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

Wednesday, September 5, 2007 General News J E 4
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FREEPORT, N.Y., Sept. 5 AGI Dermatics, the bio-pharmaceutical laboratory that pioneered DNA research for skincare, announcedtoday that U.S. Food & Drug Administration (FDA) has granted Fast Trackdesignation for Dimericine (T4N5) for treatment of solar and ultravioletphotosensitivity in patients with Xeroderma Pigmentosum (XP). Dimericine,also known as T4N5 Liposome Lotion, is a topical drug developed by AGIcurrently in clinical trials for treating XP patients with skin cancers andpre-cancers.

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

Xeroderma pigmentosum, or XP, is a rare genetic disorder that blocks thebody's natural ability to repair DNA damage caused by ultraviolet (UV) light.Minimal exposure to UV light in XP patients results in persistent DNA damageand causes severe sunburn, blistering, irregular dark spots and a 1000-foldincreased risk of skin cancer. People with severe XP often need to avoidsunlight completely. Half of these patients develop skin cancers by the age of8 and their life expectancy is shortened by 30 years.

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

About AGI Dermatics

AGI Dermatics is the bio-pharmaceutical laboratory that has led theresearch of DNA repair of the skin for more than 20 years. Founded by DanielB. Yarosh, PhD, AGI Dermatics specializes in skin photobiology, dedicatingresearch and development to DNA repair, solar impact on the immune system, andcell-signaling in skin. The company's application of groundbreaking activeingredients and meticulously engineered liposome delivery systems is validatedin controlled clinical studies and published in dozens of peer-reviewedscientific and medical journals. www.agiderm.com

SOURCE AGI Dermatics
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