Clinical Research Laboratories, Inc. To Conduct Clinical Study On Advanced Plant Pharmaceuticals, Inc.'s Lo-Chol.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--Sept. 24, 2003 Multi-Center Study To Evaluate LDL/HDL Cholesterol Ratios Of Patients Treated With Lo-Chol(TM) Advanced Plant Pharmaceuticals, Inc. (APPI APPI American Psychiatric Publishing, Inc. APPI American Psychiatric Publishing Inc. APPI American Psychiatric Press, Inc. APPI Atmospheric Pressure Photoionization APPI Advanced Peer-to-Peer Internetworking APPI Advanced Plant Pharmaceuticals Inc. ), 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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 United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) similar to food producers being permitted to claim that consumption of oats oats, cereal plants of the genus Avena of the family Gramineae (grass family). Most species are annuals of moist temperate regions. The early history of oats is obscure, but domestication is considered to be recent compared to that of the other 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 Cholesterol, High Definition Cholesterol is a fatty substance found in animal tissue and is an important component to the human body. It is manufactured in the liver and carried throughout the body in the bloodstream. 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 "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) 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 CRL - Carnegie Representation Language. Carnegie Group, Inc. Frame language derived from SRL. Written in Common LISP. Used in the product Knowledge Craft. ) 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 OTC See: Over-the-counter. OTC See over-the-counter market (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 Homeopathic A holistic and natural approach to healthcare. Mentioned in: Ehlers-Danlos Syndrome homeopathic, adj 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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. |
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