IRVING, Texas, Feb. 6 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that Carrington’s subsidiary DelSite Biotechnologies, Inc. and Nippon Chemiphar have formed a research collaboration to evaluate the feasibility of using a GelSite(R) nasal powder formulation to deliver Nippon Chemiphar’s proprietary therapeutic peptide, NC- 1900, as a treatment for Alzheimer’s Disease. The two companies plan to study a nasal powder formulation that could be delivered by a nasal inhaler.
NC-1900 has been shown in extensive preclinical studies to facilitate learning and memory behavior when administered by injection. DelSite and Nippon Chemiphar believe that a GelSite(R) nasal powder formulation could result in a highly desirable product suitable for chronic administration to patients with mild to moderately severe Alzheimer’s Disease.
Chemiphar is speeding up development and candidate screening of compounds it has discovered, and plans to license these overseas with a view to accelerating commercialization. Opportunities for venture-based drug research and for licensing are being sought so that new pharmaceuticals may be brought to the global market with minimum delay.
“We are very pleased to be working with Nippon Chemiphar to develop an enhanced formulation of NC-1900,” said Kenneth Yates, president of DelSite. “The unique functional properties of our GelSite(R) nasal powder delivery technology are well suited for creating an easy-to-use dosage form of a potentially significant new product for the treatment of Alzheimer’s disease. In addition to development costs covered to date by our organizations, we will seek additional funding and submitted a grant (February 1, 2006) to the U.S. National Institute of Health (NIH) grants program covering the development of new treatments for Alzheimer’s disease.”
About Alzheimer’s Disease
Alzheimer’s disease (AD) is dementia of the brain that seriously affects a person’s ability to carry out the activities of daily life. It involves the parts of the brain that control thought, memory and language. AD is a slowly developing disease, usually beginning after age 60, starting with mild memory problems and ending with severe brain damage. The course the disease takes and how fast changes occur vary from person to person. On average, AD patients live from 8 to 10 years after they are diagnosed; though, the disease can last for as many as 20 years. Thus far, no treatment has demonstrated the ability to stop AD but some medicines may help control symptoms such as sleeplessness, agitation, wandering, anxiety, psychosis and depression.
About five percent of men and women ages 65 to 74 have AD, and nearly half of those age 85 and older may have the disease. Approximately 2.6 million people in the U.S. and 18 million worldwide are affected. Each U.S. family with an Alzheimer’s patient spends an estimated $200,000 on healthcare. About half of nursing home residents have the disease or a related disorder, with an average annual cost of care of $64,000. Medicare and Medicaid spending for Alzheimer’s disease patients was $50.1 billion in 2000 and the estimated total cost to the U.S. economy exceeds $100 billion annually.
About GelSite(R)
GelSite(R) polymer is a high molecular weight anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite(R) is water-based and is capable of in situ gelation, i.e., changing from a solid or liquid into a gel upon contact with body fluids leading to sustained-release of active biomolecules. It also has demonstrated mucoadhesive properties making it highly suitable for mucosal delivery.
GelSite(R) is a member of a family of plant polysaccharides classified by the FDA as Generally Regarded As Safe (GRAS). The polymer is currently manufactured in accordance with cGMP standards at Carrington Laboratories’ wholly-owned subsidiary, Sabila Industrial, SA. A drug master file (DMF) was submitted in September of 2005 for mucosal delivery applications. Also, DelSite completed a Phase I safety trial for its GelVac(TM) nasal powder vaccine delivery system, which also incorporates the GelSite(R) polymer as the primary functional pharmaceutical excipient.
About DelSite
DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington Laboratories, was established to commercialize its novel polymer drug delivery technology. DelSite is focused on delivery systems for vaccines and therapeutic proteins and peptides that could benefit from improved routes of administration. For more information please visit http://www.delsite.com .
About Nippon Chemiphar
The pharmaceutical company Nippon Chemiphar Co., Ltd. was established in 1950 and has been listed in the First Section of the Tokyo Stock Exchange since 1976. With its depth of expertise in drug discovery, Chemiphar is strategically focused on scanning and identifying drug leads for further development. Its R&D centers on analgesics, therapies for life style-related diseases, and hyperuricemia (the presence in the blood of an abnormally high concentration of uric acid). For more information, please visit http://www.chemiphar.co.jp .
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 November 14, 2005.
Carrington(R), Manapol(R), AloeCeuticals(R), Hydrapol(TM), GelSite(R) and GelVac(TM) are trademarks, registered trademarks or service marks of Carrington Laboratories, Inc., in the United States and/or other countries. All other trademarks or service marks contained herein are the properties of their respective owners.
Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300
