Ser. No. 09/920,517, filed Aug. 1, 2001, now U.S. Pat. No. 6,984,522. This patent also claims priority to provisional patent applications U.S. Ser. Nos. 60/222,794, filed Aug. 3, 2000, and 60/240,317, Oct. 13, 2000.

Information about this patent was found via a Google search for "Isolation and use of solid tumor stem cells".

International Stem Cell Corporation and Sankara Nethralaya Launch Collaboration to Develop Stem Cell-Based Treatment for Corneal Vision Impairment

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, and Sankara Nethralaya, http://www.sankaranethralaya.org, announced today commencement of a collaboration to develop ISCO's 'CytoCor™' stem cell-derived corneal tissue. The goal is to use CytoCor to treat corneal blindness and vision impairment. 'This is one more step in ISCO's stated plan of building its portfolio of therapeutic agents through strategic alliances throughout the world,' said Chairman, Ken Aldrich.

CytoCor consists of transparent human tissue derived from pluripotent human stem cells. These structures are produced in the laboratory and recent testing at Sankara Nethralaya and laboratories in the US has demonstrated a range of structural, biochemical and refractory properties characteristic of human cornea.

CytoCor may offer a first-in-class opportunity for high-quality, cost-efficient transplantation tissue for the 10 million people world-wide suffering from corneal vision impairment, particularly in India and the rest of Asia, as well as in Europe. Standardized tissues derived from pluripotent stem cells, such as the CytoCor tissue, could eliminate the current problem that corneal tissue derived from donors may harbor diseases that could be transferred from the donor to the recipient. It may also provide a much needed alternative to the use of live and extracted animal eyes in the $500+million market for safety testing of drugs, chemicals and consumer products.

According to Professor Dr. S. Krishnakumar, 'Sankara Nethralaya is dedicated to the development and application of new state-of-the-art ophthalmic technologies. The need for high-volume, high-quality human corneal tissue is substantial, not only in India but across Asia and much of Europe. We appreciate the opportunity to join ISCO in their pursuit to create a new standard of care for the treatment of human corneal disease.' Initially, Dr. Krishnakumar and his team will be using the CytoCor tissue in preclinical studies to explore the ability of the tissue to withstand sutures and bio-compatible glues in order to validate the potential of the tissue for use in animal or human clinical trials.

According to Dr. Geetha Krishnan Iyer, who is involved in the management of ocular surface disease at Sankara Nethralaya, 'The team at Sankara Nethralaya is pleased to collaborate with ISCO on stem cell-derived corneal tissue. In vitro studies to evaluate safety and efficacy of the tissue, as well as surgical feasibility tests will be carried out, following which there could be clinical application in lamellar keratoplasty using the above mentioned tissue. With improvements in surgical techniques over the past few years, the indications for anterior lamellar keratoplasty have expanded significantly. With high demand for donor corneal tissue for the same but limited availability, there is definitely scope for utilizing ISCO's corneal tissue following relevant tests.'

Jeffrey Janus, Senior VP of Operations at ISCO, states: 'This collaboration with the excellent team of scientists and clinicians at Sankara Nethralaya has already proven to be productive. Sankara's ophthalmology expertise and ISCO's cell culture capabilities constitute a perfect match to perfect and advance CytoCor tissue towards future use in treating corneal disease and injuries.'

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

Key Words: Stem Cells, Biotechnology, Parthenogenesis

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

International Stem Cell Corporation Announces $25 Million Common Stock Financing Agreement

International Stem Cell Corporation (OTCBB:ISCO),http://www.internationalstemcell.com, announced today that it had entered into an agreement with Aspire Capital Fund, LLC, to provide, at the Company's sole option, up to $25 million of equity capital over the next three years. As part of this transaction, Aspire purchased, upon execution of the agreement, 333,333 shares of ISCO Common Stock at a price of $1.50 per share, a 7% premium over Friday's closing price of $1.40 per share.

Pricing of future sales under the agreement will be determined each time the Company elects to sell shares to Aspire by a formula that is based on the actual sale prices of the Company's stock over the 12 days preceding each sale to Aspire. Thus, the Company will control the timing and amount of any sales of its Common Stock to Aspire, and will always know at the time it gives a notice of sale what the cost of that round of financing will be.

Aspire has no right to require any sales by the Company, but is obligated to make purchases as the Company directs in accordance with the purchase agreement, and the Company has the right to terminate the agreement at any time. The agreement does not restrict other financings by the Company. A more detailed description of the transaction agreements with Aspire is set forth in the Company's current report on Form 8-K, filed today with the U.S. Securities and Exchange Commission.

Ray Wood, Chief Financial Officer of ISCO, commented on the agreement, "This transaction is designed to provide both a source of working capital and maximum flexibility for the Company in determining the pricing and timing of any future financing it elects to use under this agreement. It provides us with access to capital that we believe will be adequate to fund our research activities for an extended period of time, but does not preclude us from pursuing additional financing during the term of the agreement. Because of the pricing flexibility this facility gives us, we believe that this agreement will provide both the lowest cost of capital currently available, plus maximum flexibility in meeting our future financing needs. If we don't need working capital or don't need as much as expected, we may elect not to use the facility. If we do need capital, it is available and we can choose when to obtain it."

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 humanstem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryosand, 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 has developed and is now marketing a line of skin care 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.

ABOUT ASPIRE CAPITAL FUND, LLC

Aspire Capital Fund, LLC is an institutional investor based in Chicago,Illinois, with a fundamental investment approach. Aspire Capital invests in a wide range of companies and industries emphasizing life sciences, energy and technology.

FORWARD-LOOKING STATEMENTS

Statements pertaining to financing plans and capital needs, anticipatedtechnological developments and therapeutic applications, the potential benefits of 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

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman, 760-940-6383
kaldrich@intlstemcell.com
or
Ray Wood, CFO, 760-640-6383
rwood@intlstemcell.com

International Stem Cell Corporation Announces Company Update Conference Call

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that its Chairman, Kenneth Aldrich and the CEO of its Lifeline Skin Care subsidiary, Ruslan Semechkin, PhD, will present a Webinar discussion of the State of the Company and its plans for its Skin Care subsidiary on Wednesday, January 19, 2011 at 10:00 a.m. PST. In announcing the event, Mr. Aldrich stressed that its purpose is not to announce any new programs or financial results, but to attempt to provide an overview of events during the past year and offer shareholders a perspective on what to expect in the coming year. The dial-in number for participants is: 1 (800) 588-4973. Please provide the confirmation number 28808144 to the operator upon calling in. An alternate dial-in number is 1 (847) 230-5643. The confirmation number will be the same for both numbers. A replay of the call will be available on the home page of the company's website at:http://www.internationalstemcell.com.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing 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 and cell-based skin care products through its subsidiary Lifeline Skin Care. 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.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Ruslan Semechkin, PhD,
Vice President, ISCO, CEO Lifeline Skin Care
ras@intlstemcell.com

The AP on the California Stem Cell Agency: No Cures, Hazy Future


The Associated Press news service, whose reports circulate worldwide, has taken the measure of the $3 billion California stem cell agency, declaring that it has produced no cures and that it "faces an uncertain future."

The piece by science writer Alicia Chang asked whether the agency is "still relevant" nearly eight years after it was created by California voters and whether it will exist after the money for new grants runs out in about five years.

She wrote,

"Midway through its mission, with several high-tech labs constructed, but little to show on the medicine front beyond basic research, the California Institute for Regenerative Medicine faces an uncertain future."

Chang's piece carries more weight than those in most publications. The AP is the backbone of news coverage in the United States. Its news feeds appear automatically on hundreds, perhaps thousands of web sites in this country. Her article will also serve as a baseline in the future as other reporters examine the stem cell agency.

Here are excerpts from the piece:

"So what have Californians received for their money so far?

"The most visible investment is the opening of sleek buildings and gleaming labs at a dozen private and public universities built with matching funds. Two years ago, Stanford University unveiled the nation's largest space dedicated to stem cell research - 200,000 square feet that can hold 550 researchers.

"There are no cures yet in the pipeline and CIRM has shifted focus, channeling money to projects with the most promise of yielding near-term results."

Chang wrote,

"Several camps that support stem cell research think taxpayers should not pay another cent given the state's budget woes.

"'It would be so wrong to ask Californians to pony up more money,' said Marcy Darnovsky of the Center for Genetics and Society, a pro-stem cell research group that opposed Proposition 71, the state ballot initiative that formed CIRM."

The article quoted UC Davis stem cell researcher Paul Knoepfler as favoring another bond measure to keep CIRM afloat, although he said he recognizes the average Californian may disagree.

Roger Noll, professor emeritus of economics at Stanford, was quoted as saying that "CIRM's legacy has yet to be written."

"'CIRM spent a lot of money and there's a lot of stuff going on, but it's too early to know whether it was worth it,' Noll said."

Chang concluded with these four paragraphs:

"David Jensen, who runs the blog California Stem Cell Report, said Californians have benefited, but whether it will be worth the $6 billion the state has to pay back remains unclear.

"'The agency's responsibility is now to get the biggest bang for the buck, which is no easy task given the tentative nature of much of the science involved,'" he said in an email.

"Some think CIRM has left a mark whether or not it will exist in the future.

Its 'legacy will be felt in part by the stimulus that it has had on stem cell' research in California, said Fred Gage of the Salk Institute for Biological Studies."

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

Conflict of Interest: CIRM to End Contract with Consultant Linked to Grant Recipient


The California stem cell agency will
not renew a contract with a "special advisor" who has been
nominated to the board of directors of a firm that is sharing in a $14.5 million grant from the agency.
She is Saira Ramasastry, managing
partner of LifeSciences Advisory, LLC, of Emerald Lake Hills, Ca.
Ramasastry has worked for CIRM since May of 2010. Last month, she was
nominated to the board of Sangamo BioSciences, Inc., of Richmond, Ca.
Her responsibilities with CIRM have included "industry analysis
and consultation." Sangamo cited her experience with CIRM in its
press release on her nomination. She was also employed as a
consultant by Sangamo, according to the firm.
Ramasastry's dual roles raise obvious
conflict of interest questions. The case highlights the issues
that can arise between CIRM and the biotech industry as the agency
moves to engage industry more closely. CIRM's response additionally
demonstrates a lack of awareness of the potential for serious
mischief or worse when dealing with consultants.
The California Stem Cell Report asked
CIRM on May 6 for comment on the Sangamo-Ramasastry matter. The
questions included whether Ramasastry disclosed to CIRM her work for
Sangamo and whether CIRM took any action per the agency's conflict of
interest code. CIRM did not respond to the question of whether
Ramasastry ever disclosed her ties to Sangamo, which expects to
receive $5.2 million from the CIRM grant if it runs a full four
years.
Here is the text of CIRM's reply today
from spokesman Kevin McCormack.

"Saira Ramasastry was an
independent contractor. As required by law, we do ask independent
consultants to complete Form 700s(statements of economic interests)
if they participate in an agency decision making role. Her role did
not fall into that category - she was identified as a 'special
advisor' in connection with our external review process - and so she
did not have to fill out a Form 700. Her contract with CIRM comes to
an end at the end of June, and she will not be elected to Sangamo's
board of directors until July. Obviously once she is a member of the
Sangamo board she will not be consulting or advising CIRM because of
our strict conflict of interest rules."

(Editor's note: The board election is
June 21, according to the company, not July.)
Our take: CIRM is heavily dependent on
outside contractors. Expenditures for their services are the second
largest item in CIRM's operational budget, exceeded only by salaries
and benefits of regular employees. The responsibilities of outside
contractors cover a wide range of sensitive tasks including computer
system security, development of software that deals with proprietary
information from grant recipients, analysis of confidential business
operations of grant and loan applicants and much more.
The agency needs to know who their
consultants are working for besides CIRM. Whether they make decisions
for CIRM is beside the point. Gathering information that is not
normally accessible to the public can be extremely valuable to
businesses and their competitors as well as applicants for
CIRM's $3 billion. In Ramasastry's case, she was privy to a great
deal of confidential or economically useful information during her work on CIRM's external
review and likely much more.
The use of California's Form 700 is
hardly adequate to assess conflict of interest issues involving
private consultants. The form was developed in the 1970s to deal with
elected officials primarily and provides only the grossest sort of
look at financial holdings and income.
CIRM's current move to embrace industry
requires more scrutiny of conflicting interests – not less. NextThursday the CIRM board will deal with some of its conflict ofinterest rules. It is fine opportunity to ask for a sharper analysis
of conflict issues and consultants with an eye to strengthening CIRM
regulations and ensuring protection of the agency and its grantees'
work – not to mention the interests of the people of California.

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