IRVING, Texas, July 9 /PRNewswire-FirstCall/ -- 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(TM) 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(TM) platform is based on the GelSite(R) 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(R) 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(R) polymer is recognized as certified organic by the U.S. Department of Agriculture, the European Union and the government of Costa Rica.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical company currently utilizing naturally-occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care.
Carrington’s DelSite Biotechnologies subsidiary is developing its proprietary GelSite technology, which is designed to provide controlled release of peptide and protein-based drugs. Core technology is protected by more than 130 patents in 26 countries. www.carringtonlabs.com and www.delsite.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 May 15, 2007.
Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, Chief Executive Officer, +1-972-518-1300
