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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>UNITED
        STATES</strong></font></div>
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        AND EXCHANGE COMMISSION</strong></font></div>
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        DC 20549</strong></font></div>
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        8-K</strong></font></div>
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        REPORT PURSUANT</strong></font></div>
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        SECTION 13 OR 15</strong></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>(d)</strong></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>
        OF THE</strong></font></div>
      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>SECURITIES
        EXCHANGE ACT OF 1934</strong></font></div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="justify"><br>
        <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Date
          of
          report (Date of earliest event reported) </font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><u>September
          12, 2005 (September 9, 2005)</u></font></div>
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                  INC.</font></div>
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                  Name of Registrant as Specified in Its Charter)</font></div>
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                  or Other Jurisdiction</font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;</font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">of
                  Incorporation)</font></div>
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                  Employer Identification No.)</font></div>
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              <td align="justify" valign="bottom" width="6%">&#160;</td>
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              <td valign="bottom" width="38%" style="BORDER-BOTTOM: #000000 thin solid">
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                  Union Square Drive, New Hope, PA</font></div>
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                  of Principal Executive Offices)</font></div>
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              <td align="left" valign="bottom" width="6%">&#160;</td>
              <td valign="bottom" width="36%">
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                  Code)</font></div>
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              </td>
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                <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">(</font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Registrant&#8217;s
                  Telephone Number, Including Area Code)</font></div>
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              <td align="justify" valign="top" width="80%">&#160;</td>
            </tr>
            <tr>
              <td valign="top" width="80%" style="BORDER-BOTTOM: #000000 thin solid">&#160;</td>
            </tr>
            <tr>
              <td valign="top" width="80%">
                <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">(Former
                  Name or Former Address, if Changed Since Last
                  Report)</font></div>
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      </div>
      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="justify"><br></div>
      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="justify"><font id="TAB1" style="MARGIN-LEFT: 18pt"></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">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 (</font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><em>see
        </em></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">General
        Instruction A.2. below):</font></div>
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              <td align="left">
                <div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Written
                  communications pursuant to Rule 425 under the Securities Act (17
                  CFR
                  230.425)</font></div>
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              </td>
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                <div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Soliciting
                  material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
                  240.14a-12)</font></div>
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            <tr valign="top" style="LINE-HEIGHT: 1.25">
              <td style="WIDTH: 9pt">
              </td>
              <td align="left" style="WIDTH: 18pt"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Wingdings">o</font></td>
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                <div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Pre-commencement
                  communications pursuant to Rule 14d-2(b) under the Exchange Act
                  (17 CFR
                  240.14d-2(b))</font></div>
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            <tr valign="top" style="LINE-HEIGHT: 1.25">
              <td style="WIDTH: 9pt">
              </td>
              <td align="left" style="WIDTH: 18pt"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Wingdings">o</font></td>
              <td align="left">
                <div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Pre-commencement
                  communications pursuant to Rule 13e-4(c) under the Exchange Act
                  (17 CFR
                  240.13e-4(c))</font></div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><br></div><br>
      <div id="PGBRK" style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt">
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        <div id="PN" style="PAGE-BREAK-AFTER: always">
          <div style="WIDTH: 100%; TEXT-ALIGN: center">&#160;</div>
          <div style="WIDTH: 100%; TEXT-ALIGN: center">
            <hr style="COLOR: black" noshade size="2">
          </div>
        </div>
        <div id="HDR">
          <div id="GLHDR" style="WIDTH: 100%" align="right">&#160;</div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><br></div>
      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>Item
        8.01 Other Events.</strong></font></div>
      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><br></div>
      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><font id="TAB1" style="MARGIN-LEFT: 36pt"></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Protalex,
        Inc. the &#8220;Company&#8221; filed an Investigative New Drug (IND) Application with the
        United States Food and Drug Administration (FDA) on March 4, 2005. Based
        on the
        FDA&#8217;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.</font></div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><font id="TAB1" style="MARGIN-LEFT: 36pt"></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">On
        September 9, 2005, the FDA notified the Company that the clinical hold has
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        9 &#8212; Financial Statements and Exhibits</strong></font></div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>Item
        9.01.</strong></font><font id="TAB2" style="COLOR: black; LETTER-SPACING: 27pt">&#160;</font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>Financial
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">(c)
        </font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><em>Exhibits.</em></font></div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 36pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">99.1</font><font id="TAB2" style="COLOR: black; LETTER-SPACING: 36.8pt">&#160;</font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Press
        release dated September 12, 2005.</font></div>
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          <div style="WIDTH: 100%; TEXT-ALIGN: center">&#160;</div>
          <div style="WIDTH: 100%; TEXT-ALIGN: center">
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          </div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><strong>SIGNATURES</strong></font></div>
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      <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt" align="left"><font id="TAB1" style="MARGIN-LEFT: 36pt"></font><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">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. </font></div>
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            <tr valign="top" bgcolor="#ffffff">
              <td width="50%"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;</font></td>
              <td width="1%"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;</font></td>
              <td width="49%"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;</font></td>
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              <td colspan="2" style="BORDER-BOTTOM: #000000 thin solid"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Protalex,
                Inc.</font></td>
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            <tr valign="top" bgcolor="#ffffff">
              <td><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;<br>&#160;</font></td>
              <td><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;<br>&#160;</font></td>
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                <div><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#160;(Registrant)</font></div>
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{"company-data": {"conformed-name": "PROTALEX INC", "cik": "0001099215", "assigned-sic": "8731", "irs-number": "912003490", "state-of-incorporation": "DE", "fiscal-year-end": "0531"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "000-28385", "film-number": "051080131"}, "business-address": {"street1": "145 UNION SQUARE DRIVE", "city": "NEW HOPE", "state": "PA", "zip": "18938", "phone": "215-862-9720"}, "mail-address": {"street1": "145 UNION SQUARE DRIVE", "city": "NEW HOPE", "state": "PA", "zip": "18938"}}
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 Jurisdiction
of
                  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.
99.1
Press
        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