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.
Protalex is a biotechnology company engaged in the development of a new
class of drug for the treatment of Rheumatoid Arthritis, Pemphigus and other
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.