Foamix lice treatment demonstrates 96% efficacy in Phase II/III study

Foamix lice treatment demonstrates 96% efficacy in Phase II/III study
The medical start-up anticipates launching PerFoam on the Israeli market in 2006
by Globes correspondent 19/07/2005

Medical start-up Foamix Ltd. has announced the results of its Phase II/III study of one of its lead products, PerFoam, for the treatment of lice. Trial data shows evidence of safety and a 96% efficacy rate. Foamix anticipates launching PerFoam in the Israeli market in 2006, and in the global market in 2006/7. PerFoam, comprised of 1% permethrin and two proprietary enhancers, is an alcohol-free, non-irritating, drip-free foam for the treatment of head lice. 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 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. Dr. Avner Shemer, senior dermatologist was the principal investigator of the study. Fifty-six children, ages 3-16, infested with head lice, were treated with PerFoam. PerFoam was applied to the hair for 10 minutes and then washed. Treatment was repeated 10 days later. According to the study, "PerFoam 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.”
“The efficacy of PerFoam is remarkably high, despite the commonly known resistance of lice to current treatments in this region,” said Professor Arie Hadani, the entomologist of the study.

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.

The local market in Israel for anti-lice treatment products value is NIS 10 million a year. The over-the-counter (OTC) anti-lice products generates approximately NIS 7 million out of the total market. 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 $120 million.

Foamix is a pre-IPO, privately held company, currently engaged in a $5 million financing round. Headquartered in Ness Ziona, the company develops alcohol-free, non-inflammable, stable foam products for prescription, OTC and cosmetic uses. Applications include dermatology, gynecology, cosmetics, cosmeceuticals, wound healing and burn care. The company was founded in January 2003 by CEO Dr. Dov Tamarkin, COO Meir Eini and chief technology officer Dr. Doron Friedman. The Company employs 22 people and has 22 patents pending. Foamix recently received three US patent approvals for its OilGel topical delivery platform. Foamix 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.

*the author of this blog is invested in Foamix :-)