| Welcome |
| About Foamix |
| Technologies |
| Products |
| Strategy |
| Contact |
| News |
| Useful Links |
 |
||
|
01/09/2011
Foamix Receives Approval for Minocycline Foam Phase II Clinical Trial in Acne
Rehovot (Israel), September 1, 2011 The 120-patient study will run in parallel with Foamix’s Rosacea and Impetigo studies, which are underway Foamix Ltd. announced today that two Institutional Review Boards reviewed and cleared its Phase I/II clinical study for Minocycline Foam in Acne patients. The Phase II multicentre clinical trial is designed to assess the safety and clinical efficacy of Foamix’s topical Minocycline Foam in patients with moderate to severe acne. The 120 patient study will be stratified into three arms, Minocycline Foam 1%, 4% or Placebo and will be treated for 12 weeks. “We are excited to move forward with this Phase I/II clinical trial with our Minocycline Foam in Acne patients”, said Foamix CEO Dr. Dov Tamarkin. “The need for safer and more effective alternatives for managing acne is well understood within the dermatological community,” he added.
The study will commence in Fall 2011. About Minocycline Foam: Minocycline, which is currently available only in oral tablets and capsules, is primarily used to treat acne, rosacea and skin infections. In a recent survey among American dermatologists, 95% indicated that they prescribe oral Minocycline for moderate and severe Acne and Rosacea; and most of them (87%) expressed their concerns about side effects, which include upset stomach, diarrhea, dizziness, unsteadiness, drowsiness, mouth sores, headache and vomiting. Foamix’s first-in-class topical Minocycline Foam is currently being studied in two Phase II clinical trials in Rosacea and Impetigo. Foam is preferred by users for topical treatment, due to its ease in spreading and quick absorption. The current sales of oral minocycline in the U.S. exceed $ 1.0 billion. About Acne: Acne, characterized by areas of skin with comedones, papules, pustules, nodules which may lead to scarring. It affects mostly skin with the densest population of sebaceous follicles; these areas include the face, the upper part of the chest, and the back. Acne is a common skin condition affecting more than 80 percent of young adults and teenagers. The world-wide prescription acne market was approximately $2.8 billion in 2010; and it is estimated to be in excess of $3 billion by 2016. About Foamix: Foamix Ltd. is a clinical-stage, privately held specialty pharma company, focused on the development of proprietary topical foam and OilGel™ products for prescription, OTC and cosmetic applications. Foamix creates advanced products with improved convenience, higher compliance and better efficacy, which are backed by an extensive patent portfolio. The company’s development capabilities range from initial development of the formulations to scale-up, GMP manufacturing, preclinical and clinical studies. Foamix partners with leading pharmaceutical companies, including Galderma, Intendis (a unit of Bayer AG), Dr. Reddy's and Ferndale Laboratories. Foamix has a strong in-house pipeline of dermatological and gynecological drugs. The Company’s lead product, Topical Minocycline, is currently in Phase II clinical studies. To date, Foamix has 9 issued patents in the United States, covering its foam and OilGel™ technology platforms. The company has an additional 150 applications and patents worldwide, of which more than 60 applications are filed in the U.S. For additional information please see www.foamix.co.il
Contact: |