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California Stem Cell Directors Open Meeting

By Dr. Matthew Watson


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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Ruling frees FDA to crack down on stem cell clinics

By Sykes24Tracey

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.

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Malaya Business Insight

By Dr. Matthew Watson

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.

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Arroyo might undergo stem cell therapy

By NEVAGiles23

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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Israel adult stem cell trials – hope for ALS patients?

By Sykes24Tracey

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.

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Analysis: GSK bolsters medicine chest with biotechnology buy – Reuters

By Dr. Matthew Watson


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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HudsonAlpha Institute for Biotechnology joins genetic fight against ALS – al.com (blog)

By Dr. Matthew Watson


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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Companies selectively targeting cancer stem cells

By Dr. Matthew Watson

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

By Dr. Matthew Watson


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

By Dr. Matthew Watson


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

By Dr. Matthew Watson


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

By Dr. Matthew Watson

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

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

By LizaAVILA

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

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categoriaUncategorized commentoComments Off on NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement | dataJuly 17th, 2012
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Cuba uses biotechnology to revive coffee industry – Xinhua

By Dr. Matthew Watson


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 »

Source:
http://news.google.com/news?q=biotechnology&output=rss

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categoriaUncategorized commentoComments Off on Cuba uses biotechnology to revive coffee industry – Xinhua | dataJuly 15th, 2012
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Look For A Possible Long Entry In This iShares Nasdaq Biotechnology ETF (IBB) – ETF Daily News

By Dr. Matthew Watson


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.

Source:
http://news.google.com/news?q=biotechnology&output=rss

To Read More: Look For A Possible Long Entry In This iShares Nasdaq Biotechnology ETF (IBB) – ETF Daily News
categoriaUncategorized commentoComments Off on Look For A Possible Long Entry In This iShares Nasdaq Biotechnology ETF (IBB) – ETF Daily News | dataJuly 15th, 2012
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"Master Molecule" May Help Heart Treatment

By daniellenierenberg

Johns Hopkins researchers have discovered that a single protein molecule may hold the key to turning cardiac stem cells into blood vessels or muscle tissue, according to a release from the university. This finding may lead to better ways to treat heart attack patients.

Human heart tissue typically forms scars rather than healing well after an attack. However, stem cells have been shown improve the repair process by turning into the cells that make up healthy heart tissue, including heart muscle and blood vessels. The recent discovery of a master molecule that guides the destiny of these stem cells has the potential to result in even more effective treatments for heart patients, the Johns Hopkins researchers say.

In a study published in the June 5 online edition of journal Science Signaling, the Johns Hopkins team reported that tinkering with a protein molecule called p190RhoGAP shaped the development of cardiac stem cells and prodded them to become the building blocks for either blood vessels or heart muscle. The scientists said that by altering levels of this protein, they were able to affect the future of these stem cells. In biology, finding a central regulator like this is like finding a pot of gold, said Andre Levchenko, a biomedical engineering professor and member of the Johns Hopkins Institute for Cell Engineering, who supervised the research effort.

The lead author of the journal article, Kshitiz, a postdoctoral fellow who uses only his first name, said, Our findings greatly enhance our understanding of stem cell biology and suggest innovative new ways to control the behavior of cardiac stem cells before and after they are transplanted into a patient. This discovery could significantly change the way stem cell therapy is administered in heart patients.

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"Master Molecule" May Help Heart Treatment

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categoriaCardiac Stem Cells commentoComments Off on "Master Molecule" May Help Heart Treatment | dataJuly 11th, 2012
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Bibiyahe sa Germany kasama si Ruffa, Annabelle magpapakondisyon sa kampanya kaya magpapa-stem cell therapy

By NEVAGiles23

Tuloy na ang stem cell therapy ni Annabelle Rama dahil naka-schedule na siyang pumunta sa Germany sa first week ng September.

Kasama ni Annabelle sa Germany trip ang kanyang anak na si Ruffa Gutierrez. Hindi ako sure kung may plano rin si Ruffa na magpa-stem cell therapy dahil walang age limit ang procedure na pinag-uusapan na ngayon sa apat na sulok ng showbiz.

Tinutukso si Annabelle Rama na may kinalaman sa kanyang pagkandidato sa Cebu ang desisyon niya na sumailalim sa stem cell therapy.

Tumawa lang si Bisaya na mukhang seryoso na sa pagkandidato bilang kongresista ng North Cebu sa eleksiyon sa susunod na taon.

Binibiro si Bisaya na magpapa-stem cell therapy siya para kundisyon na kundisyon ang katawan niya habang nangangampanya sa North Cebu.

Ayaw kumpirmahin ni Bisaya ang political plans niya. Hintayin na lamang daw ng mga tao ang kanyang bonggang announcement sa October.

Asawa ni Jose nag-iba ng abogado matapos matalo

How true na iba na raw ang lawyers ni Analyn Manalo kaya tumanggi nang magsalita ang kanyang mga dating abogado?

Si Analyn ang kontrobersiyal na dyowa ni Jose Manalo. Ilang buwan nang nasa news ang mag-asawa dahil sa kanilang paghihiwalay.

News noong weekend na natalo si Analyn sa kaso na isinampa niya laban kay Jose.

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Bibiyahe sa Germany kasama si Ruffa, Annabelle magpapakondisyon sa kampanya kaya magpapa-stem cell therapy

To Read More: Bibiyahe sa Germany kasama si Ruffa, Annabelle magpapakondisyon sa kampanya kaya magpapa-stem cell therapy
categoriaUncategorized commentoComments Off on Bibiyahe sa Germany kasama si Ruffa, Annabelle magpapakondisyon sa kampanya kaya magpapa-stem cell therapy | dataJuly 11th, 2012
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NeoStem to Present at the Seventh Annual JMP Securities Healthcare Conference

By Dr. Matthew Watson

NEW YORK, July 10, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that its CEO will present at the Seventh Annual JMP Securities Healthcare Conference on July 12, 2012.

The presentation will be webcast live and available to view at the following web address: http://wsw.com/webcast/jmp18/nbs/. The webcast will be archived for 90 days following the live presentation.

The Seventh Annual JMP Securities Healthcare Conference

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.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's successful development of cell therapeutics, as well as the future of the cell therapeutics industry. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's periodic filings with the Securities and Exchange Commission. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

More here:
NeoStem to Present at the Seventh Annual JMP Securities Healthcare Conference

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Dr. Jue Brings Store-A-Tooth Dental Stem Cell Therapy Service to Sugarland

By raymumme

Sugarland, TEXAS (PRWEB) July 10, 2012

Sugarland cosmetic dentist Dr. Lance Jue from A Beautiful Smile at Lake Pointe has become the first provider of dental stem cell therapy in Fort Bend County.

Dental stem cell therapy saves stem cells from baby teeth, teeth removed for orthodontic reasons and wisdom teeth to help with future infections, injuries or diseases.

Dr. Jue works with Store-A-Tooth, which provides a Tooth Transport Kit, collects and validates the stems cells that are collected from the tooth. The cells are kept frozen until the day they are needed, at which time they are sent to the patients healthcare provider.

Dental stem cells have been used to treat periodontal disease, diabetes, spinal cord injury, stroke and liver disease. Stem cells are different from other cells because they can transform into many different cell types and divide more than other types of cells.

Dental stem cells are particularly effective because they replicate faster than stem cells take from other body tissues.

The initial cost of the Store-A-Tooth service is one-third to one-half the initial cost of storing umbilical cord blood, another source of stem cells.

A Beautiful Smile at Lake Pointe is the dental practice of Dr. Lance Jue. It has served the Houston area's restorative, cosmetic and general dentistry needs for 19 years. Dr. Jue makes an effort to listen to every patient to give him or her the appropriate treatment.

Excerpt from:
Dr. Jue Brings Store-A-Tooth Dental Stem Cell Therapy Service to Sugarland

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Needle-Sharing by Sex Workers Tied to Spread of Syphilis

By Dr. Matthew Watson

(HealthDay News) -- Needle-sharing among drug abusers may play as big a role as risky sexual behavior in the transmission of syphilis, a new study suggests.

American and Mexican researchers interviewed more than 900 female sex workers in the Mexican border towns of Tijuana and Ciudad Juarez, which are adjacent to San Diego and El Paso, Texas, respectively. The sex workers, who were also tested for HIV and sexually transmitted diseases (STDs), operate legally in the two Mexican towns, which are located on major drug trafficking routes.

The researchers found that female sex workers who didn't have HIV, but tested positive for active syphilis infection, were more likely than those without active syphilis infection to inject drugs, to use illegal drugs before or during sex in the past month, and to have U.S. clients who had higher rates of drug use, including the use of injection drugs. Read more…

Source:
http://feeds.feedburner.com/integratedmedicine

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categoriaIntegrative Medicine commentoComments Off on Needle-Sharing by Sex Workers Tied to Spread of Syphilis | dataJuly 8th, 2012
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