* Safer and More Economical Approach Against a Major Infectious
Disease That Causes 500,000 to 600,000 Deaths Worldwide Per Year
* Chemical Composition Similar to Marketed Typhoid Vi Polysaccharide
Vaccine
* Made From cGMP Natural Polysaccharide Material
* No Fermentation Required
* Cost Substantially Lower Than the Vi Polysaccharide Antigen
* Available for Partnering or Licensing
IRVING, Texas, June 26, 2008 (PRIME NEWSWIRE) -- DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington Laboratories, Inc. (OTCBB:CARN), today announced that it has developed a proprietary synthetic typhoid fever vaccine candidate based on a novel plant polysaccharide (high-molecular-weight polygalacturonic acid, HPGA) that holds the potential to greatly enhance production and use of typhoid fever vaccine worldwide.
Typhoid fever, caused by the bacteria Salmonella typhi, is a major infectious disease which infects 16 to 33 million people and causes 500 to 600 thousand deaths per year worldwide. Currently marketed Vi polysaccharide vaccines are made by the fermentation and extensive purification of Salmonella typhi bacteria, a costly and hazardous process. DelSite's patented synthetic vaccine is produced with a simple chemical process with a great yield (at 100%) and bypasses both fermentation and the expensive purification process. In addition, because the synthetic vaccine antigen is plant-based, it contains no lipopolysaccharide (LPS) endotoxin, a cell wall component of gram-negative bacteria such as Salmonella typhi that is the most dangerous contaminant in vaccines purified from these bacteria.
DelSite's synthetic vaccine meets the potency standards of licensed Vi polysaccharide vaccines. The starting raw material HPGA is uniquely suited for the synthetic vaccine antigen and is produced under cGMP in an ISO-certified facility at kilogram quantities, ensuring ample supply for potential vaccine production. One kilo of HPGA, when modified to produce the synthetic Vi antigen, will yield enough material for more than 20 million doses. Thus, cost for the antigen will be substantially lower than the Vi polysaccharide antigen produced by fermentation that is used in current vaccines for typhoid.
In addition to establishing the production process, DelSite has demonstrated antigenicity as well as immunogenicity of its proprietary antigen. Latest studies have shown that the DelSite's antigen may also be readily linked to a protein carrier to create a conjugate antigen. Vaccines which use conjugate antigens are more effective when inoculating children younger than two years of age.
"We believe that our synthetic typhoid antigen, when fully developed, may change the dynamics of the current typhoid vaccine program, making typhoid vaccines more affordable and more widely used," said Dr. Yawei Ni, chief scientific officer of DelSite.
"DelSite's focus is technology development and licensing, not manufacturing and marketing of final products. Thus, our technology will be available for licensing to partners or vaccine manufacturers. We believe our technology will allow for worldwide production and distribution of a typhoid vaccine at a very attractive price to foundations, governments and vaccine manufacturers," Dr. Ni continued.
While DelSite will continue the development of this vaccine candidate, samples of its synthetic typhoid antigen, protected by DelSite's patents and patent applications, may be obtained by contacting Dr. Yawei Ni, CSO of DelSite. A Non-Exclusive Evaluation License will be granted to all serious researchers, manufactures or government entities.
About DelSite
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc., under its proprietary GelSite(r) polymer technology for the controlled release of peptide and protein-based drugs and vaccines, has developed three distinct platforms: the GelVac(tm) Powder, GelSure(tm) Injectable and GPDA(tm) Adjuvant platforms. 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. A Phase I clinical trial for avian influenza vaccine (H5N1 antigen) is on track for initial dosing of patients to begin during the third quarter of 2008.
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.