Protalex Announces the Successful Completion of Its Phase I Clinical Trial.NEW HOPE, Pa. -- Protalex, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: PRTX) announces the successful completion of its Phase I trial of its lead compound, PRTX-100 in humans. This Phase I study was performed in healthy volunteers, and was designed primarily to assess the safety and tolerability of PRTX-100. The basic safety data demonstrate that PRTX-100 was safe and well tolerated. There were no deaths or serious adverse events. The pharmacokinetic profile was favorable and the preclinical pharmacokinetic data were confirmed by the data in this Phase I trial. The more comprehensive final report is expected to be available by the end of June 2006. Additionally, as part of Protalex's ongoing effort to optimize the drug production process for Phase II, a new assay was recently finalized. The application of this completed assay will assist in the optimization of the manufacturing process which will be implemented prior to the initiation of the Phase II trial. The Company now expects the Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II to commence prior to the end of 2006. Steven H. Kane, President & 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. said, "The successful completion of the Phase I trial and the development of the critical assay months ahead of schedule, demonstrate our ability to effectively execute our plan on all levels. The completion of the Phase II trial in 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 ) will serve as the next major milestone and will also provide the critical validation for PRTX-100's unique mechanism of action. We believe that success in Phase II will solidify our efforts to bring to market this much needed product for sufferers of various autoimmune disorders." Victor S. Sloan M.D., Senior Vice President and Chief Medical Officer added," I am extremely excited that the Company has cleared an important hurdle and that PRTX-100 has proven to be safe and well tolerated in its first human trial. I am looking forward to successfully demonstrating efficacy in the upcoming Phase II trial in ITP." About Protalex Protalex, Inc. is a biotechnology company engaged in the development of a new class of drugs for the treatment of Rheumatoid Arthritis (RA), Idiopathic Thrombocytopenic Purpura (ITP), and a host of other autoimmune disorders. The Company's lead compound, 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 (SpA or Protein A) naturally secreted by Staphylococcus aureus, strain A676 (S. aureus A676.) 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, cells that are involved in the development and progression of various autoimmune diseases. This ability allows PRTX to modulate the function of these cells and restore the balance in the immune system. The Company initially developed PRTX-100 for ITP because of its relatively clear-cut regulatory pathway and clinical end points, as well as its orphan status, unique mechanism of action applicable to ITP. Subsequent and/or current autoimmune indications are expected to include: Rheumatoid Arthritis (RA); Systemic Lupus Erythematosus Systemic Lupus Erythematosus Definition Systemic lupus erythematosus (also called lupus or SLE) is a disease where a person's immune system attacks and injures the body's own organs and tissues. Almost every system of the body can be affected by SLE. (SLE SLE systemic lupus erythematosus. SLE abbr. systemic lupus erythematosus Systemic lupus erythematosus (SLE) ); and other orphan indications, such as Anti-Phospholipid Syndrome (APS), Graves Disease, and Pemphigus pemphigus /pem·phi·gus/ (-gus) 1. a distinctive group of diseases marked by successive crops of bullae. 2. pemphigus vulgaris. . 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 August 26, 2005 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. |
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