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NanoBio Corporation Announces Positive Phase 1 Clinical Results for,Topical Treatment for Onychomycosis

ANN ARBOR, Mich., May 22, 2007 /PRNewswire/ -- NanoBio Corporation, a biopharmaceutical company developing novel products for the treatment and prevention of serious infections, today announced positive safety data from its Phase 1 clinical study of NB-002, the company's drug candidate currently in a Phase 2 clinical trial for the topical treatment of onychomycosis.

The Phase 1 clinical study was completed in January 2007 and involved 20 subjects who received twice-daily treatments of NB-002 (0.25% or 0.5%) for 28 days. Subjects were examined on days 1, 3, 7, 14, 28 and 58 for adverse events, dermal irritation and pharmacokinetic sampling. There were no drug- related adverse events, serious adverse events or discontinuations due to adverse events in any of the subjects treated. In addition, plasma drug levels were below the limit of detection (1 ng/mL) at all time points. Based on the remarkable safety profile demonstrated in this clinical study as well as other previously conducted clinical and toxicology studies, a 42-week double-blinded Phase 2 clinical study of NB-002 was initiated by NanoBio in the first quarter of 2007.

James R. Baker, MD, NanoBio's Chairman of the Board and Chief Science Officer, commented, "A unique aspect of products derived from the company's NanoStat(TM) technology is that the treatments are not systemically absorbed and they are selectively toxic to microbes while non-irritating to the skin and mucous membranes. This Phase 1 safety data further confirms that NB-002 will offer a safe alternative to the currently available systemic products. This is a critical factor for individuals affected by onychomycosis, given approximately 95% of people with this disease remain untreated as a result of the serious toxicities associated with the oral medications on the market."

Phase 2 Clinical Study for NB-002

A randomized, double-blinded, placebo-controlled Phase 2 c
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