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Archive for the ‘Stem Cells’ Category

Text of CIRM Chairman’s Comments on the IOM Report

Sunday, December 9th, 2012

Here is the text of comments on the IOM study of CIRM from J.T. Thomas, chairman of the agency. 

"We deeply appreciate all the hard work of the IOM committee in compiling  long and detailed report and the IOM clearly put considerable thought into compiling it. This has just been released so our Board and our staff has not had a chance to look at it yet, let alone digest its findings and recommendations, so it’s premature for us to offer any opinions. We are looking forward to the IOM presentation at the next meeting of our board, the Independent Citizens Oversight Committee (ICOC) where we’ll have a chance to talk with the IOM directly about the report. After that we’ll put together a process on how best to proceed so that we can respond in as thoughtful a manner to the recommendations as the IOM did in making them."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/YkRTcgnXNqU/text-of-cirm-comments-on-iom-report.html

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Extra, Extra! CIRM Staffers Blog the World Stem Cell Summit

Sunday, December 9th, 2012

Years ago, I worked with an editor who
used to advise his lagging scribes to put their noses in their
typewriters and peck.

Well, the folks at the California stem cell agency have their
noses in what passes today for typewriters and are pecking away
furiously. Their subject is the World Stem Cell Summit, which has
received only slight coverage in the mainstream media.
Today, the stem “cellists” from San
Francisco's King Street filed -- on the agency's blog -- three fulsome
items on doings at the summit, which is taking place in West Palm
Beach, Fla. Yesterday they filed four. Photos and charts were
included. More coverage is expected tomorrow.
CIRM staffers blogging the World Stem Cell Summit
covered UC Davis researcher Paul Knoepfler discussing
patient advocacy and its role in funding stem cell research. 

The CIRM writers are doing double-duty
in at least one case. Geoff Lomax, the agency's senior officer for
its standards group, is additionally speaking on a panel at the session. A
handful of other CIRM officials are also appearing at the conference,
which ends tomorrow.

The primary purpose, we presume, of
sending state employees across the country is to gather the latest
information on stem cell science and issues and to make contacts. It
is a bit of a bonus for the public to have the CIRM attendees also
file stories on the sessions.
A couple of the items caught my
attention. One dealt with patient advocates and their role in
energizing and helping to drive funding for research. Another item
discussed what appear to be growing issues with dubious stem cell treatments and the damage they can do to the field in general.
Lomax summarized the signs of a stem
cell scam like this:
  • “Claims of miracle cures for
    diseases
  • “Single treatments or cells that
    can treat any type of disease
  • “Lack of objective information,
    evidence (such as published medical reports) that a treatment is
    effective
  • “Treatment by a doctor who is
    not trained or certified to treat the specific disease
  • “No system exists to collect
    information and follow up with patients”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/usBXfuFwqy4/extra-extra-cirm-staffers-blog-world.html

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Collapse of Big Pharma Deal Involving California Stem Cell Agency

Sunday, December 9th, 2012

A ballyhooed deal has blown apart that
would have hooked up – for the first time – Big Pharma and the $3
billion California stem cell agency.

The breakdown of the arrangement was
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.
The deal was first announced Oct. 25
when Viacyte, Inc., of San Diego, received a $10.1 million award to
help finance a clinical trial for a diabetes treatment involving
Viacyte and GlaxoSmithKline.
The CIRM background memo said this week, however,

“We have recently been informed that
GSK was not able to obtain the final approval required due to
business reasons in the context of GSK's overall research and
development portfolio and investment needs and not as a result of any
scientific or technical assessment of ViaCyte's program.”

The memo gave no further details about
the Glaxo decision.
CIRM staff proposed that Viacyte, which
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.
The arrangement involving Glaxo,
Viacyte and CIRM was trumpeted in October, when Viacyte was awarded
the $10 million. Officials of the stem cell agency said the award
was a “watershed” for CIRM. Jason Gardner, head of the Glaxo stem
cell unit and who attended the meeting, told the California Stem Cell
Report
that the arrangement was a partnership and that the company
intended to develop a sustainable pipeline.
It was the second significant
business-connected deal that has collapsed for the $3 billion agency
within the last 13 months. In November 2011, Geron abandoned its
clinical trial for spinal injuries. CIRM had loaned Geron $25 million
for the trial just three months earlier. The company paid the money
back with interest.
CIRM staff said that advisors to the
agency remain “extremely positive” about the Viacyte research and
“strongly recommended” that the company receive the additional $3
million. The memo said that trial has a “strong potential” to be
commercialized.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/p-E0ivzGfr0/collapse-of-big-pharma-deal-involving.html

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$80 Million in Grants, Money for Viacyte and Blue-Ribbon Report on California Stem Cell Agency

Sunday, December 9th, 2012

Directors of the California stem cell
agency are expected to give away $80 million next week to 20
fortunate researchers in addition to exploring a “commercialization
and industry engagement plan.”

The subjects are on tap for the Dec. 12 meeting in Los Angeles of the governing board of the $3 billion
research effort.
The $80 million grant round is aimed at
“career development of physician scientists working in
translational stem cell research.”
The RFA said

“This award will fund promising
physician scientists in the critical early stages of their careers as
independent investigators and faculty members establishing their own
laboratories and programs.” 

Summaries of the grant reviewers
comments and application scores should be available sometime this
week. The bare-bones agenda lacked elaboration on the
commercialization plan.
Directors are additionally scheduled to
hear a presentation on the blue-ribbon report by the Institute of
Medicine
for which the agency is paying $700,000. The report has been
17 months in the making and is scheduled to be released this
Thursday.
Other interesting matters are on the
table, although the agency has yet to produce background material
laying out any details. The subjects include:
  • More money – no amount yet specified
    – for Viacyte, Inc, of San Diego, which has received more than $36
    million from CIRM.
  • An update of the agency's response to
    the only performance audit conducted at the agency. The audit
    identified 27 areas where improvement is needed, but the governing
    board has not discussed the results publicly since they were
    disclosed last May.
  • Approval of the concept plan for
    another round of basic biology grants and adoption of conflict of
    interest code changes.

Interested parties will be able to take part at the meeting location in Los Angeles and teleconference locations in La Jolla, Oakland and UCSF. If you are interested in
the teleconference locations, you will need to contact the agency for more specific directions than are provided on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/RU_xC86oAyw/80-million-in-grants-money-for-viacyte.html

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Update on Move To Curb Researcher Appeals at California Stem Cell Agency

Sunday, December 9th, 2012

Directors of the $3 billion California
stem cell agency are still mulling details of changes in their
free-wheeling and sometimes emotional appeals process for grant applications
that are rejected by the agency's reviewers.

A special task force of directors met last week
for the second time to discuss the likely alterations. Kevin McCormack, spokesman for the agency, said
the group made no decisions. Another meeting will be held later at a
date to be determined. The task force's recommendations will then go
before the full board, probably in late January.
McCormack said members of the panel
have asked for “more details regarding the process that would be
employed if the appeals and extraordinary petition processes were
merged.”
The agency has an odd, bifurcated
appeals process. Early in its existence, the agency said appeals of
reviewer decisions could be based only on conflicts of interest.
However, researchers have a right under state law to speak to the
governing board in public on any issue whatsoever. As some
researchers began to use that avenue to ask for reconsideration of
their applications, the CIRM board created what it called
“extraordinary petitions” in an effort to control the process and
limit appeals. Both the “appeals” and “extraordinary petitions”
are, in fact, appeals but on different grounds and employing different
mechanisms.
The task force was created in September
after directors complained about “arm-twisting” and “emotionally charged presentations” in connection with a record number of
appeals earlier this year.
Here is a link to an item about the task force's first meeting. Here is a link to an agency summary of the task force's deliberations prior to last week's meeting. The
transcript of the session should be available on the CIRM web site
within the next two weeks. It will be found under the meetings
section of the web and then under the heading for the task force's
November session.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Hkq7zcXyMsQ/update-on-move-to-curb-researcher.html

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Stem Cell Board Members Lubin and Sheehy Honored

Sunday, December 2nd, 2012


A couple of members of the governing
board of the $3 billion California stem cell agency were honored for
their work this month.

Jeff Sheehy
UCSF Photo
One is Jeff Sheehy, a UCSF
communications manager and nationally known HIV/AIDS advocate, who
has served on the CIRM board since its inception. He was named by POZ
magazine as one of the top 100 “soldiers” in the fight against
HIV/AIDS.
CIRM's Amy Adams filed an item on
Sheehy on the agency's blog yesterday. She said, 

“Jeff once told me
that when he joined CIRM’s board eight years ago, he didn’t see a
role for stem cells in an HIV/AIDS treatment. Now, CIRM has committed
$40 million toward HIV/AIDS projects and two teams of researchers
from City
of Hope 
and UCLA are
working toward clinical trials.”

Sheehy was also invited to the White
House to commemorate World AIDs day Dec. 1.
Bert Lubin
Childrens Hospital Photo
Also honored was Bert Lubin, CEO of
Childrens Hospital in Oakland, where he has worked since 1973, a
remarkable achievement in today's world of transitory employment. The
San Francisco Business Times named Lubin as the “most admiredCEO” in the San Francisco Bay Area. The newspaper said that since
he took charge at Childrens in 2009,

“He recruited a new senior management
team, chopped away at the pediatric hospital’s operating deficit
and worked to heal relationships with the local community and
governmental and political leaders that were deeply frayed...”

On a personal note, a friend who has
long volunteered at Childrens gives him high marks as well, citing
several encounters where he exceeded the usual CEO effort.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/9b9s3mW2ebM/stem-cell-board-members-lubin-and.html

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Knoepfler Award Update: More than a Baker’s Dozen Nominated

Sunday, December 2nd, 2012


As of this week, 14 persons have been
recommended for the Knoepfler “Stem Cell Person of the Year”
Award.

The total was reported by Paul
Knoepfler
, the UC Davis stem cell scientist and blogger, who is
putting up $1,000 for the winner of the honor.
Knoepfler announced his award plans earlier this month, declaring that he wanted to recognize scientists or others who “truly made a difference” in the stem
field. Risk-taking is one important criteria.
Knoepfler said,

“It’s something that I’m hoping I
can do every year. It would also be a reward for risk taking,
creativity and be breaking with tradition and be something new in
that regard.” 

The award has drawn some modest
attention outside of Knoepfler's blog. A few days after he introduced
the award on his blog, UC Davis decided to put out a press release and video on it. The California Stem Cell Report followed with an item. Then CIRM blogged it as well.
So far we have not detected any stories
about the award in the mainstream media, but things could change.
Deadline for entries is Dec. 17.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/cLYLc5HQUSY/knoepfler-award-update-more-than-bakers.html

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Diane Winokur, Veteran ALS Patient Advocate, Named to California Stem Cell Agency Board

Sunday, December 2nd, 2012


Longtime ALS patient advocate Diane
Winokur
of San Francisco, who has lost two sons to the disease, has
been appointed to the governing board of the $3 billion California
stem cell agency.

She fills the vacancy left by David
Serrano Sewell
, who resigned from the 29-member panel earlier this
year after serving since the agency's inception. CIRM has 10 patient advocates
on its board.
Diane Winokur
Photo -- Legal Momentum
Winokur is well-known in ALS circles.
She sat for five years on the governing board of the national ALS
advocacy group and currently serves on the board for the California
state group, the Golden West chapter. She also served for six years on the board of
trustees for the Sanford- Burnham Institute in La Jolla, which has received $37 million from the stem cell agency. She left Sanford in 2011.
Last summer Winokur appeared before the
CIRM board to successfully seek approval of an $18 million ALS grant
that was rejected by the agency's reviewers. Researcher Clive
Svendsen
of Cedars-Sinai in Los Angeles appealed the denial to the
full board and was supported in emotional testimony by other patient
advocates as well, including persons with the affliction.(See here for video of some of the testimony.)
The agency has awarded about $30.6
million, including the Svendsen grant, for research directly related
to ALS.
Golden
West issued a press release Nov. 21, lauding the Winokur appointment
by California Lt. Gov. Gavin Newsom. The release quoted Lucie Bruijn,
chief scientist of The ALS Association, as saying,

"Her
contributions have been invaluable and she will be a tremendous asset
in moving the ALS research field forward through CIRM
funding."

The stem cell agency posted a blog item
on Winokur's appointment in addition to a press release. CIRM
Chairman J.T. Thomas said,

“Her knowledge, expertise and
leadership will be a tremendous addition to the ICOC (the stem cell
agency governing board) and help guide us in our work.”

Patient advocate Don Reed of Fremont,
Ca., described Winokur in a 2008 blog item as “small, elegant, full
of energy, an exclamation point of a person.”

(Editor's note: Based on information from CIRM and Golden West, an earlier version of this item incorrectly stated that Winokur is a current member of the Sanford-Burnham board.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/dITcyP7WJbs/diane-winokur-veteran-als-patient.html

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Texas Flap Looms Over California Stem Cell Agency’s Grant Appeals

Sunday, November 25th, 2012


In nine days, the California stem cell
agency plans to take another crack at finding ways to curb its
free-wheeling appeal process involving scientists whose applications
for millions have been rejected by reviewers.

It is a matter of considerable interest
to researchers who need the cash to keep their labs running and remain in good standing with their host institutions.
The stem cell agency's governing board this fall created a task force to deal with the appeals issue after a
record-breaking number of researchers made public appeals featuring
emotional patient advocates. Even the former chairman of the agency,
Robert Klein
, made a two-time pitch for one applicant. Board members
later complained publicly about “arm-twisting,” lobbying and“emotionally charged presentations.”
The agenda for the Nov. 30 task force
meeting in Oakland -- with teleconferencing sites in San Francisco,
Irvine, Palo Alto, Seattle and Rochester, N.Y. -- contains few clues
on what the panel is hoping to specifically accomplish in next week's
90-minute session.
But interested researchers can check
the transcript from the Oct. 24 meeting, during which CIRM President
Alan Trounson described the problem as “very critical.” He said,

“I think this is a very serious
matter that could really bite us very hard in a similar way to what's
happened in Texas. Unless we come up with some kind of process that
really addresses the science, it's a very large concern.”

Trounson's Texas reference was to the
mass resignations of reviewers at that state's $3 billion cancer
research effort. Questions have been raised about integrity of its grant review process and the program's political and biotech industry
relationships. James Drew of the Dallas Morning News produced a bit of an overview this week. In another piece, Eric Berger of the
Houston Chronicle provided quotes from emails from the infighting on
a controversial $18 million grant.
Changes in California's grant appeal process may well
be also discussed at the agency's board meeting Dec. 12 in Los Angeles.
The board hopes to wrap up its action by late January.
Here is a link to an item with more specifics on material presented to the task force in October. Here is a link to an August 2012 list of articles and documents related to the CIRM appeals process.
Interested parties can address comments
to the agency at info@cirm.ca.gov.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5vUXCLMoJz8/texas-flaps-looms-over-california-stem.html

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California Stem Cell Agency Still in Talks on $40 Million for StemCells, Inc.

Sunday, November 25th, 2012


The California stem cell agency and
StemCells, Inc., are still trying to reach agreement on a deal in
which the company would receive $40 million from the state's
taxpayer-funded research effort.

The sticking point is the $40 million
in matching funds required from the Newark, Ca., firm under the terms
of the two awards approved in July and September. The latter award
was okayed on a 7-5 vote by the governing board after it was rejected
twice by the agency's reviewers.
On Monday the California Stem Cell
Report
queried the agency about the status of the awards. Kevin
McCormack
, the agency's spokesman, replied,

“We are still in talks with them over
the terms of the funding. Hopefully, we'll have an agreement soon.”

He did not elaborate further.
CIRM staff normally reviews
applications after they are approved by the agency's governing board
to be sure that all conditions are being met. However, in the case of
the September award to StemCells, Inc., CIRM's governing board took
the unusual step of publicly stating that the firm must demonstrate
it has the $20 million in matching funds before it receives any
payments from CIRM. The board did not take that sort of public
position on the $20 million grant approved earlier in the summer,
although matching funds are required in that case as well.
The former chairman of the $3 billion
stem cell agency, Robert Klein, appeared twice before the board to
lobby for approval of the second award to StemCells, Inc., which is a
publicly traded firm.. It was the first such appearance by Klein
before his former colleagues since leaving the agency in June 2011.
Action on the StemCells, Inc., awards
attracted attention from the Los Angeles Times last month. Pulitzer
Prize-winning columnist Michael Hiltzik wrote that the process was “redolent of cronyism.” He said a “charmed relationship”
existed among StemCells, Inc., its “powerful friends” and the
stem cell agency.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/MeZfo2qdxDQ/california-stem-cell-agency-still-in.html

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Pomeroy Moving On, Will Leave Stem Cell Board

Sunday, November 25th, 2012


Claire Pomeroy, one of the longtime
members of the governing board of the $3 billion California stem cell agency,
will be leaving her position at UC Davis and the stem cell board next
June.

Pomeroy yesterday announced her departure from Davis as vice chancellor for human health services and
dean of the medical school. In a telephone interview, she told the
California Stem Cell Report that she is examining a “few select
opportunities” to work at a national level on health reform and
health policy issues.
Claire Pomeroy
UC Davis photo
Pomeroy, 57, will be spending time in
Washington, D.C., working on health issues on behalf of the
University of California during the transition period before she
leaves her position in California.
Pomeroy came to UC Davis 10 years ago,
shortly before the Golden State's stem cell agency was created in
2004. At that time, UC Davis had what she called a “fledgling”
stem cell research effort. Today the school has chalked up $128 million in
grants from the stem cell agency, ranking fifth among institutions
funded by the agency.
She said that creation of the stem cell
agency “catalyzed development of our program,” which she said has
risen to “national prominence.”
Pomeroy's service on the stem cell
agency board was also instrumental in attracting a $100 million grant
from the Moore Foundation to start a new school of nursing at UC
Davis in 2009. Through her service on the board, she met Ed Penhoet,
who also served on the board and was one of the co-founders of Chiron
and then president of the Moore Foundation. Subsequently, Penhoet
called her for lunch to discuss her thoughts on nursing education,
and developments moved on from there.
The $100 million commitment was the
nation's largest grant for nursing education, according to the Moore Foundation.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/aS-PH9NtXbA/pomeroy-moving-on-will-leave-stem-cell.html

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‘The Knoepfler Award:’ Recognizing Risk and Those Who Make a Difference

Sunday, November 25th, 2012


A UC Davis stem cell researcher-blogger has announced a “stem cell person of the year” award
complete with a $1,000 cash prize that he is putting up himself.

Paul Knoepfler, who may be the only
stem cell scientist in the U.S. actively blogging on the subject,
said he has decided to put his money where his mouth is. 
Since announcing the contest in a Nov.13 blog item, Knoepfler has already received eight nominations,
including one for a scientist. Three days after the item aappeared, UC Davis
featured Knoepfler in a press release that included a video of
Knoepfler explaining the effort.
Paul Knoepfler
UC Davis photo

He said he wanted to go beyond “old
fashioned awards” given by “stodgy committees.” Knoepfler said he
is seeking to recognize that stem cell research is “transcending the
lab.”

The goal of the award, Knoepfler said,
is “to advance the stem cell field and give credit to those who
make a real difference.”
Knoepfler wrote,

“The criteria are that the person
made a truly outstanding difference in the stem cell field for 2012.
The winner could be a scientist, a patient advocate, someone in
industry, a student, a physician…really anyone who has made the
field better. For non-scientist nominees I’m particularly
interested in those who took personal risks or gave of themselves to
help others. For scientists I am looking for outstanding scientific
achievement and in particular out-of-the-box thinking. Folks in any
country are eligible.”

Deadline for nominations is Dec. 17.
Self-nominations are permissible. Knoepfler plans to pick five
finalists and interview them by phone. He also plans an online vote
that he said  “may” influence his decision.
Complete details are available on Knoepfler's blog

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/D_njqx1jc1U/the-knoepfler-award-recognizing-risk.html

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California Stem Cell Agency Blogs on Geron Clinical Trial

Sunday, November 25th, 2012


The California stem cell agency
published an article online last week concerning the hESC clinical
trial that Geron abandoned last year, dealing mainly with one of the
participants in the program.

The piece was studiously non-committal
about whether the $3 billion research program is likely to fund the
trial once again, should BioTime, Inc., of Alameda, Ca., be
successful in acquiring the assets of once was the first hESC
clinical trial in the United States. The agency loaned Geron $25
million a few months before the company cancelled the trial.
Amy Adams, CIRM's communications
manager, simply wrote,

“They (BioTime) would need to apply
for a loan if they want CIRM to financially support the continued
trial.”

The latest round of funding that
BioTime could apply for has a deadline of Dec. 18 for letters of
intent. In addition to a loan, a grant is also a possibility.
Adams focused on Katie Sharify, who was
enrolled in the clinical trial shortly before Geron said it was
dropping the effort for financial reasons. Adams interviewed Sharify
before an audience of scientists.
Adams wrote,

“Katie told me that it would be
impossible not to hope that a trial would help her, but that by the
time she made the decision to participate she knew she was doing it
to further science, not necessarily to further her own recovery. She
told the audience, 'I was part of something that was bigger than me,
and bigger than all of you.'”

Stem cell scientist Paul Knoepfler of
UC Davis also wrote about the BioTime-Geron deal last week. Noting
that Geron's decision a year ago left many “upset to put it
mildly,” Knoepfler said the “idea of BioTime buying the Geron
stem cell program is a great one that provides new hope on many
levels.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VlS7kYH6oy4/california-stem-cell-agency-blogs-on.html

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Researcher Alert: Keeping Tabs on the Stem Cell Exchequer

Sunday, November 25th, 2012


The California stem cell agency has
posted the dates for meetings of its board of directors for 2013
with most of the sessions scheduled for the San Francisco Bay Area.

One is expected to take place in San
Diego in August, and another in Los Angeles 13 months from now. The
other five are in Northern California. Not yet on the schedule is a board workshop in early January that will be open to the public.
Why is this of interest to researchers
and others? The  board controls the purse strings to $3 billion for research grants and determines what areas are to be funded. Astute scientists would do well to take in the sessions.
They offer insights into board thinking and opportunities to deal
with the agency staff and directors on an informal basis. Only a
handful of researchers – or less – attend the meetings on a
regular basis, but have been well-served by the time spent. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/YJowRDshtEY/researcher-alert-keeping-tabs-on-stem.html

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BioTime Will Have to Compete for California Cash for Geron’s Dormant Clinical Trial

Sunday, November 18th, 2012


The California stem cell agency said
today it does not plan to reactivate the $25 million loan to assist
in Geron's spinal injury clinical trial despite an impending deal that would turn the effort over to BioTime, Inc.

Kevin McCormack, senior director for
public communications for the agency, said BioTime will have to
compete in an upcoming award round if it wants to win California
dollars.
Responding to a question from the
California Stem Cell Report, McCormack said,

“That (earlier) loan was specific to
Geron and when the trial was ended the loan ended too. Of course if
Biotime and Geron do complete their deal then Biotime would be free
to apply to us for a new disease team grant.”

McCormack later added that BioTime
could also compete in other appropriate rounds, including the
strategic partnership round just posted by CIRM. It provides for four
awards of up to $15 million. Funding could come as early as October
of next year. The strategic partnership round is a business-friendly
effort that is aimed at attracting “industry engagement and
investment.” The deadline for letters of intent is Dec. 18.
The stem cell agency made its $25
million loan to Geron in 2011 just a few months before the Menlo Park
firm abandoned its human embryonic stem cell trial for financial
reasons. (The full text of the loan agreement can be found here.) The company has repaid the loan with interest.
The company has tried to sell the
assets associated with the clinical trial since last November. The only public
interest that has surfaced has come from BioTime, Inc., of Alameda,
Ca. Michael West, founder of Geron, is the CEO of BioTime. Tom
Okarma
, CEO of Geron from 1999 to 2011, is CEO of the BioTime
subsidiary that would assume the clinical trial.
News from clinical trial is expected to
be published soon, according to a story in the San Francisco Business
Times
by Ron Leuty. He quoted CIRM President Alan Trounson as saying
that “some findings” from the trial would be published next month
in a medical journal.
Geron's stock traded at $1.24 at the
time of this writing today, up from $1.21 yesterday. BioTime's stock
stood at $2.99, up from $2.97.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DS-6n2DoRy0/biotime-will-have-to-compete-for.html

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Geron, BioTime Deal Moves Forward with Letter of Intent

Sunday, November 18th, 2012


Geron Corp., which once pioneered human
embryonic stem cell research, is close to selling off its hESC business in a complicated deal involving two former CEOs of the company and
BioTime, Inc., of Alameda, Ca.

The two publicly traded firms yesterday
announced a “letter of intent” involving a transaction in which
BioTime would acquire the assets of Geron's hESC clinical trial that
the company suddenly abandoned last year. The firm also laid off 66 people,
about 40 percent of its staff.
Abandonment of the program came only a
few months after the $3 billion California stem cell agency loaned Geron $25 million to assist in the trial. The agency could
restore the loan for the trial, but the Geron-BioTime announcement
did not mention that possibility. The California Stem Cell Report has
asked the agency for comment.
The letter of intent came one year and
one day after Geron announced that it was giving up the hESC spinal injury trial because of financial reasons. The Menlo Park, Ca., firm
has been trying to sell its hESC assets since then. BioTime has
been the only firm to express public interest. The Geron trial was
the first hESC trial approved by the FDA.
The proposed deal involves Michael
West
, who founded Geron and is now head of Biotime, and Tom Okarma,
who was CEO of Geron from 1999 to 2011. Okarma is now head of BioTime
Acquisition Corp.
,(BAC) a subsidiary of BioTime.
Also involved is an unnamed private investor who would provide $10 million.
Here is how yesterday's press release
described the deal in which BioTime would acquire Geron's
“intellectual property and other assets related to Geron’s
discontinued human embryonic stem cell programs.”

“ BioTime would contribute
to BAC $5 million in cash, $30 million of BioTime common
shares, warrants to purchase eight (8) million common shares
of BioTime at a pre-specified price, rights to use certain
human embryonic stem cell lines, and minority stakes in two of
BioTime’s subsidiaries. In addition, a private investor would
invest $5 million in cash in BAC. 

“Following consummation of the
potential transaction, Geron stockholders would receive
shares representing 21.4% of the common stock of BAC as well as
warrants to purchase 8 million shares of BioTime common
stock at a pre-specified price. BioTime would own
approximately 71.6%, and a private investor would own approximately
7.0% of the outstanding BAC common stock for their $5
million investment. BioTime would also receive
warrants that would enable it to increase its ownership in BAC by
approximately 2%, which would reduce the Geron stockholders’
ownership in BAC to 19.2%. BAC would also be committed to pay
to Geron royalties on the sale of products that are
commercialized in reliance upon Geron patents acquired by
BAC.”

Prior to release of the letter of
intent, an article earlier this week by Vickie Brower in The Scientist said,

“The offer couldn’t come at a
better time for Geron, which in recent months has started to feel
pressure from its shareholders to boost its stock price and move
products through the pipeline. Since last November, when the company
announced its decision to shutter its hESC and regenerative medicine
business and funnel its resources into developing telomerase-related
treatments for cancer, the stock price has dropped more than 50
percent to $1.30 a share. Geron claimed the move was simply to save
money, but many took the decision—which effectively terminated a
clinical trial of an hESC treatment for spinal cord injury—as a
setback for the entire field." 

News coverage of yesterday's
announcement was light. Here is a link to a piece by Ryan McBride on
Fierce Biotech.

Geron's stock price closed at $1.21
yesterday and rose to $1.24 in after hours trading. BioTime closed at
$2.97. No after hours trading was reported for BioTime.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/b-E7JaABIOI/geron-biotime-deal-moves-forward-with.html

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Geron Weighs Biotime Bid for hESC Biz

Sunday, November 4th, 2012


Geron, Inc., of Menlo Park, Ca., said
today it is assessing an offer by two of its former executives to buy
the human embryonic stem cell program that it abandoned nearly a year
ago.
Geron startled the stem cell world,
including the $3 billion California stem cell agency, when it
jettisoned the first clinical trial of an hESC therapy for financial
reasons. The agency had loaned the company $25 million just a few
months earlier. Geron repaid the loan with interest.
Geron has been mum until today about the Oct. 18 offer by Biotime, Inc., of Alameda, Ca., which is headed
by Michael West, who founded Geron in 1990. Tom Okarma, president of
Geron from 1999 to 2011, is involved with West on the deal and is now
working at Biotime.
Geron's remarks came during a
conference call on its third quarter earnings. A spokesman said the
company is working with Biotime to “assess the feasibility” of
the proposal. He said the proposed transaction is complex and the
company is seeking “additional important details.”
The spokesman declined to offer any
additional comments on the Biotime proposal when questioned following
his initial statement.  
See here and here for earlier stories on the California Stem Cell Report on the Biotime offer. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4JnJvoKwHpA/geron-weighs-biotime-bid-for-hesc-biz.html

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Study of California Stem Agency Likely to be Released in About a Month

Sunday, November 4th, 2012


The $700,000, Institute of Medicine performance study of the $3 billion California stem cell agency is expected to be
released in late November or early December, the IOM said today.

In response to a question last week
from the California Stem Cell Report, Christine Stencel, senior media
relations officer for the IOM in Washington, D.C., briefly discussed
the release plans and the impact of the East Coast super-storm.
Here is the text of her response:

“The DC area escaped the worst of
Sandy’s thumping but nonetheless our schedules and planning have
been somewhat thrown off as we’re playing catch up after two days
of being shut down and some of our committee members and reviewers
are in the areas that got the brunt of the storm. We’re not sure
whether the storm will cause any delays in peer review, but we’re
working toward the goal of publicly releasing the report in late
November or early December. The study staff is working with committee
members to determine the best release format but I anticipate there
will be a press briefing. I’ll send a media advisory when we’ve
got all the details worked out.”

The stem cell agency is paying for the
report, which is examining the performance of the agency. The IOM
began its work in the summer of 2011.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iNEFrnWvUO0/study-of-california-stem-agency-likely.html

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Biotime-Geron Deal Attracts Interest from Brit Investor

Sunday, November 4th, 2012


A British investment trust that has
invested in Geron says it is going to take an advantage of an offer
by an Alameda firm that is seeking to acquire Geron's human embryonic
stem cell assets.

Jonathan C. Woolf, managing director
of British & American Investment Trust PLC, said last week in a letter to its
shareholders that it is disappointed in Geron's performance and the abandonment of its hESC program last November. The sudden halt to the
program and its historic clinical trial also surprised the California
stem cell agency, which had loaned Geron $25 million just a few
months earlier. The agency has expressed an interest in continuing the trial.
Woolf said,

“We have been highly critical of
Geron management's decisions and strategy over the past 20 months, in
particular the decision in November 2011 to abruptly exit Geron's
regenerative medicine (stem cell) business in which it was the
acknowledged world leader. Since that time, Geron management has
attempted to sell or partner this business but to date has been
unable to announce any progress on this.”

Woolf's trust is not listed as a major
Geron shareholder by Morningstar, but Woolf said 17 percent of his firm's
investments are in the Menlo Park, Ca., company. The
specific size of the trust's holdings in Geron was not immediately
known.
Woolf pointed to the offer by Biotime,
Inc
., of Alameda, Ca., as a way for Geron shareholders to benefit. On
Oct. 18, Biotime proposed a complicated deal in which it would
acquire Geron's hESC program. Biotime's president, Michael West,
founded Geron in 1990. The head of the Biotime subsidiary that would acquire
the Geron assets is Tom Okarma, who was CEO of Geron from 1999 to 2011. (Here are links to brief stories on the offer: Fiercebiotech, New Scientist.)
In his letter, Woolf noted Geron's
declining stock performance. He said he is “seriously concerned”
that Geron has failed to find a buyer for the assets. Woolf said,

“These now dormant and untended
assets are inevitably losing value as competitors make progress in
Geron's absence from the field and patent protection periods
decline.”

Woolf continued,

“We believe BioTime's proposals would
make Geron's stem cell assets in combination with those of BioTime
once again the world's leading stem cell business with sufficient
resources to recommence the discontinued programmes and develop the
business further into the medium term.”

Woolf urged Geron directors and other
Geron shareholders to work with Biotime to complete the deal. Geron
has not commented on the offer.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/va_Yea0dbF8/biotime-geron-deal-attracts-interest.html

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California Stem Cell Agency First: Big Pharma Hook Up

Sunday, October 28th, 2012


BURLINGAME, Ca. – For the first
time, a Big Pharma company has hooked into the $3 billion California
stem cell agency, a move that the agency described as a “watershed”
in its efforts to commercialize stem cell research.

The involvement of GlaxoSmithKline
comes via a partnership with ViaCyte, Inc., of San Diego, Ca., in a
clinical trial, partially financed with a $10.1 million grant today
from the stem cell agency. The trial involves a human embryonic stem
cell product that has “the potential to essentially cure patients
with type 1 diabetes and provide a powerful new treatment for those
with type 2 disease,” ViaCyte said. Scientific reviewers for the agency, formally known as the California Institute for Regenerative Medicine(CIRM),  “characterized the goal of the proposed therapy as as the 'holy grail' of diabetes treatments.”
CIRM Director Jeff Sheehy, who is co
vice chair of the agency's grant review group, said the ViaCyte product
could be manufactured on a large scale and basically involves “taking
(small) pouches and popping them into patients.”
The stem cell agency's award triggered
arrangements between ViaCyte and Glaxo that will bring in financial
and other support from Glaxo. The exact amount of cash was not
disclosed. CIRM said Glaxo will “co-fund and, assuming success,
conduct the pivotal trial and commercialize the product.” Under the terms of the grant, Glaxo and ViaCyte will have to meet CIRM milestones in order to secure continued funding. 
Following board approval, Jason
Gardner
, head of the Glaxo stem cell unit, characterized the
arrangement as a partnership. He told the board that the company
intends to develop a “sustainable pipeline.”
Gardner credited CIRM President Alan
Trounson
with being instrumental in helping to put the arrangement
together, beginning with their first meeting three years ago.
Trounson said the deal will resonate not only in California but
throughout the world.
Paul Laikind, president of ViaCyte,
also addressed the board, stressing the importance of CIRM's
financial support for his company over past years. It has received
$26.3 million (not including the latest grant) from California taxpayers at a time when stem cell
funding was nearly dried up. He noted that small companies such as ViaCyte do not have the resources to carry a product through the
final stages of clinical trials and subsequent production. Gardner also said,

“When the commercial funding avenues
have become much more risk averse, CIRM support (has ensured) that
promising, innovative cell therapy technologies are fully explored.”

In comments to the California Stem Cell
Report,
Elona Baum, CIRM's general counsel and vice president for
business development, described the award as a “watershed” for
the eight-year-old agency, linking the agency with Big Phama for the
first time. Much of CIRM's current efforts are aimed at stimulating
financial commitments from large companies, which are necessary to
commercialize stem cell research.
Arrangements between Big Pharma and
small companies are not unusual and can vanish quickly. However, the
CIRM-ViaCyte-Glaxo deal sends a message to other Big Pharma companies
and smaller ones, perhaps clearing away concerns that have hindered
other deals that could involve the stem cell agency.
The stem cell agency is pushing hard to
fulfill the promises of the 2004 ballot campaign that created CIRM.
Voters were led to believe that stem cell cures were virtually around
the corner. None have been developed to date.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Jt1JalGURys/california-stem-cell-agency-first-big.html

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