IRVING, Texas, Nov. 21 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. reported today that a presentation entitled "Immunoenhancing Effect of a Novel In Situ Gelling Polygalacturonate, GelSite(R) Polymer" was presented at the 4th International Conference on Vaccines, which met November 16-17, 2006 in Washington, D.C. The presentation was authored by scientists from DelSite Biotechnologies, Inc., with contributions from scientists from Texas A&M University and the National Cancer Institute (NCI), and showed that the GelVac(TM) powder formulation developed for nasal application can also be injected after reconstituted, with enhanced immune response.
Data showed that the GelVac(TM) vaccine formulations with the Company's proprietary GelSite(R) polymer had a strong immunoenhancing effect in preclinical models with different vaccine antigens through in situ gelling and sustained antigen release. This finding confirms that the GelVac(TM) base powder formulation can also be used for injectable delivery; thus, expanding its application to various vaccine programs.
The key is GelSite(R) polymer's ability to bind to and stabilize antigens used for vaccines. The presentation describes the enhanced immune response observed with powder or dried formulations after reconstitution and injection in animal models. The antigens included monovalent and trivalent inactivated influenza whole virion and split virion antigens and human papillomavirus type 16 L1 protein virus-like particles (HPV 16 L1 VLP). GelSite(R) polymer increased the immune response two to ten-fold when measured at week four, following intramuscular injection. In addition, the GelVac(TM) nasal formulations provided better protection than the antigen injected by itself in an influenza virus challenge test.
DelSite has been developing the GelVac(TM) powder vaccine formulation, which contains its proprietary GelSite(R) polymer, for nasal delivery. The findings described in this presentation further expand the applications of this powder or dried vaccine formulation technology.
DelSite has been working on an inactivated influenza vaccine with GelVac(TM) nasal powder, which is in part funded by NIAID, and recently formed a CRADA with NCI to evaluate it for mucosal delivery of HPV antigens.
An abstract of this presentation can be found on DelSite's website at http://www.delsite.com/newfiles/sci_pubs.html .
About GelSite(R) 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.
About GelVac(TM)
GelVac(TM) is a proprietary nasal powder vaccine delivery system based on the GelSite(R) 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.
About DelSite
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.
About 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(R) 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 November 14, 2006.
Carrington Laboratories, Inc.CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300
