BOTHELL, Wash., Sept. 26 Nastech PharmaceuticalCompany Inc. (Nasdaq: NSTK) announced today the start of a Phase 2 clinicaltrial evaluating the Company's rapid-acting Insulin Nasal Spray inapproximately 20 patients with type 2 diabetes. The study is a randomized,crossover study evaluating formulations of Insulin Nasal Spray as compared toNovoLog(R) insulin aspart (rDNA origin), an approved, rapid-acting injectableinsulin, on post-meal glycemic control.
Data from Nastech's earlier Phase 1 pharmacokinetic and safety studiesdemonstrated that the Company's Insulin Nasal Spray achieved faster time tomaximum plasma levels than NovoLog injection and Exubera(R) (insulin human[rDNA origin]) Inhalation Powder in healthy subjects. Additionally, theintranasal formulations tested were well-tolerated and did not show anyclinically significant hypoglycemia.
The Phase 2 study design will evaluate different doses of Nastech'sInsulin Nasal Spray compared to NovoLog and a placebo. Over the course of thestudy, patients will receive different doses of Insulin Nasal Spray or NovoLogprior to a standardized meal. Following the meal, glucose levels will bemeasured at specific time points with the objective of achieving glycemiccontrol without hypoglycemia. Screening of patients is being conducted anddosing is scheduled to begin in October.
"Nastech's Insulin Nasal Spray has the potential to offer a unique productprofile for diabetic patients and their physicians compared to existingmarketed products due to its rapid onset of action and patient friendly, non-invasive dosage form that we believe avoids the potential safety concerns ofpulmonary delivery," stated Steven C. Quay, M.D., Ph.D., Chairman, Presidentand CEO of Nastech. "The initiation of the Phase 2 trial is a significant stepforward in the clinical program and the results, if positive, could be acatalyst towards partnering the product with a major pharmaceutical company."
About Diabetes and Insulin
In the United States, approximately 21 million people have diabetes and1.5 million new patients are diagnosed every year, according to the AmericanDiabetes Association. Type 2 diabetes accounts for an estimated 90 to 95percent of all cases. Complications can include cardiovascular disease, kidneydisease, blindness and diseases of the central nervous system. Injectableinsulin has been used to treat diabetes since the early 1920s and continues tobe the definitive treatment for diabetes worldwide. Branded insulin productsales were approximately $9 billion worldwide in 2006. The total direct andindirect economic cost related to diabetes in 2002 was estimated to be $132billion annually in the United States.
Nastech is a biopharmaceutical company developing innovative productsbased on proprietary molecular biology-based drug delivery technologies.Nastech and our collaboration partners are developing products for multipletherapeutic areas including osteoporosis, obesity, diabetes, autism,respiratory diseases and inflammatory conditions. Additional information aboutNastech is available at http://www.nastech.com.
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statementswithin the meaning of Federal Securities laws that are subject to certainrisks and uncertainties and involve factors that may cause actual results todiffer materially from those projected or suggested. Factors that could causeactual results to differ materially from those in forward-looking statementsinclude, but are not limited to: (i) the ability of Nastech to obtainadditional funding; (ii) the ability of Nastech to attract and/or maintainmanufacturing, research, development and commercialization partners; (iii)Nastech's and/or a partner's ability to successfully complete product researchand development, including preclinical and clinical stu