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FDX104 prevented the development of moderate-to-severe antibody-induced rash in the majority of cases. FDX104 appears safe and was well-tolerated.
REHOVOT, Israel and BRIDGEWATER, N.J., Dec. 3, 2015 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) ("Foamix"), a clinical stage specialty pharmaceutical company focused on
developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced positive top-line results from its Phase 2 clinical study of FDX104 (a topical
foam containing 4% doxycycline) in the prevention of moderate-to-severe skin rashes in patients treated with the epidermal growth factor receptor antibody inhibitors (EGFRI) cetuximab
(Erbitux®, Eli Lilly) or panitumumab (Vectibix®, Amgen) for head and neck and colon cancers, among others. The results showed a statistically significant effect of FDX104 in reducing the
severity of the antibody-induced rash.
The rash, also referred to as acneiform (acne-like) rash, is the most common side effect of EGFRI drugs, and can severely impact patients' physical, psychological and social well-being,
often leading to treatment discontinuation or dose reduction. According to the prescription information of cetuximab and panitumumab, in the event of a severe rash, the dosing of the EGFRI
drug should be withheld, reduced or discontinued.(1,2)
Twenty-four patients were enrolled and received study drug in a multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical study to evaluate the safety and efficacy of
FDX104. Each patient acted as his or hers own control by treating one side of the face with FDX104 and the other side with the matching foam vehicle (Placebo) in a blinded and randomized
manner. Photographs of the front and each side of the face were taken at each study visit; these photographs were used for blinded grading of rash severity by an independent dermatologist at
the end of the study. The ratings of rash severity were: None=0, Mild=1, Moderate=2 and Severe=3, as described by Scope et al.(3) The key findings were:
In the entire study population (N=24) the severity of rash on the FDX104 treatment side of the face was overall better than in the Placebo-treated side. The mean Maximal rash severity (N=24)
was 1.33 and 1.71 in the FDX104- and placebo-treated sides respectively. Nine of the 24 patients in the study (37.5%) developed severe (Grade 3) rash during the study on the placebo-treated
side, while only 4 of the 24 patients in the study (16.7%) developed severe rash on the FDX104-treated side. Comparison of the two treatments on the prevention of severe rash reached
statistical significance (p