* First Nasal Powder H5N1 Influenza Vaccine Candidate
* Distinct Advantages for Pandemic Preparedness
* Phase I Dose-Escalating Study
IRVING, Texas, June 26, 2008 (PRIME NEWSWIRE) -- Carrington Laboratories, Inc. (OTCBB:CARN) today announced its wholly-owned subsidiary, DelSite Biotechnologies, Inc., and Accelovance, Inc. have entered into a Master Service Agreement for the purpose of providing human clinical trial services for DelSite's GelVac(tm) Nasal Powder H5N1 Influenza Vaccine. The agreement covers the full Clinical Research Organization (CRO) service for the phase I first-time-in-man dose-escalating clinical study.
There is a significant unmet global health need for influenza vaccines and pandemic preparedness. All current influenza vaccines are liquid formulations that have a limited shelf life, require refrigeration for storage and distribution and, with the exception of one live vaccine product, are administered by injection.
DelSite's GelVac(tm) nasal powder platform represents a new approach for vaccine delivery. It holds distinct advantages over current vaccine technologies by providing long-term stability at room temperature, shipping and distribution with no need for refrigeration, and administration without a needle. In addition, the vaccine is preservative-free and induces both mucosal and systemic responses. These attributes make DelSite's nasal powder influenza vaccine particularly well suited for pandemic preparedness when such products may need to be stockpiled for extended periods of time and rapidly distributed and self-administered under emergency conditions.
Accelovance, Inc., based in Rockville, Maryland, is a highly experienced CRO in vaccine clinical trials. It owns and operates its own clinical sites and patient recruitment department with a call center. Accelovance brings an unprecedented level of control to trials. The result is high quality trials completed in compressed timelines with cost effectiveness.
"We are very pleased to work with Accelovance for the phase I clinical study of DelSite's nasal powder H5N1 Influenza Vaccine," said Dr. Carlton Turner, chief executive officer of DelSite. "Accelovance's experience and cost-effective approach in providing full CRO services will certainly facilitate a smooth and timely completion of the planned study. The technological attributes associated with GelVac(tm) nasal powder can potentially represent a paradigm shift in vaccine technologies. We are very excited to have brought this nasal powder influenza vaccine closer to the clinical stage."
DelSite's GelVac(tm) nasal powder is based on a chemically and functionally distinct high-molecular-weight ionic polysaccharide-designated GelSite(r) polymer. The polymer allows dry powder to change into gel particles upon contact with liquids in the nasal cavity. The in-situ gel provides sustained antigen release and prolonged nasal residence, thereby increasing exposure to the antigen, resulting in increased immune response.
About Accelovance
Accelovance is a clinical services provider with a proven system of enrolling high numbers of patients, through fewer sites, in reduced timelines. The company brings a new level of control to trials and has a particular focus in vaccine clinical research. Accelovance owns nine (9) research-dedicated clinical sites, operates an internal patient recruitment department, and offers a full service experienced CRO to meet sponsors' needs.
About DelSite
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite(r) technology designed to provide controlled release of peptide and protein-based drugs and vaccines. DelSite is currently developing a nasal powder vaccine using its GelVac(tm) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from NIAID (National Institute of Allergy and Infectious Diseases) of NIH (National Institutes of Health) under the Department of Health and Human Services.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical company currently utilizing naturally-occurring complex carbohydrates technology at its DelSite Biotechnologies subsidiary to develop its proprietary GelSite(r) technology designed for controlled release of peptide and protein-based drugs. Carrington's technology is protected by more than 130 patents in 26 countries. Manufacturing operations comply with cGMP standards. For more information, visit 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-K filed March 31, 2008.