Former FDA Commissioner Offers Path Toward a 21st-Century FDA

Former commissioner of the Food and Drug Administration Andrew von Eschenbach (2005-2009) recently wrote an op-ed article for the Wall Street Journal outlining actions which he believes will strengthen the FDA and make a more efficient path for approval of new biopharmaceutical drugs and treatments.  

In this article Eschenbach, currently the chairman of the Manhattan Institute's Project FDA, points to a lack of sufficient funding of the FDA which he claims made it difficult for the agency to procure "scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pathways for state-of-the-art therapies that defy current agency conventions." These deficits, he argues, has halted the approval of treatments as the FDA scrambled to keep up with new science and techniques.  

He opined,

"The FDA isn't obstructing progress because its employees are mean-spirited or foolish. But for decades, Congress has starved the agency of critical funding, limiting its scientists' ability to keep up with peers in private industry and academia. The result is an agency in which science-based regulation often lags far behind scientific discovery. This forces the FDA to slow the approval of new treatments—and at times creates acrimonious litigation between the FDA and innovators, not to mention disillusionment among desperate patients."

To alleviate this problem, Eschenbach calls for increased funding of the FDA as well as greater collaboration between this agency and other leaders in the field, such as physicians and companies currently developing new technologies and techniques.  By working in tandem, Eschenbach feels the FDA would establish greater understanding of new science and be in a better position to more efficiently and accurately evaluate breakthroughs.    

Read the full article here.  

NeoStem Study indicates Bone Marrow Stem Cells May Preserve Heart Tissue After Heart Attack ($NBS)

NeoStem (NYSE Amex: NBS) is a leader in the development and manufacture of cellular therapies. NeoStem has a  strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. NeoStem endeavors to be an integrative force in the cell therapy industry. By vertically integrating the collection, storage and processing of cell units and the development, manufacturing, distribution, and delivery of cell therapy products, they are positioned to take advantage of growth in the cell therapy industry as a whole.

Results from the The PreSERVE-AMI Study, sponsored by Amorcyte, LLC, a NeoStem, Inc. company, indicate that stem cells retrieved pelvic bone marrow restore tissue and improve heart function in heart attack patients.  The study evaluated the safety and efficacy of stem cell treatments and focused on patients who had received a stent to open the blocked artery and heart attack injuries caused by a prolonged period of blocked blood supply.  The NeoStem company Progenitor Cell Therapy also assisted this study by processing stem cells in preparation for infusion.  

Vijaykumar S. Kasi, MD, PhD, principal investigator for the clinical trial at Orlando Regional Medical Center, commented,

"Severe heart failure, often the end result of large or multiple heart attacks, is a major health care challenge, impacting more than five million people in the United States and costing more than $35 billion annually. Stem cell therapy is part of the movement from treatment to cure and has the potential to overcome limitations and expenses of heart transplants and offers hope for patients who are desperately praying for another chance at life."

Read the full article here.  

Pluristem Receives U.S. FDA Clearance for Phase II Clinical Trial in Intermitten Claudication ($PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory 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 or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

Pluristem Theapeutics announced that the FDA has approved the commencement of Phase II clinical trials of PLX-PAD cell product candidate for the treatment of a form of peripheral artery disease, Intermittent Claudication (IC).  This trial will investigate the safety and effectiveness of of PLX-PAD cells versus placebo.  

Zami Aberman, Chairman and CEO of Pluristem, commented,

"We are excited to receive the world's FDA first clearance for an Intermittent Claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for IC. We believe that our approach of repeatable intramuscular injections will potentially enable us to boost the healing process of our patients. In this trial, we will take benefit of our 'off-the-shelf' PLX properties achieved by our three dimensional (3D) proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of IC patients around the world."

Read the full press release here.  

Access Pharma ($ACCP) announces interim data from MuGard: Phase 4 clinical trial in oral mucositis

MuGard Interim Analysis Demonstrates Statistically Significant Reduction in Pain Associated With Oral Mucositis and Reduction in the Use of Opioid Pain Medication

Access Pharmaceuticals (OTCBB: ACCP) announced interim results from its ongoing MuGard Phase 4 clinical trial in oral mucositis. An interim analysis from the first forty (40) patients enrolled in the trial showed that patients using MuGard experienced a statistically significant reduction in mouth and throat soreness and a reduction in the use of opioid pain medication compared to patients in the control arm. Other highlights from today's press release:

Click to read more ...

Athersys ($ATHX): Another Patent, GvHD

Athersys has obtained a U.S patent for its MultiStem technology, a stem cell treatment for graft-versus-host disease that employs cells from adult bone marrow and other nonembryonic sources. The product has shown the ability to limit inflammation, protect impaired tissue and aid in the formation of new blood vessels.

See the full press release.

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Advanced Cell Technology (ACTC): Second Patient in Dry AMD

Advanced Cell Technology (OTCBB: ACTC) announced that the second patient was dosed in the company’s Phase I/II trial for dry age-related macular degeneration using retinal pigment epithelial cells derived from human embryonic stem cells.

The patient is recovering uneventfully.

See the full press release.

Daily Dose Conclusion: AMD is a big market and dry AMD is an un-met medical need. Should these patients start to have vision improvement the sky's the limit.

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Prima BioMed Ltd to Ring The NASDAQ Stock Market Opening Bell to Celebrate Listing on The NASDAQ Stock Market

Prima BioMed Ltd, a world leader in cancer immunotherapies, will visit the NASDAQ MarketSite in Times Square to celebrate its listing on The NASDAQ Stock Market. Prima BioMed Ltd. begins trading on NASDAQ today, April 16, 2012.

Prima's listing on NASDAQ comes at a significant point in the development timeline for CVac(TM) ovarian cancer vaccine. The timing should offer U.S, investors an opportunity to share in this growth phase of the Company.

In honor of the occasion, Martin Rogers, CEO will ring the Opening Bell.

Where:

NASDAQ MarketSite -- 4 Times Square -- 43^rd & Broadway -- Broadcast Studio

When:

Monday, April 16, 2012 -- 9:15 a.m. to 9:30 a.m. ET

Contact:

Ian Bangs
+61 9276 1250
Ian.bangs@primabiomed.com.au

NASDAQ MarketSite:

Jen Knapp
(212) 401-8916
Jennifer.knapp@nasdaqomx.com

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For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies please visit our Facebook page at:
http://www.facebook.com/#!/NASDAQ.

For news tweets, please visit NASDAQ Twitter page at:
http://twitter.com/nasdaqomx

Webcast:

A live webcast of the NASDAQ Opening Bell will be available at:
http://www.nasdaq.com/about/marketsitetowervideo.asx.

Photos:

To obtain a hi-resolution photograph of the Market Open, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market open of your choice.

About Prima BioMed Ltd:

Prima BioMed is an ASX and NASDAQ listed Australian health care company. The Company is focused on technologies in the fields of cancer immunotherapy and immunology.

Prima's lead product is the CVac^TM ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally.

The Company's broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.

Texas Discusses Changes in Stem-Cell Rules

The Texas Medical Board is contemplating changes to existing rules and allow doctors to bypass federal approval when offering experimental adult stem cell treatments.  Govenor Rick Perry has urged the Board to draft new rules regarding stem cell treatements following his own successful treatment of a back injury which utilized his own stem cells.

The changes in the rules will apply to only adult stem-cell treatments (not to embryonic stem cells treatments which have proven to be politically controversial), which involve removing a patient's own stem cells and reinjecting them at sites of damaged tissue.  Such treatments are could be used in cancer, osteoarthritis or multiple sclerosis patients.  These new relaxed guidelines would allow doctors more freedom in offering these treatments as well as testing newer treatments.

Wall Street Journal contributor, Nathan Koppel, commented,

"One obstacle to doctors has been the Food and Drug Administration, which requires physicians to seek the agency's approval before offering experimental, adult stem-cell treatments. Doctors complain the FDA approval process can be costly and time-consuming...

The proposed Texas rules would allow doctors to bypass the FDA so long as they satisfy other conditions before offering certain experimental adult stem-cell treatments, including obtaining patient consent and securing approval from a so-called independent review board, a committee that monitors medical research and is often affiliated with a hospital or university."

Critics, however, offer that the language of these new rules open the door to untested, unproven, or unsafe experimental treaments and do not place large enough emphasis on consumer safety.  

Read the full article here.