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<SEC-DOCUMENT>0000950123-08-017950.txt : 20081219
<SEC-HEADER>0000950123-08-017950.hdr.sgml : 20081219
<ACCEPTANCE-DATETIME>20081219094845
ACCESSION NUMBER:		0000950123-08-017950
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20081219
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20081219
DATE AS OF CHANGE:		20081219

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:		081259050

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100

	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>y00805e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>8-K</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->
<H5 align="left" style="page-break-before:always"><A HREF="#toc">Table of Contents</A></H5><P>

<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: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></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<BR>
Pursuant to Section&nbsp;13 or 15(d)<BR>
of the Securities Exchange Act of 1934</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of earliest event reported): December&nbsp;19, 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" nowrap>(State or other jurisdiction of incorporation)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(Commission File Number)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(IRS Employer Identification No.)</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><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 align="center"><DIV style="font-size: 1pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 0pt">(Former Name or Former Address, if Changed Since Last Report)</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 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"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</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"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</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"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))</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"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))</TD>
</TR>

</TABLE>
</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>



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

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<P><HR noshade><P>

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

<!-- TOC -->
<A name="toc"><DIV align="CENTER" style="page-break-before:always"><U><B>TABLE OF CONTENTS</B></U></DIV></A>

<P><CENTER>
<TABLE border="0" width="90%" cellpadding="0" cellspacing="0">
<TR>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="76%"></TD>
</TR>
<TR><TD colspan="9"><A HREF="#000">Item&nbsp;8.01. Other Events</A></TD></TR>
<TR><TD colspan="9"><A HREF="#001">Item&nbsp;9.01. Financial Statements and Exhibits</A></TD></TR>
<TR><TD colspan="9"><A HREF="#002">SIGNATURES</A></TD></TR>
<TR><TD colspan="9"><A HREF="y00805exv99w1.htm">EX-99.1: PRESS RELEASE</A></TD></TR>
</TABLE>
</CENTER>
<!-- /TOC -->
<P><HR noshade><P>
<H5 align="left" style="page-break-before:always"><A HREF="#toc">Table of Contents</A></H5><P>


<!-- link1 "Item&nbsp;8.01. Other Events" -->
<DIV align="left"><A NAME="000"></A></DIV>

<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 December&nbsp;19, 2008, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing the enrollment of the first patient in a worldwide, multi-center, open-label, switchover
trial to assess the safety and efficacy of prGCD. prGCD is the Company&#146;s proprietary plant cell
expressed recombinant form of human glucocerebrosidase (GCD)&nbsp;that is in development for the
treatment of Gaucher disease, a rare and serious lysosomal storage disorder in humans. prGCD is
also currently being evaluated in a pivotal phase III, multi-center, randomized, double-blind,
parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in naive patients
suffering from Gaucher disease. The Company recently announced that it had completed patient
enrollment in the phase III clinical trial. A copy of the press release is attached hereto as
Exhibit&nbsp;99.1.
</DIV>

<!-- link1 "Item&nbsp;9.01. Financial Statements and Exhibits" -->
<DIV align="left"><A NAME="001"></A></DIV>

<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 align="left" style="font-size: 10pt; margin-top: 6pt">99.1 Press release dated December&nbsp;19, 2008.

</DIV>

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

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<H5 align="left" style="page-break-before:always"><A HREF="#toc">Table of Contents</A></H5><P>

<DIV style="font-family: 'Times New Roman',Times,serif">
<!-- link1 "SIGNATURES" -->
<DIV align="left"><A NAME="002"></A></DIV>

<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: December 19, 2008&nbsp;</TD>
    <TD valign="top">By:&nbsp;&nbsp;</TD>
    <TD colspan="2" style="border-bottom: 1px solid #000000" align="left">/s/ David Aviezer
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>

    <TD valign="top" colspan="2">Name:&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>

    <TD valign="top" colspan="2">Title:&nbsp;&nbsp;</TD>
    <TD align="left">President and Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>
<TR>
    <TD colspan="5">&nbsp;</TD>
</TR>
</TABLE>


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

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</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y00805exv99w1.htm
<DESCRIPTION>EX-99.1: PRESS RELEASE
<TEXT>
<HTML>
<HEAD>
<TITLE>EX-99.1</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->

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

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


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>Protalix BioTherapeutics Announces First Patient Enrolled in Open-Label, Switchover<BR>
Trial of prGCD for the Treatment of Gaucher Disease</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, December&nbsp;19, 2008 (Business Wire) &#151; Protalix BioTherapeutics, Inc. (Amex: PLX),
announced today enrollment of the first patient in a worldwide, multi-center, open-label,
switchover trial to assess the safety and efficacy of prGCD. prGCD is the Company&#146;s proprietary
plant cell expressed recombinant form of human glucocerebrosidase (GCD)&nbsp;that is in development for
the treatment of Gaucher disease, a rare and serious lysosomal storage disorder in humans. The
trial is designed to include 15 patients with Gaucher disease that are currently undergoing enzyme
replacement therapy with imiglucerase (Cerezyme<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP>).
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Patients that are eligible for the switchover trial will be evaluated to establish the stability of
their disease. In the trial, patients with stable disease will be switched from intravenous
imiglucerase treatment every two weeks to intravenous infusions of prGCD every two weeks for a
nine-month period. The prGCD dose administered to each patient will be equal to the patient&#146;s
previous imiglucerase dose and the infusions will be administered at selected investigational
sites. At the end of the nine-month treatment period, all eligible patients will be offered the
opportunity to enroll in the Company&#146;s on-going extension study.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;We are pleased to announce the initiation of our switchover trial,&#148; said Dr.&nbsp;Einat Brill-Almon,
Vice President of Product Development at Protalix BioTherapeutics. &#147;While this trial is not
required by the FDA for the approval of prGCD, we believe the results of the trial will demonstrate
the safe and efficacious transition of Gaucher patients, who are currently undergoing other
treatments, to our novel drug. Data from this trial should provide additional confidence to
physicians regarding our treatment for Gaucher disease and provide support for the widespread use
of prGCD.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">prGCD is also currently being evaluated in a pivotal phase III, multi-center, randomized,
double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in
naive patients suffering from Gaucher disease. The Company has completed patient enrollment in the
phase III clinical trial and plans to announce top-line results in the second half of 2009. The
Company expects to file a New Drug Application with the United States Food and Drug Administration
in the fourth quarter of 2009.
</DIV>


<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
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<DIV style="font-family: 'Times New Roman',Times,serif">




<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><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 conducting a phase III pivotal study
for its lead product candidate, prGCD, to be used in enzyme replacement therapy for Gaucher
disease, a lysosomal storage disorder in humans. Protalix 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 has completed enrollment for
this study and is treating patients in its pivotal phase III clinical trial in North America, South
America, Israel, Europe and South Africa. Protalix is also advancing additional recombinant
biopharmaceutical drug development programs.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><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
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, the risk that we
may fail to satisfy certain conditions relating to grants we have received from the Office of the
Chief Scientist of Israel&#146;s Ministry of Industry and Trade which may lead to our being required to
refund grants previously received together with interest and penalties, the risk that the Office of
the Chief Scientist may not deliver to us all of the funds awarded to us, 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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