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Biotech / Medical : RNAi

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To: Thomas who wrote (220)5/19/2004 9:57:59 AM
From: Thomas  Read Replies (1) of 671
 
Bob, no idea on implications for atugen-ISIS partnership. Sorry.

Courtesy of my Google filter, here is a new siRNA delivery formulation announcement (see my bold emphasis below). Anyone have a view on Nastech? TIA.

Cheers,
Thomas

Press Release Source: Nastech Pharmaceutical Company Inc.

Nastech Presents Scientific Abstracts at AAPS National Biotechnology Conference
Wednesday May 19, 9:04 am ET

BOTHELL, Wash., May 19 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - News) announced today that the Company is presenting five abstracts at the ongoing American Association of Pharmaceutical Scientists National Biotechnology Conference in Boston, Massachusetts. Chuck Foerder, Ph.D., Head of Analytical Services; Conor MacEvilly, Ph.D., Analytical Chemist; Mary Kleppe, Formulations Scientist; Rick Costantino, Ph.D., Head of Formulations Development; and Kunyuan Cui, Ph.D., Head of Molecular Biology of Nastech, are presenting the data.
The abstracts are:

Quantitative Determination of Peptide YY3-36 in Plasma by
Radioimmunoassay Foerder, C.A., McEvilly, C., Haugaard, D., and Crosby, P.

Nastech has developed and validated a radioimmunoassay method for the determination of Peptide YY3-36 (PYY), a satiety hormone, in plasma samples to support preclinical and clinical studies. The method is robust, sensitive, specific, accurate, and reliable and has been used to quantify PYY in rat, rabbit, dog, and human plasma for pharmacokinetic and drug safety studies, as well as the ongoing clinical trials.

Stability Assessment of an Intranasal Formulation of Peptide YY3-36
Mary Kleppe, Garland Bellamy, Ken Farber, Conor MacEvilly, Charles A.
Foerder and Henry R. Costantino

Nastech has evaluated the stability of an intranasal formulation of Peptide YY3-36 (PYY), a candidate therapeutic for treatment of obesity. An HPLC method was developed and evaluated as a sensitive stability-indicating method for PYY in an intranasal formulation. Under routine storage conditions there was no significant loss of native PYY or the appearance of degradants. These data demonstrate that an intranasal PYY formulation can be stored for at least six months under routine storage conditions without significant loss of native peptide. Longer-term stability studies are ongoing.

Development and Phase I Clinical Testing of an Intranasal Formulation of Interferon-beta-1a

Henry R. Costantino and Gordon Brandt

Nastech has developed and tested an intranasal formulation of interferon-beta-1a suitable for initial human clinical testing for the treatment of multiple sclerosis. An in vitro screening method was successfully employed to identity a candidate intranasal formulation of interferon-beta-1a. An early human clinical study suggested that there was about 20-25 percent bioavailability for this formulation. Ongoing work has identified an improved formulation.

Development of Peptide-Based siRNA Delivery Formulations

Lishan Chen, Ben Dutzar, Mohammad Ahmadian, James Dattilo, Garland Bellamy, Ken Farber, Kunyuan Cui, and Paul H. Johnson

Nastech has investigated the function of cell penetrating peptides (CPP) for enhancing the uptake of siRNA into cells and developed novel siRNA delivery agents for RNAi-based therapeutic drugs. Flow cytometry was utilized to rapidly assess the cell uptake efficiency and toxicity of fluorescence-labeled siRNA targeting the inhibition of beta-galactosidase expression. Nastech systemically investigated published cell penetrating peptides reported to have nucleic acid delivery capability. Based on the analysis of CPP structures, we evaluated several newly designed peptides and demonstrated significant improvements in transfection efficiency. Formulations containing these peptides may be useful as effective siRNA delivery vehicles for therapeutic applications.

Characterization of Tight Junction Function in Respiratory Epithelia Using RNA Interference

B. Dutzar, L. Chen, S-C. Chen, K. Cui, P. H. Johnson, G. Brandt, and S. C. Quay

Nastech has investigated the structural and functional properties of the epithelial tight junction (TJ) and identified those components that are amenable to functional manipulation for nasal drug delivery of large molecules, such as peptides. The effects of siRNA knockdown of individual genes on tight junction formation were monitored using measurements of transepithelial electric resistance (TER) and dextran permeability in epithelial monolayers. Nastech's results indicate that TJ formation is differentially regulated and that modulation of individual tight junction proteins function affects paracellular permeability.

"Thought leaders from every discipline in the pharmaceutical sciences gather at the prestigious AAPS National Biotechnology Conference to discuss and learn about the significant and growing impact of biotechnology in the development of new medicines to treat human diseases," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. "We are grateful to the AAPS for the opportunity to present our clinical development programs relating to PYY Nasal Spray for obesity and Interferon beta 1-a Nasal Spray for multiple sclerosis as well as our drug delivery research programs involving the use of RNAi and siRNA technology."

ABOUT NASTECH

Nastech Pharmaceutical Company Inc. is an emerging pharmaceutical company developing products based on applying our proprietary drug delivery technologies, with over 200 patents and applications filed. The Company is developing molecular biology-based technologies for delivering both small- and large-molecule drugs by nasal administration, along with an extended-release oral delivery technology. The Company's intranasal drug delivery technology may lead to greater drug efficacy, speed of action, safety, and patient compliance. Nastech is developing a diverse product portfolio across multiple therapeutic areas, including products targeted for the treatment of sexual dysfunction, obesity, pain management, osteoporosis, and multiple sclerosis. Additional information about 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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 ability of the Company to obtain additional funding; (ii) the ability of the Company to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the Company's and/or a partner's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (iv) the Company's and/or a partner's ability to obtain required governmental approvals, including product and patent approvals; and (v) the Company's and/or the Company's partner's ability to develop and commercialize products that can compete favorably with those of competitors. In addition, significant fluctuations in quarterly results may occur as a result of the timing of milestone payments, the recognition of revenue from milestone payments and other sources not related to product sales to third parties, and the timing of costs and expenses related to the Company's research and development programs. 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 and Quarterly Reports on Form 10-Q, which the Company urges investors to consider. The Company undertakes no obligation to publicly release the revisions in such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrences of unanticipated events or circumstances, except as otherwise required by securities and other applicable laws.

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Source: Nastech Pharmaceutical Company Inc.
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