Carrington Subsidiary DelSite Predicts Preservative-Free Vaccines in World’s Future
IRVING, Texas, June 25 /PRNewswire-FirstCall/ — Vaccines are one of the earliest “wonder drugs” having saved millions of lives since their inception, and virtually wiped out killer diseases like smallpox, diphtheria and whooping cough in the developed world. Despite their great success, questions have been raised about possible adverse reactions, relating either to the vaccine or to the preservatives many vaccines contain to prevent bacterial and fungal contamination.
In view of the current public concerns over vaccine preservatives, Carrington Laboratories, Inc. wants to update the progress that its wholly-owned subsidiary, DelSite Biotechnologies, Inc., continues to make in developing its novel drug delivery technology that aims to eliminate the need for preservatives in vaccines in the future.
Preservatives are currently required in the U.S. for all biologic vaccines to prevent bacterial and fungal contamination of the product. Carrington believes this could change if DelSite is successful in its quest to commercialize its proprietary GelVac(TM) and GelSite(R) vaccine and drug delivery systems which could revolutionize how vaccines are stabilized, transported, stored and delivered to the body without risk of contamination.
GelVac(TM) is a dry powder delivery system containing the unique, organically derived GelSite(R) polymer that gels in situ, that is, when it comes into contact with body fluids. The system requires no organic solvent in the manufacturing process, uses no preservatives, and does not require refrigeration. As a nasal delivery system, because it gels in situ, the polymer is mucoadhesive and thus provides prolonged nasal residence time, which optimizes antigen delivery. Both systemic and mucosal immunity are induced with nasal immunization. Further, the system offers room temperature stability, prolonged shelf life, distribution without refrigeration, and needle-free administration.
Later this year DelSite plans to file an IND and initiate human clinical testing of its GelVac(TM) delivery system utilizing a H5N1 bird flu antigen suitable for use in human clinical studies.
In 2004, DelSite received two government grants from the National Institute of Allergy and Infectious Diseases (NIAID) to partially fund preclinical work for the development of this delivery system utilizing the H5N1 antigen. DelSite successfully completed a Phase I clinical trial of its GelVac(TM) system without antigen in 2005, and has been cleared by the FDA to proceed to toxicology studies with the antigen. DelSite secured a strategic source of the antigen in early 2007, and has received the permit from the USDA for its import. Toxicology studies will be initiated as soon as the antigen is received, and once these studies demonstrate the vaccine to be safe in animals DelSite plans to progress to human clinical studies.
“We are excited that human testing will likely become a reality within months, a goal that we’ve worked diligently toward for the past several years,” said Yawei Ni, PhD, DelSite’s chief scientific officer and the discoverer of the polymer on which GelVac(TM) and GelSite(R) are based. “We greatly sympathize with the parents who believe their children may have been adversely affected by preservative additives in vaccines. If our human clinical trials are as successful as we hope, we will contribute greatly to a world where preservatives will no longer be necessary to add to vaccines for any disease, thus reducing the risk of negative side effects.”
So far this year, DelSite has signed five technology rights evaluation agreements with commercial partners who are interested in its technology. EndoBiologics, Inc. of Missoula, Montana is evaluating the GelSite(R) polymer for use in a vaccine to prevent Shigellosis, a form of dysentery. AriaVax, Inc. of Gaithersburg, Maryland is evaluating the GelSite(R) polymer for delivery of a novel HIV vaccine. ElSohly Laboratories is evaluating the GelSite(R) polymer to deliver a novel cancer therapy. International Vaccine Institute is evaluating the polymer for oral delivery of vaccines, and Nastech Pharmaceutical Company Inc. is evaluating it for use in its nasal delivery formulations. Additionally, DelSite initiated work with the National Institutes of Health to evaluate a modification of its GelSite(R) polymer for use as the antigen for a typhoid vaccine; and, with the National Cancer Institute, aimed at the development of a needle-free nasal powder delivery of future HPV vaccines.
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 DelSite Biotechnologies subsidiary is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs. Carrington’s technology is protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. 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 May 15, 2007.
Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300
Web site: http://www.carringtonlabs.com/