Dimercine® Receives FDA Fast Track Designation for Treatment of Photosensitivity in XP Patients
DNA Repair Formula Holds Promise for Treatment of Rare, Life-Threatening Genetic Disorder
Freeport, NY (August 30, 2007) -- AGI Dermatics, the bio-pharmaceutical laboratory that pioneered DNA research for skincare, announced today that Dimericine (T4N5) has been designated as a Fast Track development program by the U.S. Food & Drug Administration (FDA) for treatment of solar and ultraviolet photosensitivity in patients with Xeroderma Pigmentosum (XP). Dimericine, also known as T45N5 Liposome Lotion, is a topical drug developed by AGI currently in clinical trials for treating 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 this revolutionary treatment and provide hope 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.
Dimericine uses liposome-encapsulated DNA repair enzymes to restore natural DNA repair in skin damaged by UV light. The potential benefits for XP patients are protection of their immune systems, reduced frequency of skin cancers and fewer disfiguring surgeries.
Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat 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 life threatening disease and has also determined there is no drug currently marketed for treatment of XP.
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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.
