Healthcare Industry News:   cervical cancer vaccine 

Biopharmaceuticals Drug Delivery Oncology

 News Release - September 28, 2006

Carrington Subsidiary to Develop Needle-less Delivery of Cervical Cancer Vaccine With the National Cancer Institute (NCI)

DelSite Nasal Powder Delivery System Could Possibly Increase Immunogenicity and, Combined With Non-refrigerated Transport, Could Enhance Reach of HPV Vaccination Programs Worldwide

IRVING, Texas, Sept. 28 (HSMN NewsFeed) -- Carrington Laboratories, Inc. (Nasdaq: CARN ) today announced that its wholly owned subsidiary, DelSite Biotechnologies, Inc., entered into a three-year Cooperative Research and Development Agreement (CRADA) with the Laboratory of Cellular Oncology at the National Cancer Institute (NCI) to determine if DelSite's GelVac(TM) nasal powder delivery system is adaptable for delivering human papillomavirus virus- like particle (HPV VLP) vaccines in a powder dosage form for mucosal immunization.

The CRADA covers formulation development and immunogenicity studies in animal models.

"Dr. John Schiller of the Laboratory of Cellular Oncology at NCI has extensive experience in the development of HPV VLP vaccines and their application in the prevention of cervical cancer and other genital HPV- associated diseases, and our team is looking forward to his guidance and contributions to this important and timely program," said Carlton E. Turner, PhD, CEO of Carrington.

Dr. Turner noted that in June the US FDA approved a new injectable version of an HPV vaccine, now marketed in the US by Merck & Co. under the name Gardasil®, that requires three needle shots over six months to confer immunity to four types of HPV virus that can cause cervical cancer and genital warts. "It is our hope," he said, "that DelSite's needle-less technology will enhance patient compliance of HPV vaccination programs and make them easier to implement, especially in the remote tropical villages of the Third World where HPV is particularly endemic and where limited infrastructure foils many inoculation programs before they even start."

The Company listed the following benefits as potentially achievable in formulating an HPV vaccine with DelSite's needle-less delivery technology:
  1. Based on earlier preclinical studies, the DelSite technology may lower the number of HPV vaccine inoculations required for immunity, owing to the technology's ability to effect both systemic (whole body immune system) and mucosal immunity. Mucosal tissue is often the point of entry for invading pathogens, and has long been considered an effective site for inducing immunity to foreign invaders. HPV is known to infect epithelial cells of mucosal surfaces of the reproductive tract. Thus, mucosal immunity could potentially enhance prevention of HPV infection. [note: the Merck vaccine protects very well without specific induction of mucosal immunity]

  2. Since a vaccine based on DelSite's technology would be needle-less, it could be self-administered; also, the fact that a nasal vaccine may be used as a booster immunization would likely increase the number of women willing to be vaccinated, a concern cited in a recent (8/23/06) article in The Wall Street Journal.

  3. The dry powder formulation of the nasal vaccine won't require cold storage, as is the case with almost all current vaccines as well as many drugs. This has the potential to reduce cost and speed use of an HPV vaccine in remote villages of developing countries that often lack sufficient refrigeration systems.

  4. Needle-less delivery would eliminate the discomfort and safety hazards of needle sticks and would allow US health officials to more fully implement the Needlestick Safety and Prevention Act of 2000, which requires the Occupational Safety and Health Administration (OSHA) to seek safer medical devices.
"We are excited with this opportunity of working with Dr. Schiller and his team to expand and broaden our vaccine research efforts," Dr. Turner continued. "Based on the ability of the GelSite® polymer to bind to and protect proteins and peptides over a range of temperatures, we have a scientific basis in our expectation for the successful development of a human papillomavirus vaccine system. Additionally, the dry nasal powder delivery system has potentially opened up new opportunities for the delivery of many vaccines restricted by cold chain distribution and may possibly eliminate dependence on medical professionals for administration."

Human papillomavirus (HPV) is the primary cause of cervical cancer in women. HPV affects millions of people worldwide, and the current vaccine strategy requires several immunizations over time to achieve protective immunity. Nasal immunization induces not only systemic but also mucosal immunity, is easy to administer, and is suitable for mass immunization. These advantages of nasal immunization are particularly relevant to pathogens that affect mucosal surfaces.

About DelSite

DelSite Biotechnologies, Inc. is a drug delivery and biotechnology company established to provide the pharmaceutical and biotechnology industries with novel delivery solutions for vaccines and therapeutic agents. DelSite is a wholly owned subsidiary of Carrington Laboratories, Inc. and was formed based on discoveries at Carrington.

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® 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 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 August 14, 2006.


Source: Carrington Laboratories

Issuer of this News Release is solely responsible for its content.
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