Nastech Pharmaceutical Company Announces Initiation of Phase 2 Clinical Trial for Insulin Nasal Spray to Treat Diabetes
- Category: Proteins and Peptides
- Published on Thursday, 27 September 2007 04:00
- Hits: 2015
BOTHELL, WA, USA | September 26, 2007 | Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today the start of a Phase 2 clinical trial evaluating the Company's rapid-acting Insulin Nasal Spray in approximately 20 patients with type 2 diabetes. The study is a randomized, crossover study evaluating formulations of Insulin Nasal Spray as compared to NovoLog(R) insulin aspart (rDNA origin), an approved, rapid-acting injectable insulin, on post-meal glycemic control.
Data from Nastech's earlier Phase 1 pharmacokinetic and safety studies demonstrated that the Company's Insulin Nasal Spray achieved faster time to maximum plasma levels than NovoLog injection and Exubera(R) (insulin human [rDNA origin]) Inhalation Powder in healthy subjects. Additionally, the intranasal formulations tested were well-tolerated and did not show any clinically significant hypoglycemia.
The Phase 2 study design will evaluate different doses of Nastech's Insulin Nasal Spray compared to NovoLog and a placebo. Over the course of the study, patients will receive different doses of Insulin Nasal Spray or NovoLog prior to a standardized meal. Following the meal, glucose levels will be measured at specific time points with the objective of achieving glycemic control without hypoglycemia. Screening of patients is being conducted and dosing is scheduled to begin in October.
"Nastech's Insulin Nasal Spray has the potential to offer a unique product profile for diabetic patients and their physicians compared to existing marketed products due to its rapid onset of action and patient friendly, non- invasive dosage form that we believe avoids the potential safety concerns of pulmonary delivery," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "The initiation of the Phase 2 trial is a significant step forward in the clinical program and the results, if positive, could be a catalyst towards partnering the product with a major pharmaceutical company."
About Diabetes and Insulin
In the United States, approximately 21 million people have diabetes and 1.5 million new patients are diagnosed every year, according to the American Diabetes Association. Type 2 diabetes accounts for an estimated 90 to 95 percent of all cases. Complications can include cardiovascular disease, kidney disease, blindness and diseases of the central nervous system. Injectable insulin has been used to treat diabetes since the early 1920s and continues to be the definitive treatment for diabetes worldwide. Branded insulin product sales were approximately $9 billion worldwide in 2006. The total direct and indirect economic cost related to diabetes in 2002 was estimated to be $132 billion annually in the United States.
Nastech is a biopharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and our collaboration partners are developing products for multiple therapeutic areas including osteoporosis, obesity, diabetes, autism, 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 Inc.