NESS ZIONA, Israel, July 18 /PRNewswire/ -- Foamix Ltd. (www.foamix.co.il) announced today the results of its Phase II/III study of one of its lead products, PerFoam(TM), for the treatment of lice. Trial data shows evidence of safety and a 96% efficacy rate. Foamix anticipates launching PerFoam(TM) in the Israeli market in 2006, and in the global market in 2006/7.
Lice are parasitic insects generally found on human heads. Preschool and elementary-age children, 3-10 years of age, and their families are infested most often from this easily spread condition. Hundreds of millions of cases of louse infestation are reported annually worldwide, with a clear increase over the past few decades. It has been estimated that 10-12 million Americans are infested yearly with lice. Elementary school-age children account for a quarter of this number. The current US market for head-lice treatment products is estimated at US$120 million.
PerFoam(TM), comprised of 1% Permethrin and two proprietary enhancers, is an alcohol-free, non-irritating, drip-free foam for the treatment of head lice. The study, titled, An open study to assess the efficacy, safety and usability of a 1% Permethrin Foam, in the treatment of head lice (pediculosis capitis) in pediatric patients, was conducted at the Laniado Medical Center, Netanya, Israel.
“Fifty-six children, ages 3-16, infested with head lice, were treated with PerFoam(TM). PerFoam(TM) was applied to the hair for 10 minutes and then washed. Treatment was repeated 10 days later. PerFoam(TM) proved effective in killing the lice on the first application in 54 of the 56 children (96.4%). Furthermore, in 60% of the children, lice eggs were completely eradicated after the first application. The product was easily applied and caused no discomfort to the treated children. There was no evidence of eye or skin irritation,” said Dr. Avner Shemer, senior dermatologist and Principal Investigator of the PerFoam(TM) study.
Permethrin is the recommended active ingredient for the treatment of lice by the American Academy of Pediatrics. However, data show that lice have developed resistance to Permethrin in shampoo, lotion and cream rinse formulations. There is also evidence of scalp and eye irritation resulting from the application of the currently available products.
“The efficacy of PerFoam(TM) is remarkably high, despite the commonly known resistance of lice to current treatments in this region,” said Professor Arie Hadani, the entomologist of the PerFoam(TM) study.
“PerFoam(TM) is an exceptional product, which will hopefully encourage treatment compliance and bring relief to the patient and caregiver. Because of its high efficacy, safety and ease of use, we expect this product to be a winner and to capture a significant share of the market within the next couple of years,” said Dr. Dov Tamarkin, CEO of Foamix.
Foamix also announced today that it will be exhibiting at booth 1713 at the American Academy of Dermatology meeting in Chicago from July 20 - 24th at the Hyatt Regency in Chicago.
About Foamix
Headquartered in Ness Ziona, Israel, Foamix Ltd. develops alcohol-free, non-inflammable, stable foam products for prescription, Over-the-Counter and cosmetic uses. Applications include dermatology, gynecology, cosmetics, cosmeceuticals, wound healing and burn care. Foamix’s state-of-the-art foams provide controlled delivery of a variety of active ingredients. They are also able to enhance intradermal delivery of actives, for optimal effect. The Company’s development capabilities range from initial development of foam formulations to scale-up, GMP manufacturing and clinical supplies. The Company was founded in January 2003 by CEO Dr. Dov Tamarkin, COO Mr. Meir Eini and Chief Technology Officer Dr. Doron Friedman. The Company employs 22 people and has 22 patents pending. In addition, Foamix recently received three U.S. patent approvals for its OilGel(TM) topical delivery platform. Foamix Ltd. is a pre-IPO, privately held company, currently engaged in a $5 million financing round.
For additional information or to schedule an appointment with the Foamix management at the AAD 2005 in Chicago: Marjie Hadad, Media Liaison, Marjie@foamix.co.il or +972-54-536-5220.
Foamix Ltd.
CONTACT: For additional information or to schedule an appointment with theFoamix management at the AAD 2005 in Chicago: Marjie Hadad, Media Liaison,Marjie@foamix.co.il or +972-54-536-5220.
