Navigation Links
Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
Date:9/5/2007

FREEPORT, N.Y., Sept. 5 /PRNewswire/ -- 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. http://www.agiderm.com


'/>"/>
SOURCE AGI Dermatics
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
4. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
5. Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkins Lymphoma
6. Accentia Biopharmaceuticals Announces Favorable Interim Blinded Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial for Chronic Sinusitis
7. Stanford Researchers Track Human Stem Cells Transplanted Into Rat Brain
8. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
9. Staphylococcus aureus vaccine development on track ? safe and immunogenic in Phase I clinicaltrials
10. Allos Therapeutics PDX Granted Orphan Medicinal Product Designation by the European Commission
11. Point of Care Strep Tests Speed Treatment, Lower Costs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... Oct. 2, 2017  AllianceRx Walgreens Prime, the combined ... Walgreens and pharmacy benefit manager Prime Therapeutics LLC (Prime), ... which included the unveiling of new signage at its ... well as at a few other company-owned facilities across ... to patients, some of whom will begin to see ...
(Date:10/2/2017)... Denmark , Oct. 2, 2017 The Rebound ... in the struggle to reverse the tide of prescription drug ... for regulating their medicine intake and stepping down their dosage ... set to launch in December 2017; the first 100,000 people ... Learn more at http://www.rebound-solution.com/ ...
(Date:9/28/2017)... 2017 Cohen Veterans Bioscience and Early Signal ... wearable and home sensors for real-time monitoring of patients ... a nonprofit organization focused on disruptive health solutions for ... analytical system to record and integrate behavioral, cognitive, physiological ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The Visiting ... Day Market. Featuring a collection of specialty vendors and unique items from across the ... and quality-focused health and wellness services offered by the VNA. The boutique will ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Global Healthcare ... scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare ... activity. The fun run is geared towards children of all ages; it is ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of ... Philippines. “The Journey: From the Mountains to the Mission Field” is the creation of ... taught all ages and currently teaches a class of ladies at her church, which ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare ... program management, will showcase a range of technology and learning solutions at the ... Convention and Expo to be held October 14–18, 2017 at the Mandalay Bay ...
Breaking Medicine News(10 mins):