Healthcare Industry News:  skin cancer 

Biopharmaceuticals Dermatology FDA

 News Release - September 5, 2007

Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients

FREEPORT, N.Y., Sept. 5 (HSMN NewsFeed) -- AGI Dermatics, the bio- pharmaceutical laboratory that pioneered DNA research for skincare, announced today that U.S. Food & Drug Administration (FDA) has granted Fast Track designation for Dimericine (T4N5) for treatment of solar and ultraviolet photosensitivity in patients with Xeroderma Pigmentosum (XP). Dimericine, also known as T4N5 Liposome Lotion, is a topical drug developed by AGI currently in clinical trials for treating XP patients with skin cancers and pre-cancers.

"Dimericine is the result of decades of research into DNA repair and its potential to prevent skin cancer and photodamage caused by UV radiation," said Daniel Yarosh, Ph.D., President and CEO of AGI Dermatics. "We are optimistic that this Fast Track designation will accelerate our efforts to bring to market a treatment option for the thousands of people who suffer from the life-threatening disease XP."

Xeroderma pigmentosum, or XP, is a rare genetic disorder that blocks the body's natural ability to repair DNA damage caused by ultraviolet (UV) light. Minimal exposure to UV light in XP patients results in persistent DNA damage and causes severe sunburn, blistering, irregular dark spots and a 1000-fold increased risk of skin cancer. People with severe XP often need to avoid sunlight completely. Half of these patients develop skin cancers by the age of 8 and their life expectancy is shortened by 30 years.

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life- threatening conditions and that demonstrate the potential to address unmet medical needs. It grants accelerated review for all steps of the process, including the applications related to clinical developments and may reduce the time required to bring the drug to market. With this designation, the FDA has acknowledged XP as a serious or life threatening disease and has also determined there is no drug currently marketed for treatment of XP.

About AGI Dermatics

AGI Dermatics is the bio-pharmaceutical laboratory that has led the research of DNA repair of the skin for more than 20 years. Founded by Daniel B. Yarosh, PhD, AGI Dermatics specializes in skin photobiology, dedicating research and development to DNA repair, solar impact on the immune system, and cell-signaling in skin. The company's application of groundbreaking active ingredients and meticulously engineered liposome delivery systems is validated in controlled clinical studies and published in dozens of peer-reviewed scientific and medical journals. www.agiderm.com


Source: AGI Dermatics

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