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Protalex Announces the Successful Completion of Its Phase I Clinical Trial.

NEW HOPE, Pa. -- Protalex, Inc. (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 to commence prior to the end of 2006.

Steven H. Kane, President & CEO 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 (ITP) 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 Protein A (SpA or Protein A) naturally secreted by Staphylococcus aureus, strain A676 (S. aureus A676.) PRTX-100 binds directly to monocytes 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 (SLE); and other orphan indications, such as Anti-Phospholipid Syndrome (APS), Graves Disease, and Pemphigus.

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 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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Publication:Business Wire
Date:May 4, 2006
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