Protalex Inc. Announces the FDA'S Lifting of Clinicial Hold

Sep 12, 2005, 01:00 ET from Protalex Inc.

    NEW HOPE, Pa., Sept. 12 /PRNewswire-FirstCall/ -- Protalex Inc. (OTC
 Bulletin Board: PRTX) announced today that the United States Food and Drug
 Administration ("FDA") has removed the clinical hold on its Investigational
 New Drug ("IND") application for their lead compound PRTX-100.  "This
 represents a significant milestone achievement for our company," said Steven
 H. Kane, President and Chief Executive Officer.  "We now have FDA clearance to
 immediately proceed with the planned Phase I safety trial in healthy
 volunteers. Although the pathway to healthy volunteers presented the Company
 with greater challenges, we believe we are now strategically in a better
 position to accomplish our future goals."
     Victor S. Sloan, M.D., Senior Vice President and Chief Medical Officer
 added, "I am particularly excited about conducting trials in healthy
 volunteers, as a successful completion of Phase I trials will give the Company
 the option to start Phase II trials in several different indications, rather
 than being restricted to only the indication studied in Phase I."
     As previously announced the Company submitted its IND on March 4, 2005 and
 on March 31, 2005, the FDA placed on the Company's IND on clinical hold
 pending additional product characterization.  On August 10, 2005, the Company
 filed its official response to the clinical hold issue with the FDA.
     About Protalex
     Protalex is a biotechnology company engaged in the development of a new
 class of drug for the treatment of Rheumatoid Arthritis, Pemphigus and other
 autoimmune diseases.
     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.

SOURCE Protalex Inc.