BOTHELL, Wash., Aug. 14 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. announced today the initiation of a dose ranging study designed to evaluate the pharmacokinetic parameters, appetite, food intake and safety of various doses of Nastech’s proprietary PYY(3-36) nasal spray in obese subjects. The objective of the study is to identify a dose or doses which would be appropriate for further study in a long-term Phase II efficacy and safety clinical trial.
The study design is a double blind, cross-over test of multiple doses of PYY(3-36) nasal spray in 12 obese subjects with a Body Mass Index of 30-40 kg/m(2). The study includes intravenous (IV) PYY and placebo treatment arms. The purpose of the intravenous arms is to confirm the pharmacodynamics of IV PYY, which in three prior publications* demonstrated an approximate 30 percent reduction of caloric intake at the following meal. Subjects will be randomized to each treatment arm with approximately one week between treatments. A goal of the study is to identify nasal spray doses that result in similar caloric reduction to the intravenous dose. It is expected this study will be completed during the fourth quarter 2006 and with a budget of approximately $400,000.
“We are pleased to be back in the clinic with PYY(3-36). This study will provide insight into the optimal doses of PYY to reduce food intake,” stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. “With obesity reaching epidemic levels worldwide, the need for a safe and effective product that promotes weight loss has become critically important.”
About PYY
Peptide YY is a naturally occurring hormone that is believed to function as a physiologic inhibitor of food intake. PYY is produced by specialized endocrine cells (L-cells) in the gut after a person eats and is believed to trigger the feeling of satiety, or fullness. Because PYY is a protein, initial studies focused on PYY delivery by injection. Utilizing its proprietary drug delivery technology, Nastech developed the nasal spray formulation of PYY as a unique, non-invasive treatment option for obesity.
About Obesity
There are more than 1 billion overweight adults worldwide, 300 million of whom are clinically obese according to World Health Organization. Obesity contributes to increased risk for chronic diseases including type 2 diabetes, cardiovascular disease and hypertension. PYY nasal spray may offer a novel treatment option for those suffering from this condition.
* References Batterham RL, Cowley MA, Small CJ, Herzog H, Cohen MA, Dakin C, Wren AM, Brynes A, Low M, Ghatei M, Cone R & Bloom SR. Gut hormone PYY3-36 physiologically inhibits food intake. Nature. 2002, 418: 650-654. Batterham RL, Cohen MA, Ellis SM, Le Roux CR, Withers DJ, Frost GS, Ghatei M and Bloom SR. Inhibition of food intake in obese subject by peptide YY3-36. The New England Journal of Medicine. 2003, 349: 941-948. Degen L, Oesch S, Casanova M, Graf S, Ketterer S, Drewe J, Beglinger C. Effect of PYY3-36 on food intake in humans. Gastroenterology. 2005, 129: 1430-1436. About Nastech
Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions. Additional information about Nastech is available at www.nastech.com .
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Nastech to obtain additional funding; (ii) the ability of Nastech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) Nastech’s and/or a partner’s ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) Nastech’s and/or a partner’s ability to obtain required governmental approvals; and (v) Nastech’s and/or a partner’s ability to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Nastech’s most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Nastech assumes no obligation to update and supplement forward-looking statements because of subsequent events.
CONTACTS: Nastech Pharmaceutical Company Inc. Ed Bell Senior Investor Relations Manager (425) 908-3639 ir@nastech.com Noonan Russo Matthew Haines (Investors/Media) (212) 845-4235
Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell of Nastech Pharmaceutical Company Inc., Senior InvestorRelations Manager, +1-425-908-3639, ir@nastech.com; or Investors and Media:Matthew Haines of Noonan Russo, +1-212-845-4235, for Nastech PharmaceuticalCompany Inc.
Web site: http://www.nastech.com/
