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Nastech Initiates Intranasal Interferon Alpha Phase I Clinical Trial


HAUPPAUGE, N.Y., Jan. 30 /PRNewswire/ -- Nastech Pharmaceutical Company, Inc. (Nasdaq: NSTK) announced today it has commenced a Phase I clinical trial in the United States to evaluate the nasal administration of interferon alpha. The objective of the multi-dose Phase I study is to determine nasal absorption, tolerance, and safety of interferon alpha in healthy volunteers.

Interferon alpha is indicated for the treatment of certain forms of cancer and hepatitis. It is a protein of relatively high molecular weight and as such is currently administered by injection only.

"Interferon alpha is a major therapeutic tool in the treatment of a number of important and serious medical conditions, including hairy cell leukemia, malignant melanoma, follicular lymphoma, condylomata acuminata, AIDS-related Kaposi's Sarcoma, and chronic hepatitis B and C," stated Dr. Eric Rowinsky, M.D., Director of Clinical Research, Cancer Therapy and Research Center, San Antonio, TX and Advisor to Nastech on this project. "The prospect of an alternative route of administration that might provide a unique pharmacokinetic profile for interferon is an interesting approach to improving safety, efficacy, and patient compliance. I look forward to working with Nastech now that this project has moved into the clinical phase of testing."

"Consistent with Nastech's new business model, we have embarked on the first of several significant product opportunities in macromolecules that may be administered by the nasal or oral route," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. "Interferons are an important class of therapeutic agents that are effective for a wide variety of cancer and viral illnesses. We believe that a Formulation Science strategy resulting in a painless nasal dosage form of interferon alpha may result in greater patient compliance and a broadening market for this important therapy."

The medical literature suggests that continuous administration of interferon alpha to patients with hepatitis permits the use of a lower dose, with subsequent lowering of significant 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. Finally, in many patients with significant chronic diseases, weight loss, with accompanying loss of skeletal muscle and subcutaneous tissue depots, makes drug injection a less reliable route of administration.

Interferons are a family of glycoproteins derived from human cells that normally have a role in fighting viral infections by preventing virus multiplication in cells. In recent years, interferons are increasingly being studied for applications in treating a host of major diseases.
Credit Suisse First Boston estimates that sales of Schering Corporation's injectable interferon alpha-2b product, Intron A/Rebetron, will increase from $1.4 billion in 2000 to $2.0 billion in 2002.

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.

NOTE: An Interferon Fact Sheet is available at http://www.nastech.com

SOURCE Nastech Pharmaceutical Company, Inc.