Lowering of Cholesterol with Lo-Chol Begins at Clinical Research Laboratories, Inc.
via COMTEXMarch 16, 2004
NEW YORK, Mar 16, 2004 (PRIMEZONE via COMTEX) --
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).
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