Foamix Pharmaceuticals Announces Publication of Abstract on FDX-104 in the Treatment of EGFRI Induced Rash for the 2016 ASCO Meeting
In the poster entitled "Safety and Activity of Topical 4% Doxycycline Foam (FDX-104) in Epidermal Growth Factor Receptor Inhibitor (EGFRI) Induced Skin Toxicity," the authors highlighted data from a Phase 2 randomized, double-blind, multicenter study investigating the safety and efficacy of self-applied, twice-daily, FDX-104 in 24 patients receiving cetuximab (Erbitux®,
Acneiform rash is a common treatment-limiting side effect of antibody and small molecule EGFRIs used to treat various cancers. Absent an approved product, off-label oral doxycycline, a tetracycline analog, has been used with various degrees of success to prevent the rash. Oral doxycycline, however, may also cause limiting systemic side effects.
Foamix conducted a Phase 2, randomized, double-blind, multicenter study investigating the safety and efficacy of self-applied, twice-daily, FDX-104 in 24 patients receiving cetuximab or panitumumab for metastatic colon cancer. Each patient acted as her/his own control by applying FDX-104 to one side of the face and matching foam vehicle (placebo) to the other side, beginning one week prior to starting treatment with the EGFRI. Patients were evaluated until 4 weeks after EGFRI initiation. Rash was quantified by an independent blinded dermatologist using a Global Rash Severity (GSS) scale and by study investigators using a modified MASCC EGFRI Skin Toxicity Tool (MESTT). Maximum-grade rash severity on each side of the face at any visit was used in all analyses.
Foamix previously announced results showing that the overall difference in GSS grade 3 rash favored the FDX-104 treatment side. The comparison of a ranked difference between the two treatments, based on clinical importance, reached statistical significance (p=0.047, Wilcoxon Signed-Rank test) in favor of FDX104 over vehicle for the prevention of severe rash. Grade 3 rash developed in 9 patients (37.5%) on the placebo side, compared with only 4 patients (16.7%) on the FDX-104 side. Four patients had a 2-grade difference in GSS scoring (severe vs. mild) between sides. FDX104 applied to skin was well tolerated and safe, and caused no systemic side effects.
The time from EGFRI treatment initiation to first grade 3 rash trended in favor of FDX104 (hazard ratio = 0.2; p=0.096), as did the probability of remaining free of severe rash over time (p=0.096). MESTT-based analyses had similar but nonstatistically significant results.
"We are very pleased to have the results of this Phase 2 study on FDX 104 accepted for
|ASCO Poster Details|
|Abstract Title:||Safety and Activity of Topical 4% Doxycycline Foam (FDX104) in Epidermal Growth Factor Receptor Inhibitor (EGFRI) Induced Skin Toxicity|
|Session Title:||Patient and Survivor Care|
|Poster Hall Location:||Hall A, Poster Session (Board #118)|
|Presentation Time:||Monday June 6, 1:00 PM to 4:30 PM (Central Time)|
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. The Company's clinical stage product candidates include FMX101, a novel minocycline foam for the treatment of moderate-to-severe acne, now in Phase 3 clinical studies, FMX102 for the treatment of impetigo, FMX103 for the treatment of rosacea, and FDX-104, a doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs. In addition, Foamix has development and license agreements relating to its technology with various pharmaceutical companies including
For more information, please visit www.foamixpharma.com.
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Erbitux® is a registered trademark of
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Dorit Hayon Foamix Pharmaceuticals Ltd.+972-8-9316233 BD@foamixpharma.com US Investor Relations Michael Rice LifeSci Advisors, LLC646-597-6979 email@example.com