Wednesday July 18, 9:18 am Eastern Time
Press Release
SOURCE: Nastech Pharmaceutical Company Inc.
Successful Delivery of Apomorphine to the Brain
Following Intranasal Administration Demonstrated in
Clinical Study
New Approach to Treatment of Central Nervous System Diseases
Bypasses the Blood - Brain - Barrier
HAUPPAUGE, N.Y., July 18 /PRNewswire/ -- Nastech Pharmaceutical Company Inc.
(Nasdaq: NSTK - news) announced today that it has demonstrated the preferential uptake
of intranasally administered Apomorphine directly into the cerebral spinal fluid (CSF), a fluid
that surrounds and supports the brain and spinal cord. The nasal delivery of pharmaceutically
active compounds that are not able to cross the blood-brain-barrier when given by other
routes of administration may provide a new, non-invasive way of treating Alzheimer's
disease, Parkinson's disease, stroke and other important brain diseases and conditions.
The study, which was initiated in May, was conducted as a Phase I, single dose, open label
clinical trial in 12 healthy male subjects at SUNY Stony Brook Medical Center in Stony
Brook, New York. Apomorphine was administered intranasally to each subject, and
thereafter blood was drawn, and CSF samples were obtained by spinal tap. Apomorphine
levels were determined by HPLC-MS- MS, a state-of-the-art analytical tool. The results
were expressed as a ratio of CSF level to blood level at various times indicated. The data
indicate that Nastech's intranasal Apomorphine HCl formulation produced a CSF to plasma
ratio of 0.27 to 0.44 at 20 minutes. This can be compared to a ratio of less than 0.05
resulting from the subcutaneous administration of Apomorphine under the same experimental
conditions as noted in published clinical studies. No significant adverse events were observed
during the study.
The results of the clinical study are promising because distribution of drugs to the brain tissue
is highly restricted even though the brain receives approximately 20% of cardiac output.
Drugs normally reach the central nervous system (CNS) via two mechanisms: the brain
capillaries and the CSF. The endothelial cells of the brain's capillaries, which appear to be
more tightly joined to one another than are those of other capillaries, contribute to the fact
that many drugs enter the brain slowly or not at all. In addition to the restrictive capillary walls, there are also connective tissue
cells that form an astrocyte sheath close to the basement membrane of the capillary endothelium. Together the capillary walls
and the astrocytic sheath form what is commonly referred to as the blood-brain-barrier. The results of the clinical study indicate
that certain drugs via nasal administration may be deposited directly into the CSF, bypassing the blood-brain-barrier.
``We are pleased by the results of this clinical study, which confirms that nasal drug delivery, unlike other drug delivery
modalities, provides a unique pathway for drug molecules to reach the brain,'' stated Steven C. Quay, M.D., Ph.D., Chairman,
President and Chief Executive Officer of Nastech. ``We intend to expand our internal research programs and the breadth of
our therapeutic focus to include intranasal delivery of drugs to potentially treat major diseases of the central nervous system,
such as Parkinson's, Alzheimer's and Multiple Sclerosis. We also believe this provides unique intellectual property opportunities
that should enhance Nastech's valuable patent estate.''
Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to
improving patient care by using ``Formulation Science'', a systematic approach to drug development using biophysics, physical
chemistry, and pharmacology to maximize therapeutic efficacy and safety, and provide new therapeutic options. Additional
information on Nastech is available at 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.
Contact: Matthew D. Haines
Director, Corporate Communications
(631) 273-0101, ext. 329
mhaines@nastech.com
Noonan/Russo Communications
(212) 696-4455
Ellie Kline, ext. 254 (media)
David Walsey, ext. 230 (investors)
SOURCE: Nastech Pharmaceutical Company Inc. |
