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<SEC-DOCUMENT>0000950123-08-011239.txt : 20080922
<SEC-HEADER>0000950123-08-011239.hdr.sgml : 20080922
<ACCEPTANCE-DATETIME>20080922105738
ACCESSION NUMBER:		0000950123-08-011239
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20080917
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20080922
DATE AS OF CHANGE:		20080922

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			FL
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		081081672

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			21000
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			21000

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ORTHODONTIX INC
		DATE OF NAME CHANGE:	19980422

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	EMBASSY ACQUISITION CORP
		DATE OF NAME CHANGE:	19960124
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>y00172e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>8-K</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->
<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 1pt solid black; font-size: 1pt">&nbsp;</DIV>




<DIV align="center" style="font-size: 14pt; margin-top: 12pt"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B>Washington, D.C. 20549</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

<DIV align="center" style="font-size: 18pt; margin-top: 12pt"><B>FORM 8-K</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B>CURRENT REPORT</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 0pt"><B>Pursuant to Section&nbsp;13 or 15(d)<BR>
of the Securities Exchange Act of 1934</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of earliest event reported): September&nbsp;17, 2008</B></DIV>

<DIV align="center" style="font-size: 24pt; margin-top: 12pt"><B>Protalix BioTherapeutics, Inc.</B>
</DIV>

<DIV align="center" style="font-size: 10pt">(Exact name of registrant as specified in its charter)</DIV>


<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top">Florida
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">000-27836
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">65-0643773</TD>
</TR>
<TR style="font-size: 1px">
    <TD align="center" valign="top" style="border-top: 1px solid #000000">&nbsp;
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top" style="border-top: 1px solid #000000">&nbsp;
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top" style="border-top: 1px solid #000000">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">(State or other <BR>
jurisdiction of <BR>
incorporation)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(Commission<BR>
File Number)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(IRS Employer<BR>
Identification No.)</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>2 Snunit Street<BR>
Science Park<BR>
POB 455<BR>
Carmiel, Israel 20100</B><BR>
<DIV style="margin-top: 1px"><FONT style="border-top: 1px solid #000000">(Address of principal executive offices) (Zip Code) </FONT></DIV></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV style="margin-top: 1px"><FONT style="border-top: 1px solid #000000">(Former Name or Former Address, if Changed Since Last Report)</FONT></DIV></DIV>


<DIV align="CENTER" style="font-size: 10pt; margin-top: 12pt">Registrant&#146;s telephone number, including area code: &#043;972-4-988-9488
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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):
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
</DIV>


<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>





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</DIV>

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<DIV style="font-family: 'Times New Roman',Times,serif">

<!--TOC-->
<!--/TOC-->

<!-- link1 "Item&nbsp;7.01. Regulation&nbsp;FD Disclosure" -->

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;7.01. Regulation&nbsp;FD Disclosure</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On September&nbsp;17, 2008, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing that Dr.&nbsp;David Aviezer, the Company&#146;s President and Chief Executive Officer, will
present at the UBS Global Life Sciences Conference on Wednesday, September&nbsp;24, 2008 at 1:30 PM, ET.
The conference is being held at the Grand Hyatt Hotel in New York City. A copy of the press
release is furnished as Exhibit&nbsp;99.1.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">An audio
webcast of the corporate presentation will be available on the
Company&#146;s website at www.protalix.com under the events calendar
section.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The information in Item&nbsp;7.01 of this report (including Exhibit&nbsp;99.1) is being furnished pursuant to
Item&nbsp;7.01 of Form 8-K and shall not be deemed to be &#147;filed&#148; for purposes of Section&nbsp;18 of the
Securities Exchange Act of 1934 (the &#147;Exchange Act&#148;) or otherwise subject to the liabilities of
that section, nor shall it be deemed to be incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act.
</DIV>

<!-- link1 "Item&nbsp;8.01. Other Events" -->

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;8.01. Other Events</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On September&nbsp;22, 2008, the Company issued a press release announcing that it has enrolled more than
75% of the patients required for the Company&#146;s on-going phase III clinical trial of its lead
product candidate, prGCD, a proprietary plant cell expressed recombinant form of human
Glucocerebrosidase (GCD)&nbsp;for the treatment of Gaucher disease, and that the Company anticipates
completion of enrollment in the clinical trial during the second half of 2008. A copy of the press
release is attached hereto as Exhibit&nbsp;99.2.
</DIV>

<!-- link1 "Item&nbsp;9.01. Financial Statements and Exhibits" -->

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;9.01. Financial Statements and Exhibits</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>(d)&nbsp;Exhibits</B>
</DIV>


<DIV style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="1%" nowrap align="left">99.1</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated September&nbsp;17, 2008.</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="1%" nowrap align="left">99.2</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated September&nbsp;22, 2008.</TD>
</TR>

</TABLE>
</DIV>
<P align="center" style="font-size: 10pt"><!-- Folio -->2<!-- /Folio -->
</DIV>

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<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV style="margin-top: 6pt"><TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">



</TABLE>
</DIV>
<!-- link1 "SIGNATURES" -->

<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>SIGNATURES</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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.
</DIV>


<TABLE width="100%" border="0" cellspacing="0" cellpadding="0" style="font-size: 10pt">
<TR>
    <TD width="48%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="35%">&nbsp;</TD>
    <TD width="15%">&nbsp;</TD>
</TR>
<TR>
    <TD valign="top" align="left">&nbsp;</TD>
    <TD colspan="3" align="left"><B>PROTALIX BIOTHERAPEUTICS, INC.</B><BR>
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left"> Date: September 22, 2008&nbsp;</TD>
    <TD valign="top">By:&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD colspan="1" style="border-bottom: 1px solid #000000" align="left">/s/ David Aviezer
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>Name:</TD>
    <TD valign="top">&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>Title:</TD>
    <TD valign="top">&nbsp;</TD>
    <TD align="left">President and
Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>

</TABLE>

<P align="center" style="font-size: 10pt"><!-- Folio -->3<!-- /Folio -->
</DIV>

</BODY>
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</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y00172exv99w1.htm
<DESCRIPTION>EX-99.1: PRESS RELEASE
<TEXT>
<HTML>
<HEAD>
<TITLE>EX-99.1</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
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<DIV style="font-family: 'Times New Roman',Times,serif">


<TABLE width="100%" border="0" cellspacing="0" cellpadding="0" style="font-size: 10pt">
<TR>
    <TD width="48%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="35%">&nbsp;</TD>
    <TD width="15%">&nbsp;</TD>
</TR>

</TABLE>

<DIV align="right" style="font-size: 10pt; margin-top: 12pt">Exhibit&nbsp;99.1
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Protalix BioTherapeutics to Present at the UBS Global Life Sciences Conference</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, September&nbsp;17, 2008 (Business Wire) &#151; Protalix BioTherapeutics, Inc. (Amex: PLX),
announced today that Dr.&nbsp;David Aviezer, President and CEO, will present at the UBS Global Life
Sciences Conference on Wednesday, September&nbsp;24, 2008 at 1:30 PM ET. The conference is being held at
the Grand Hyatt Hotel in New York City.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">An audio webcast of the corporate presentation will be available on Protalix&#146;s website at
www.protalix.com under the events calendar section.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>About Protalix BioTherapeutics</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company. Its goal is to become a fully integrated
biopharmaceutical company focused on the development and commercialization of proprietary
recombinant therapeutic proteins to be expressed through its proprietary plant cell based
expression system. Protalix&#146;s ProCellEx(TM) presents a proprietary method for the expression of
recombinant proteins that Protalix believes is safe and scalable and will allow for the
cost-effective, industrial-scale production of recombinant therapeutic proteins. Protalix is
enrolling and treating patients in its pivotal phase III clinical trial in Israel, the United
States and other locations for its lead product candidate, prGCD, for its enzyme replacement
therapy for Gaucher disease, a lysosomal storage disorder in humans, and has reached an agreement
with the United States Food and Drug Administration on the final design of the pivotal phase III
clinical trial through the FDA&#146;s Special Protocol Assessment (SPA)&nbsp;process. Protalix is also
advancing additional recombinant biopharmaceutical drug development programs.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Contact:</B><BR>
Marcy Strickler<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: mstrickler@troutgroup.com

</DIV>

<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>

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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.2
<SEQUENCE>3
<FILENAME>y00172exv99w2.htm
<DESCRIPTION>EX-99.2: PRESS RELEASE
<TEXT>
<HTML>
<HEAD>
<TITLE>EX-99.2</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
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<DIV style="font-family: 'Times New Roman',Times,serif">

<DIV align="right" style="font-size: 10pt; margin-top: 12pt">Exhibit&nbsp;99.2
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>Protalix BioTherapeutics Provides Enrollment Update for<BR>
the Phase III Clinical Trial of prGCD</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, September&nbsp;22, 2008 &#151; Protalix BioTherapeutics, Inc. (Amex: PLX), today announced
that the Company anticipates completion, during the second half of 2008, of enrollment in its
on-going pivotal phase III clinical trial of prGCD, a proprietary plant cell expressed recombinant
form of human Glucocerebrosidase (GCD)&nbsp;for the treatment of Gaucher disease. Currently, clinical
trial sites that are participating in the trial are recruiting patients in Europe, the United
States, Israel and other countries.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;We are pleased to announce that, to date, we have enrolled more than 75% of the patients required
for our phase III clinical trial for prGCD,&#148; said Dr.&nbsp;David Aviezer, President and Chief Executive
Officer of the Company. &#147;Given the recent and current rates of patient screening and recruitment,
we anticipate that we will soon be able to complete enrollment for this study. We expect to submit
a New Drug Application (NDA)&nbsp;with the United States Food and Drug Administration (FDA)&nbsp;in the
second half of 2009. In addition, we are very encouraged by the fact that Gaucher disease patients
that have completed our phase III clinical trial have chosen to continue to be treated with prGCD
as part of our on going follow-on extension study.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The pivotal phase III clinical trial of prGCD is a multi-center, randomized, double-blind, parallel
group, dose-ranging trial to assess the safety and efficacy of prGCD in 30 naive patients suffering
from Gaucher disease. In the trial, patients are selected randomly for one of two dosing arms and
receive IV infusions every two weeks for nine months. The primary endpoint of the study is the
percent change in spleen volume from baseline, as measured by MRI.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>About Protalix BioTherapeutics</B>

</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company. Its goal is to become a fully integrated
biopharmaceutical company focused on the development and commercialization of proprietary
recombinant therapeutic proteins to be expressed through its proprietary plant cell based
expression system. Protalix&#146;s ProCellEx(TM) presents a proprietary method for the expression of
recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale
production of recombinant therapeutic proteins. Protalix is enrolling and treating patients in its
pivotal phase III clinical trial in Europe, the United States, Israel, and other locations for its
lead product candidate, prGCD, for its enzyme replacement therapy for Gaucher disease, a lysosomal
storage disorder in humans, and has reached an agreement with the United States Food and Drug
Administration on the final design of the pivotal phase III clinical trial through the FDA&#146;s
Special Protocol Assessment (SPA)&nbsp;process. Protalix is also advancing additional recombinant
biopharmaceutical drug development programs. For more information, please
visit our website at www.Protalix.com.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Safe Harbor Statement:</B>

</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">To the extent that statements in this press release are not strictly historical, all such
statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private
</DIV>



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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Securities Litigation Reform Act of 1995. These forward-looking statements are subject to known
and unknown risks and uncertainties that may cause actual future experience and results to differ
materially from the statements made. These statements are based on our current beliefs and
expectations as to such future outcomes. Drug discovery and development involve a high degree of
risk. Factors that might cause such a material difference include, among others, uncertainties
related to the ability to attract and retain partners for our technologies and products under
development, the identification of lead compounds, the successful preclinical development of our
products, the completion of clinical trials, the review process of the FDA, foreign regulatory
bodies and other governmental regulation, and other factors described in our filings with the
Securities and Exchange Commission. The statements are valid only as of the date hereof and we
disclaim any obligation to update this information.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Contact:</B><BR>
Marcy Strickler<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: mstrickler@troutgroup.com

</DIV>


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