NEW YORK, March 10, 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 approval of clinical studies to be conducted by Clinical Research Laboratories, Inc. (www.crl-inc.com) of Piscataway, New Jersey and the Neuropsychiatric Center of the Palm Beaches in Boynton Beach, Florida.
The Allendale Investigational Review Board in Allendale, NJ, a private review board, approved the trial protocols. Under FDA regulations, an Institutional Review Board is a group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is 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, IRBs 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 and the Neuropsychiatric Center of the Palm Beaches in Boynton Beach, Florida can now begin recruiting patients in preparation for conducting a 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). A statistical analysis by qualified bio-statisticians 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. Lo-Chol(tm) is 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 that is produced utilizing APPI's patent pending "Whole Plant" process which develops whole plant pharmaceuticals and nutritionals. 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. Our 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 Neropsychiatric 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) Lo-Chol(tm). Corporate website: 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.