Nitric BioTherapeutics Initiates Phase II Onychomycosis Study

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 16 Jul 2010 - 1:00 PDT

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Nitric BioTherapeutics, Inc. (Nitric Bio) announced the initiation of a Phase II clinical trial of the company's proprietary drug/device combination, which delivers terbinafine via the process of iontophoresis for the treatment of onychomycosis. Onychomycosis is commonly known as toenail fungus. Separately, the company announced the appointment of industry expert, Al Altomari, as Executive Chairman of the Board and the closing a $6 million financing, led by inside investors, NewSpring Capital and Quaker BioVentures.

Nitric Bio's proprietary drug/device combination delivers very high doses of a unique formulation of terbinafine, the most effective medication used to treat onychomycosis, directly to the site of the infection -- on, around and under the toenail. The drug is delivered through a simple 20 minute, in-office procedure using iontophoresis. Iontophoresis is the application of a small external electric current to actively push drugs into skin and nails quickly and at high levels. The one-year study will be a single blind, placebo controlled trial at seven sites, which will cumulatively enroll at least 150 patients. The trial is designed to have a six-month interim analysis.

"We are pleased to be initiating our Phase II onychomycosis trial with some of the top investigators in North America. We believe that the combination of the most efficacious oral drug with a robust topical delivery system will provide a great treatment option for the more than 35 million Americans and equal number of Europeans who suffer from onychomycosis," commented Frank J. McCaney, CEO of Nitric Bio. "It is also a major milestone for the company to bring on Al Altomari in the Chairman's role. We are extremely fortunate to have a seasoned leader with Al's expertise join us."

Mr. Altomari is an industry expert with more than 25 years of executive leadership experience in the pharmaceutical industry, with a focus on the development and successful commercialization of specialty pharmaceutical products, in particular in dermatology and women's health.

Mr. Altomari was the Chief Executive Officer of Barrier Therapeutics, a specialty dermatology company, which he helped spin out from Johnson & Johnson in 2002. He was with the company at inception and led the sale of the company to Steifel Laboratories in 2008. Mr. Altomari served at Johnson & Johnson from 1982 to 2003, where he most recently served as General Manager of the Ortho Neutrogena prescription drug development group, where he successfully led the integration of Ortho Dermatological and Neutrogena Professional. Mr. Altomari serves as Chairman of the Board of Agile Therapeutics, Inc. and Director of Auxilium Pharmaceuticals Inc., Signum Biosciences, Inc., and DUSA Pharmaceuticals, Inc.

About Onychomycosis

Onychomycosis is a chronic fungal infection that affects the toenails and the fingernails. The currently available treatment options for onychomycosis are limited by liver toxicity complications, long courses of therapy and low efficacy. The only approved topical treatment showed low efficacy rates in clinical trials. The disease can cause pain, discomfort and disfigurement. Onychomycosis can lead to co-morbid infections and may produce serious physical and occupational limitations. Psychosocial and emotional effects resulting from onychomycosis are widespread and may have a significant impact on quality of life. It is generally accepted that in the United States there are more than 35 million patients suffering from onychomycosis. The global market for onychomycosis treatments is estimated to be $2B in 2010. The global market for onychomycosis treatments is anticipated to grow to $3.6 billion by 2010.

Source:
Nitric BioTherapeutics, Inc.

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