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Foamix Pharmaceuticals Ltd. Announces Initiation of Phase II Trial With FDX104 in Chemotherapy Induced Rash

REHOVOT, Israel and BRIDGEWATER, N.J., Oct. 6, 2014 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX) ("Foamix Pharmaceuticals," or "Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced the initiation of a Phase II trial with FDX104, its topical formulation of doxycycline, to prevent rash in cancer patients taking epidermal growth factor receptor inhibitors (EGFRI). Between 45% and 100% of patients receiving EGFRI drugs, such as Erbitux® (cetuximab) and Vectibix® (panitumumab) are currently affected by severe acne-like rashes.

The trial is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of FDX104 administered topically for prevention of EGFRI related skin toxicity in 24 cancer patients. There is an initial screening period, 5 weeks of treatment, and a post-treatment follow up visit 4 weeks later. Approximately seven days after randomization and study drug initiation, patients will start their EGFRI treatment. The primary objective is to demonstrate the safety and tolerability of FDX104 adjunct to either Erbitux or Vectibix treatment. Safety and tolerability will be evaluated by measurements of vital signs, incidence and severity of adverse events and evaluation of skin tolerability. The trial is being conducted in Israel. For more information, please go to www.clinicaltrials.gov.

Dov Tamarkin, Ph.D., Chief Executive Officer of Foamix, commented, "Skin rash is the most common side effect in patients undergoing treatment with EGFRIs, and can lead to patients modifying their dosages of the anti-cancer drugs or discontinuing treatment completely. FDX104 holds the promise of treating these patients with a convenient, topical foam, while avoiding the risk of the systemic side effects and potential drug-drug interactions of oral antibiotics, which are the current standard of care."

About Chemotherapy Induced Rash

EGFRI are targeted agents used for treating lung, pancreatic, breast, head & neck and colo-rectal cancers as first line through third line treatment, as single or combination drugs. They cause various dermatologic side effects in the majority of patients; the most common being severe acne-like rashes on the face and upper trunk, which occur in between 45% and 100% of the patients being administered EGFRIs. This toxicity results in significant physical and emotional patient stress, which in many cases (~30%) result in changes in the oncological treatment regimen. While there are no approved treatments for EGFRI-induced rash, physicians have been treating patients off label with the oral tetracycline analogs minocycline and doxycycline to prevent and decrease the acne-like rash. Although these treatments have shown benefit, the efficacy can be improved and there can be significant drawbacks with these therapies, including systemic side effects and potential drug-drug interaction with the patients' primary oncology treatment.

About Foamix Pharmaceuticals Ltd.

Foamix Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing and commercializing its proprietary minocycline foam for the treatment of acne, impetigo and other skin conditions. Foamix Pharmaceuticals' lead product candidates, FMX101 for moderate-to-severe acne and FMX102 for impetigo, are novel topical foam formulations of the antibiotic minocycline. Foamix Pharmaceuticals also has early-stage stable foam formulations of various drugs for the treatment of common dermatological indications.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements" relating to future events, such as statements regarding the closing of the offering. Forward-looking statements are based on Foamix Pharmaceuticals' current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. The forward-looking statements made herein speak only as of the date of this release and Foamix Pharmaceuticals undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Erbitux is a registered trademark of Bristol-Myers Squibb and Eli Lilly and Co.

Vectibix is a registered trademark of Amgen Inc.

CONTACT: Dov Tamarkin, CEO Foamix Pharmaceuticals Ltd. +972-8-9316233 dov.tamarkin@foamixpharma.com U.S. Investor Relations Michael Rice LifeSci Advisors, LLC 646-597-6979 mrice@lifesciadvisors.comSource:Foamix, Ltd.