Department of Defense Provides Funding to Lonza to Move Therapeutic Candidate PermaDerm™ into the First Clinical Trials for Adults
NEW YORK, Nov. 22, 2010 /PRNewswire-FirstCall/ -- The U.S. Department of Defense recently awarded more than $18 million in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm™ for the treatment of severe burns among U.S. troops and civilians. The funding was announced at a conference celebrating advancements in regenerative medicine on November 9th in Walkersville, MD.
Regenicin, Inc. (OTC Bulletin Board: RGIN), has an agreement with Lonza pursuant to which Regenicin has been charged to obtain FDA approval for the commercial sale of PermaDerm. The funding will assist Regenicin and Lonza in advancing the clinical trials to be conducted in connection with the FDA approval process. Regenicin was a presenter at the conference at which the funding was awarded.
PermaDerm™, an engineered skin substitute grown from a patient's own skin cells, has already been used to treat more than 150 pediatric, catastrophic burn victims through an Investigation Device Exemption issued by U.S. Food and Drug Administration (FDA). This is PermaDerm's first clinical trial to be conducted on adults, a major milestone for achieving pre-market approval by the FDA.
The initial trial will contain 10 patients, both male and female, between the ages of 18 and 40, who suffer third-degree burns. These trials and future trials will take place at the United States Army Institute of Surgical Research at Fort Sam Houston and at a second site to be determined.
Regenicin, Inc. (OTC Bulletin Board: RGIN), is a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs. Regenicin, which was founded in 2010, has assembled a world class management team with a proven track record for developing and bringing innovative medical devices and biotechnology products to market. Regenicin is playing a critical role in the development of the therapeutic candidate, PermaDerm™, an exciting breakthrough technology that uses the patient's own skin cells to generate living, tissue-engineered skin for the treatment of chronic burns. The company is publicly traded with headquarters in New York City.
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SOURCE: Regenicin(TM), Inc.