Protalex Announces Preliminary Results in Phase I Clinical Trial
The study, in which 16 volunteers received PRTX-100 and four received placebo, will complete when day 30 and day 60 study visits have occurred for all volunteers. No moderate or severe adverse events have occurred to date with preliminary results indicating that the drug was safe and well tolerated.
Edward W. Bernton M.D., Medical Director of Protalex commented, "Preliminary data indicate improved product tolerability compared to the initial Phase I study. No febrile or hypersensitivity responses were seen after dosing and laboratory markers for immune activation indicate that the product can be dosed with an acceptable toxicity profile in upcoming patient studies. We are pleased to have significantly extended the safety database for PRTX-100, and await the full study results which are expected in September."
Steven H. Kane, President & Chief Executive Officer of Protalex said, "The completion of process improvements in PRTX-100 manufacturing and of our single-dose Phase I program, lays the scientific and regulatory groundwork to support upcoming studies in patients with rheumatoid arthritis and idiopathic thrombocytopenic purpura. Our development team is working diligently to meet the key clinical milestones and we look forward to demonstrating proof-of-concept for our novel molecule, PRTX-100."
About PRTX-100
PRTX-100 is a highly-purified form of the Staphylococcal bacterial protein known as Protein A. PRTX-100 has the ability, at very low concentrations, to bind to and to down regulate activation of human B-lymphocytes and macrophages which are key cells mediating inflammation in certain autoimmune diseases. Laboratory studies indicate the mechanism involves interference with specific intracellular signaling pathways. Pre-clinical studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects on model inflammatory diseases.
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 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
Contact
Protalex, Inc.
Marc L. Rose, 215-862-9720
Vice President and Chief Financial Officer
Fax: 215-862-6614
mrose@protalex.com
Posted: July 2007
