NEW YORK, March 16, 2004 (PRIMEZONE) -- Advanced Plant Pharmaceuticals, Inc. (OTCBB: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 beginning of clinical studies conducted by Clinical Research Laboratories, Inc. (http://www.crl-inc.com) of Piscataway, New Jersey for the lowering of cholesterol.
As previously announced, an Institutional Review Board (IRB) has reviewed the study protocols to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRB's use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. (http://www.fda.gov/cder/about/smallbiz/humans.htm)
Clinical Research Laboratories, Inc. (CRL) in Piscataway, New Jersey has initiated the clinical study with the recruitment of 67 patients so far. The 12 month, randomized, placebo-controlled, double blind, cross-over study to evaluate the LDL/HDL Ratios & total cholesterol levels of patients treated with Lo-Chol(tm) is anticipated to have preliminary results tabulated by August 2004. A statistical analysis by qualified bio-statisticians at the four month and eight month stage will be compiled and reported to APPI to provide data for a peer-reviewed scientific journal article.
David Lieberman, CEO of Advanced Plant Pharmaceuticals, Inc., stated, "It is exciting to see the beginning of the clinical studies that will enable us to apply for a disease claim. The Neuropsychiatric Center of the Palm Beaches, our second clinical site, is expected to begin their studies with their own trial population in the near future. As we progress in these trials, we are hopeful that we can interest one of the pharmaceutical companies exploring promising products in the cholesterol-lowering marketplace."
Lo-Chol(tm) is an all-natural nutraceutical that in clinical blind studies improved the HDL/LDL ratio by up to 46% and reduced overall cholesterol by up to 58%. Lo-Chol(tm) is a unique, proprietary supplement produced utilizing APPI's patent pending "Whole Plant" process that develops whole plant pharmaceuticals and nutritionals. The Company believes 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).
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. CRL's large recruiting department and database allow for rapid, block enrollment of patients.
About Neuropsychiatric Center of the Palm Beaches
Dr. Veronica Motiram is the clinical director of the Neuropsychiatric Center of the Palm Beaches, which is currently running clinical trials for a number of major pharmaceutical companies in the United States. Dr. Motiram has 20 years of field experience and also is a faculty member at the West Boca Medical Center in Boca Raton, Florida.
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) and Lo-Chol(tm). Corporate website: http://www.advancedplantpharm.com
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.