Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency
By Dr. Matthew Watson
advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a
firm that is sharing in a $14.5 million grant from the state research
enterprise.
Emerald Lake Hills, Ca., and who also has worked as a consultant to
Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010,
when she served as a consultant for the panel that CIRM hired to
review its operations. The panel strongly recommended that CIRM
engage industry more warmly. Since then Ramasastry's contracts with
CIRM have totalled $65,000. Her current $25,000 contract describes
her work for CIRM as "industry analysis and consultation."
website says she serves as "a special advisor to CIRM in
industry engagement initiatives and strategic projects." Her
firm also offers expertise to life sciences firms in "strategic
alternatives advisory, strategic options analysis, tailored business
development solutions and innovative financing strategies."
directors, said,
"Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."
Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options.
Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year. Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.
scheduled to vote on Ramasastry's nomination on June 21.
Stem Cell Report has asked Ramasastry if she has any comment for
publication. We are also querying CIRM and Sangamo. Their comments
will be carried verbatim when we receive them.
Ramasastry's consulting work with both CIRM and Sangamo demonstrates
again the tiny size of the world of stem cell science. It also raises
questions about conflicts of interest involving CIRM and industry. Can
a consultant in such a position serve two masters and serve them both
equally well? CIRM's interests are not necessarily the same as
Sangamo's, which is a publicly traded firm working diligently to
generate profit and financial returns for its shareholders. To do
that, it needs capital from its financial "backers,"
including CIRM. The stem cell agency, however, is in the business of
getting the results that it wants from Sangamo. If not, the grant
can be cancelled. Working for both the stem cell agency, whose
paramount obligation is to the people of California, and a recipient
of the agency's millions is incompatible.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
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May 13th, 2012
Neuralstem Reports First Quarter Financial Results And Provides Business And Clinical Update
By Dr. Matthew Watson
ROCKVILLE, Md., May 9, 2012 /PRNewswire/ -- Neuralstem, Inc. (CUR) today reported its financial results for the three months ended March 31, 2012 and provided a business and clinical update.
(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )
"In the first Quarter of 2012, we entered the final cohort of our Phase I clinical trial in ALS at Emory University Hospital. We are encouraged with the recent approval by the FDA to amend the trial protocol to bring back previously transplanted patients for additional dosing. These patients, who have each received ten lumbar injections earlier in the trial, may now receive an additional five cervical injections. These three patients in our ALS Phase I trial will become the first patients to receive neural stem cell injections up the full length of the spinal cord," said Karl Johe, PhD, chairman of the board and chief scientific officer of Neuralstem, Inc. "These patients are currently 15 to 17 months out from their original surgeries, so we are further encouraged by the fact that their disease progression has been slow enough that they can still be considered for these additional cervical injections. These segments of the spinal cord control breathing, and we believe that multiple injections in the cervical region may be the most effective way to help ALS patients. In order to be eligible, these three patients must meet the same inclusion criteria as new patients into the trial both before and at the time of surgery."
Dr. Johe continued, "This year will also see the start and finish of our neuroregenerative small molecule NSI-189 Phase Ib trial to treat major depressive disorder. This is a novel orally active drug that stimulates new neuron growth in the hippocampus which we believe can help patients with major depressive disorder. We are finalizing the preparations for the first of three cohorts of eight patients each that are scheduled to demonstrate the safety of escalating doses of daily administration of NSI-189 during a 28-day cycle. Dr. Maurizio Fava of Harvard University and Massachusetts General helped to design the trial and we thank him for his efforts.
"Internationally, we expect to commence a combined Phase I/II/III clinical trial for chronic motor disorders from stroke at BaYi Brain Hospital in Beijing through our wholly owned subsidiary, Neuralstem China later in the year. We are currently engaged in test runs at our facility in Suzhou, China where we will manufacture the neural stem cells for the trial," concluded Dr. Johe.
Neuralstem's President and CEO Richard Garr added, "This New Year has seen us actively engaged in licensing discussions for our proprietary surgical device, invented by our ALS surgeon, Dr. Nicholas M. Boulis, with both the industry and Academia. We believe it will be the industry standard for such intraspinal procedures.
"We continue to work with our partner Sumitomo's Summit Pharmaceuticals International Corporation with the goal of licensing NSI-189 to a Japanese pharmaceutical company for development of the Japanese market this year," Mr. Garr continued. "We also continue to see strong interest in co-development opportunities for our preclinical library of additional patented novel neuroregenerative compounds. The company is committed to finding the right partner to move these preclinical compounds forward."
Clinical Program and Business Highlights
Cellular Therapy: Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University Hospital
Corporate News
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Neuralstem Reports First Quarter Financial Results And Provides Business And Clinical Update
Spinal Cord Stem Cells
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May 10th, 2012
StemCells, Inc. to Provide Progress Report on Spinal Cord Injury Trial at the Interdependence 2012 Global SCI …
By Dr. Matthew Watson
NEWARK, Calif., May 9, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced that Armin Curt, MD, FRCPC, Professor and Chairman, Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the Balgrist University Hospital and principal investigator for the Company's Phase I/II clinical trial in chronic spinal cord injury, will provide a progress report on the trial on Thursday, May 17 at the Interdependence 2012 Global SCI Conference. Interdependence 2012, which is being held in Vancouver, British Columbia on May 15-17, 2012, is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.
In addition, on Thursday, May 17, Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc., will make a presentation on neural stem cell transplantation in neurological disorders. Dr. Huhn will describe the scientific and preclinical rationale for the Company's extensive clinical development program which encompasses all three elements of the central nervous system -- spinal cord, brain, and eye. StemCells was the first company to receive authorizations from the US Food and Drug Administration and Swissmedic to conduct clinical trials to evaluate purified human neural stem cells as potential therapeutic agents.
The goal of Interdependence 2012 is to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.
The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. For information on patient enrollment, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at stemcells.pz@balgrist.ch.
Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.
About Balgrist University Hospital
Balgrist University Hospital, University of Zurich is recognized worldwide as a highly specialized center of excellence providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions. The clinic owes its leading international reputation to its unique combination of specialized medical services. The hospital's carefully-balanced, interdisciplinary network brings together under one roof medical specialties including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology, and physical medicine. More information about Balgrist University Hospital is available at http://www.balgrist.ch.
The rest is here:
StemCells, Inc. to Provide Progress Report on Spinal Cord Injury Trial at the Interdependence 2012 Global SCI ...
Spinal Cord Stem Cells
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May 10th, 2012
Compassionate Use of Pluristem's PLX Cells Saves the Life of a Child After Bone Marrow Transplantation Failure
By Dr. Matthew Watson
HAIFA, Israel, May 9, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI - News) (TASE:PLTR) today announced that a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating is now experiencing a reversal of her condition with a significant increase in her red cells, white cells and platelets following the intramuscular injection of the company's PLacental eXpanded (PLX) cells. Aplastic bone marrow is a disease where the patient has no blood-forming hematopoietic stem cells in the bone marrow.
"With her body rejecting all possible treatment -- and with no other options -- we finally turned to Pluristem's PLX cells, which literally saved her life," said Professor Reuven Or, Director of Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center at Hadassah Medical Center and the child's physician. "The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."
The patient has been hospitalized at the Hadassah Hebrew University Medical Center, Jerusalem since August 2011. Her aplastic bone marrow had been refractory to treatment and, therefore, she underwent allogeneic stem cell transplantation from a matched unrelated donor. The first transplant was unsuccessful and the patient remained with bone marrow failure. Therefore, the patient underwent a second allogeneic stem cell transplantation from a second donor. Unfortunately, the bone marrow function was very poor and the patient suffered from recurrent infections. Approximately two months after the patient's second bone marrow transplant, the child received PLX cells intramuscularly in two doses approximately one week apart. Approximately 10 days after the last administration of PLX cells, the patient's hematological parameters began to significantly increase, an effect that has persisted to date. Additionally, the patient's general clinical status has improved. Subsequent analysis has indicated that the PLX cells worked by stimulating the recovery of the hematopoietic stem cells contained in the second bone marrow transplant that she had received over two months earlier. Finally, after nine months of hospitalization, the child will be discharged from the hospital.
"Pluristem is extremely happy that our PLX cells have helped this little girl," said Zami Aberman, Chairman and CEO of Pluristem. "Remarkably, these beneficial effects were seen in the patient after our PLX cells were administered intramuscularly and correlates with the positive effects on the bone marrow when we administered our PLX cells intramuscularly (IM) in animals exposed to toxic levels of radiation. Pluristem now has several data points to indicate that our PLX cells may work for systemic diseases when given locally, away from the target organ, and without a need to give cells intravenously."
In February 2012, Pluristem announced the results of animal studies suggesting PLX cells can be potentially effective in treating the life threatening hematopoietic complications associated with Acute Radiation Syndrome (ARS). In these experiments, animals given PLX cells IM up to 24 hours post irradiation demonstrated a recovery of their red cells, white cells, platelets and bone marrow to almost normal levels. It was that announcement, and the significant deterioration of the patient following two bone marrow transplants, that led Professor Reuven Or to contact Pluristem about the possible compassionate use of PLX cells to treat his young patient.
Pluristem recently received U.S. FDA Clearance to begin a Phase II clinical trial using the company's proprietary PLX-PAD cell product candidate intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). In April, the Company was awarded a $3.1 Million grant by the Israeli Government, which will be used to help fund R&D and clinical trials.
About Pluristem Therapeutics Inc.
Pluristem Therapeutics Inc. (Nasdaq:PSTI - News) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the use of PLX cells administered locally to treat systemic diseases and potentially obviating the need to use the intravenous route.
Data from two phase I/II studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-BMP for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.
Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities as well as strategic relationships with major research institutions.
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Compassionate Use of Pluristem's PLX Cells Saves the Life of a Child After Bone Marrow Transplantation Failure
Bone Marrow Stem Cells
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May 10th, 2012
Pluristem stem cell therapy saves a patient, shares jump
By Dr. Matthew Watson
Wed May 9, 2012 3:35pm BST
(Reuters) - Pluristem Therapeutics Inc said a 7-year old girl suffering from a bone marrow disease experienced a reversal of her condition after receiving its experimental stem cell therapy, sending the Israeli company's shares up 32 percent.
The girl, suffering from aplastic bone marrow in which the patient has no blood-forming stem cells, had a significant rise in her red cells, white cells and platelets following an injection of Pluristem's therapy -- PLacental eXpanded cells.
"The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow," Reuven Or, the child's physician at Hadassah Medical Center, was quoted in a statement by Pluristem.
Last September, the company said animal studies showed that the therapy had the potential to treat blood tissue complications related with acute radiation syndrome, commonly called radiation sickness.
Last month, the U.S. health regulators gave a go ahead to the company to start a mid-stage trial of the therapy for treating Intermittent Claudication -- a subset of peripheral artery disease.
Pluristem shares, which have gained 5 percent since receiving the FDA nod for the mid-stage trial, were up 15 percent at $2.70 in morning trade on the Nasdaq. They touched a high of $3.10 earlier.
(Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier)
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Pluristem stem cell therapy saves a patient, shares jump
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May 10th, 2012
Complex cancer industry trial literature is too confusing for patients to understand
By Dr. Matthew Watson
Have you ever read something so complex and confusing that it frustrated you to
the point of distraction? Well, a new study has found that cancer trial
literature causes that kind of frustration - and may be misleading to patients
as well.
According to Prof. Mary Dixon-Woods, professor of Medical Sociology at the
University of Leicester Department of Health Sciences in Great Britain, a
number of cancer patients found information leaflets describing cancer trials
too long, too incomprehensible and too intimidating.
"These information sheets are poorly aligned with patients' information
needs and how they really make decisions about whether to join a cancer
trial," said Dixon-Woods, lead author of the research http://www.eurekalert.org/pub_releases/2012-03/uol-cti032612.php,
which was published in the international journal Sociology of Health and
Illness.
"Some patients did find them very useful, but many others paid them little
attention. They preferred to rely on discussions they had with their doctor to
make up their minds," she said. Read more…
Integrative Medicine
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May 6th, 2012
Johnson & Johnson (China) Investment Ltd. Acquires Guangzhou Bioseal … – MarketWatch (press release)
By Dr. Matthew Watson
 The Star-Ledger - NJ.com | Johnson & Johnson (China) Investment Ltd. Acquires Guangzhou Bioseal ... MarketWatch (press release) GUANGZHOU, China, May 3, 2012 /PRNewswire via COMTEX/ -- Johnson & Johnson (China) Investment Ltd. today announced it has acquired Guangzhou Bioseal Biotechnology Co., Ltd. (Bioseal) a privately held biopharmaceutical company specializing in the design ... Johnson & Johnson buys Chinese sealant makerBioscience Technology |
Source:
http://news.google.com/news?q=biotechnology&output=rss
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May 6th, 2012
UAB Professor Louise Chow elected to National Academy of Science – UAB News
By Dr. Matthew Watson
 UAB News | UAB Professor Louise Chow elected to National Academy of Science UAB News By Beena Thannickal Louise Chow, Ph.D., professor in the Department of Biochemistry and Molecular Genetics at the University of Alabama at Birmingham and senior scientist at the UAB Comprehensive Cancer Center, was elected a member of the National ... UAB researcher elected to prestigious National Academy of Sciencesal.com (blog) Six Stanford faculty elected to National Academy of SciencesStanford University News |
Source:
http://news.google.com/news?q=molecular-genetics&output=rss
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May 6th, 2012
Another > $100M month for companies in the cell therapy space
By Dr. Matthew Watson
Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S. Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.
Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant. The application to proceed with this trial is currently under review by Health Canada.
Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".
The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR. We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that. We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.
The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.
Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3. The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.
Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture. This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.
ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones.
Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula. This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.
..
So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.
Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.
--Lee
p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.
Regenerative Medicine
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May 6th, 2012
Gene Hunt Is On for Mental Disabilities in Children
By Dr. Matthew Watson
To Read More: Gene Hunt Is On for Mental Disabilities in Children
Source:Uncategorized
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May 6th, 2012
April 2012 Advances: Additional Resources
By Dr. Matthew Watson
The Advances news section in April's issue of Scientific American included stories on digital textbooks, the promise of using gene therapy to fight blindness and how fragile orchids survive. To learn more about any of the stories, follow these links.
Source:Uncategorized
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May 6th, 2012
Processed EHR text can be used to develop CDS tools Read more: Processed EHR text can be used to develop Clinical decision support tools with automated text processing
By Dr. Matthew Watson
See on Scoop.it – inPharmatics
Free text in electronic health records, with the help of natural language processing (NLP) technology, can be used to create accurate clinical decision support (CDS) tools, according to a study published this week in the Journal of the American Medical Informatics Association
See on jamia.bmj.com
Source:Uncategorized
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May 6th, 2012
Why mHealth hasn’t created an Instagram (yet)
By Dr. Matthew Watson
See on Scoop.it – inPharmatics
Read about why a Qualcomm Life executive says mobile health doesn’t yet have an Instagram, and why it eventually will.
See on http://www.medcitynews.com
Source:Uncategorized
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May 6th, 2012
Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure
By Dr. Matthew Watson
billion California stem cell agency yesterday voted unanimously to
retain full public disclosure of the financial interests of its
directors and top executives.
bypassed a proposal that would have substantially weakened disclosure at a time when the agency is moving closer to industry in an effort
to develop cures.
and the agency's longstanding commitment to transparency," said
Kevin McCormack, the agency's spokesman, "they believed that
CIRM should continue to set an example by requiring the broadest
disclosure of members of the board and high level staff."
executives must disclose all their investments and income – in a
general way – along with California real property that they hold.
Under the rejected changes, disclosures would have instead been
required only "if the business entity or source of income is of
the type to receive grants or other monies from or through
the California Institute for Regenerative Medicine."
relieved CIRM officials of reporting investment in or income from
venture capital or other firms that may be engaged in financing
biotech or stem cell enterprises, since the firms do not receive cash
from CIRM or engage in biomedical research.
The subcommittee's action will go before the full CIRM board later this month, where it is expected to be ratified.
took the right action and is to be commended for going beyond the
letter of the law. The integrity and credibility of CIRM are
paramount. As the California Stem Cell Report wrote last week, narrowing disclosure would only have engendered suspicion and
unnecessarily raised questions about the conduct of the agency as it
embarks on an aggressive push for stem cell cures.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Stem Cell Therapy
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May 6th, 2012
Researcher Alert: First Look at Proposed Rules for California’s Stem Cell Bank
By Dr. Matthew Watson
The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
CIRM's communications manager wrote earlier this year on the agency's research blog,
"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."
The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use. The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
of the grantee, as the current IP rules state.
directors, Elona Baum, general counsel for the agency, said,
"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine which is also creating a repository for iPSC lines and
derived materials."
"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."
following summary of the $30 million banking initiative:
"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."
for the public meeting locations can be found on the agenda.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Stem Cell Therapy
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May 6th, 2012
ACT and CIRM Together on Eye Research Webinar
By Dr. Matthew Watson
which has been repeatedly rejected for funding by the $3 billion
California stem cell agency, will participate this week in the agency's Internet "webinar" on research involving the human eye.
clinical trial in the nation, was held up earlier this month (see
here and here) at an Institute of Medicine hearing as a prime example
of the California's agency's failure to fund the stem cell industry
in any significant way.
 |
| Gary Rabin, CEO of ACT |
ACT; Matthew Vincent, director of business development, and Edmund
Mickunas, vice president of regulatory affairs. The webinar will deal with regulatory issues
with the FDA and clinical trials involving the eye.
medical officer with the FDA, and Mark Humayun, professor of
opthamology at USC, who is the PI on a $16 million macular
degeneration grant from CIRM.
participation in the CIRM event? If the relationship between ACT and
CIRM has been touchy, this sort of cooperation is probably a good
sign for both. For one, CIRM could have hardly staged the webinar
without ACT, given the subject matter. But if the agency did not
want to engage ACT, it could have simply done nothing about setting
up a webinar in which the firm would participate.
receive a handsome grant or loan from CIRM? CIRM has established
procedures (RFAs, peer review, etc.) for approval of funding, and ACT
would have to go through that process unless CIRM does something very
unusual.
is likely to be technical. Persons interested in taking part must
register in advance.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Oxford Scientists Seek to Test Genetic Solution to Dengue-Carrying Mosquitoes … – OregonLive.com
By Dr. Matthew Watson
Bloomberg | Oxford Scientists Seek to Test Genetic Solution to Dengue-Carrying Mosquitoes ... OregonLive.com LONDON — British biotechnology start-up Oxitec wants to start US tests of a new weapon in the war on dengue fever: genetically modifying mosquitoes that carry the disease so that their progeny self-destruct. Dengue, endemic in more than 100 countries, ... Scientists modifying mosquitoes to prevent dengueVaccine News Daily (blog) |
Source:
http://news.google.com/news?q=biotechnology&output=rss
Uncategorized
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May 6th, 2012
Kashi is latest food to go anti-biotechnology – Oregon Natural Resources Report
By Dr. Matthew Watson
 Oregon Natural Resources Report | Kashi is latest food to go anti-biotechnology Oregon Natural Resources Report Tellingly, the press release issued by Kashi comes quickly on the heels of an agenda-driven campaign to “out” the health food maker's use of foods produced with biotechnology. The declaration of the cowardly cereal creator's about-face on biotechnology ... |
Source:
http://news.google.com/news?q=biotechnology&output=rss
Uncategorized
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May 6th, 2012
New muscular dystrophy treatment approach developed using human stem cells
By Dr. Matthew Watson
ScienceDaily (May 4, 2012) Researchers from the University of Minnesota's Lillehei Heart Institute have effectively treated muscular dystrophy in mice using human stem cells derived from a new process that -- for the first time -- makes the production of human muscle cells from stem cells efficient and effective.
The research, published May 4 in Cell Stem Cell, outlines the strategy for the development of a rapidly dividing population of skeletal myogenic progenitor cells (muscle-forming cells) derived from induced pluripotent (iPS) cells. iPS cells have all of the potential of embryonic stem (ES) cells, but are derived by reprogramming skin cells. They can be patient-specific, which renders them unlikely to be rejected, and do not involve the destruction of embryos.
This is the first time that human stem cells have been shown to be effective in the treatment of muscular dystrophy.
According to U of M researchers -- who were also the first to use ES cells from mice to treat muscular dystrophy -- there has been a significant lag in translating studies using mouse stem cells into therapeutically relevant studies involving human stem cells. This lag has dramatically limited the development of cell therapies or clinical trials for human patients.
The latest research from the U of M provides the proof-of-principle for treating muscular dystrophy with human iPS cells, setting the stage for future human clinical trials.
"One of the biggest barriers to the development of cell-based therapies for neuromuscular disorders like muscular dystrophy has been obtaining sufficient muscle progenitor cells to produce a therapeutically effective response," said principal investigator Rita Perlingeiro, Ph.D., associate professor of medicine in the Medical School's Division of Cardiology. "Up until now, deriving engraftable skeletal muscle stem cells from human pluripotent stem cells hasn't been possible. Our results demonstrate that it is indeed possible and sets the stage for the development of a clinically meaningful treatment approach."
Upon transplantation into mice suffering from muscular dystrophy, human skeletal myogenic progenitor cells provided both extensive and long-term muscle regeneration which resulted in improved muscle function.
To achieve their results, U of M researchers genetically modified two well-characterized human iPS cell lines and an existing human ES cell line with the PAX7 gene. This allowed them to regulate levels of the Pax7 protein, which is essential for the regeneration of skeletal muscle tissue after damage. The researchers found this regulation could prompt nave ES and iPS cells to differentiate into muscle-forming cells.
Up until this point, researchers had struggled to make muscle efficiently from ES and iPS cells. PAX7 -- induced at exactly the right time -- helped determine the fate of human ES and iPS cells, pushing them into becoming human muscle progenitor cells.
Once Dr. Perlingeiro's team was able to pinpoint the optimal timing of differentiation, the cells were well suited to the regrowth needed to treat conditions such as muscular dystrophy. In fact, Pax7-induced muscle progenitors were far more effective than human myoblasts at improving muscle function. Myoblasts, which are cell cultures derived from adult muscle biopsies, had previously been tested in clinical trials for muscular dystrophy, however the myoblasts did not persist after transplantation.
Read more from the original source:
New muscular dystrophy treatment approach developed using human stem cells
Skin Stem Cells
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May 6th, 2012
Two Drugs Safe for Rare Forms of Kidney Cancer
By Dr. Matthew Watson
Using a combination of the drugs temsirolimus (Torisel) and Bryostatin appears
to be safe in patients with metastatic kidney cancer, according to early data
from 25 patients in a phase 1 trial.
The researchers said a pathway known as mTOR signaling promotes tumor cell
proliferation and tumor blood vessel development. The temsirolimus-bryostatin
combination blocks two portions of the mTOR signaling pathway, and the early
data suggests the drugs may be active in patients with rare forms of renal cell
cancer that are less likely to respond to other therapies.
"We have certainly seen sustained responses with this combination, which
are encouraging," Dr. Elizabeth Plimack, a medical oncologist and attending
physician at Fox Chase Cancer Center in Philadelphia, said in a news release
from the center.
"Patients with non-clear cell renal cell cancer, including papillary renal
cancer, don't respond as well to tyrosine kinase inhibitors, such as sunitinib [Sutent]
and sorafenib [Nexavar], as patients with clear cell renal cell. So there is an
unmet need for therapy for these patients. We've seen that this combination may
be active to some degree for them," Plimack said.
The findings were to be presented Sunday at the American Society of Clinical
Oncology annual meeting, in Orlando, Fla. Read more…
Integrative Medicine
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April 29th, 2012