Biotech Advancements Coupled with Collaborative Partnerships Focus on Developing Orphan Drug Products & Treatments for Critical-Care Patients With Severe Wound Conditions

Aug 03, 2015, 08:56 ET from FN Media Group LLC

CORAL SPRINGS, Florida, August 3, 2015 /PRNewswire/ --

Cooperative research and development agreements between biotech companies, military surgical research and top-tier universities for identifying biotech solutions & therapies with regards to severe wound treatments for critical-care patients lead to positive clinical enhancements for regenerative medicine and tissue-engineered skin substitute advancements.  Biotech companies with recent developments, partnerships and advancements in focus are Amarantus Bioscience Holdings, Inc. (OTCQX: AMBS), Osiris Therapeutics, Inc. (NASDAQ: OSIR), Ocata Therapeutics, Inc. (NASDAQ: OCAT), Oragenics, Inc. (NYSE: OGEN) and ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)

Amarantus Bioscience Holdings, Inc. (OTCQX: AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced the signing of a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR) and Rutgers, The State University of New Jersey (Rutgers University) to expand the development of Amarantus' autologous full thickness skin replacement product, Engineered Skin Substitute (ESS), for the treatment of deep partial- and full-thickness burn wounds in adult patients.  "This CRADA represents an important partnership for Amarantus as we work with the USAISR and Rutgers to advance the clinical program for ESS," said Gerald E. Commissiong, President & CEO of Amarantus. "The study is designed to evaluate patient response to ESS as compared to meshed split-thickness autograft (AG). We believe the autologous dermal and epidermal cell matrix from ESS has the potential to provide a more effective direct permanent restoration of structure and function of full thickness skin with minimal scarring."

Read the full AMBS Press Release at http://www.financialnewsmedia.com/profiles/ambs.html

Amarantus is developing ESS for the treatment of severe burns and is preparing to commence Phase 2 clinical studies in the third quarter of 2015. ESS has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hospitalized patients with deep partial and full thickness burns requiring grafting, and has an open corporate-sponsored IND under which the clinical study can proceed.  Rick Jocz, Program Manager, Research Directorate, at USAISR, commented, "The U.S. Army is working to address the need for more effective treatments for severe burns. We expect this partnership with Amarantus and Rutgers to enhance our capabilities given that ESS has the potential to provide meaningful reduction in morbidity after life-threatening burns by decreasing the need for skin grafts following wound closure."

The USAISR's mission is to provide combat casualty care medical solutions and products for injured soldiers, from self-aid through definitive care across the full spectrum of military operations; provide state-of-the-art trauma, burn, and critical care to Department of Defense beneficiaries and civilians; and provide Burn Special Medical Augmentation Response Teams.  Read more at http://usaisr.amedd.army.mil/beta/

In other regenerative medicine and biopharmaceutical news and developments of interest:  Osiris Therapeutics, Inc. (NASDAQ: OSIR) researches, develops, manufactures, markets, and distributes regenerative medicine products in the United States. Its products include Grafix, a cryopreserved placental membrane for treating hard-to-treat acute and chronic wounds, venous leg ulcers, and burns.  According to recent Zacks Rating Report, OSIR remains a strong buy in the latest set of rankings. The shares have received an average rating of 1 by 2 analysts. Research Analysts at Zacks has the shares a rating of 3, which implies that the firms recommendation is Neutral on the company.

Ocata Therapeutics, Inc. (NASDAQ: OCAT), a leader in the field of Regenerative Ophthalmology™, announced this month that it continues to fortify the patent protection covering its retinal pigment epithelium (RPE) transplant technology for macular degeneration with the issuance by the United States Patent and Trademark Office (USPTO) of U.S. Patent No 9,080,150.  "The issuance of this 9th U.S. patent in our global RPE portfolio represents yet another example of the leadership position we have established as pioneers in Regenerative Ophthalmology," said Paul K. Wotton, Ph.D., President and Chief Executive Officer. "In particular, this new patent provides coverage for the manufacture of all RPE products from any pluripotent source by defining the basic universal markers of RPE essential for therapeutic use. We have recently received patent protection for the manufacture of human RPE cell products from pluripotent stem cell sources, including manufacture of formulation forms for use as therapeutic agents as well as the use of these RPE formulations for treating degenerative ophthalmic diseases, such as dry age-related macular degeneration (dry AMD) and Stargardt's macular degeneration (SMD)."

Oragenics, Inc. (NYSE: OGEN) and Intrexon Corporation (NYSE: XON), a leader in synthetic biology, announced positive data on multiple compounds from Oragenics' Mutacin 1140 ("MU1140") lantibiotic platform in a critical animal model study, as well as the selection of a lead clinical candidate. The compounds were subjected to a standardized "proof of concept" animal model evaluating efficacy for reducing clinically relevant C. difficile infection(s) and increased survival relative to vancomycin positive control.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced last week that it will receive $100 million in cash - $50 million upon deal execution late yesterday and an additional $50 million in one year - through a synthetic-royalty financing from PDL BioPharma, Inc. (PDLI) in exchange for paying PDL a mid-single-digit royalty on future sales of Iclusig® (ponatinib) until PDL receives a fixed internal rate of return (IRR). ARIAD also has an option, in its discretion, to receive up to an additional $100 million at any time between 6 and 12 months from the date of the agreement, in one or two tranches on comparable terms.

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