NEW YORK--Sept. 24, 2003--
Multi-Center Study To Evaluate LDL/HDL Cholesterol Ratios Of
Patients Treated With Lo-Chol(TM)
Advanced Plant Pharmaceuticals, Inc. (APPI), a company that utilizes whole plants through a proprietary (patent pending) manufacturing process to develop all-natural Whole Plant Pharmaceuticals and Nutritionals, has announced the signing of a clinical study agreement with Clinical Research Laboratories, Inc. (www.crl-inc.com) of Piscataway, New Jersey.
Clinical Research Laboratories, Inc. will conduct a 12 month, randomized, placebo-controlled, cross-over study to evaluate the LDL/HDL cholesterol ratios of patients treated with Lo-Chol(TM). A statistical analysis by a qualified bio-statistician at the 4 month and 8 month stage will be compiled and reported to APPI to provide data for a peer-reviewed scientific journal article. The multi-center study will involve 132 patients to assure bio-statistical significance.
In addition, the company believes that study results may permit the company to apply for a disease claim approval from the United States Food and Drug Administration (FDA) similar to food producers being permitted to claim that consumption of oats helps lower cholesterol. A joint venture agreement with a major pharmaceutical company, supported by the Lo-Chol clinical results, is targeted after final results are reported.
Lo-Chol(TM) is a unique, proprietary supplement that is produced utilizing APPI's patent pending "Whole Plant" process, which develops whole plant pharmaceuticals and nutritionals (http://www.uspto.gov). Patients with high cholesterol who experience the worst of the documented side effects that many prescription cholesterol-lowering drugs cause often seek alternative, natural supplements such as Lo-Chol(TM). This non-prescription market is $250 million for the U.S. alone and rapidly growing as a percentage of the overall $20 Billion prescription cholesterol-lowering U.S. market. A recent National Institute of Health (NIH) study reports that up to 101 million of the U.S. population has borderline high cholesterol--a market that may be addressed by non-prescription supplements such as Lo-Chol(TM).
About Clinical Research Laboratories, Inc.
Incorporated in 1992, Clinical Research Laboratories, Inc. (CRL) is an independent contract laboratory providing a wide range of clinical safety and efficacy testing to the cosmetic and pharmaceutical industries. CRL is dedicated to conducting human clinical test procedures to determine the safety and efficacy of cosmetic, personal care, and OTC drug products. CRL is a dedicated, state-of-the-art research facility offering a full line of services from the development of a protocol through the statistical analysis and comprehensive final report. Our staff consists of physicians, clinical coordinators, registered nurses, and statisticians with an average of fifteen years of clinical trial experience. CRL conducts Phase II-IV clinical trials in a wide variety of therapeutic areas working with the major OTC healthcare and pharmaceutical companies. Our large recruiting department and database allow for rapid, block enrollment of patients.
About Advanced Plant Pharmaceuticals, Inc.
Advanced Plant Pharmaceuticals, Inc. (APPI) focuses on the research and development of plant-based dietary and health supplements. The Company has a patent pending process that utilizes whole plants to manufacture all natural dietary and health supplements. APPI uses this process to manufacture products, which the company distributes worldwide through various marketing and distribution contracts. Current products include Sinusol (homeopathic allergy and nasal spray), Garlic, ABAVCA(TM) (immune system booster) and Lo-Chol(TM). Corporate website: www.appi.cc
FORWARD LOOKING STATEMENTS:
This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the Company.