Gov. Gregoire attends life sciences seminar – Snohomish Times
By Dr. Matthew Watson
 Snohomish Times | Gov. Gregoire attends life sciences seminar Snohomish Times “Washington state has always promoted technology innovation and biotechnology has been one of our areas of focus for research and development,” Gregoire said. “This exciting partnership between WBBA and ABLE will spur progress in this sector in India ... |
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October 7th, 2012
UCLA Scientist Awarded $500K Grant – LA Canyon News
By Dr. Matthew Watson
 LA Canyon News | UCLA Scientist Awarded $500K Grant LA Canyon News According to a UCLA news release that announced the annual award, Hallem, 34, is an assistant professor in the Department of Microbiology, Immunology and Molecular Genetics and explores physiology and behavioral consequences of odor detection. |
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October 7th, 2012
Trio of Genome-Sequencing Studies Offers a Broader View of Lung Cancer
By Dr. Matthew Watson
To Read More: Trio of Genome-Sequencing Studies Offers a Broader View of Lung Cancer
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October 7th, 2012
"Junk" DNA Holds Clues to Common Diseases
By Dr. Matthew Watson
When the draft of the human genome was published in 2000, researchers thought that they had obtained the secret decoder ring for the human body. Armed with the code of 3 billion basepairs of As, Ts, Cs and Gs and the 21,000 protein-coding genes, they hoped to be able to find the genetic scaffolds of life --both in sickness and in health. [More]
http://rss.sciam.com/click.phdo?i=7b0ed7df96d7add1e7b201dddb2869c5
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October 7th, 2012
Are Phage Viruses the Forgotten Cure for Superbugs? [Excerpt]
By Dr. Matthew Watson
Excerpted from The Forgotten Cure: The Past and Future of Phage Therapy , by Anna Kuchment . (Copernicus Books, 2011. Reprinted by permission of Springer Science+Business Media)
http://rss.sciam.com/click.phdo?i=24e2a1c4c798a3535a9c98999e220977
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October 7th, 2012
Researcher Alert: California Stem Cell Agency Tightening Budget Oversight on Grants
By Dr. Matthew Watson
Some of California's top stem cell
researchers are going to have to sharpen their spreadsheets if they
want to win money from the state's $3 billion stem cell agency.
scrutiny of the high-profile, big-ticket grant applications
that it will consider during the next several years. The effort may well extend to all grant programs. The move also makes
it clear to researchers that the CIRM staff is in the driver's seat
when it comes to budgeting on research projects.
president for research and development. She said,
“Increasing the importance of
budgetary review will encourage applicants to propose rigorous,
realistic and vetted budgets, and will further our mission to be good
stewards of taxpayer dollars. These additions will not significantly
increase the workload burden on GWG members (grant reviewers) and
explicitly acknowledge that program goals, scientific plans, accurate budgeting and prudent spending are inextricably linked.”
directors' Science Subcommittee next Monday and would alter the
closed-door grant review process in the following manner, according
to Feigal's memo.
• “To assist GWG review,
appropriate expertise on budget and financial matters (e.g., this
could be in the form of a specialist reviewer, or can also be
assigned to a GWG reviewer with the appropriate background and
expertise), will review applications for sound budgeting and provide
comments or questions to the GWG for consideration by the reviewers
before the reviewer’s final scores are entered.
• “If the financial/budgetary
matter potentially directly impacts on the design or feasibility of
conducting the project, the GWG may consider this issue in the
scoring; otherwise, budgetary and financial issues and questions will
not contribute to the scientific score.
• “As appropriate, review summaries
sent to the ICOC (the CIRM governing board) will identify scientific
as well as budget or other issues. To the extent endorsed by the
GWG, the review summaries will also identify potential resolution
should the ICOC approve a given award with budget issues.
• “CIRM officers should be provided
explicit discretion to consider the budget comments, as well as
budget or other issues. To the extent endorsed by the GWG, the
review summaries will also identify potential resolution should the
ICOC approve a given award with budget issues.”
CIRM staff has experienced push-back from recalcitrant researchers
when efforts have been made to bring costs under control. She noted that
the agency's staff examines a research project's budget during the
“prefunding” review that follows board approval. However, Feigal
said, at that stage, “It is often challenging to make substantive
changes to the budget, based on appropriateness of study activities
and costs, given the ICOC approval at a given budget amount.”
budgets prior to board approval. One grant review in a $200
million-plus round this summer, for example, declared that costs to
prepare regulation packages had “overlap” and were “excessive,”
along with costs dealing with manufacturing and per patient expenses.
That was for a high-scoring application by Antoni Ribas of UCLA, and
he was not alone.
of budgetary shortcomings in recent applications:,
• “Budget does not align with the
program deliverables and milestones. For example, the budget
includes activities not relevant to project objective(s) or that are
out of scope.
•”Budget does not contain adequate
expenses for known costs. For example, an applicant may budget
$100,000 for a GMP manufacturing run of a biologic in which it is
generally accepted knowledge that the actual expenses are typically
much greater.
•“Budget item significantly exceeds
a known cost or seems excessive without adequate justification. For
example, an applicant may propose a surgical expense of $100,000 per
patient for a procedure with Medicare reimbursement set at $15,000.
•“Cost allocations are not done
properly. For example, an applicant is developing the same
therapeutic candidate for 3 indications, and is applying for CIRM
funding for 1 of the 3, but is charging CIRM for the cost of the
entire manufacturing run.”
be used in disease team, early translational, strategic partnership
rounds, and any new rounds “as deemed appropriate.” Feigal said,
however, that “all applications for CIRM awards should be
carefully examined for budgetary appropriateness.”
well-advised move, albeit one that is not likely to find favor with
researchers accustomed to loose oversight. It moves budgetary review
to an earlier stage and gives the CIRM directors a chance to weigh in
on those matters prior to approval of grants, instead of creating a
sense of entitlement on the part of recipients that may pop up
following board approval of their applications. Indeed, the plan
makes such good sense that it raises the question why it was not in
place years ago.
excellent example of the type of information that clarifies issues
and helps CIRM directors make the best possible decisions. It
provides some history, good evidence for a change and an explanation
of benefits. Additionally, the memo is timely, having been posted on
the CIRM website sufficiently in advance of next week's meeting to give affected parties and others time to comment
and make constructive suggestions. The memo is also far superior to
the Power Point presentations that are often submitted to the board
minus any nuanced, written discussion of the issue at hand.
San Francisco but also has teleconference locations in Irvine (2), La
Jolla, Stanford, Pleasanton, Oakland and Los Angeles where the public
and researchers can participate. The specific addresses can be found on the agenda.
Source:Stem Cell Therapy
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October 7th, 2012
UCD’s Knoepfler’s ‘Somewhat Provocative Paper’ on iPS
By Dr. Matthew Watson
UC Davis researcher Paul Knoepfler is
the rare stem cell scientist who blogs about his work as well as
writing about issues in the field.
what he described as a “somewhat provocative paper” published by his lab in
“Stem Cells and Development.” He said the paper argued
that iPS cells “are very similar in some ways to cancer cells.”
technical details and background of the research. But at the end of
this item, Knoepfler wrote,
“So what does this mean in the big
picture?
“I believe that iPS cells and cancer
cells are, while not the same, close enough to be called siblings. As
such, the clinical use of iPS cells should wait for a lot more study.
Even if scientists do not use iPS cells themselves for transplants,
but instead use differentiated derivatives of iPS cells, the risk of
patients getting malignant cancers cannot be ignored.
“At the same time, the studies
suggest possible ways to make iPS cells safer and support the notion
of reprogramming cancer cells as an innovative new cancer therapy.
“Stay tuned in the next few days for
part 2 where I will discuss what this paper went through in terms of
review, etc. to get published. It wasn’t a popular story for some
folks.”
research, which was financed by the California stem cell agency and the NIH, was picked up by several online sites, including Redorbit,
Medicalexpress and geekosystem.
Source:Stem Cell Therapy
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October 7th, 2012
California initiative to test appetite for ‘genetically engineered’ food – CTV News
By Dr. Matthew Watson
 MiamiHerald.com | California initiative to test appetite for 'genetically engineered' food CTV News How about "produced with genetic engineering?" California voters will soon decide whether to require certain raw and processed foods to carry such a label. In a closely watched test of consumers' appetite for genetically modified foods, the special ... Genetically modified food debate muted in generally accepting science communityContra Costa Times Prop 37: California Soil Scientist Says Label Up!Huffington Post Proposition 37: In some circles, GMO stands for "God Moves Over"San Jose Mercury News ForUm -AllAfrica.com all 263 news articles » |
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October 7th, 2012
Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy
By Dr. Matthew Watson
SAN DIEGO--(BUSINESS WIRE)--
Cytori Therapeutics (CYTX) announced that three oral presentations related to its cell therapy are being presented today at the 10th annual International Federation for Adipose Therapeutics and Sciences meeting. The findings provide insights into the mechanisms-of-action for Cytoris cell therapy. One study identified high levels of micro-RNA (miRNA) markers in human tissue thought to play a role in the repair of tissue injury resulting from ischemia, or lack of blood flow. Two additional characterization and comparative analysis studies on human tissue reaffirmed cellular characteristics of Cytoris cell therapy and distinguished the safety, viability and cell make-up as compared to cell outputs derived from alternate approaches.
Results from all three studies have important implications for how the cells repair injured tissue and on the safety and viability of cell-based treatments derived from adipose tissue, said John Fraser, Ph.D., Chief Scientist of Cytori Therapeutics. Mechanisms identified in our miRNA analysis are consistent with our prior clinical and preclinical data, which suggest these mechanisms include angiogenesis, immune-modulation, and remodeling and wound repair. The miRNA study provides baseline data, which we can apply to our U.S. ATHENA clinical trial in refractory heart failure patients and other activities including our recently announced contract with BARDA for thermal burns.
In one study, miRNA profiles were assessed in adipose-derived stem and regenerative cells (ADRCs) derived from human tissue samples. The purpose was to determine which miRNA markers are expressed, miRNA variability from patient to patient, cellular functions of miRNA, and to establish a baseline miRNA population on healthy patients to compare against patients with a specific disease. Specifically, miRNA markers associated with angiogenesis, tissue remodeling and wound repair, and modulation of the immune response were found to be highly represented in ADRCs.
Our two additional characterization and comparative analysis studies evaluated alternate processing techniques and reaffirmed our proprietary enzyme-based process using Celution is the clear gold standard, added Dr. Fraser. If the composition of a cell population extracted from adipose tissue by an alternative process is not equivalent to Cytoris ADRC population, one cannot claim equivalence to ADRCs in terms of safety or efficacy in preclinical or clinical outcomes.
The characterization and comparative analysis studies reaffirmed the high cell yield and viability as well as the heterogeneity in Cytoris cell therapy approach. Cytoris cells are derived with a proprietary formulation of clinical grade enzymes which break up the connective tissue and which are removed at the end of the process. Cytoris cell mixture includes adipose-derived stem cells, based on the measure of colony forming units, and a high yield of CD34+ cells. By contrast, data in these studies showed that alternate approaches such as ultrasound or emulsification, contained little to no adipose-derived stem cells, a high concentration of red and white blood cells, and did not meet the key criteria for safe clinical use.
About Cytori
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution system product family. http://www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements including our ability to apply this data to our ATHENA study and other projects are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.
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Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy
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October 5th, 2012
FDA Approves Stemedica Phase II Clinical Trial For Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem …
By Dr. Matthew Watson
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of Stemedyne-MSC (Stemedicas human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct.
San Diego, CA (PRWEB) October 02, 2012
The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the Untied States annually; another 800,000 have the procedures each year in Europe.
Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDA-approved study. Dr. Nib commented, We've learned from bench top research that not all stem cells are created equally. We believe that the ischemic tolerance of Stemedica's MSCs and the robustness of their protein array will translate into significant patient benefits post myocardial infarction.
Stemedicas interest in this indication was triggered by a successful randomized study in acute myocardial infarction conducted by the National Scientific Medical Center (NSMC) in Astana, Kazakhstan using Stemedyne-MSCs. The study was conducted under clinical protocol and in compliance with the ICH-E6 (Good Clinical Practice) guidelines and local laws. All patients signed an informed consent. Nineteen (19) patients in this study received Stemedyne-MSCs after PTCA and stenting. Administration of Stemedyne-MSC resulted in a statistically-significant decrease in inflammation as judged by the level of C-reactive protein, significant decrease in end-systolic and end-diastolic volume of left ventricle, as well as significant increase in the left ventricular ejection fraction (LVEF) from 38.4% to 54.7% at 6 months post administration, bringing this parameter to a normal range for healthy individuals (50-65%).
Professor Daniyar Jumaniyazov, M.D. Ph.D., principal investigator of the NSMC study commented, The stem cell transplantation was safe and the procedure was well tolerated. No product-related adverse events were reported. Treatment of patients in this study resulted in improvement of overall and local contractive myocardium functions and also normalization of systolic and diastolic filling of the left ventricle as compared to the control group. Based upon the safety and efficacy results, we will soon conduct a Phase III myocardial infarct clinical trial at the NSMC with Stemedicas ischemia tolerant mesenchymal stem cells.
Lev Verkh, Ph.D., Stemedica Chief Regulatory and Clinical Development Officer commented, Stemedicas FDA submission included data from the NSMC clinical trial, the results of which were also reported at the annual American College of Cardiology meeting in April, 2012. These results contrasted with reports, at the same conference, of minimal improvement in studies with autologous stem cells. In addition to the United States sites, the study will be duplicated at leading hospitals in Europe, Asia and the Middle East. With regard to the spectrum of stem cell treatment for cardiovascular disease, Dr. Verkh noted that, Stemedyne-MSC has been approved for the treatment of chronic heart failure at Hospital Angeles, Tijuana, Mexico by COFEPRIS (the Mexican equivalent of the FDA).
Jackie See, M.D., F.A.C.C., founder of interventional cardiology at the University of California, Irvine, noted, "In the days and weeks following a myocardial infarction we may have the ability to intervene with stem cells to minimize scarring, enhance the amount of functional heart tissue, and restore the microcirculation. Stemedica's ischemia tolerant mesenchymal stem cells are ideal for this purpose. I can foresee the day when all coronary stenting is accompanied by stem cell injection. It is not unreasonable to postulate that the anti-inflammatory and anti-fibrotic effects of the mesenchymal stem cells may have an impact on the incidence of restenosis, a common condition caused by blockage of the stents.
The Stemedyne-MSC product is uniquely manufactured to contain increased amounts of the important growth factors that combat ischemic damage. According to Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica, Our ischemia tolerant MSCs secrete increased amounts of vascular endothelial growth factor (VEGF), which is necessary for new blood vessel development and stromal cell-derived factor (SDF), which is responsible for rescuing dying cells. Stemedyne-MSCs also demonstrate significantly higher migratory abilities. As a company we are unique in our unparalleled scalability, with our master bank at two passages and the cells that go into patients having only been expanded four times. We have the ability to treat more than 500,000 patients with cells created from a single organ donation.
Stemedyne-MSC is one of the three adult allogeneic stem cell products developed by the Company. Other products include Stemedyne-NSC neural human stem cells and Stemedyne-RPE, retinal progenitor epithelial cells available in early 2013. All Stemedica products are unique in their ability to tolerate ischemic conditions.
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FDA Approves Stemedica Phase II Clinical Trial For Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem ...
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October 2nd, 2012
Histogenics Honored as a 2012 “Fierce 15” Company by FierceMedicalDevices
By Dr. Matthew Watson
WALTHAM, Mass.--(BUSINESS WIRE)--
Histogenics, a regenerative medicine company combining cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration, announced today that it has been named to the FierceMedicalDevices Fierce 15 list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevicesEditors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this years winners based on their top management teams, notable financial backing, and promising technologies and market opportunities.
We have worked hard over the past year, securing $49 million in financing and adding key new staff, investors and board members, so that we are now in the position to focus our full attention on continued successful clinical and regulatory execution for NeoCart cartilage regeneration implant, which is currently enrolling patients into the Phase 3 IND clinical study, and the EU regulatory development of our VeriCart cartilage repair scaffold, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. We believe our product candidates have the potential to transform the treatment of cartilage injury with the goal of returning some of the estimated 1.8 million patients each year in the U.S. and E.U. that undergo arthroscopy for knee cartilage defects to their pre-injury level of activity.
Nailing down $49 million in financing in July reinforces the notion that this regenerative medicine company stands out for doing things differently.One example how: The company is well underway enrolling patients in a Phase 3 trial for NeoCart, a cartilage implant that uses a patients own cells to build it before treating cartilage lesions in the knee, said Hollmer.
NeoCart is an autologous neocartilage tissue implant in an ongoing Phase 3 clinical program that utilizes the patients own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee.VeriCart, is a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patients own stem cells to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Histogenics is seeking regulatory clearance in the European Union for VeriCart.
An internationally recognized e-newsletter reaching more than 34,000 medical device and diagnostic industry professionals, FierceMedicalDevices provides subscribers with a quick authoritative briefing on the days top stories, with a special focus on clinical studies, FDA/EMEA regulations and post-marketing. Sign up is free at http://www.fiercemedicaldevices.com/signup.
About FierceMarkets
FierceMarkets, a wholly owned subsidiary of Questex Media Group, is a leader in B2B emedia, providing information and marketing services in the telecommunications, life sciences, healthcare, IT, energy, government and finance industries through its portfolio of email newsletters, websites, webinars and live events. Every business day, FierceMarkets wide array of publications reaches more than 1.3 million executives in more than 100 countries.
About Histogenics
Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.
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Histogenics Honored as a 2012 “Fierce 15” Company by FierceMedicalDevices
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October 2nd, 2012
Translational Regenerative Medicine: Market Prospects 2012-2022
By Dr. Matthew Watson
NEW YORK, Oct. 1, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Translational Regenerative Medicine: Market Prospects 2012-2022
Report Details
New study shows you commercial potential of regenerative treatments
See what the future holds for translational regenerative medicine. Visiongain's updated report lets you assess forecasted sales at overall world market, submarket, product and regional level to 2022.
There you investigate the most lucrative areas in that research field, industry and market. Discover prospects for tissue-engineered products, stem cell treatments and gene therapy.
We pack our study with information and analysis to help your work and save you time:
Access to present and predicted trends, with commercial opportunities and prospects revealed
Data and discussions - including our revenue forecasts to 2022 - for your research, analyses and decision making
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Translational Regenerative Medicine: Market Prospects 2012-2022
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October 2nd, 2012
Celprogen Obtained US Patent (US8,236,297B2) Method of Treating Lactose Intolerance Utilizing Genetically Engineered …
By Dr. Matthew Watson
LOS ANGELES--(BUSINESS WIRE)--
Celprogen Inc., a leader in the Stem Cell Research and Therapeutics industry for the development of stem cell technologies for regenerative medicine, today announced that they obtained a Patent for Treating Lactose Intolerance Utilizing Genetically Engineered Bacteria US8,236,297B2. Acquired lactase deficiency is the most common disorder of complex carbohydrate absorption throughout the world, affecting 75% of world population. In the United States 15% of Caucasians, over 50% of Hispanics and over 80% of African-Americans suffer from lactose intolerance.
The present invention relates to genetically engineered bacteria that are able to colonize the mammalian intestine and actively produce mammalian lactase. This lactose-digesting enzyme is stable and active under the conditions normally found in the mammalian small intestine. Experimental subjects colonized with the genetically engineered bacteria show improved ability to digest lactose in dairy foods.
About Celprogen Inc.
Celprogen Inc. is a global Stem Cell Research & Therapeutics company which is developing a proprietary portfolio of unique therapeutics products and life science research tools that includes genetic engineering technologies, stem cell technologies for regenerative medicine, as well as bio-engineering products for tissue & organ transplants. Headquartered in San Pedro, California, Celprogen is committed to the research, development, and manufacture of quality Stem Cell, Cancer Stem Cell and Primary Cell Culture products to serve our global community. Additional information about Celprogen is available at http://www.celprogen.com.
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September 30th, 2012
‘Enrolments for biotechnology will see a rise in three years’ – The Hindu
By Dr. Matthew Watson
 The Hindu | 'Enrolments for biotechnology will see a rise in three years' The Hindu Biotechnology education in the State is undergoing course correction and will get its shine back in a couple of years, chairperson, Karnataka Vision Group on Biotechnology, Kiran Mazumdar-Shaw, said in Bangalore on Tuesday. There was a temporary dip in ... Biotech courses in Bangalore not industry ready: Kiran Mazumdar-ShawDaily News & Analysis |
Source:
http://news.google.com/news?q=biotechnology&output=rss
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September 30th, 2012
The 48th Nobel Conference: Our Global Ocean – Gustavus Adolphus College News (blog)
By Dr. Matthew Watson
 Gustavus Adolphus College News (blog) | The 48th Nobel Conference: Our Global Ocean Gustavus Adolphus College News (blog) Next week, distinguished scholars and researchers in the fields of biogeochemistry, oceanography, deep-sea biology, molecular genetics, and coral ecology will travel to Gustavus Adolphus College to take part in the 48th annual Nobel Conference, titled ... |
Source:
http://news.google.com/news?q=molecular-genetics&output=rss
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September 30th, 2012
Anticipated short-term cell therapy industry clinical milestones
By Dr. Matthew Watson
There are other commercial milestones we are monitoring as well as other clinical milestones we expect to see related to cell therapy products in earlier stages of the development pipeline that are not included below.
CellCoTec (http://www.cellcotec.com)
- Having completed a trial in Europe of their device to enable POC production of an autologous chondrocyte cellular product in/with a biodegradable, load-bearing scaffold for the treatment of articular cartilage defects, they have now submitted their CE market application. The CE mark application is under review and they anticipate a response in October.
- This device and the potential emergence of Sanofi's MACI in the European market next year may have an impact on Tigenix (EBR:TIG) most directly.
ERYtech Parma (http://www.erytech.com)
- Their 'pivotal' phase 2/3 trial in Europe of lead product, GRASPA, for the treatment of Acute Lymphoblastic Leukemia (ALL) is scheduled for completion 2H 2012.
GamidaCell (http://www.gamidacell.com)
- Their 'pivotal' phase 2/3 trial in the US, Israel, and Europe of lead product, StemEx, for the treatment of leukemia and lymphoma, in joint development with Teva, completed enrollment in February and is scheduled for completion 2H 2012. They have not been shy about the fact they expect to be in the market in 2013.
Innovacell (http://www.innovacell.com)
- They raised over 8m Euro in April for a phase 3 trial in Europe for their lead product, ICES13, for the treatment of stress-urinary incontinence which was scheduled for a preliminary clinical data readout in Q4 2012 and be ready for market authorization in 2013. Since announcing the capital raise the company has been stone silent and no clinical trial registry has been filed. Status unknown.
Miltenyi Biotec (www.miltenyibiotec.com)
- Their phase 3 trial in Germany of CD133+ cells as an adjunct to CABG surgery for myocardial ischemia or coronary artery disease is scheduled for completion in January.
NovaRx (http://www.novarx.com)
- Their phase 3 trial in US, Europe, and India of their lead product, Lucanix, for the treatment of advanced Non-small Cell Lung Cancer (NSCLC) following front-line chemotherapy is scheduled in clnicaltrials.gov for completion in October but we have learned they expect their next 'interim analysis' in February.
NuVasive (http://www.nuvasive.com)
- They have a series of trials scheduled to complete 2H 2012 intended to provide additional clinical data to support its marketing of Osteocel Plus for the treatment of a growing number of orthopedic applications.
Sanofi's Genzyme (http://www.genzyme.com)
- Having completed their phase 3 trial in Europe of MACI for knee repair (symptomatic articular cartilage defects of the femoral condyle including the trochlea), they expect to file their market authorization application (MAA) in 1H 2013.
Hope that's helpful and gives you a sense some of the late-stage things to watch for in the coming weeks and months.
--Lee
Regenerative Medicine
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September 30th, 2012
The cost of clinical trial data bias/loss, FDA’s new job and the need for bold leadership.
By Dr. Matthew Watson
The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.
Before you right this post off as the stuff of conspiracy theories, fear-mongering, and 'alternative world views' consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.
Here's the underlying premise as succinctly described by author Ben Goldacre:
"Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.
When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."
Authors M. Todwin and J. Abramson summarize it thusly:
"Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge."
Here is a great list of very recent resources that may convince you of the merits of this concern:
- What doctors don't know about the drugs they prescribe (2012: TED video)
- The drugs don't work: a modern medical scandal (2012: The Guardian)
- Clinical Trial Data as a Public Good (2012: JAMA [subscription req'd])
- Registering Clinical Trial Results. The Next Step (2010: JAMA [subscription req'd])
- The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience (2012: Plos Medicine)
Regenerative Medicine
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September 30th, 2012
Fortune Magazine on California Stem Cell Agency: Warm, Personal and Favorable
By Dr. Matthew Watson
California's $3 billion stem cell
research effort today garnered a handsome dollop of favorable
national news coverage– a lengthy piece in Fortune magazine that
spoke of looming stem cell cures and the leading role of the state
stem cell agency.
likely will be read by tens of thousands of persons, although it was not the cover story on the print product.
the magazine, Jeffrey O'Brien of Mill Valley, Ca., the piece was warm
and personal. He began with the story of his 95-year-old
grandmother and her health issues, ranging from arthritis to macular
degeneration. And he wrote,
“The citizens of California have
spoken. If my grandmother and I had the power to get the rest of the
country to follow, we would.”
finances of the stem cell business. He said,
“To be clear, the earliest stem cell
therapies are almost certainly years from distribution. But so much
progress has been made at venerable research institutions that it now
seems possible to honestly discuss the possibility of a new medical
paradigm emerging within a generation. Working primarily with rodents
in preclinical trials, MDs and Ph.D.s are making the paralyzed walk
and the impotent virile. A stem cell therapy for two types of macular
degeneration recently restored the vision of two women. Once they
were blind. Now they see!“Some experts assert that AMD could
be eradicated within a decade. Other scientists are heralding a
drug-free fix for HIV/AIDS. Various forms of cancer, Parkinson's,
diabetes, heart disease, stroke, and ALS have already been eradicated
in mice. If such work translates to humans, it will represent the
type of platform advancement that comes along in medicine only once
in a lifetime or two. The effect on the economy would be substantial.
Champions of stem cell research say it would be on the order of the
Internet or even the transistor.”
“The obstacles along the road from
lab rat to human patients are many, of course, but the biggest by far
is money. With the dramatic events in the lab, you might think that a
gold rush would be under way. That's far from true. Long time
horizons, regulatory hurdles, huge R&D costs, public sentiment,
and political headwinds have all scared financiers. Wall Street isn't
interested in financing this particular dream. Most stem cell
companies that have dared go public are trading down 90% or more from
their IPOs. Sand Hill Road is AWOL. The National Venture Capital
Association doesn't even have a category to track stem cell
investments.”
itself, the article contained remarks from its Chairman J.T.Thomas,
President Alan Trounson and former chairman Robert Klein about the origins and progress of the California Institute for Regenerative Medicine (CIRM).
“The $1.7 billion awarded so far has made one obvious mark on the state: a dozen gleaming research institutions. CIRM has proved adept at getting billionaires to donate funds to the cause.”
prominent businessmen who have contributed tens of millions of
dollars to stem cell research “about the prospects of a legitimate industry emerging.” One was “bond genius” Bill Gross, who has
contributed to UC Irvine. Gross replied.
“Goodness, you're talking to the
wrong guy. Our donation had nothing to do with business.”
said pretty much the same thing. And Andy Grove, the former chairman
of Intel, was “surprisingly full of doom and gloom.” O'Brien
wrote,
“For close to two hours, Grove argues
passionately about how the FDA is enabling predatory offshore
industries by impeding progress and the many reasons financiers want
no part of stem cells. "VCs aren't interested because it's a
shitty business," he says. Big Pharma? Forget it. CIRM? "There
are gleaming fucking buildings everywhere. That wasn't necessary."
When I press him to be constructive, he wearily offers one possible
solution. Rather than courting billionaires to put their names on
buildings, we need a system of targeted philanthropy in which the 99%
can sponsor the individual stem cell lines that matter to them.”
“It was clear during our talk that
Grove wants an economic model for stem cell research and development
to emerge, even if he's not willing to bet money on its happening.
And that puts him in good company.”
negative points about stem cell research, it is about as laudatory as
it is going to get at this point for the California stem cell agency.
The piece recognizes and even celebrates much of the work of the
agency. The article clearly details the void in financing
for commercialization of stem cell research, bolstering support for
efforts like those in California. Importantly, it also helps to push
the activities of the stem cell agency more fully into the national
discussion of stem cell research and its future. That should pay off
again and again in future news coverage and also benefit the stem
cell agency as it explores the possibility of additional funding –
either private or public – after the cash for new awards runs out
in 2017.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Stem Cell Therapy
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September 30th, 2012
$700,000 Blue-ribbon Study of CIRM All But Finished
By Dr. Matthew Watson
The $700,000 study of the $3 billion
California stem cell agency is nearly concluded and is expected to be
released sometime in November.
for “peer review” and no additional public meetings are
scheduled, according to a spokeswoman for the Institute of
Medicine(IOM), which is conducting the study. The IOM did not respond
to questions from the California Stem Cell Report about the number of peer reviewers or how they were selected.
part, because agency directors hoped the findings by the blue-ribbon
panel would bolster efforts to win voter approval of another multi-billion dollar state bond issue. More recently the agency has
explored the possibility of private financing to continue operations.
funds for new awards in 2017. It currently has something in the
neighborhood of $700 million for awards that is not already committed
in one fashion or another.
relations officer for the IOM, said in an email,
“There will be no
further information-gathering meetings. The committee members have
finished drafting their report and it is now undergoing peer review.
Reviewers are anonymous to study staff and committee members; they
will be listed in the front matter of the report when it’s finished
and released.”
cell agency will not be given an opportunity to comment further.
Stencel said,
“Sponsors are not
treated as peer reviewers; that is, they’re not afforded an
opportunity to comment on IOM draft reports prior to public release.
IOM is aiming for a public release in November (the exact time frame
will hinge on the duration of the peer review, which is influenced by
people’s schedules and adherence to deadlines). IOM is looking at
options for how best to hold this release, whether there will be an
event of some sort. Once plans are set, they’ll be noted on the
project web pages and IOM will alert the various stakeholders and
interested parties of the plans. The study is moving along and we’re
looking forward to the report’s debut in the not too distant
future.”
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Stem Cell Therapy
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September 30th, 2012
October CIRM Board Meeting Moved to Burlingame
By Dr. Matthew Watson
The location of the October meeting of
the governing board of the California stem cell agency has been
changed from Irvine to Burlingame, near San Francisco International
Airport, in an effort to save travel costs.
one-day meeting is being moved because the session will require the
attendance of a large number of CIRM staffers who are based in the
agency's San Francisco headquarters. They will be involved in
presentations involving the agency's new strategic partnership fund and other matters.
unchanged – Oct. 25. Look for posting of the agenda on the CIRM web
site on Oct. 15. The site of the meeting is the Hilton Bayfront
Hotel, 600 Airport Blvd.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Stem Cell Therapy
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September 30th, 2012