Healthcare Industry News: osteoporosis
News Release - June 7, 2006
Nastech Submits Investigational New Drug Application for PYY3-36 Nasal Spray to Treat ObesityBOTHELL, Wash., June 7 (HSMN NewsFeed) -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK ) announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for PYY3-36 (PYY) nasal spray, the company's lead investigational product candidate for treatment of obesity. The filing of the IND precedes the initiation of clinical studies in the United States.
The study included in the IND is designed to evaluate the pharmacokinetic parameters, appetite, food intake and safety of various dosing regimens of PYY nasal spray in obese subjects. The objective of study is to determine the optimal dosing regimens that will be used to conduct a Phase II clinical study based on the successful completion of this initial trial.
"We're moving aggressively to demonstrate the potential for PYY nasal spray to treat obesity," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "We have been working with recognized experts in the obesity field to design the appropriate clinical trial program for this exciting candidate. Positive Phase II safety and efficacy data would be the basis for establishing a collaboration with a major pharmaceutical company for the remaining development and commercialization of PYY nasal spray."
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.
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.
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 http://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.
Source: Nastech Pharmaceutical Company
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