Nastech
Pharmaceutical Company Inc. (Nasdaq: NSTK) announced 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.
About Nastech
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 nastech.
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.
Nastech Pharmaceutical Company Inc.
nastech
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