Healthcare Industry News: influenza
News Release - November 1, 2006
Carrington's DelSite Subsidiary Presents Data on Needle-Free Vaccine TechnologyGelSite(R) Polymer Shows Distinct Antigen Stabilization Effects
Nasal Powder Formulations With influenza Antigens Highly Immunogenic and Stable Over Time
IRVING, Texas, Nov. 1 (HSMN NewsFeed) -- Carrington Laboratories, Inc. (Nasdaq: CARN ) reported today that GelVac(TM), a dry powder nasal delivery formulation for vaccines, showed both antigen stabilization and high immunogenic effect in preclinical models. In addition, ongoing studies of GelVac(TM) formulations incorporating influenza antigens exhibited the potential for long-term stability during storage at room temperature.
In a presentation entitled "A Stable Dry Powder Vaccine Formulation (GelVac(TM)) for Nasal Delivery" at the 2006 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition October 29- November 2, 2006 in San Antonio, Texas, Babu M. Medi, PhD, Pharmaceutical Scientist at DelSite Biotechnologies, Carrington's wholly-owed subsidiary, described preparation and characterization of GelVac(TM) stable dry powder vaccine formulations for nasal delivery of vaccines using different drying methods.
The data showed the antigens were protected from activity loss during the dry powder formulation process, maintaining their potency. In addition, the GelSite® polymer, the key ingredient of GelVac(TM) powder formulations, exhibited a distinct antigen stabilization effect in addition to conferring in situ gelling properties, both of which serve to increase the uptake of active antigens in the nasal cavity.
Equally important, the preservative-free dry powdered formulations incorporating influenza antigens were shown to be stable for over 18 months during storage at ambient room temperature (still ongoing). They were also highly immunogenic, eliciting robust immune responses in animals after nasal delivery.
GelSite® polymer provides an in situ gelling property for optimal nasal delivery. Upon hydration by nasal fluid, the GelVac(TM) formulation changes from dry powder particles to wet gel particles, resulting in the formation of a gel that adheres to nasal mucus, thus maximizing antigen exposure through prolonged nasal residence time and sustained antigen release.
An abstract of this presentation can be found on DelSite's website at http://www.delsite.com/newfiles/sci_pubs.html .
About GelSite® Polymer
GelSite polymer is a novel, naturally derived high-molecular-weight polygalacturonic acid. It possesses distinct chemical and functional properties proprietary to the Company, including in situ gelling. It is manufactured under cGMP as a highly pure dry substance.
GelVac(TM) is a proprietary nasal powder vaccine delivery system based on the GelSite® polymer, the primary functional ingredient that confers its unique in situ gelling property. The GelVac(TM) system combines the advantages of dry powder formulations and nasal immunization, including room temperature stability, prolonged shelf life, and no need for preservatives, and induction of systemic and mucosal immune responses.
DelSite Biotechnologies, Inc. is a drug delivery and biotechnology company established to provide the pharmaceutical and biotechnology industries with novel delivery solutions for vaccines and therapeutic agents. DelSite is a wholly owned subsidiary of Carrington Laboratories, Inc. and was formed based on discoveries at Carrington.
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company currently utilizing naturally- occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol® and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. Carrington's technology is protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized worldwide. For more information, visit http://www.carringtonlabs.com .
Certain statements in this release concerning Carrington 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 August 14, 2006.
Source: Carrington Laboratories
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