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 this year," stated Dov Tamarkin, Ph.D., Foamix's CEO. "There is a significant unmet need for a safe and effective treatment for EGFRI-induced rash, which is the most noticeable side effect of the EGFRI class of drugs. FDX104 has the potential to improve patients' quality of life and help maintain patients on their optimal anti-cancer treatment."
|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)|
For more information, please visit www.foamixpharma.com.Forward Looking StatementsThis press release may include forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations. Forward-looking statements are based on our current knowledge and our 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 various factors including, but not limited to, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital. We discuss many of these risks in greater detail under the heading "Risk Factors" in our most recent Annual Report on Form 20-F (File No. 161477078) filed on March 7, 2016, and elsewhere in that Annual Report. Any forward-looking statements that may be made herein speak only as of the date of this release and Foamix 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 Eli Lilly & Co.Vectibix ® is a registered trademark of Amgen Inc.
Contact:Dorit HayonFoamix Pharmaceuticals Ltd.+972-8-9316233BD@foamixpharma.comUS Investor RelationsMichael RiceLifeSci Advisors, LLC646firstname.lastname@example.org