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Nastech Reports Positive Clinical Results Using its Proprietary Breast Disease Cytology Test Device.

Fifteen Minute Proprietary Test Intended as an Adjunct to Mammography and

Physical Examination in Diagnosis of Breast Cancer

HAUPPAUGE, N.Y., July 10 /PRNewswire/ --

Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today results from a clinical trial that evaluated the safety and efficacy of its non-invasive Mammary Aspiration Specimen Cytology Test (MASCT) device. The MASCT is a non-invasive, non-powered device that draws Nipple Aspirate Fluid (NAF) from the breast for cytological examination. The study showed that the device provides clinically useful Mammary Aspiration Specimens (MAS) for cytological examination that may prove useful in the diagnosis of breast cancer. The device is being developed as an adjunct to current standards of medical care, which include mammography and clinical breast exams.

The MASCT device is a patent pending, modified breast pump in design, permitting the aspiration and collection of microliter quantities of fluid and designed to be conveniently operated with one hand.

The clinical trial was conducted at the Company's clinical research unit in Stony Brook, New York, with 31 healthy, non-pregnant, non-lactating, pre-menopausal female subjects ages 30 - 49 years. Based on cytological evaluation and/or measurable weight changes on the sample collection membrane filter within the device, all breasts evaluated in the clinical trial with the bilateral mammary aspiration technique yielded Nipple Aspirate Fluid (NAF). Cytological findings from the study correlated well with mammogram and clinical breast exam results. No adverse events were reported. Following the non-invasive 15-minute procedure, which received favorable patient and physician acceptance, the specimens were sent to a laboratory for cytological examination, a process that evaluates certain cellular changes as a precursor to, or indication of, cancer. These changes are very similar to those seen in the standard "Pap" smear test that is done 100 million times each year as a screen for cervical cancer.

Other non-invasive methods of obtaining intraductal fluid have reported successes rates between 50-84 percent of women, and intraductal fluid containing sufficient cells for cytological evaluation has been reported as low as 20 percent of women. The Company anticipates that a successful breast aspirator device for cytological evaluation may provide adjunct diagnostic information for the early detection of breast cancer, similar to the way a Pap smear provides diagnostic information for the early detection of cervical cancer. This is especially important for the subset of women ages 20-40 not identified as "high risk", and therefore, for whom mammography is not routinely recommended.

"The ability to evaluate women non-invasively with a test that can provide an early report of changes in the cells lining the breast ducts, where about 85% of cancers arise in the milk ductal system of the breast may prove to be an important addition to the armamentarium of the women's health specialist," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech and inventor of MASCT. "Cytological testing of mammary aspirate specimens may prove to be an important adjunct to the currently accepted standard of medical care, that is, mammography coupled with physical examination, for the diagnosis of breast cancer."

According to the American Cancer Society (ACS), breast cancer is the most common form of cancer among women, excluding non-melanoma skin cancers, and a leading cause of cancer deaths among women in the United States. Over 85 million American women ages 20 and over are candidates for breast cancer screening. ACS and the National Comprehensive Cancer Network currently recommend annual mammograms for women identified as normal risk beginning at age 40 and for women identified as high-risk beginning at age 25.

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

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 of Nastech Pharmaceutical Company Inc., 631-273-0101, ext. 329,; or Media - Ellie Kline, 212-696-4455, ext. 254, or Investors - David Walsey, 212-696-4455, ext. 230 both of Noonan-Russo Communications for Nastech Pharmaceutical Company Inc.

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Publication:PR Newswire
Date:Jul 10, 2001
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