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Category Archives: Stem Cell Therapy

Short-term Borrowing to Continue to Provide California Stem Cell Cash

Posted: July 29, 2012 at 3:53 pm


The California stem cell agency will continue to be funded with short-term borrowing -- commercial paper -- provided through the state treasurer's office, J.T. Thomas, chairman of the agency's governing board, said today. 

Until late last year, the $3 billion agency was funded through state bond funds, but California Gov. Jerry Brown is trying to reduce the state's long-term debt load, which has skyrocketed in the last decade. 
Thomas told directors this morning that short-term funding comes at "the lowest possible interest rate." He said the arrangement leaves the agency in "very good shape."
The state will provide the funding to CIRM on a month-to-month basis in addition to providing a two month cushion, Thomas said. 
At some point, the short-term debt is likely to covered by state bonds.  As of June 30, CIRM
had $50.9 million on hand, down $42 million from April 30. During the fiscal year ending June 30, the agency paid out $232.7 million compared to $201.4 million in the previous fiscal year. 

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California Stem Cell Directors Open Meeting

Posted: July 29, 2012 at 3:53 pm


Today's session of the governing board of the $3 billion California stem cell agency has begun. The major item on the agenda is a $243 million grant round that has triggered a record pace for appeals by rejected applicants. At the request of the California Stem Cell Report, the agency has provided the conflict of interest list used by the agency to determine which directors will not be allowed today to vote or participate in the discussion of specific applications.  The list can be found below. Conflict of Interest List  -- CIRM Directors Meeting 7-26-12ound below.  

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Arroyo might undergo stem cell therapy

Posted: July 26, 2012 at 9:10 pm

MANILA, Philippines - Former President Gloria Macapagal-Arroyo might undergo stem cell therapy to improve her health, according to the alternative medicine facility in Tagaytay City that the Pampanga lawmaker visited Thursday.

Arroyo came to the facility complaining of difficulty in swallowing because of a bulge in her throat, according to a statement from the Green 8 Young Health & Wellness Center.

Her voice has also changed and she is losing weight because she can't swallow solid food. She also has angina, the center said.

Arroyo also complained of continuing neck and back pain.

"Our center is accepting her for possible stem cell therapy," the alternative medicine facility said. "The stem cell therapy is... strongly considered."

It said the Arroyo can undergo such therapy in the Tagaytay center while her physical therapy will continue at the Veterans Memorial Medical Center 4 times a week.

The Pampanga lawmaker is seeking treatment at the center through her sister, Cielo Macapagal-Salgado.

The center said Salgado was previously diagnosed with a cancerous lump in her breast.

"She consulted several doctors and was subsequently subjected to a myrad of treatment procedures. These, however, did not produce the desired results. When she came to our center she was cured of her cancer," it claimed.

Arroyo heads to Pampanga

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Arroyo might undergo stem cell therapy

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Ruling frees FDA to crack down on stem cell clinics

Posted: July 26, 2012 at 3:13 am

Peter Aldhous, San Francisco bureau chief

It's official: stem cells are drugs. At least, that's the opinion of the US District Court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use.

Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. "This is really round one," he says. "Our position remains that a patient's cells are not drugs."

Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.

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Ruling frees FDA to crack down on stem cell clinics

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Israel ALS stem cell trials hopeful

Posted: July 24, 2012 at 12:11 pm

2012-07-23 19:43

Tel Aviv - A clinical trial of ALS patients conducted by BrainStorm Cell Therapeutics shows its adult stem cell therapy is well-tolerated, appears to be safe and does not present undue risk, according to an interim safety review.

Moreover, in some patients signs of stabilisation of the disease were detected.

Israel-based BrainStorm is developing NurOwn for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.

"It's very uncommon to give at such an early point in a clinical study efficacy data, but we cannot ignore the fact on an individual basis we could see improvement in many of the patients involved, each one in different areas," Moshe Neuman, CEO of Biomedical Research Design, which serves as a contract research organisation for the trial, said.

In some patients breathing improved, in others it was muscle strength and in others it was speech, he told Reuters.

Neuman said a final report was expected by the end of the year after each patient has been observed for nine months.

BrainStorm President Chaim Lebovits said the preliminary results demonstrate that the stem cells have the potential not only to stop deterioration but perhaps even cure ALS.

"The coming phases in the trial will have to prove this, but these results also reaffirm our belief that we have an enormous potential of being successful with less severe indications such as multiple sclerosis and Parkinson's," he said.

Patients in the trial were transplanted with stem cells derived from their own bone marrow and treated with the NurOwn stem cell technology.

See the article here:
Israel ALS stem cell trials hopeful

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Companies selectively targeting cancer stem cells

Posted: July 22, 2012 at 3:54 pm

Today, I posted this to Twitter:

3 Innovative Cancer Treatments...But Which Is The Best Bet? seekingalpha.com/a/fjed $GSK $IMUC $VSTM #cancerSC via @seekingalpha — Jim Till (@jimtill) July 17, 2012

The article is about three companies that are working on treatments designed to target cancer stem cells (CSCs). The companies are OncoMed, Verastem and ImmunoCellular Therapeutics. The article is interesting.

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Royalty Rules at the California Stem Cell Agency: Business Friendly Changes Proposed

Posted: July 22, 2012 at 3:54 pm


If you are looking to follow the money
trail at the $3 billion California stem cell agency, next Thursday's meeting of its 29-member board of directors is a good place to start.


On the agenda are revisions in its
intellectual property rules, which are all about who gets paid and how much and when – should an agency-financed product generate
significant cash.
The key question about the proposed changes is whether they will generate an appropriate return for the state, given its $6 billion investment, including interest on the bonds that finance CIRM. The impact of the changes is not crystal clear. And the staff memo does not mention two important definition changes that appear to be quite business friendly.

During the 2004 ballot campaign that
created the stem cell agency, California voters were told that the
state would share as much as $1 billion or more in royalties. Eight
years later, no royalties have materialized since CIRM research has
not yet resulted in a commercial therapy. 
At next week's meeting in Burlingame,
directors will be asked to modify CIRM rules for royalties that CIRM
staff said "could be a disincentive" for business. A staff memo said the proposals would alter provisions that create "administrative challenges and uncertainty." The memo asserted
the proposed changes would ensure "a comparable economic
return to California" equal to the existing provisions.
However, the memo provided no explanation or evidence for how that
result would come about. The proposed changes could also be applied
retroactively with the agreement of CIRM and the grantee.
Currently CIRM grantees and
collaborators must share as much as 25 percent of their licensing
revenue in excess of $500,000, depending on the proportion of agency
funding for the product. The IP rules also contain a provision for
payments in the event of development of a "blockbuster" therapy.
The staff memo described how that would work.

“It provides that grantees and
collaborators must share revenues resulting from CIRM funded research
as follows: after revenues exceed $500,000, three times the grant
award, paid at a rate of 3% per year, plus upon earning
$250M(million) in a single calendar year, a onetime payment of three
times the award, plus upon earning revenues of $500M in a single
calendar year, an additional onetime payment of three times the award
and, finally, in the instance where a patented CIRM funded invention
or CIRM funded technology contributed to the creation of net
commercial revenue greater than $500M in a single calendar year, and
where CIRM awarded $5 million or more, an additional 1% royalty on
revenues in excess of $500 million annually over the life of the
patents.”

The proposed changes would exempt "pre-commercial revenues" from the state's revenue sharing, the
memo said, in order to maximize the amount businesses can "re-invest
in product development." The proportionality payment provision
would be changed to require only 15 percent of licensing revenues if
CIRM's investment is less than 50 percent and 25 percent if it is
more than 50 percent. Revenue sharing would be extended to "commercializing entities." No definition of "commercializing entities" was provided in the board agenda material, but a June version of the changes defined them as "A For-Profit Grantee and its Collaborator or Licensee that sells, offers for sale or transfers a Drug, product(s) or services resulting in whole or in part from CIRM-Funded Research."

Not mentioned in the CIRM staff memo were two new provisions in the rules involving the definition of licensing revenue and the sale of a therapy. Both could be construed as quite favorable to businesses. According to the June version of the changes, licensing revenues are defined as a figure minus "a proportion of expenses reasonably incurred in prosecuting, defending and enforcing related patent rights equal to CIRM’s percentage of support for development."  The sale provision says that royalties on "net commercial revenue" are not due until received from sales in the United States or Europe. That provision would appear to exclude California from receiving royalties on product sales in most of the world, where it is easier to receive regulatory approval for sale of new therapies and drugs. (See here -- page 2 -- for royalty provision and here for definition of "first commercial sale"-- page 3.)

The existing IP regulations are
enshrined in a 2011 state law. However, the law also provided that
they can be altered by the agency, the CIRM memo said, “if it
determined that it was necessary to do so either to ensure that
research and therapy development are not unreasonably hindered as a
result of CIRM’s regulations or to ensure that the State of
California has an opportunity to share in the revenues derived from
such research and therapy development.”

The memo continued,

"The proposed amendments re-strike
the balance both to ensure that industry will partner with CIRM and
to ensure that the State has the opportunity to benefit from
successful therapy development."

Board action next week will give the
go-ahead for posting the proposals as part of the official state
administrative rules process. They are subject to additional changes
in that process. 
The agenda originally contained the full text of the changes. However, that material has been dropped from the board agenda. An earlier version can be found here and here. We have queried the agency about the reason for dropping the text in the board agenda.

(Editor's note: The agency has now reposted the version of the text of the changes that was on the agenda earlier, saying that it was having problems with its web site. For the definitions of terms, however, it is still necessary to refer to the June documents.)

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California’s $12.4 Million Stem Cell Recruitment Lure

Posted: July 22, 2012 at 3:54 pm


Directors of the California stem cell
agency next Thursday are likely to approve spending $12.4 million to
lure a couple of stem cell stars to the Golden State.

It is part of a $44 million recruitment
program that has brought three highly regarded scientists to three
California research institutions, all of which have representatives
on the CIRM board. (See here, here and here.)
As usual, the $3 billion stem cell agency does not
identify the potential recipients in advance of the meeting or the
institutions that are recruiting them. However, if you have a modicum
of knowledge about the specific fields involved, it is likely that
you can identify them based on the information in CIRM's review summaries and some Internet searching.
One of the proposed research grants–a
$5.7 million award--would go a scientist who won raves from CIRM's
reviewers. The researcher was described as an “exceptional
scientist and one of the leading young developmental biologists.”
Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the
candidate's exceptional productivity and contributions to the fields
of mammalian embryology and kidney development, the significance and
potential of the research program, the PI's proven leadership
capabilities, and the outstanding institutional commitment.”

 The other grant was larger–$6.7
million–but reviewers raised a number of questions about the
candidate although they recommended it for funding. The review summary ranked the application at 57 and said,

“In summary, this is an application
from an established leader in NSC biology to pursue research focused
on disease mechanisms in PD. Strengths of the proposal include the
quality of the PI, the focus of the project on an interesting
hypothesis, and the leadership in basic science that the candidate
would bring to the applicant institution. Weaknesses included
deficiencies in the research plan, the limited track-record of the PI
in PD research and an institutional environment lacking adequate
support for basic science investigations.“

Last January, in a rare move, CIRM
directors rejected a $6.3 million recruitment grant with a score of
76 sought by the Buck Institute, which is not represented on the
board.
The proposals are scheduled to be acted
on at a public CIRM board meeting in Burlingame, Ca.

(Editor's note: an earlier version of this item incorrectly said the total of both grants was $13.4 million.)

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UC Davis Researchers Score Big in $113 Million Stem Cell Award Round

Posted: July 22, 2012 at 3:54 pm


Scientists at the University of
California at Davis are set to win nearly half of $113 million
expected to be awarded next week by the California stem cell agency
as it pushes aggressively to turn research into marketplace cures.

Directors of the $3 billion agency are
virtually certain to approve awards to three researchers at UC Davis,
which operates its medical school and other research facilities in
nearby Sacramento. The other three expected winners are from UCLA,
Stanford and StemCells, Inc., of Newark, Ca., a publicly traded firm.
The $113 million round is the second largest research round in CIRM's history, surpassed only by an
another, earlier $211 million “disease team” round. The latest
effort is aimed at bringing proposed clinical trials to the FDA for approval or possibly starting trials within four years. That deadline
is close to the time when CIRM is scheduled to run out of cash unless
new funding sources are developed.
CIRM is currently exploring seeking
private financing. It could also ask voters to approve another state
bond issue. (Bonds currently provide the only real source of cash for
CIRM.)  In either case, the agency needs strong, positive results from
its grantees to support a bid for continued funding.
The CIRM board is scheduled to approve
the latest awards one week from tomorrow at a public meeting in Burlingame in the San Francisco area. The agency's policy is to
withhold the identities of applicants and winners until after formal
board action. The California Stem Cell Report, however, has pieced
together their identities from public records.
Here are the winners and links to the
grant review summaries, listed in order of the CIRM scientific
scores:
  • Vicki Wheelock, UC Davis, $19 million,
    for development of a genetically modified cell therapy for
    Huntington's disease, an inherited neurodegenerative disorder.
    Scientific score 87.
  • Antoni Ribas, UCLA, $20 million, for
    genetic reprogramming of cells to fight cancer. Scientific score 84.
  • Nancy Lane, UC Davis, $20 million, for
    development of a small molecule to promote bone growth for the
    treatment of osteoporosis. Scientific score 80.
  • John Laird, UC Davis, $14.2 million,
    for development of mesenchymal stem cells genetically modified for
    treatment of critical limb ischemia, which restricts blood flow in
    the lower leg and can lead to amputation. Scientific score 79.
  • StemCells, Inc., (principal
    investigator not yet known), $20 million, for development of human
    neural stem cells to treat chronic cervical spinal cord injury. The
    company, founded by Stanford scientist Irv Weissman, who serves on
    its board, said earlier this year that it had filed two applications
    in this round, one of which dealt with cervical cord spinal injury.
    No other applicants filed a proposal for such research. Scientific score 79.
  • Robert Robbins, Stanford, $20 million,
    development of a human embryonic stem cell treatment for end-stage
    heart failure.     Scientific score 68.

In the case of businesses, the awards
come in the form of loans. Grants go to nonprofits. One of the
reasons behind the varying mechanisms is the difference in CIRM's
intellectual property rules for businesses and nonprofits.

CIRM's Grant Working Group earlier this
year approved the applications during closed door sessions. The full
CIRM board has ultimate authority on the applications, but it has
almost never rejected a positive action by the grant reviewers.
The board originally allotted $243 million for this round. Directors could reach into the 15
applications rejected by reviewers and approve any of them, which the
board has done in other rounds. In this round, three rejected
applications scored within seven points of the lowest rated
application approved by reviewers, which could lead some directors
to argue that the scores are not significantly different. One of the
three came from Alexandra Capela of StemCells, Inc., and was scored at 61. The other two and their scores are Clive Svendsen of
Cedars-Sinai, score 64, for ALS research, and Roberta Brinton of
USC, score 63, for an Alzheimer's project.
Rejected applicants also can appeal
reviewer decisions to the full CIRM board in writing and in public
appearances before directors.
Twenty-three researchers were eligible
to apply for funding, CIRM told the California Stem Cell Report.
Applicants qualified by either winning a related planning grant from
CIRM last year or by being granted an exception to that requirement
by CIRM staff. Of the 22 researchers who ultimately applied(one
nonprofit dropped out), six came from biotech businesses. Three of
those qualified through exceptions. Three other businesses won
planning grants last year out of the eight businesses that applied.
CIRM has come under fire for its
negligible funding of stem cell firms and is moving to embrace
industry more warmly.
Only one of the grants approved by
reviewers involves research with human embryonic stem cells, which
was the critical key to creation of the California stem cell agency.
California voters established the agency in 2004 on the basis that it
was needed because the Bush Administration had restricted federal
funding of human embryonic stem cell research.  

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Companies selectively targeting cancer stem cells

Posted: July 22, 2012 at 3:53 pm

Today, I posted this to Twitter:

3 Innovative Cancer Treatments...But Which Is The Best Bet? seekingalpha.com/a/fjed $GSK $IMUC $VSTM #cancerSC via @seekingalpha — Jim Till (@jimtill) July 17, 2012

The article is about three companies that are working on treatments designed to target cancer stem cells (CSCs). The companies are OncoMed, Verastem and ImmunoCellular Therapeutics. The article is interesting.

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

Posted in Stem Cells, Stem Cell Therapy | Comments Off on Companies selectively targeting cancer stem cells

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