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CIRM’s Improving Openness

By Dr. Matthew Watson

The California stem cell agency this
week once again posted in a timely fashion important information
dealing with matters to be decided next Thursday by directors of the
$3 billion stem cell agency.
The agency's actions are a marked
improvement in openness and transparency compared to the practices
prior to the election last June of J.T. Thomas as chairman of the
CIRM board. Previously, background material on multimillion dollar
matters was not available much of the time until shortly before the directors meeting, making it virtually impossible for interested
parties or the public to comment or attend the sessions. Even CIRM directors would complain from time to time about the laggard performance.
According to the agenda, next week's meeting in San Francisco
will include approval of $95 million in new grants, consideration of
the first-ever performance audit of  which made 27
recommendations for improvement, action on the first-ever CIRM directors' code of conduct along with conflict of interest rules, changes in its loan policy and consideration of the agency's
strategy for the next five years.
In addition to the meeting site in San
Francisco, a public teleconference location will be available at UC
San Francisco
, two in Los Angeles and one in La Jolla. Specific
addresses can be found on the meeting agenda.


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

By Dr. Matthew Watson

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
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.


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Scripps CEO Joins Stem Cell Agency Board; Love Leaves

By Dr. Matthew Watson

Michael Marletta
Scripps Photo

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

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


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

By Dr. Matthew Watson

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

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

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

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

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


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IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

By Dr. Matthew Watson

The $3 billion California stem cell
agency is laboring under a range of problems that include protection of
its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month
study said yesterday.
The performance audit by the Moss Adams accounting
firm of Seattle, Wash., made 27 recommendations for improvements,
including more effort to ease strain connected to the agency's
controversial dual executive arrangement. The study said that the
nearly eight-year-old agency has many "opportunities" to
"enhance performance reporting and decision making, strengthen
effectiveness and efficiency, retain essential human resources and
leverage technology."
In response to the report, the stem
cell agency said, "(M)anagement concurs with the findings and
recommendations....The recommendations are focused and constructive.
CIRM is already implementing many of these recommendations, and we
will be investigating the others in the coming months."
The performance audit is the first ever
made of the California Institute for Regenerative Medicine. The
audit is required by state law and was commissioned by the agency at
a cost of $234,944. For years, the agency for years had resisted calls for a
performance audit until it sought legislative approval in 2010 for
removal of a 50-person cap on its staff. Originally, the performance
audit legislation would have put the study in the hands of the only
state body charged with oversight of the agency and its board. CIRM,
however, was successful in lobbying to have that provision removed.
The 54-page report identified once
again a number of issues that have troubled the stem cell agency for
some years. Moss made 12 top priority recommendations, many of which
dealt with information technology and grants management. Many of the
recommendations focused on providing better and faster information on
performance outcomes, which the audit said has been slow to come and
hard to generate.
The report said,

"Key performance information is
not readily available to CIRM leadership and other stakeholders on an
ongoing basis. CIRM board members and senior management do not
receive regularly updated, enterprise-level performance information.
The ability to evaluate performance against strategic goals is
critical to effective leadership and program monitoring, evaluation,
and reporting."

The audit stated,

"CIRM does not effectively
communicate outcome-based performance internally or externally. As
such, CIRM does not focus on performance metrics as part of its
(staff) meeting process."

The report additionally said,

"CIRM does not have an integrated
financial information system....The use of spreadsheets results in
labor intensive processes to generate reports and respond to
information inquiries, since data must be pulled from multiple
spreadsheets, a process that may be prone to error. ...Spreadsheets
are not linked to each other or a master report. CIRM does not have a
comprehensive list of spreadsheets or instructions for how to
maintain the files or generate reports from them."

Moss Adams said that CIRM needed to do
a better job in "bond forecasting," a reference to the
California state bonds that finance virtually every aspect of the
agency's operations. CIRM directors were caught by surprise a few
years ago when they suddenly learned the agency was up against a
major cash crunch.
Some of the recommendations will
require more work from CIRM grantees and their technology transfer
offices in an effort to track intellectual property and grant outcomes.
The report also recommended a speed-up in CIRM's review of progress
reports from grant recipients, which have been lagging completion by
several months.
The dual executive arrangement, which
was written into law by Prop. 71, has troubled CIRM since nearly day
one. CIRM's own external review panel also identified it as problem
two years ago. The executive structure is virtually impossible to
change because of the political difficulty in making alterations in
the ballot initiative.
Moss-Adams said,

"The working relationship between
the chairman’s office and the president’s office has vastly
improved over the past year, but there are still opportunities for

The performance audit recommended,

"Make every effort to manage and
operate as one cohesive organization, while recognizing the varying
roles, responsibilities, and authorities that exist with positions in
both the chairman’s office and president’s office."

One of the top 12 recommendations
involved CIRM's public relations/communications effort. CIRM
Chairman J.T. Thomas told directors last June that the agency was in
a "communications war."
Moss-Adams said,

"CIRM does not have a
communication plan, and there is lack of clarity on how to address
mission-based communication to CIRM’s various target audiences,
especially the general public....The best way to facilitate
results-based communications is to 1) quantify goals and outcomes in
CIRM’s strategic plan and 2) report on achievement of those goals
and outcomes by enhancing CIRM’s annual report with additional
performance-based information."

Another performance assessment of the
stem cell agency is also underway. It is being conducted by the
prestigious Institute of Medicine and is costing CIRM $700,000. That
report is expected this fall.
CIRM's board of directors is scheduled
to consider the Moss Adams report at its meeting May 24.
Our take: While the findings and
recommendations of the performance audit were delicately worded in
many cases, they brought out issues that need to be addressed, many
of which have been around for a great deal of time. At their meeting
next week, CIRM directors should act very directly on the
recommendations. They can do that by requiring a written report each
month from CIRM Chairman J.T. Thomas and CIRM President Alan Trounson
on the specific steps that they are taking to implement the
performance audit's recommendations. Otherwise, the inevitable drift
will set in.


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California Budget Slashing Misses Stem Cell Agency

By Dr. Matthew Watson

The $3 billion California stem cell
agency dodged the governor's financial knife today.
This morning, Gov. Jerry Brown
announced sweeping cuts throughout California state government as he
attempted to close a new, $15.7 billion deficit. A report in the Los
Angeles Times
 said the governor was "grabbing any spare change available." But this afternoon, in response to a
query, Kevin McCormack, CIRM's spokesman, said,

"The answer is no, we won't be

The question arose because California's
financial picture is much bleaker than it was just four months ago.
And the stem cell agency's only real source of cash is money borrowed
by the state -- general obligation bonds.
Under Prop. 71, which created the
agency in 2004, the bond funds flow directly to the agency without
intervention by the legislature or the governor. However, Brown has
been chary of additional bond sales since they create an increasing
burden in the form of interest costs. Those costs must be financed
out of money that otherwise might go to the University of
, K-12 schools and medical help for the poor.
Under an agreement arrived at last year, CIRM has what amounts to a $225 million line of credit with the
state, which should take care of its needs until January. The cash is
coming from short-term borrowing by the state instead of bonds.

The Brown Administration has cut back
on bond borrowing and intends to cut more this fall. According to the state Department of Finance, the cost of borrowing
has declined $173 million this fiscal year, down to $5.2 billion.
CIRM's share of the debt service is more than $200,000 a day.  


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StemCells, Inc. Reports Positive Interim Safety Data From Spinal Cord Injury Trial


NEWARK, Calif., May 17, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced completion of the first planned interim safety review of the Company's Phase I/II spinal cord injury clinical trial, which indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated. The trial, which is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells), represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. A summary of the data will be presented by Armin Curt, M.D., principal investigator for the clinical trial, at the Interdependence 2012 Global SCI Conference, which is being held in Vancouver, British Columbia, from May 15 to 17, 2012.

The interim data is from the first cohort of patients, all of whom suffered a complete spinal cord injury in which there is no neurological function below the level of the injury. All patients enrolled were transplanted with a dose of 20 million cells at the site of injury in the thoracic spinal cord. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first four months following transplantation of the cells. Changes in sensitivity to touch were observed in two of the patients. The data from multiple evaluations of the patients during this four month period have been reviewed by an independent Data Safety Monitoring Committee, which has recommended that the study advance to enrollment of patients with incomplete neurological injury. Enrollment is now underway and is open to patients in Europe, the United States and Canada with incomplete spinal cord injury. The trial, which is being conducted at Balgrist University Hospital, Zurich, Switzerland, is the only ongoing clinical trial evaluating neural stem cell transplantation in spinal cord injury.

"We are very encouraged by the interim safety outcomes for the first cohort," said Dr. Curt, who is Professor and Chairman of the Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at Balgrist University Hospital. "The patients in the trial are being closely monitored and undergo frequent clinical examinations, radiological assessments by MRI and sophisticated electrophysiology testing of spinal cord function. The comprehensive battery of tests provides important safety data and is very reassuring as we progress to the next stage of the trial."

The Interdependence 2012 Global SCI Conference is intended to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and to discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research. Interdependence 2012 is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.

About the Spinal Cord Injury Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.

The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at

Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at and at, including video interviews with Company executives and independent collaborators.

About Balgrist University Hospital

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Stem Cells for Spinal Cord Injury: Some Patients Have Long-Term Improvement


Thirty Percent of Patients Show Improved Functioning after Stem Cell Therapy

Philadelphia, Pa. (May 17, 2012) One of the first long-term studies of stem cell treatment for spinal cord injury shows significant functional and other improvements in three out of ten patients, reports a study in the May issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The results support the safety of mesenchymal stem cells (MSCs) derived from the patient's own bone marrow, showing "continuous and gradual motor improvement" in at least some patients with disability caused by spinal cord injury. The lead author of the new study was Dr. Sang Ryong Jeon of University of Ulsan College of Medicine, Seoul, South Korea.

Evidence of Improved Function after MSC Treatment for Spinal Cord Injury The researchers performed MSC transplantation in ten patients with permanent motor (movement) deficits or paralysis (paraplegia or quadriplegia) after spinal cord injury. Mesenchymal stem cells are a type of "multipotent" cell that can be cultured from adult bone marrow and induced to develop into many different types of cells.

The cultured MSCs were injected directly into the injured spinal cord and the surrounding (intradural) space. Additional cells were injected after another four and eight weeks. The results were assessed by measuring improvement in the patients' ability to move their arms and hands and to perform key activities of daily living. Imaging scans and tests of muscle activity were performed as well.

During the first six months after MSC transplantation, six of the ten patients showed improvement in motor power of the arms and hands. Of these, three patients had gradual improvement in the ability to perform daily activitiesfor example, preparing meals and typing on a keyboard.

These three patients also showed significant changes on MRI scans of the spinal cord, including evidence of healing around the injured area of the spine. They also had improvement in electrophysiologic studies of muscle electrical activity.

No Long-Term Safety Problems of MSC Transplant None of the ten patients had any permanent complications related to MSC transplantation. This helps to alleviate concerns that MSC injection could lead to later problems like the development of tumors or calcifications.

Previous studies have shown promising results with MSC transplantation in animals and humans with spinal cord injury. Mesenchymal cells have some important potential advantages for stem cell therapy, as they are a relatively easily accessible source of the patient's own cells. The ten patients treated by Dr. Jeon and colleagues represent the first attempt at direct spinal injection of MSCs for the treatment of spinal cord injury in humans.

Following up on a previous study reporting initial improvement in six patients, the new paper describes continued improvementincluding meaningful gains in the ability to perform everyday functional tasksin three patients. Dr. Jeon and colleagues note that all three patients with progressive improvement had some "residual neurological function." They write, "Therefore, MSC treatment is more likely to enhance the remaining neurological function rather than rengeneration." They call for further studies to understand the mechanism of improvement after MSC treatment and to clarify which patients with spinal cord injury are most likely to benefit.

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Cardio3 BioSciences Has Been Selected to Present C3BS-CQR-1 Trial Data in Late Breaking Clinical Trial Session at …


MONT-SAINT-GUIBERT, Belgium, May 18, 2012 /PRNewswire/ --

The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces that the final results of its Phase II clinical trial of C3BS-CQR-1 is will be presented at the late breaking clinical trial session at the European Society of Cardiology 2012 Heart Failure Congress in Belgrade, Serbia taking place on May 19-22.

Andr Terzic, M.D., Ph.D, Director at Center of Regenerative Medicine, Mayo Clinic, the co-lead investigator on the trial, will present new final follow up data on the Company's stem cell therapy for heart failure, C3BS-CQR-1, which is based on "Cardiopoiesis" proprietary technology. The presentation will be held on Sunday, May 20th in Belgrade, Serbia.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: "Being selected to present the final follow-up data in the late breaking clinical trial session at this prestigious cardiology congress highlights the quality of our technology and reiterates our belief in C3BS-CQR-1 as a potential treatment for patients with heart failure, a condition with a significant unmet medical need. We look forward to advancing the product into Phase III."

About Cardio3 BioSciences

Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.

The Company's lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3 BioSciences has also developed C-Cath, the next-generation injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.

C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities. As a result, of these factors investors and prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or review any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information contact:

Cardio3 BioSciences: Dr Christian Homsy, CEOTel : +32-10-39-41-00 Anne Portzenheim, Communication Manager

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MURRIETA: Surprise cord-blood find is 'godsend' for ailing boy

By JoanneRUSSELL25

After half a year of blood transfusions to treat life-threatening anemia, 9-year-old Ricky Martinez was running out of time.

The Murrieta boy needed a bone marrow transplant to save his life. Although his parents had held numerous drives seeking a match for their son, the perfect donor eluded them.

Then another option appeared ---- doctors found Ricky's own blood from his umbilical cord, banked at birth, and stored in a medical facility.

"I had donated it at birth, when I delivered," said Ricky's mother, Cynthia Martinez. "I had no idea that I'd be using it for him nine years later."

The cord blood discovery represents a "godsend" for the family, Martinez said, because Ricky's body began rejecting the transfusions that keep him alive.

Cord blood contains stem cells ---- undifferentiated cells that can spur production of healthy tissue to help treat various diseases. Doctors believe it could jump-start Ricky's bone marrow, allowing his body to resume normal blood production.

But it's not a guarantee.

Ricky's condition, aplastic anemia, is an extremely rare disease, and cord blood transplantation is an experimental procedure for the condition, said David Buchbinder, a hematologist and transplant physician who is treating Ricky at Children's Hospital Orange County, in the city of Orange.

Although the procedure offers few risks of complications, it also pushes the boundaries of medical practice, placing Ricky in a realm of mixed medical opinions and uncertain results, Buchbinder said.

His parents say they're willing to go there to save their son's life.

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Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

By JoanneRUSSELL25


California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.

Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).

Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.

This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London



Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.

Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).

ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

About SMD, Dry AMD and Degenerative Diseases of the Retina

Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit

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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

By Sykes24Tracey


Osiris Therapeutics Inc. (NASDAQ:OSIR - News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope," said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. "As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine."

Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.

Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal's safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses, said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. "I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD."

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.

Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research, said Peter Friedli, Chairman and Co-founder of Osiris. It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.

In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada's decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.

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Canada approves stem cell therapy

By raymumme

Osiris Therapeutics Inc says Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient's body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company's chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal's future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD -- those who have more or less failed all other therapies -- Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.


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Osiris Wins Canadian Approval for First Stem-Cell Therapy


By Meg Tirrell - 2012-05-18T20:13:19Z

Osiris Therapeutics Inc. (OSIR) rose after the company said it won the worlds first approval for a stem- cell drug, gaining clearance in Canada to sell Prochymal for a disease that can attack patients who received bone-marrow transplants.

Osiris climbed 5.5 percent to $5.55 at 4 p.m. New York time. The shares have lost 24 percent in the last 12 months.

Prochymal was approved for the treatment of acute graft versus host disease in children for whom steroids havent worked, the Columbia, Maryland-based company said yesterday in a statement. Steroids have a 30 percent to 50 percent success rate, and severe GvHD can be fatal in 80 percent of cases, according to the company.

The therapy uses mesenchymal stem cells derived from bone marrow that can take on different forms to combat the immune reaction that causes patients to literally peel out of their skin and shed their intestinal lining, Osiris Chief Executive Officer Randal Mills said in a telephone interview. The disease has no equal.

The company hasnt sought approval for this indication in the U.S., where regulators asked for more data before considering whether to allow sales of the drug, Mills said. Prochymal is used in eight countries, including the U.S., on an expanded-access program basis, which allows patients to receive experimental medicines without participating in clinical trials.

This is the first regulatory approval of a stem-cell drug -- where the active ingredient of the drug is a stem cell -- in the world, Mills said. Its a huge deal for us and a huge deal for the entire field of stem-cell therapy.

Osiris shares declined from an all-time high of $28.56 in 2007 as the biotechnology company faced clinical setbacks, including two studies in 2009 that failed to show statistical improvement of Prochymal versus placebo.

The Canadian approval was based on data showing a clinically meaningful response 28 days after starting therapy for 61 percent to 64 percent of patients treated, Osiris said in the statement.

Prochymal may draw $16.7 million in revenue next year with Canadian approval, estimated Edward Tenthoff, an analyst with Piper Jaffray & Co., before the companys announcement. He said that while Prochymal would be the first stem-cell drug to receive approval, other regenerative products used for wound- healing that employ stem cells are already on the market, such as Carticel from Sanofis Genzyme unit.

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CUR – Initiating Coverage of Neuralstem, Inc.

By Sykes24Tracey

By Jason Napodano, CFA

We are initiating coverage of Neuralstem Inc. (CUR) with an Outperform rating and $3.00 price target. We believe the companys dual-technology platform focused on cell therapy and traditional pharmaceutical products provides investors with the best of both worlds an early-stage investment in a potentially revolutionary pipeline in regenerative medicine and an attractive and under-valued small molecule pipeline sure to attract interest from larger pharmaceutical partners given the novel mechanism of action and broadapplication potential into multiple indications.

Neuralstems cell therapy technology enables the isolation and large-scale expansion of human neural stem cells from all areas of the developing human brain and spinal cord. Neuralstems technology was created to assist the body in producing new cells to replace malfunctioning or dead cells as a way to treat disease and injury. The companys preclinical research shows these cells both help create new circuitry (neurogenesis) and express factors that protect existing cells (neuroprotective). We believe this platform may be useful in treating many diseases and conditions of the central nervous system (CNS) and neurodegenerative disorders. The lead development programs are currently focused on amyotrophic lateral sclerosis (ALS) and spinal cord injuries (SCI).

Preliminary data from the companys phase 1 clinical trial in ALS (abstract / poster) shows encouraging trends in both safety and efficacy. In this trial, the company is injecting human spinal stem cells (HSSC) directly into the gray matter of the spinal cord. This is no easy task. Management licensed a floating injection platform technology from the Cleveland Clinic that allows the injection of the cells into the spinal cord without risk of trauma. Neuralstems Spinal Cord Delivery Platform and Floating Cannula are being utilized in the current phase 1 ALS program, but have the potential for use in additional clinical applications where injection directly into the cord is needed or advantageous, including spinal cord injury. We believe the Floating Cannula technology alone nearly supports the current market value of only $55 million. Now that safety and feasibility have been demonstrated, if Neuralstem were to spin-out this technology into a separate company, we think given the potential to out-license or commercialize with other companies looking to do direct injections into the spine, it would be worth $25 to $50 million in value.

The phase 1 trial is now progressing into the next six patients, all of which will have direct injections into the cervical spine. The previous twelve patients all had injections into the lumbar spine. The FDA wanted to make sure that the safety and adverse event profile was acceptable before progressing into areas of the spine that affect breathing and upper limb function. So far, three patients have been dosed in the cervical spine with no serious complications. We are excited to see the first efficacy data points in approximately six months.

Neuralstem and the FDA are currently in discussions on potentially expanding the phase 1 program, right now capped at 18 patients, into an additional 9 patients bringing the total to 27 that will include reinjecting patients from previous cohorts and increasing the number of cells per injection from 100,000 to 200,000 or 300,000. We think the more data the company can amass from this phase 1 / 2 program, the better chance the FDA will allow movement into a registration program in 2014. The FDA has already granted Neuralstem Orphan Drug designation for ALS. The FDA allowing Neuralstem to move into phase 3 in 2014 is comparable to Fast Track development status. We see the ALS market as wide open. If successful, Neuralstems HSSC for ALS would be a very attractive treatment option for patients with little hope to date.

We have built a sales model for HSSC in ALS that assumes a U.S. filing in 2016 and approval in 2017. Depending on the magnitude of the efficacy, we think Neuralstems HSSC could capture 15% to 20% market share of the vastly underserved 30,000 U.S. ALS population. We think as many as 50% of these patients could be eligible for Neuralstems HSSC treatment. Our model assumes that Neuralstem commercializes HSSC on its own at a price of approximately $100,000 per treatment. With 20% market share, we see the opportunity for Neuralstem at approximately $300 million (30,000 x 50% x 20% x $100,000).

Given the current market capitalization at only $55 million, we think there is little to no value being assigned to the companys novel oral small molecule platform. Neuralstem has developed the ability to screen and test small molecules on living human neurons in vitro. The companys research into hippocampal atrophy as it relates to neurodegenerative diseases such as major depressive disorder (MDD) and Alzheimers disease (AD) has allowed the company to be granted patents on four first-in-class chemical entities.

The first of these oral small molecule compounds to enter human clinical testing is NSI-189. Preclinical data suggests that NSI-189 significantly stimulates the generation of new neurons (neurogenesis) in vitro and in animal models. The data demonstrates clear evidence of increased hippocampal volume in animals with a model of depression. Neuralstem believes NSI-189 has the potential to reverse the hippocampal atrophy associated with major depressive disorder and other related disorders, and to restore fundamental brain physiology. NSI-189 has the potential to address directly the pathology of the disease itself. This is a major paradigm shift from the traditional oral serotonin or norepinephrine molecules currently approved to treat depression and bipolar disorder.

We think if positive, Neuralstem will seek to strike a development and commercialization partnership on NSI-189 in 2013. We believe that management will be seeking enough cash from partnering NSI-189, and additional hippocampal neurogenesis / neuroprotectant molecules can be brought into the clinic. We expect that milestones on the development of NSI-189 will help fund the pivotal registration trials in ALS or SCI in the companys stem cell pipeline. This is a unique opportunity that many of Neuralstems competitors are lacking the ability to self-fund a potentially revolutionary breakthrough in stem cell technology through the advancement of a traditional small molecule platform.

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CUR - Initiating Coverage of Neuralstem, Inc.

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Pluristem trial finds stem cells improve cardiac dysfunction

By daniellenierenberg

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today reported that the cardiac function in a diabetic-induced diastolic dysfunction in animals improved following PLacental eXpanded (PLX cells) administration.

The study was conducted as part of the European Commission's Seventh Framework Program (FP7) in collaboration with Prof. Doctor Carsten Tschope and his staff at the Charite Universitaetsmedizin Berlin, Berlin-Bradenburg Center for Regenerative Therapies (BCRT), Berlin, Germany.

Dr. Tschope said, "Currently, there are limited treatment options for diastolic dysfunction and even fewer options for diabetic induced diastolic dysfunction. This study holds promise that PLX cells might be able to inhibit diabetic induced diastolic dysfunction progression as well as possibly repair the existing damage, hypotheses that will be further explored in future studies."

Diabetes was induced in thirty-six mice resulting in the development of diastolic heart failure. After seven days, the animals received either PLX cells from two separate batches or placebo (12 subjects in each of the three groups). Ten mice were not treated (controls).

After three weeks, several cardiac parameters were assessed and found to be significantly improved following the treatment with PLX cells. Important measurements included the cardiac ejection fraction and the left ventricular (LV) relaxation time constant, believed to be the best index of LV diastolic function and a determination of the stiffness of the ventricle. Cardiac ejection fraction improved 19%, the left ventricular relaxation time constant fell 16% and stiffness of the ventricle fell 19%.

Administration of either batch of PLX cells also resulted in a significant anti-inflammatory effect.

Pluristem chairman and CEO Zami Alberman said, "As we demonstrated last week with the announcement that our cells successfully treated the seven year old patient suffering from aplastic bone marrow disease, our strategy is to develop a minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our initial testing of a treatment for diastolic heart disease opens a new potential indication where our cells can be used and potentially positions Pluristem as a "first-line of defense" for diastolic dysfunction."

Pluristem's share price jumped 5.6% in pre-market trading on Nasdaq to $3.01, giving a market cap of $126.33 million. The share rose 10.6% on the TASE today to NIS 11.50.

Published by Globes [online], Israel business news - - on May 15, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Stem Cells May Help Heart Patients


What if your very own bone marrow stem cells, upgraded with more immune cells, could be used to increase your chances of survival after a heart attack? Sounds like the stuff of science fiction, but according to a study done by Timothy Henry, MD of the Minneapolis Heart Institute and colleagues, it may in fact be possible. The findings, which were presented at the Society for Cardiovascular Angiography, are considered preliminary until they are published in a peer-reviewed journal, but they are definitely promising.

"With stem cells, we've been successful with processes that improve blood flow," Henry told MedPage Today, and added that there is a significant number of class III heart failure patients who don't do well on medications or with devices.

"A therapy that would delay heart failure progression would be a major step forward," he said. "This small trial proved the intervention is safe and all the trends were in the right direction."

The next phase of the trial will begin in the summer. Stay tuned!

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International Stem Cell Corporation Scientists to Present Pre-Clinical Research Results at American Society of Gene …

By NEVAGiles23

CARLSBAD, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB: ISCO) ( today announced that several of its leading scientists will present experimental results from three of ISCOs pre-clinical therapeutic programs.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinsons disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinsons.

Secondly, the differentiation of hpSC and embryonic stem cells into cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases, says Dr. Ruslan Semechkin, Vice President of Research and Development.

The presentations will take place at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

About International Stem Cell Corporation

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

To receive ongoing corporate communications, please click on the following link:

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VistaGen CEO Issues Update Letter to Stockholders

By Sykes24Tracey

SOUTH SAN FRANCISCO, CA--(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh.

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company's 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model -- to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective -- is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission -- "putting humans first" -- bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.


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