More MS news articles for Nov 2001

Nastech Initiates Intranasal Interferon Beta Phase I Clinical Trial

http://news.excite.com/news/pr/011128/ny-nastech-trial

Updated: Wed, Nov 28 9:24 AM EST

HAUPPAUGE, N.Y., Nov. 28 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (NASDAQ:NSTK) announced today that it has commenced a Phase I clinical trial in the United States to evaluate the nasal administration of interferon beta. The clinical program will explore the tolerance, safety and absorption of interferon beta in 12 healthy male subjects and ultimately aims to validate this technology in the treatment of Multiple Sclerosis (MS).

The continuous administration of interferon beta to MS patients allows the use of a lower dose and may significantly reduce the incidence of drug related side effects. Since continuous infusion outside the hospital setting is impractical, the nasal route may allow one to approximate a continuous administration, with the accrued benefits, including improved patient-to-patient dose variability.

"We believe that a nasal formulation of interferon beta with an improved safety and efficacy profile may address a significant unmet medical need in patients with this CNS disease," stated Steven C. Quay, M.D., Ph.D., Chairman, President, and Chief Executive Officer of Nastech. "Initiation of clinical trials with interferon beta is a further execution of our strategy to identify and assess macromolecules that are FDA approved, administered by injection, have two or more innovators, and address billion-dollar market opportunities."

MS is a chronic, often disabling disease of the central nervous system. It is caused by the destruction of myelin by the immune system. Myelin is the fatty tissue that surrounds and protects central nervous system nerve fibers and facilitates the flow of nerve impulses to and from the brain. The loss of myelin disrupts the conduction of nerve impulses, producing the symptoms of MS. Symptoms may be mild -- numbness in the limbs, or severe -- paralysis or loss of vision. The onset of MS generally occurs between the ages of 15 and 55. Approximately 300,000 people in the U.S., the majority of whom are women, suffer from MS.

Interferon beta is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS). It is a protein of relatively high molecular weight (approximately 19-24kD) and is currently administered by injection only. Interferon beta is marketed worldwide by Biogen, Inc. and Berlex Laboratories, Inc., and in 72 countries outside the U.S. by Ares-Serono. Total sales exceed $1.1 billion annually.

Nastech Pharmaceutical Company Inc, recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science to 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.
 

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Matthew D. Haines
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