Mar 21, 2002
PR Newswire - USA
Nastech Pharmaceutical Company Inc. today announced interim results from its Phase I pharmacokinetic, pharmacodynamic, safety and tolerance study demonstrating the successful nasal delivery of Interferon beta-1a. The Company believes that additional research may provide multiple sclerosis patients with an easy-to-use, non-invasive alternative to injectable Interferon beta.
The single dose, open-label study involving healthy male volunteers is being conducted at Nastech's clinical research unit at Stony Brook Medical Center in Stony Brook, New York. Each subject received either a 60 mcg dose of Interferon beta-1a as an intramuscular injection, or a 30-60 mcg nasally administered Interferon beta-1a spray of either Nastech's formulation or a standard formulation without absorption enhancers. The subjects were evaluated at various time intervals after dosing. Administration of the standard nasal formulation did not result in detectable elevations in biologic markers for Interferon beta-1a. However, subjects receiving Nastech's novel formulation showed elevations in biologic markers similar to those produced by the intramuscular product, suggesting a pharmacologic effect. In addition, the Nastech formulation was well tolerated with fewer reported side effects than for the injected product. No nasal irritation was observed during the study.
"Having previously demonstrated the successful nasal delivery of Interferon alpha, we consider these results a further validation of our core technology," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. "Nasally administered Interferon beta may potentially provide MS patients with a more convenient alternative to Interferon beta injections, and we look forward to sharing the results from our ongoing Phase I study in their entirety once the research is completed."
Interferon beta is a drug used to reduce the frequency and severity of relapses afflicting people suffering from multiple sclerosis (MS). MS is a neurological disorder affecting the brain and spinal cord, which over time can lead to poor coordination and severe disabilities. It affects approximately 350,000 people in the U.S. Relapses vary but are basically painful and distressing episodes that can result, in extreme cases, in blindness, paralysis, incontinence and hospitalization. The market for Interferon beta is greater than $1.4 billion. Companies currently marketing Interferon beta products for treatment of MS include, Biogen, Berlex, and Serono.
Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using "Formulation Science," a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety, and provide new therapeutic options. Additional information on Nastech is available at http://www.nastech.com/.
NASTECH SAFE HARBOR STATEMENT
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company's ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company's ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company's research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K.
Contact: Matthew D. Haines, Director, Corporate Communications, (631) 273-0101, ext. 329, email@example.com; or Noonan/Russo Communications, (212) 696-4455, Ellie Kline, ext. 254 (media), David Walsey, ext. 230 (investors)
Nastech Pharmaceutical Company Inc.
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