July 15, 2008
DelSite Advances Nasal Delivery of Therapeutic Peptide
-- GelVac(tm) Nasal Powder Platform Delivers Peptide Arginine-Vasopressin (AVP) Into Systemic Circulation -- Peptide Widely Used to Control Urine Output in Patients With Diabetes Insipidus -- Additional Commercial Opportunities Could Include a Treatment for Heart Failure -- Formulation Stable at Room Temperature For More Than 18 Months
IRVING, Texas, July 15, 2008 (PRIME NEWSWIRE) -- DelSite, Inc. (OTCBB:CARN) announced that its GelVac(tm) intranasal powder platform was successfully used in achieving systemic delivery of arginine-vasopressin (AVP), an off-patent peptide therapeutic for controlling urine volume. AVP is normally administered as an injection or as a liquid nasal spray and has a worldwide market of approximately 300 million dollars.
The findings were presented yesterday at the 35th Annual Meeting of the Controlled Release Society in New York City by Paul Stroud, PhD, director of Polymer Research and Development at DelSite, in a presentation entitled "GelVac(tm) Nasal Powder Delivery System for Sustained Intranasal Delivery of Peptide and Protein Therapeutics."AVP, a nine-amino-acid peptide hormone, is primarily used for the treatment of uncontrolled urine flow in patients with diabetes insipidus. AVP is being investigated as an aide in the revival of patients in cardiac arrest. A dry powder nasal delivery of AVP, providing rapid systemic uptake, is viewed as a beneficial product profile.
Dr. Yawei Ni, chief scientific officer of DelSite, said, "The GelVac(tm) nasal powder delivery platform potentially provides the same advantages for therapeutic peptides and proteins as already demonstrated by our nasal vaccine program. We are very excited about this delivery platform, and we feel that this technology can significantly expand the nasal therapeutics market."
Dr. Stroud's presentation discussed the findings regarding delivery of AVP in the GelVac intranasal powder platform whose key component is GelSite(r) polymer, its functional excipient. The novel polymer provides in-situ gelling and mucoadhesive properties that keep the formulation longer in the nasal cavity, allowing for sustained release of potential peptide/protein therapeutics to the systemic circulation while bypassing first-pass liver metabolism.
The GelVac powder formulation holds several advantages over traditional delivery methods, including room temperature stability, prolonged shelf life, no preservatives, and no requirement of cold chain distribution. The nasal delivery route allows for several advantages, including rapid therapeutic absorption and onset of pharmacological activity and an easy and fast needle-free route of administration. Room temperature stability of 19 months has been demonstrated with the GelVac(tm) formulation containing the peptide arginine-vasopressin.
This same powder delivery system (GelVac(tm)) is currently being utilized for the intranasal delivery of vaccine antigens including influenza and human papillomavirus (HPV). A Phase I safety study of the nasal powder platform has been completed in Europe. A Phase I trial of GelVac(tm) nasal powder H5N1 avian influenza vaccine is scheduled for patient dosing later this year in the United States.
DelSite, Inc. is an ISO 9001-certified, research-based, biopharmaceutical company currently utilizing naturally-occurring complex carbohydrates technology to develop its proprietary GelSite(r) technology designed for controlled release of peptide and protein-based drugs. DelSite's technology is protected by more than 130 patents in 26 countries. Manufacturing operations comply with cGMP standards. For more information on DelSite's platform technologies, visit www.delsite.com.
Certain statements in this release concerning DelSite may be forward-looking. Actual events will be dependent upon a number of factors and risks including but not limited to: subsequent changes in plans by the Company's management; delays or problems in formulation, manufacturing, distribution, production and/or launch of new finished products; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company's filings with the Securities & Exchange Commission, including the Form 10-Q filed May 15, 2008.
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CONTACT: DelSite, Inc. Carlton E. Turner, Chief Executive Officer (972) 518-1300