The California stem cell agency today
cleared the way for approval of an $18 million grant to develop a new
cell-based therapy for treatment of ALS.

Source:
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Two California stem cell firms today
won a reprieve from rejection in their bids for $40 million in
funding from the California stem cell agency.

“We have a fiduciary responsibility
to select the best science.”

Source:
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Directors of the California stem cell
agency today deferred action on a $20 million proposal that was
rejected by its grant reviewers and sent it back for more consideration. 

Source:
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California stem cell agency chairman J.T. Thomas has raised the possibility of sending some of the disease team applications back for additional review if the board feels that is necessary to consider new information and resolve scientific disputes. 

Source:
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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. 

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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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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.

It was on this basis that in 2008 the FDA began moves to shut downRegenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx.

Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling.

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."

Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials.

"I think it's a good ruling, and I'm glad to see that that the FDA has exercised its muscle on the case," says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.

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.

Last month, the Houston Chronicle revealed that FDA inspectors had found multiple violations of good manufacturing practice at Celltex.

See the original post here:
Ruling frees FDA to crack down on stem cell clinics

Details Published on Friday, 27 July 2012 00:00

STEM cell therapy is being eyed to cure the neck and back pains and other illnesses of former president and now Pampanga Rep. Gloria Arroyo, alternative medicine doctor Antonia Park said yesterday.

Arroyo went to Parks Green and Young Health and Wellness Center in Tagaytay City yesterday morning for cleansing and alternative healing.

A guard at the La Vista Subdivision in Quezon City, who requested anonymity, said Arroyo left the subdivision at around 7:30 a.m., accompanied by a few staff and a personal nurse. She rode a white Nissan Patrol and her convoy included a gray Toyota Land Cruiser and a police escort.

Arroyo was granted bail Wednesday by a Pasay City court after finding that the electoral sabotage case against her was weak. She posted a P1-million cash bond.

Stem cell treatment involves the introduction of new adult stem cells into the damaged tissue in order to treat a disease or injury. The ability of new cells to regenerate is seen as having significant potential to replace diseased areas of the body, with minimal risk of rejection and side effects.

Park, in a statement distributed to the media, said Arroyo complained of difficulty in swallowing with choking due to her bulge along the posterior pharyngeal wall, together with a change of her voice and losing weight due to her difficulties of swallowing the food (solid) and angina as well as continuous neck and back pain.

Thats why our center is accepting her for possible stem cell therapy and another treatment of pain management and giving natural food by means of fresh fruit and vegetable juices for which management is warranted and which the stem cell therapy is contemplated and strongly considered, she said.

She said the stem cell therapy can be given by her clinic in Tagaytay while Arroyo can continue her physical therapy at the Veterans Memorial Medical Center four times a week.

Park said Arroyo can to go her district, referring to the second district of Pampanga, over the weekend provided she takes care to wear a brace and avoid talking too much so as to protect the bulging interior of the throat, and provided she resumes physical therapy as soon as possible.

View original post here:
Malaya Business Insight

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

Read more:
Arroyo might undergo stem cell therapy

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 stabilization 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 organization 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.

The Phase I/II trial, designed to evaluate the safety and preliminary efficacy of BrainStorm's therapy, is being conducted at Jerusalem's Hadassah Medical Center. The company submitted the interim safety report to Israel's Health Ministry.

Go here to see the original:
Israel adult stem cell trials - hope for ALS patients?

AFP

Analysis: GSK bolsters medicine chest with biotechnology buy Reuters LONDON (Reuters) - GlaxoSmithKline chief executive Andrew Witty has an eye for a bargain. Despite paying a 99 percent premium for Human Genome Sciences, he is still getting the biotechnology company for less than half what it was worth 14 months ago. GSK bolsters medicine chest with biotechnology buyReuters UK GSK clinches $3B deal to buy Human GenomeNational Post Glaxo to Buy Human GenomeWall Street Journal all 606 news articles »

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al.com (blog)

HudsonAlpha Institute for Biotechnology joins genetic fight against ALS al.com (blog) HUNTSVILLE, Alabama -- Huntsville's HudsonAlpha Institute for Biotechnology is joining top researchers across America and Canada to fight one of the world's most devastating diseases. HudsonAlpha will work with Duke University to sequence the ... Biogen to map genomes of ALS patientsMass High Tech all 17 news articles »

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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:
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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.

“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 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."

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

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.

“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.“

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

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.

• 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.

Source:
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LEUVEN, BELGIUM--(Marketwire -07/17/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today that after obtaining national reimbursement for ChondroCelect in the Netherlands last month, the company has now contracted with four major hospitals to make its innovative cartilage repair therapy available to their patients on a routine basis: University Medical Center Utrecht, University Hospital Maastricht, Martini Hospital Groningen, and, most recently, the Elisabeth Hospital Tilburg. Discussions with other Cartilage Expert Centers are ongoing. Reimbursement for ChondroCelect in the Netherlands is retroactive per January 1, 2011.

"Our close collaboration with the Dutch hospitals is key to making ChondroCelect available to patients in the Netherlands," said Eduardo Bravo, CEO of TiGenix. "Dutch scientists and clinicians have made important contributions to the development of this innovative cartilage repair therapy. Patients who suffer from cartilage lesions in the knee that cause recurrent pain and can be incapacitating can now be routinely treated and literally find their footing again. We expect to soon expand the number of hospitals in the Netherlands where ChondroCelect is available."

Damage to the articular cartilage in the knee can be caused by sports or professional activities in which the knee is repeatedly and forcefully impacted. It is a condition that predominantly occurs in young adults, who as a result suffer from recurrent pain, locking or limited range of motion, and risk being incapacitated. TiGenix has developed ChondroCelect as a therapy to help patients regain their mobility and fully active lives by effectively repairing the damaged cartilage in the knee.

About ChondroCelect ChondroCelect for cartilage regeneration in the knee is an implantation suspension of characterized viable autologous (from the patient her- or himself) cartilage cells. The product is administered to patients in an autologous chondrocyte implantation procedure known as Characterized Chondrocyte Implantation (CCI), a surgical procedure to treat cartilage defects, in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.

Cartilage defects of the knee are very common and the spontaneous healing capacity of cartilage is limited. Currently, roughly 2 million cases of articular cartilage defects of the knee are diagnosed worldwide every year. TiGenix estimates that in Europe and the United States around 130,000 patients are eligible for treatment with cartilage regeneration products such as ChondroCelect.

ChondroCelect is the first cell-based product to successfully complete the entire development track from research to clinical development, and was approved by the European Medicines Agency as an Advanced Medicinal Therapy Product in October 2009. ChondroCelect is to date the only EMA approved cartilage repair therapy, and is commercially available in Belgium, the Netherlands, Luxemburg, Germany, the United Kingdom, Finland, and Spain.

About TiGenixTiGenix NV (EURONEXT:TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit http://www.tigenix.com.

Forward-looking informationThis document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

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TiGenix Signs Up 4th Major Hospital in the Netherlands for Innovative Cartilage Repair Therapy

ALLENDALE, N.J. and WILMINGTON, Del., July 16, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized Contract Development and Manufacturing Organization (CDMO), and SOTIO, LLC, a Delaware limited liability company that is responsible for organizing the U.S. part of a global pivotal Phase 3 clinical trial of SOTIO, LLC's affiliate, SOTIO a.s. ("SOTIO"), announced today that SOTIO, LLC has retained the services of PCT to manufacture clinical products for SOTIO's U.S. part of a global pivotal Phase 3 clinical trial. SOTIO, LLC is an affiliate of a Czech Republic-based biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. SOTIO, LLC will use the services of PCT to transfer and qualify at PCT's Allendale, New Jersey facility, SOTIO's GMP manufacturing process for the U.S. part of a global pivotal Phase 3 clinical trial for SOTIO's autologous dendritic cell vaccine expected to launch in early 2013, subject to FDA approval.

As part of this agreement, PCT will complete a technology transfer of SOTIO's current product manufacturing and analytical procedures into PCT's ongoing CDMO operations. PCT will then implement and perform process qualification at the Allendale facility, and manufacture, store, and release the product for SOTIO's U.S. part of its global pivotal Phase 3 trial. The U.S. part of this double-blinded, randomized trial will enroll up to 250 patients and will be SOTIO's first trial in the U.S.

"We are very excited to enter into this agreement to continue and to expand on our relationship with SOTIO, LLC, an innovator for cellular immunotherapies to treat prostate cancer," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. "Given our best in class capabilities in the manufacture and distribution of cell-based immunotherapies, we are pleased to work with SOTIO, LLC to assist with bringing this exciting therapy and its potential to the U.S. PCT will offer SOTIO, LLC the same expertise and dedicated service it has offered past clients like the Dendreon Corporation (DNDN), for whom we were the primary manufacturer for PROVENGE(R) for more than seven years during its clinical trials."

"This agreement with PCT represents a major risk mitigation step in conducting the U.S. part of our global pivotal Phase 3 clinical trial," said Karel Nohejl, Chairman and CEO of SOTIO. "PCT has significant experience in manufacturing patient-specific products and capabilities to provide the scale-up needed for late-stage clinical trials. PCT's competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for SOTIO, LLC as we look forward to launching this trial in anticipation of entering the U.S. market."

"PCT offers cell therapy companies around the world a cost-effective method to transfer product candidate development to the U.S. and launch their products commercially," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "PCT's track record, experience with technology transfer, and U.S. footprint including its East and West Coast (Mountain View, California) facilities, make it an excellent partner for companies like SOTIO, LLC. Manufacturing contracts for cell therapy products can generate millions of dollars of revenue for the manufacturing partner over the span of a late stage clinical trial. We foresee meaningful client base growth as therapeutic development companies from Europe and Asia seek access to the American market and look for a U.S. contract development and manufacturing partner."

About SOTIO Group

SOTIO Group is a biotechnology group developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Its mission is to develop new medical therapies using SOTIO's proprietary cell-based technologies to treat highly unmet medical conditions using SOTIO's immunotherapy platform. World renowned scientists are working at SOTIO's research facilities in Prague using state-of-the art technologies to understand the role of dendritic cells in the therapeutic activation of the body's immune response. SOTIO plans to start a global pivotal Phase 3 clinical trial which will enroll U.S. as well as E.U. patients under the supervision of FDA and EMA. SOTIO, LLC is an affiliate of SOTIO and is responsible for organizing SOTIO Group's activities in the United States.

For more information on SOTIO, please visit http://www.sotio.com

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

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NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement

IANS

Cuba uses biotechnology to revive coffee industry Xinhua HAVANA, July 10 (Xinhua) -- Cuban researchers are trying to revive the nation's wilting coffee production by using bio-technology, an industrial expert said. A research project involving three institutions nationwide has made headway in developing new ... Cuba Coffee industryLive Trading News all 9 news articles »

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ETF Daily News

Look For A Possible Long Entry In This iShares Nasdaq Biotechnology ETF (IBB) ETF Daily News Stocks recovered dramatically from session lows yesterday, on higher volume. All five major indices closed lower on the session but well off their worst levels of the day. The S&P 500 contained losses to 0.5% after being as much as 1.2% down on the day.

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