Nastech Pharmaceutical Company Announces Initiation of Phase 2 Clinical Trial for PYY3-36 Nasal Spray to Tre...( BOTHELL Wash. Oct. 1 /- Nastech P...),Health

BOTHELL, Wash., Oct. 1 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today the start of a Phase 2 clinical trial evaluating the Company's PYY3-36 Nasal Spray in obese patients. The study will enroll approximately 500 obese patients for a six-month, randomized, placebo-controlled dose ranging study with weight loss as the primary endpoint.

The Phase 2 study design will evaluate three different doses of Nastech's PYY3-36 Nasal Spray compared to placebo and sibutramine (Meridia(R)), a commercially available oral weight loss drug, with the primary endpoint being weight loss. Patients in the active PYY treatment arms will take PYY3-36 Nasal Spray or nasal spray placebo three times daily prior to a meal over the 24-week period. The study design will enable patients to undergo an initial dose optimization period to establish an optimal dose to continue over the duration of the trial. Although the primary endpoint is weight loss the study will also evaluate other effects including comparing the proportion of patients who lose at least 5 % or 10 % of their baseline body weight as well as the effect on hemoglobin A1c (HbA1c) levels. Lowering HbA1c levels has been shown to delay or prevent problems associated with diabetes such as damage to the eyes, kidneys and nerves. Screening of patients is in process and dosing is scheduled to begin this month. More details are available at http://www.clinicaltrials.gov.

"Nastech has developed a patient friendly, non-invasive nasal spray dosage form of a naturally occurring peptide, PYY, which in the body signals the brain that you have consumed sufficient calories and to therefore
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