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Nastech
Initiates Intranasal Interferon Alpha Phase I Clinical Trial
HAUPPAUGE, N.Y., Jan. 30 /PRNewswire/ -- Nastech Pharmaceutical
Company, Inc. (Nasdaq: NSTK) announced today it has commenced
a Phase I clinical trial in the United States to evaluate the
nasal administration of interferon alpha. The objective of the
multi-dose Phase I study is to determine nasal absorption, tolerance,
and safety of interferon alpha in healthy volunteers.
Interferon
alpha is indicated for the treatment of certain forms of cancer
and hepatitis. It is a protein of relatively high molecular weight
and as such is currently administered by injection only.
"Interferon
alpha is a major therapeutic tool in the treatment of a number
of important and serious medical conditions, including hairy cell
leukemia, malignant melanoma, follicular lymphoma, condylomata
acuminata, AIDS-related Kaposi's Sarcoma, and chronic hepatitis
B and C," stated Dr. Eric Rowinsky, M.D., Director of Clinical
Research, Cancer Therapy and Research Center, San Antonio, TX
and Advisor to Nastech on this project. "The prospect of
an alternative route of administration that might provide a unique
pharmacokinetic profile for interferon is an interesting approach
to improving safety, efficacy, and patient compliance. I look
forward to working with Nastech now that this project has moved
into the clinical phase of testing."
"Consistent
with Nastech's new business model, we have embarked on the first
of several significant product opportunities in macromolecules
that may be administered by the nasal or oral route," stated
Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive
Officer of Nastech. "Interferons are an important class of
therapeutic agents that are effective for a wide variety of cancer
and viral illnesses. We believe that a Formulation Science strategy
resulting in a painless nasal dosage form of interferon alpha
may result in greater patient compliance and a broadening market
for this important therapy."
The
medical literature suggests that continuous administration of
interferon alpha to patients with hepatitis permits the use of
a lower dose, with subsequent lowering of significant drug related
side effects. Since continuous infusion outside the hospital setting
is impractical, the
nasal route may allow one to approximate a continuous administration,
with the accrued benefits, including improved patient-to-patient
dose variability. Finally, in many patients with significant chronic
diseases, weight loss, with accompanying loss of skeletal muscle
and subcutaneous tissue depots, makes drug injection a less reliable
route of administration.
Interferons
are a family of glycoproteins derived from human cells that normally
have a role in fighting viral infections by preventing virus multiplication
in cells. In recent years, interferons are increasingly being
studied for applications in treating a host of major diseases.
Credit Suisse First Boston estimates that sales of Schering Corporation's
injectable interferon alpha-2b product, Intron A/Rebetron, will
increase from $1.4 billion in 2000 to $2.0 billion in 2002.
Nastech
Pharmaceutical Company Inc, recognized worldwide as a leader in
nasal drug delivery technology, is dedicated to improving patient
care by using Formulation Science to provide new therapeutic options.
Additional information on Nastech is available at http://www.Nastech.com.
Nastech
Safe Harbor Statement
Statements
contained herein that are not historical fact may be forward-looking
statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of
1934, that are subject to a variety of risks and uncertainties.
There are a number of important factors that could cause actual
results to differ materially from those projected or suggested
in any forward-looking statement made by the Company. These factors
include, but are not limited to: (i) the Company's ability to
successfully complete product research and development, including
pre-clinical and clinical studies and commercialization; (ii)
the Company's ability to obtain required governmental approvals,
including product and patent approvals; (iii) the Company's ability
to attract and/or maintain manufacturing, sales,
distribution and marketing partners; and (iv) the Company's ability
to develop and commercialize its products before its competitors.
In addition, significant fluctuations in quarterly results may
occur as a result of varying milestone payments and the timing
of costs and expenses related to the Company's research and development
program. Additional factors that would cause actual results to
differ materially from those projected or suggested in any forward-looking
statements are contained in the Company's filings with the Securities
and Exchange Commission, including those factors discussed under
the caption "Risk Factors" in the Company's most recent
Annual Report on Form 10-K.
NOTE:
An Interferon Fact Sheet is available at http://www.nastech.com
SOURCE
Nastech Pharmaceutical Company, Inc.