PALO ALTO, CA, Dec 05, 2011 (MARKETWIRE via COMTEX) –TOPICA Pharmaceuticals, Inc., a privately held biotechnologycompany, today announced that Amir Tavakkol, Ph.D., has joined thecompany as senior vice president of clinical development andoperations. with 20 years of experience in the pharmaceuticalindustry, consumer healthcare and academia, Dr. Tavakkol will beresponsible for advancing the clinical development of luliconazole,TOPICA’s broad-spectrum topical antifungal agent, for the treatmentof onychomycosis, fungal infections of the nail.
“Dr. Tavakkol’s considerable drug development skills and successes,particularly his clinical development expertise in onychomycosis, arean ideal fit for TOPICA. We are excited to have him join our team andare pleased that he shares our enthusiasm for luliconazole and itspotential to be the first truly effective and safe topical therapyfor onychomycosis,” said Greg Vontz, president and chief executiveofficer of TOPICA. “We look forward to his leadership in takingluliconazole through our key Phase 2b/3 trial, a pivotal step invalidating the molecule’s considerable potential.”
Dr. Tavakkol most recently served as senior director and projectleader in the Infectious Diseases Franchise at Merck & Co, Inc.,where he was the product development team leader for Merck’s oralanti-fungal programs. before Merck’s acquisition of Schering-Plough,Dr. Tavakkol was senior director and head of Dermatology GlobalClinical Research at Schering-Plough, where he led the clinicaldevelopment of posaconazole oral suspension for onychomycosis throughPhase 2. Prior to Schering-Plough, Dr. Tavakkol was the medicalaffairs medical director for Lamisil(R) (antifungal) and Famvir(R)(antiviral) products at Novartis. he led the onychomycosis trialIRON-CLAD(TM), which evaluated the safety of Lamisil(R) inonychomycotic patients, including elderly on multiple medications,and the effect of debridement plus Lamisil(R) on clinical outcomes.Earlier in his career, Dr. Tavakkol led antioxidant skin clinicalresearch at Colgate Palmolive and was a faculty member at theUniversity of Michigan Dermatology Department.
Dr. Tavakkol has been awarded several patents and trademarks and isthe author of more than 50 publications in leading medical andscientific journals. he earned a Ph.D. in bacteriology and virologyfrom the University of Manchester, UK, and has a postgraduate diplomain infectious diseases. he spent a year of internship in infectiousdiseases at PHLS, Leeds Seacroft Hospital, UK, and holds a B.S. inmedical technology.
About Luliconazole Luliconazole is one of the most potent andbroad-spectrum topical antifungal agents. in numerous, rigorouspreclinical models of onychomycosis, luliconazole has demonstratedrapid penetration of full thickness human toenails (infected andhealthy) reaching concentrations well in excess of the MIC 90concentrations needed to eradicate the dermatophytes that mostcommonly cause onychomycosis. this preclinical profile suggests thatluliconazole has the potential to be an effective and safe topicaltherapy for onychomycosis.
TOPICA plans to initiate a robust Phase 2b/3 clinical trial ofapproximately 300 patients with mild-to-moderate distal subungualonychomycosis of the toenail in the first half of 2012. the trialwill involve approximately 20 centers in the U.S. It will assess thesafety and efficacy of the 10 percent luliconazole solution in twodosing regimens applied for 48 weeks and will evaluate the impact ofluliconazole on clear nail growth and fungal eradication at week 52.the primary endpoint of the trial will be “complete cure at week 52,”a combined endpoint of clinical assessment of a completely clear nailand a negative fungal assessment by KOH (potassium hydroxidestaining) and mycologic culture. Complete cure is the primaryclinical endpoint for the conduct of pivotal clinical trials seekingU.S. Food and Drug Administration approval.
TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. todevelop and market luliconazole for onychomycosis in the Americas andEurope. Luliconazole in 1 percent cream and solution formulations wasapproved in Japan in 2005 for the treatment of tinea infections ofthe skin. to date, more than 10 million patients have been treatedwith the product in Japan, where luliconazole is one of the leadingtopical anti-fungal prescription products for tinea infections.
About Onycomycosis More than 35 million Americans are estimated tosuffer from onychomycosis, for which treatment options are limited.the potential annual U.S. market for onychomycosis treatment isestimated at approximately $3 billion.
About TOPICA Pharmaceuticals, Inc. TOPICA Pharmaceuticals, Inc. isa privately held clinical research stage pharmaceutical companyfocused on developing luliconazole for the treatment ofonychomycosis, fungal infections of the nail. in a Phase 1/2aclinical trial completed in 2011, TOPICA’s proprietary 10 percentluliconazole solution was shown to have the ability to rapidly crossthe nail plate and to be well tolerated by patients. the company isnow focused on conducting a robust dose finding and proof of efficacystudy with luliconazole in onychomycosis starting in mid-2012 withthe goal of making luliconazole the first highly effective and safetopical therapy for the treatment of onychomycosis. for moreinformation, please visit http://www.topicapharma.com .
Contact: Joey Fleury WCG 415-946-1090 Email Contact
SOURCE: TOPICA Pharma
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