REHOVOT, Israel and BRIDGEWATER, N.J., May 31, 2016 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that its drug candidate FDX-104, for the treatment of skin toxicity due to Epidermal Growth Factor Receptor Inhibitors (EGFRI), will be featured in a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, on Monday June 6, 2016 in Chicago. Abstracts are available to the public online on the ASCO website: www.abstract.asco.org.
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®, Eli Lilly) or panitumumab (Vectibix®, Amgen) for metastatic colon cancer.
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 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)|
About Foamix Pharmaceuticals
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 Bayer HealthCare, Merz, Allergan and Prestium.
For more information, please visit www.foamixpharma.com.
Forward Looking Statements
This 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.