WAKEFIELD, MA, April 27 /PRNewswire-FirstCall/ - NUCRYST Pharmaceuticals Corp. today announced the completion of patient enrollment in the second Phase 2 clinical trial with its lead pharmaceutical product candidate, a topical cream formulation of its nanocrystalline silver (NPI 32101). The investigational drug is being studied for the treatment of atopic dermatitis, a common form of eczema.
In total, 409 patients, aged two to 17 years of age, with mild to moderate eczema, have been enrolled to be treated for up to 12 weeks in a double-blind, randomized, placebo-controlled study involving 29 clinical sites across the United States and Canada. Enrollment for the study began in October, 2005.
Patients in the Phase 2 clinical study are being treated with one of three cream formulations, either 1% or 2% concentrations of NPI 32101 or with a placebo, which is the cream without any drug. The participating dermatologists will evaluate the effectiveness of topical NPI 32101 in improving the signs and symptoms of atopic dermatitis and its safety. As a double-blind study, neither the physician nor the patient will know the treatment allocation until the end of the study, and as the sponsor of the study, nor will NUCRYST. Results of the study are expected by the end of 2006.
“We see great potential for NPI 32101 as a well-tolerated treatment for atopic dermatitis,” said Scott H. Gillis, President & CEO, NUCRYST Pharmaceuticals Corp. “In our preclinical studies, NPI 32101 in a cream formulation has demonstrated the ability to address inflammation that is a hallmark of atopic dermatitis. We believe our unique nanocrystalline silver holds great promise in treating a number of conditions where inflammation and infection are present.”
Prior to beginning the Phase 2 trial, safety data were gathered from a tolerance study involving children and a pharmacokinetics study in adults that measured serum concentrations and urine excretion of silver after application of the cream formula to the skin. Both studies were completed in the third quarter of 2005 and provided promising data concerning the safety profile of NPI 32101 in a cream formulation.
Atopic dermatitis is a chronic inflammatory disease of the skin, which affects more than 15 million people in the United States. The cause of atopic dermatitis is unknown. In the US alone, the market for prescription topical anti-inflammatory products in 2005 was approximately US$1 billion according to IMS Health, a leading provider of information and solutions in the pharmaceutical and healthcare industries.
NUCRYST Pharmaceuticals develops, manufactures and commercializes medical products that fight infection and inflammation using its patented atomically disordered nanocrystalline silver technology. Smith & Nephew plc sell a range of advanced wound care products under their Acticoat(TM) trade mark: Acticoat(TM) products incorporate NUCRYST’s SILCRYST(TM) coatings and are sold in over 30 countries.
NUCRYST is also developing pharmaceutical products to address medical conditions that are characterized by both infection and inflammation. The company has developed its proprietary nanocrystalline silver in a powder form for use as an active pharmaceutical ingredient, referred to as NPI 32101.
Acticoat(TM) is a trademark of Smith & Nephew plc SILCRYST(TM) is a trademark of NUCRYST Pharmaceuticals Corp.
Some of the statements above may constitute forward-looking statements within the meaning of securities legislation in the United States and Canada. In particular, statements regarding the timing of the results of our Phase 2 clinical trial, the promise associated with safety data results, the market size for and potential of an NPI 32101 topical cream formulation, and the medical conditions that might be addressed by present or future NUCRYST products may be forward-looking statements for purposes of the U.S. and Canada securities laws or otherwise. These statements are based on current expectations that are subject to risks and uncertainties outside of the control of NUCRYST, and NUCRYST can give no assurance that these expectations are correct. Various factors could cause actual results to differ materially from those projected in such statements, including but not limited to: clinical trials may be suspended or terminated at any time due to the actions of the FDA, other regulatory authorities, our collaborators, or due to our own actions; clinical trials could be delayed or prevented by several factors, including improper enrollment practices resulting in protocol management problems and statistical analysis problems; regulators may not agree with our results and delay or deny the requisite regulatory approvals for a new product; commercialization of an approved new product could fail due to various causes, including unexpected side effects of the product that were not discovered during the clinical trial; and numerous other factors described under “Risk Factors” in our Registration Statement on Form F-1 filed with the U.S. Securities & Exchange Commission. NUCRYST disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
NUCRYST Pharmaceuticals Corp.
CONTACT: Investor Relations: David Wills, (416) 504-8464,info@nucryst.com, www.nucryst.com; Media Contact: Evan Ard, SouthardCommunications, (212) 777-2220, evan@southardinc.com
