Protalex Appoints Edward W. Bernton, MD as Medical Director and Updates Development Plans for 2007.NEW HOPE, Pa. -- Protalex, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : PRTX) announced today the appointment of Edward W. Bernton, MD, to the position of Medical Director. Dr. Bernton has over 20 years experience in medical research and therapeutic product development specializing in Pharmacology, Clinical Immunology, Immunotoxicology, and Experimental Medicine. His broad experience includes planning and execution of numerous Investigational New Drug (IND) applications as well as authoring protocols for over 30 Phase I & II studies. Prior to positions with Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. , Inc., Analytica Therapeutics, and Parexel International, Dr. Bernton spent 11 years in laboratory and clinical research at Walter Reed Army Institute of Research This article is about the U.S. Army medical research institute (not the hospital). Otherwise, see Walter Reed (disambiguation). The Walter Reed Army Institute of Research (WRAIR) is the largest biomedical research facility administered by the U.S. . As Medical Director, Dr. Bernton will be responsible for directing the activities of an expanded team of experts whose primary focus will be to file an IND application for Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Definition Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood. (ITP ITP - Intent to Package ) and to update the active IND in Rheumatoid Arthritis (RA). This group includes: Michael J. Hensley, MD, former Medical Officer with 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. ), and former VP of Clinical & Regulatory affairs at Quintiles; Barry M. Sherman, MD, Executive Vice President, Development of BiPar Sciences and former Chief Medical Officer at Genentech; Kevin Dwyer, Co-Founder, Managing Partner, and VP, Regulatory Affairs at Pacific BioDevelopment, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control .; and Paula M. Jardieu, PhD, Vice President of Biosciences of Prevalere Life Sciences and former Senior Vice President of Development at Genetech. Quoting Dr. Bernton, "Protalex's Phase I safety and pharmacokinetics study accomplished the Company's goals of defining the safety and tolerability profile of a single-dose of PRTX-100 in healthy volunteers. Additionally, both safety and pharmacodynamic markers to be used in upcoming patient trials were defined." Dr. Bernton continued, "Our immediate plans are to file an update to the Rheumatoid Arthritis IND, including a new safety and pharmacokinetic protocol, followed shortly by an IND application for the indication of Idiopathic Thrombocytopenic Purpura, a disease with immune-mediated destruction of platelets." Steven Kane, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. added, "We are pleased with the outcome of our first-in-man study. I believe that this accomplished team, among the most experienced and successful in the industry, will help us accelerate the development and commercialization of PRTX-100 in ITP, RA and other autoimmune disorders". Key objectives in 2007 include: Q1 - PRTX-100 Patent Q2 - File update to active RA IND with the FDA Q2 - File IND in ITP with the FDA Q3 - Initiate Phase II study in ITP Q4 - Proof of concept in ITP About PRTX-100 PRTX-100 is a highly-purified form of Staphylococcal staphylococcal pertaining to Staphylococcus spp. staphylococcal clumping test used as a means of measuring the quantity of fibrinogen-split products in a sample of blood. Protein A. PRTX-100 binds directly to monocytes monocytes, n.pl the largest of the white blood cells. They have one nucleus and a large amount of grayish-blue cytoplasm. Develop into macrophages and both consume foreign material and alert T cells to its presence. and a subset of B-cells that are involved in the development and progression of various autoimmune diseases, enabling the compound to modulate the function of these cells and restore the balance of the immune system. About Protalex, Inc. Protalex, Inc. is a biotechnology company engaged in the development of a new class of drugs for the treatment of Rheumatoid Arthritis, Idiopathic Thrombocytopenic Purpura and a host of other autoimmune disorders. Additional information about Protalex, Inc. can be found at www.protalex.com. Cautionary Statement Regarding Forward Looking Information This release contains forward-looking information about Protalex, Inc. that are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Forward-looking statements are statements that are not historical facts. These statements can be identified by the use of forward-looking terminology such as "believe," "expect," "may," "will," "should," "project," "plan," "seek," "intend," or "anticipate" or the negative thereof or comparable terminology, and include discussions of strategy, and statements about industry trends and Protalex's future performance, operations and products. This forward-looking information should be considered only in connection with "Risk Factors" in Protalex's Annual Report on Form 10-KSB filed with the Securities and Exchange Commission ("SEC") on July 28, 2006 and its other periodic reports filed with the SEC. Protalex assumes no obligation to update any forward-looking statements or information set forth in this press release. PRTX-G |
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