Irradiating brain’s stem cell niche

Irradiating brain's stem cell niche doubles survival time for patients with brain cancers by Kim Irwin, News Release, UCLA Newsroom, July 23, 2010. Excerpt:

Patients with deadly glioblastomas who received high doses of radiation that hit a portion of the brain which harbors neural stem cells had double the progression-free survival time as patients who had lower doses or no radiation targeting the area, a study from the radiation oncology department at UCLA's Jonsson Comprehensive Cancer Center has found.

The news release is based on this OA publication: Irradiation of the Potential Cancer Stem Cell Niches in the Adult Brain Improves Progression-free Survival of Patients with Malignant Glioma by Patrick Evers and 6 co-authors, including Frank Pajonk, BMC Cancer 2010(Jul 21); 10(1):384. [Epub ahead of print][FriendFeed entry].

Comment: On the brain as a model system to study the impact of radiation dose given to stem cell niches. Provides clinical evidence, based on an improvement in progression-free survival, to support the hypothesis that higher radiation doses to neural stem cell (NSC) niches improves patient survival by eradicating CSCs.

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

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

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

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

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

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

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

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

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

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

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

ABOUT SRISTI BIOSCIENCES

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

FORWARD-LOOKING STATEMENTS

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

Key Words: Stem Cells, Biotechnology, Parthenogenesis

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

International Stem Cell Corporation Announces Company Update Conference Call. ISCO Chairman Kenneth Aldrich to Discuss ‘Status of the Company’

International Stem Cell Corporation (OTCBB:ISCO), a California-based biotechnology company creating human stem cell lines through its patented parthenogenetic process that requires no use of fertilized embryos, today announced that it is has scheduled a conference call for June 15, 2010 at 10:00 a.m. PST. ISCO Chairman, Mr. Kenneth Aldrich will discuss the Company's newly issued patent, its recently completed financing, and the present status of the company and its vision for the coming year. The dial-in number for participants is 1 (800) 774-6070 and the pass code ID is 8273 225#. An alternate dial-in number is: 1 (630) 691-2753 and the pass code will be the same for both numbers. A replay of the call will be available on the home page of the company's web site at: http://www.internationalstemcell.com.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

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

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

FORWARD-LOOKING STATEMENTS:

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "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.

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

OncoMed Has ‘Wnt’ in its Sails

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

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

.....

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

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

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

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

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



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



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

Q&A with ISCO



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

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



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

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

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

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

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

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

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



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

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



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

Q3. Is the company running out of money?



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



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

For transformational profits,

Patrick Cox

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

California Stem Cell Agency's $150,000 Search for Its Financial Future

A San Francisco consultant, who is
often known as an “economic therapist,” has been selected to
devise a “strategic road map” for the financial future of the $3
billion California stem cell agency.
James Gollub: 'economic therapist'
Gollub Associates photo
James Gollub, managing director of the
firm bearing his name, is under a $150,000 contract to lay out by
this fall a detailed plan for the agency. The nine-year-old research
effort is scheduled to run out of money for new awards in 2017.
Gollub was selected after the agency
posted a request for proposals (RFP) last spring. The RFP assumed an
additional $50 million to $200 million in a onetime “public
investment.” The RFP also assumed additional private funding of a
yet-to-be-determined nature.

“A leading expert in innovation
bridge building....
“Global experience assisting
universities, institutes, government agencies and public-private
partnerships link innovation sources to innovation
seekers.
“Committed to the goal of increasing flow of needed
solutions, optimizing financial returns and sustainable economic
impacts from innovation.”

Gollub's current firm dates back to
March of this year. His Linked In profile says,

James Gollub Associates
(JGA) LLC was launched to build on 36 years of Gollub’s
professional research and consulting experience. That experience
began with 16 years at SRI International, three years at
DRI/McGraw-Hill, five years at IDeA, nine years at ICF International
and three years with E-Cubed Ventures LLC. During that
time Gollub has worked globally to deliver
economic strategies for over 30 national, state and metropolitan
regions, develop strategies to accelerate growth of new industries
(clusters), plan public and private R&D institutes and advise on
over 15 science and technology parks.”

The need for a financial transition plan for CIRM was publicly identified as long ago as 2009 by the Little Hoover Commission in its lengthy study and has been reiterated periodically by other bodies since then. Under the terms of Prop. 71, which created the agency, CIRM has only  a 10-year authority to issue state bonds, the borrowed funds that have sustained the research effort. Legal maneuvering blocked the issuance of bonds until 2007.

The California Stem Cell Report asked
the stem cell agency on May 31 for a copy of Gollub's response to the
RFP. Yesterday we asked for a copy of the contract with Gollub. Those
documents will be published when they are received.
Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tncFJBJJM5I/california-stem-cell-agencys-150000.html

International Stem Cell Corporation’s Parthenogenetic Stem Cell Patent is Approved by the United States Patent and Trademark Office

International Stem Cell Corporation (OTCBB:ISCO), http://www.intlstemcell.com, announced today that the United States Patent and Trademark Office (USPTO) has granted ISCO patent number 7,732,202, the first of several pending patents relating to its development of human parthenogenetic Stem Cells (hpSC). Human parthenogenetic stem cells are a new type of pluripotent stem cell that allows immune matching to potentially solve critical immune rejection problems, and does not involve the ethical issues that surround the use of fertilized human embryos.

Although ISCO's creation of human parthenogenetic stem cells was first announced in a peer review publication in 2007, the formal allowance of claims by the USPTO will greatly advance the field of regenerative medicine by allowing ISCO to share its knowledge of these hpSC lines more freely with researchers in the US and around the world through partnerships, joint ventures, funded research and licensing arrangements.

The patent protects ISCO's technology platform, allowing the creation of hpSC from unfertilized eggs, exhibiting similar qualities and pluripotency as embryonic stem cells, with the added ability to be immune-matched to the donor, as illustrated in published peer-reviewed articles. Additional discoveries, also previously published in a peer reviewed journal and the subject of pending ISCO patents, illustrate the creation of 'homozygous' hpSC that can be immune matched to millions of persons of differing sexes and racial backgrounds, rather than only to the donor or her family, raising the potential of eventually creating a universal source of stem cells that could benefit most the of the world's population.

Researchers across the world work with ISCO to study different therapeutic applications of hpSC. Through previously announced collaborative arrangements, ISCO's scientists are working with major universities and private research organizations to study hpSC to treat liver disease, diabetes, Age-related Macular Degeneration (AMD), corneal blindness and various neural degenerative diseases. In one such research collaboration, internationally-recognized stem cell researcher Hans Keirstead, PhD, at the Reeve-Irvine Research Center (University of California, Irvine), recently published a paper, referring to his use of embryonic stem cells and ISCO's hpSC in work focused on the derivation of early retinal progenitor tissue.

Andrey Semechkin, PhD, CEO of ISCO said, 'Other than parthenogenetic stem cells, the three most commonly used and described types of stem cells are human embryonic stem cells (hESC), induced pluripotent stem cells (iPS), and adult stem cells, such as those derived from cord blood, adipose tissue or bone marrow. Parthenogenetic stem cells have unique advantages over each of these other cell types, and we anticipate that since our core patent has been issued, we can now accelerate the adoption of our hpSC lines by researchers in the US and throughout the world.'

'International Stem Cell Corporation is particularly proud of these accomplishments because we have been funded thus far entirely by investors, without NIH or other governmental aid,' said Jeffrey Janus, Senior Vice President of ISCO. 'However, once it is generally recognized that parthenogenetic cells have similar characteristics of embryonic stem cells and offer the potential to solve critical immune rejection issues - while not requiring the destruction of viable human embryos - we expect these cells to be increasingly used in government funded research to study ways of reducing human suffering and treating intractable human diseases.'

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). 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(TM), while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO's website, http://www.internationalstemcell.com.

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

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "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
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

A $2 Million Bill: Outside Contracting by California Stem Cell Agency

The $3 billion California stem cell
agency this week posted a list of its outside contractors, who range
from a a $25,000 stem cell licensing consultant to a $550,000-a-year law firm.
The agency expects to spend $2
million during 2013-14 on outside contracting, down from $2.9 million
in 2012-13. This week's report covers the 2012-13 year.
Outside contracting is the second
largest item in the agency's budget, which is slated to spend $17.4
million this fiscal year for operational expenses, up 5 percent
from last year's spending. The largest amount, $12.2 million, goes
for salaries and benefits. (For more on the budget, see here, here
and here.)
Topping the contractor list is the law
firm of Remcho, Johansen & Purcell of San Leandro, Ca., which had
the $550,000 contract. CIRM, as the agency is known, reported that Remcho came in under
budget by $95,595. That contrasts to some previous years when the
firm, which has represented the stem cell agency since its inception,
required additional cash on top of its original contract. James
Harrison
of the Remcho firm is its face at the agency and is
designated as the outside counsel to the agency's governing board. In
all, the agency is slated to spend $2.2 million on legal expenses,
including in-house work.
David Earp is the stem cell licensing
contractor. He was paid only $13,125 on his $25,000 contract during
2012-13. It is unclear whether he will be paid the $11,875 balance.
Earp was chief patent counsel and senior vice president for business
development for Geron before it dropped its stem cell program. Earp was heavily involved in the $25 million loan that CIRM made to Geron in 2011. In
February 2008, he testified before CIRM about its then proposed loan
program.
The list of contractors included
$200,000 to the AlphaMed Press of Durham, N.C., as seed funding for a
stem cells translational journal, $156,434 to Hyatt Hotels for the
meeting of CIRM grant recipients, $250,000 to Kutir Corp. of Newark, Ca., for
informational technology services and $290,000 to the Mitchell
Group
of Woodland Hills, Ca.also for information technology services.
The list of contractors will be
presented to the CIRM governing board at its meeting next week. The
list does not usually trigger any significant discussion.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5UwFuEaKpJM/a-2-million-bill-outside-contracting-by.html

New Ties to Big Pharma and Venture Capital Proposed at California Stem Cell Agency

The $3 billion California stem cell
agency wants to recruit major biotech and venture capital firms to
help provide tens of millions of dollars in research awards to
California enterprises.
It's part of a move to “jump start”
partnerships in a relatively new, $80 million, business-friendly program that is aimed at pushing therapies into the
marketplace. The recruitment plan will come before the agency's governing board at its meeting next Wednesday in San Diego. 
Participating companies will have a
special relationship with the state agency, including early input
into concept funding proposals prior to their being presented to the
agency's governing board. The “industry collaborators” will also
be able to attend agency workshops and meetings involving
hundreds of grant recipients. Presumably other, non-collaborating
firms would be barred.
Other provisions of the plan call for
special event-hosting arrangements aimed at creating more
collaborations and posting of information from the selected
collaborators on the CIRM website.
According to a CIRM staff document, the
initiative would be limited to biotech and pharmaceutical firms with
a market capitalization of at least $500 million and “qualified
venture capital firms.” The document did not define what a
“qualified a venture capital firm” is. The document also appeared
to bar participation of privately held firms because of the “market
capitalization” criteria, which typically uses a formula involving
publicly traded shares.
Elona Baum, the agency's general
counsel and vice president, business development, said in a statement
provided to the California Stem Cell Report,

“This is aimed at trying to jump
start the creation of the partnerships that are required to satisfy
the commercial validation requirements of the Strategic Partnership
Funding Initiative so that timelines are better synced-up as between
our review and approval cycles for the Strategic Partnership RFAs and
the lengthy time required for investors to conduct due diligence and
negotiate an agreement with prospective applicants to Strategic
Partnership RFAs.  CIRM's independent review and approval
remains the same and is wholly independent. While there may be input
given to a particular RFA it only at the high level concept stage and
of course CIRM has no obligation to agree. In the context of the
Strategic Partnership awards, CIRM wants to fund innovative high
quality science that has attracted additional  investors.
 Investors will help leverage CIRM fund and will be an important
source of future funding to further the project.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZtmnBmRh5K0/new-ties-to-big-pharma-and-venture.html

Stem Cell Agency Seeks Stronger Ties with Possible Industry Funding Partners

The California stem cell agency today triggered a new program aimed at recruiting major biotech and venture capital firms to assist in providing tens of millions of dollars for research by California enterprises.

The effort, part of an $80 million business-friendly initiative, was approved by the agency's governing board on a voice vote.

Participating companies will have a special relationship with the state agency, according to a staff document. The "industry collaborators" will have early input into concept funding proposals prior to their presentation to the agency's governing board. The companies will also be able to attend agency workshops and meetings involving hundreds of grant recipients. 
Other aspects of the proposal call for special event-hosting arrangements aimed at creating more collaborations along with posting of information from the selected collaborators on the CIRM website.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/TEKA-IbpQCo/stem-cell-agency-seeks-stronger-ties.html

UCLA Takes Four of 13 Awards Today; One Business Wins

The California stem cell agency has
made it official, sending out its press release on the $41 million in grants
approved today for institutions throughout the state. 

Most of the 13 awards, as usual, went to organizations represented on the governing board of
the agency. Individual board members, however, are barred from voting on specific grants
to their organizations. 
UCLA topped the list with four grants. No other
institution received more than one, including only one business, Numerate, Inc., of San Bruno,
via John
Griffin
, the firm's chief scientific officer. The lack of awards
to businesses has long been a sore subject in the biotech community. 
 
The only news story so far was written by Bradley Fikes of the San Diego U-T, which circulates in an area that is a hotbed of biotech research. Institutions there snagged $12.6 million in four grants. Fikes also
identified one of the five researchers who lost their appeals on negative grant
review decisions. He is Evan
Snyder
,
 leader of stem cell research at Sanford-Burnham Medical Research
Institute
 in La Jolla, who
had a $5 million request before the agency.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/cdlc-HWVO2c/ucla-takes-four-of-13-awards-today-one.html

Tracking the Fruits of California Stem Cell Agency Research

The California stem
cell agency yesterday shed some interesting light on the awards in its $41
million round this week and their pathway to actually producing a product that
can be used to treat persons who are suffering from diseases.

It is a difficult and
long journey to generate usable therapies, a process poorly understood by the
public, which was promised in 2004 that the stem cell agency would produce
cures for ailments afflicting half the population of the state.

Writing on the agency’s blog, Amy Adams, CIRM communications manager, dealt with the issue indirectly.
She said,

“Many scientists who
receive our early translation awards first got their idea for a therapy while
carrying out research with one of our other awards. In fact, eight of the
scientists in this round of funding had previous CIRM funding for an earlier
stage of research. If a scientist's early translation award provides good
results, the scientists are then able to apply for one of our disease team
awards, which fund the effort of compiling data to convince the Food and Drug
Administration
to allow them to test it in people.  Other organizations
fund only early discovery research or only preclinical research. Under those
conditions, researchers continually pause their projects to look for new
sources of funding as the project moves through the phases toward clinical
trial.

One of the virtues of
the California stem cell agency is its promise of a continued stream of
funding. Former Chairman Robert Klein used to tout that particular aspect of
the agency, particularly in light of limited federal resources.

Adams’ comments
implicitly raise important questions concerning CIRM’s entire portfolio. How
many CIRM grants have led to additional funding from CIRM? How many are
basically one-off shots that have not led to research that has advanced the
development of stem cell therapies, either via CIRM or other funding. What is the
therapeutic and scientific significance of the research that is linked by more
than one CIRM award?  What previously
funded CIRM research could be fruitfully funded again to advance the science
and not necessarily through the traditional grant rounds, which sometimes have
awkward timing?

Unmentioned in Adams’
item is an application from a UC Irvine researcher that came up at Wednesday’s
meeting of the governing board of the stem cell agency. The woman, whose name
was not clearly audible on the Internet audiocast, publicly appealed rejection
of her application by reviewers. She noted that it was an extension of work
that was previously funded by the agency. She also noted that the score on her
review was all but identical to work that was funded. The board, however,
turned her appeal aside, which had already been rejected behind closed doors by
CIRM staff.

Hers is not the only
such case in CIRM history. But they are virtually impossible to track systematically
because of the structure of the CIRM grant-making progress. It is also not
clear whether the agency itself is tracking its research awards to determine if
they result in continuing, fruitful research in a specific area. Nonetheless,
the matter deserves some public attention. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iPivfY1LHPk/tracking-fruits-of-california-stem-cell.html

$41 Million in California Stem Cell Grants Virtually Approved

Directors of the California stem cell agency today all but approved about $41 million in early translational grants, rejecting all appeals by applicants and accepting staff recommendations on marginal grants.

The roll call vote was held open this morning to record a vote by one board member who was not present at the time. It is virtually certain that the member will vote in favor of affirmative action on the applications in question.

One member of the board, Joan Samuelson, abstained from voting on any of the applications. She said she did not think the board had adequate information on its total grant portfolio, particularly in view of the declining amount of money available.

The agency has about $600 million in uncommitted funds and is scheduled to run out of cash for new grants in 2017.

The research acted on today is aimed at “proof of concept for development of a therapy candidate and/or studies to select a development candidate. The approved grants can be found on this CIRM website page and are listed in tier one and tier two.  Identities of the applicants are withheld by CIRM to avoid embarrassing rejected candidates and to avoid disclosing the names of applicants to board members before they vote. However, applicants often appear before the board, as they did today, and identify themselves.

Five applicants appealed negative decisions on their applications by grant reviewers. The agency declined to disclose the appeal letters or identify the applicants, information that was a public record under the previous appeal procedures. New processes were put in place this spring that moved the appeals behind closed doors and made them subject to staff instead of board review. Nonetheless, rejected researchers have a legal right to address the board on appeals or any other matters.

At the request of the California Stem Cell Report, the agency provided the numbers of the grants on which appeals were filed. They are: 06787, 06888, 06761, 06793 and 06830. Review summaries on the applications can be found here. 

We have asked the agency to provide its legal and policy justification for now withholding information that was once a public record.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QDuPoOEt0Xc/41-million-in-california-stem-cell.html

UCLA Snags $3.6 Million from California Stem Cell Agency

UCLA scored today with at least two grants, totaling $3.6 million, from the California stem cell agency. 

Seeking the cash were Donald Kohn,  application 6823, and Gerald Lipshutz, application 6831. Both of the  grants are for $1.8 million each. 


Their applications were initially in the agency's tier two category, which means that CIRM's reviewers did not approve them outright for funding.  CIRM staff, however, did under a new procedure, and the agency's governing ratified the recommendation. 

Lipshutz also appeared before the board along with several patient advocates who made emotional appeals for funding. Lipshutz's research deals with urea cycle disorders, which occur in one out of 8,200 births. Current treatment is arduous and can involve liver transplants.  

Kohn's research deals with sickle cell disease, which afflicts primarily African-Americans. His efforts are aimed at correcting the sickle gene defect in the blood stem cells before transplanting them back into the patient.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/2AMVhKsdgfc/ucla-snags-36-million-from-california.html

Skin in California’s Stem Cell Game

The California stem cell agency’s road map to its
financial future makes a big, $200 million assumption.

The amount would be the agency’s skin in the game for a new,
public-private partnership to continue with the agency’s work after 2017, when
its cash basically runs out.

The $200 million figure is contained in the
assumptions for development of the proposed partnership, which is now in the very early stages of being crafted by a Marin County consultant, James Gollub.
He was told that whatever he comes up with can assume a onetime, $50 million to
$200 million public contribution.

The sixty-four-dollar question – to use a term from
the 1940s -- is how to raise that sort of cash. Consider two unappetizing possibilities.
The 29 members of the agency’s governing board could go to Sacramento and ask
lawmakers and the governor to give them the money, a prospect that most of them
would not relish. Such a move would open the door to tinkering or more with the
agency’s structure and operations.  Or
the board could seek more bond financing via a statewide election, requiring an
electoral campaign that would cost many millions to mount. In both cases, there
is no guarantee that funds would be forthcoming. Money is still tight in
California government, and voters may not fancy spending more on stem cell
research, especially if the agency has not delivered on the promises of the
2004 ballot campaign that created the $3 billion program.

A third possibility, however, exists, but it also could
be difficult considering pressures to spend all that the agency has. The
board of the California Institute for Regenerative Medicine (CIRM), as the agency
is formally known, has about $600 million in uncommitted cash. It could take
$200 million off the table and reserve it as seed money for whatever future
plans would involve. Or the board could simply roll back commitments it has
made for lower priority grant rounds – ones that have not yet been initiated.
Some are in concept stages, and others have not yet been posted as RFAs.

Scrimping on existing efforts is not going to suit
the condition of all board members. The question of priorities on spending came
up last month in connection with the agency’s generous, $69 million researcher
recruitment effort that benefits many institutions represented on the agency’s
board. Jeff Sheehy, who is a patient advocate member of the board but also a
communications manager at UC San Francisco, and others bridled at adding more money to the
recruitment program. Sheehy cited scarcity of funds and said it was a “distraction”
from more important efforts. His view, however, did not prevail.
Today the board is scheduled to act on a grant round that is budgeted for $70 million. However, grant reviewers have approved grants
totaling only $37 million. Board members, if they wish, could indicate that the
surplus $33 million be designated as a down payment on the future of the agency
– an organization in which they take great pride.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/H4C5-MLOao4/skin-in-californias-stem-cell-game.html

Stem Cell Agency Pays Tribute to the Late Duane Roth

The governing board of the California stem cell agency today paid tribute to the late Duane Roth, co- vice chairman of the agency, who died recently as the result of a bicycle accident.

With members of Roth's family present, CIRM Chairman J.T. Thomas characterized Roth, 63, as a "voice of reason" on the 29-member board. The video included testimonials from both staff and board members.

He was described as a "kind person" who could find "common ground" on difficult issues. Roth was deeply involved in San Diego affairs that went well beyond the stem cell agency. More than 1,000 persons attended memorial services for Roth earlier this month in San Diego.

CIRM President Alan Trounson said following the video that he will "miss (Roth) terribly" and expressed  "hope that his memory will lighten and brighten the day for all of us."

Jeanne Loring, a stem cell researcher at Scripps, said Roth "inspired us to do more than we thought we could do." She said he was an unusual kind of businessman who respected science.  "I wish I could thank him one more time," she said.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Oq2mWojUfsQ/stem-cell-agency-pays-tribute-to-late.html

California Stem Cell Researchers to Receive $70 Million Next Week

The California stem cell agency is
scheduled to give away $70 million next week as it moves forward on
its efforts to turn research into cures.
As many as 20 grants and loans are
projected to be awarded in the early translation round. The awards will range up to $3.5 million over a three year period.  The round was open to
both businesses and academic institutions. Collaborators from Germany
were involved, although funding for research in that country is not provided by the state stem cell agency.
The applications will come before
the $3 billion agency's governing board at its Aug. 28 meeting in La Jolla. After next week's awards, the agency, which is known as CIRM,  will have about $500
million left to hand out before cash for new awards runs out in 2017.
The agency is currently examining ways to continue its awards with
some sort of public-private partnership.
Also on the board's agenda is a
proposed announcement for a CIRM/industry co-funding agreement. No
further details on that program were available early today on the agenda.
Other matters to be considered include final approval of the changes
in the agency's IP regulations, appointment of new members to the
grant review group and the latest report on the outside contracts
held by the agency. Details on those matters are yet to be posted by
the agency.
A tribute to the late Duane Roth,
co-vice chairman of the agency, is also scheduled. The board will
additionally meet behind closed doors to evaluate the performance of
CIRM President Alan Trounson.
The California Stem Cell Report will
carry more information on the meeting as it becomes available.
In addition to the La Jolla location
for the meeting, other locations where the public can take part in
the meeting are in Menlo Park and Duarte. Specific addresses can be
found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/rt53_NIUkj8/california-stem-cell-researchers-to.html

Flim-Flam Stem Cell Artists Targeted by CIRM

The California stem cell agency has
joined with other prestigious stem cell organizations to help put a
stop to the flim-flam artists that prey on desperate people by
promising miracle cures from stem cell treatments.
The agency announced the action today on its blog, declaring that it has posted a new patient advisory document that provides a “ robust and detailed set of issues
patients should consider when making treatment decisions.”
Don Gibbons, CIRM's senior science and
education communications officer and author of the blog item, said
the document addresses one of his special concerns: Internet “ads
that come up on web searches and seem to be offering everything to
everyone.”
Some of those ads can be found on many stem cell-related web sites, including this one, that carry ads that are placed there
automatically by Google.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/MsXTjRpEcFY/flim-flam-stem-cell-artists-targeted-by.html

California Stem Cell Agency Spending: Where the Money Is Going

Analysis of CIRM funding by Pat Olson, executive director of CIRM scientific activities July 2013
The California stem cell agency will
have committed $472 million to translational research – a key to
commercializing stem cell therapies – if it awards the full $70
million in new grants and loans slated to come before its governing
board next week.
The nearly $500 million will amount to
about 17 percent of its funding so far, according to an analysis last
month by Pat Olson, the agency's executive director of scientific activities. The
largest percentage of the agency's cash, however, will be going for
“development” – 35 percent or $970 million. Olson defined
“development” as “essentially our IND enabling, our
preclinical development programs and our clinical development
programs.”
Basic research is to receive 17 percent
or about $469 million with buildings and facilities taking up $443
million or 16 percent. Training and career development has consumed
about 15 percent or $414 million.
However, those calculations include
$577 million in funds that have been allocated but not yet awarded.
Another $491 million is “concept approved” but also not awarded.
The agency's governing board could change those allocations or
withdraw approval of concepts, although it has not yet shown signs
that it might do so.
The agency will run out of money for
new grants in 2017 and is examining the possibility of generating
more cash through some sort of public-private partnership. To develop
support for continued funding, the agency is under pressure to
generate results that will resonate with the public and potential
private funding sources. Those results are most likely to come from
a late stage translational/clinical trial effort.
Here is a link to CIRM's translational portfolio as of September 2012.

(An earlier version of this item incorrectly said that the agency would run out of money for new grants in 2013. The correct year is 2017,.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/gzZM85Gu0ME/california-stem-cell-agency-spending.html

California Gov. Jerry Brown Vetoes Pay-for-Eggs Legislation

California Gov. Jerry Brown today
vetoed a fertility industry-backed measure that would have permitted
women to sell their eggs for the purposes of scientific research.
In his veto message, Brown said,

“Not everything in life is for sale
nor should it be.”

The bill would have repealed a ban on
compensation of women who provide their eggs for scientific purposes.
The measure would not have changed existing law that allows women to
be paid for their eggs for IVF purposes with fees that range up to
$50,000. The bill also would not have affected the ban on compensation for
eggs for research that is financed by the $3 billion California stem
cell agency.
The legislation (AB926) by
Assemblywoman Susan Bonilla, D-Concord, was sponsored by the American
Society for Reproductive Medicine
and easily swept through the Democratic-dominated legislature. Bonilla said the measure would have placed women on an
equal footing with men, who are paid for their sperm contributions
for research. She also said that it would help to encourage more
research into fertility issues.
Some stem cell scientists have
complained that not enough women are willing to donate eggs without
compensation, but stem cell researchers were not publicly involved in
supporting the bill.
The fertility industry group had
confidently predicted that Brown, a Democrat like Bonilla, would sign the bill. The governor's
action could be overridden by a 2/3 vote of each house of the
Legislature. It is not clear whether Bonilla will make such an
attempt.
Here is the text of Brown's veto
message:

"Not everything in life is for sale
nor should it be.

"This bill would legalize the payment of
money in exchange for a woman submitting to invasive procedures to
stimulate, extract and harvest her eggs for scientific research.

"The questions raised here are not
simple; they touch matters that are both personal and philosophical.

"In medical procedures of this kind,
genuinely informed consent is difficult because the long-term risks
are not adequately known. Putting thousands of dollars on the table
only compounds the problem.

"Six years ago the Legislature, by
near unanimity, enacted the prohibition that this bill now seeks to
reverse. After careful review of the materials which both supporters
and opponents submitted, I do not find sufficient reason to change
course.

"I am returning this bill without my
signature."

You can read more about the bill and
its history here, here, here and here.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1eDn2Is8V8E/california-gov-jerry-brown-vetoes-pay.html