Carrington Subsidiary DelSite Enters Into Consulting Agreement With Biologics Consulting Groups, Inc.

Irving, TX - Carrington Laboratories, Inc. today announced its wholly-owned subsidiary, DelSite Biotechnologies, Inc., and Biologics Consulting Group, Inc. of Alexandria, Virginia, entered into a consulting agreement for regulatory and product development advice with the H5N1 bird influenza vaccine.

Biologics Consulting Group, Inc. (BCG) is a team of consultant experts who provide regulatory and product development advice on the development and commercial production of biotechnological and biologics products.

BCG's staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. BCG has extensive biologics and influenza vaccine experience. BCG staff members include professionals formerly employed at the FDA's Center for Biologics Evaluation and Review (CBER), the Centers for Disease Control and Prevention (CDC) and in the biotech industry.

Dr. Carlton Turner, President and CEO of DelSite, stated, "We are pleased to work with regulatory experts at BCG, who are highly skilled in developing regulatory strategies for biologics product development. This is integral to DelSite's plans to expeditiously initiate clinical studies of this H5N1 bird flu vaccine using DelSite's GelVac dry powder delivery system. This vaccine possesses highly advantageous features including room temperature stability and cold chain-free distribution that are critical in meeting the needs of pandemic preparedness."

DelSite has completed the Phase I safety study for the powder system without an antigen which showed that the system was safe and well tolerated. The company has secured a source of GMP H5N1 antigen suitable for clinical studies and plans to file an IND with the FDA for the Phase I clinical study later this year.

DelSite's GelVac platform is based on the GelSite polymer, a negatively-charged linear polymer with a molecular weight greater than 450,000 which is derived from a natural source and is classified as a GRAS (generally regarded as safe) by the FDA. GelSite is produced in kilogram quantities under FDA good manufacturing practices for human drugs (cGMP) in an ISO- certified facility. Each kilogram of the GelSite(R) polymer can be used to manufacture approximately 10 million vaccine doses. Plant material used in the production of GelSite polymer is recognized as certified organic by the U.S. Department of Agriculture, the European Union and the government of Costa Rica.

SOURCE: Carrington Laboratories, Inc.