8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported) September 12, 2005 (September 9, 2005)

PROTALEX, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdictionof Incorporation)

000-28385	91-2003490
(Commission File Number)	(IRS Employer Identification No.)
145 Union Square Drive, New Hope, PA	18938
(Address of Principal Executive Offices)	(Zip Code)

215-862-9720

(Registrant’s Telephone Number, Including Area Code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

Protalex, Inc. the “Company” filed an Investigative New Drug (IND) Application with the United States Food and Drug Administration (FDA) on March 4, 2005. Based on the FDA’s review, the FDA disclosed to the Company, that it has placed the Company on clinical hold effective March 31, 2005, pending additional product characterization. On August 10, 2005, the Company filed its official response to the clinical hold issue with the FDA, as disclosed in prior Form 8-K filings dated March 7, 2005, April 4, 2005 and August 10, 2005, respectively.

On September 9, 2005, the FDA notified the Company that the clinical hold has been removed and that the Company’s proposed study may proceed.

Section 9 — Financial Statements and Exhibits

Item 9.01.Financial Statements and Exhibit

(c) Exhibits.

99.1Press release dated September 12, 2005.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Protalex, Inc.
		(Registrant)
Date: 9/12/05	By:	/s/ Marc L. Rose

Name:	Marc L. Rose
Title:	Vice President of Finance, Chief Financial Officer, Treasurer and Corporate Secretary

EX-99.1

EXHIBIT 99.1

Protalex, Inc.

145 Union Square Drive

New Hope, PA 18938

(P) 215-862-9720

(F) 215-862-6614

FOR IMMEDIATE RELEASE

PROTALEX INC. ANNOUNCES THE FDA’S LIFTING OF CLINICIAL HOLD

New Hope, PA. September12, 2005. Protalex Inc. (OTCBB: 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.

Contact:

Marc L. Rose

Vice President and Chief Financial Officer

(p) 215-862-9720

(f) 215-862-6614

mrose@protalex.com