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<SEC-DOCUMENT>0000950123-10-056482.txt : 20100608
<SEC-HEADER>0000950123-10-056482.hdr.sgml : 20100608
<ACCEPTANCE-DATETIME>20100608080918
ACCESSION NUMBER:		0000950123-10-056482
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20100608
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20100608
DATE AS OF CHANGE:		20100608

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:		10883004

	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
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<DOCUMENT>
<TYPE>8-K
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<FILENAME>y03610e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>e8vk</TITLE>
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<BODY bgcolor="#FFFFFF">
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<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: 18pt; 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: 18pt; margin-top: 12pt"><B>FORM 8-K</B>
</DIV>

<DIV align="center" style="font-size: 18pt; 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: 12pt; margin-top: 12pt"><B>CURRENT REPORT<BR>
Pursuant to Section&nbsp;13 or 15(d) of<BR>
the Securities Exchange Act of 1934</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of Earliest Event Reported): June&nbsp;8, 2010 (June&nbsp;8, 2010)</B><BR>
<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: 24pt; margin-top: 12pt"><B>Protalix BioTherapeutics, Inc.</B>
</DIV>

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

<DIV align="center"><DIV style="FONT-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></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>
<TR></TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>Florida</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>001-33357</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>65-0643773</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>(State or other jurisdiction <BR>
of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(Commission File Number)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(IRS Employer<BR>
Identification No.)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</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="47%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="47%">&nbsp;</TD>
</TR>
<TR></TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street <BR>
Science Park, POB 455<BR>
Carmiel, Israel</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="bottom"><B>20100</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>(Address of principal executive offices)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(Zip Code)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

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

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>(Former name or former address, if changed since last report.)</B></DIV>

<DIV align="center"><DIV style="FONT-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></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="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><FONT style="font-family: Wingdings">&#168;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><FONT style="font-family: Wingdings">&#168;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><FONT style="font-family: Wingdings">&#168;</FONT></TD>
    <TD>&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>
</TABLE>
</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><FONT style="font-family: Wingdings">&#168;</FONT></TD>
    <TD>&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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<DIV style="font-family: 'Times New Roman',Times,serif">










<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 June&nbsp;8, 2010, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release announcing
the completion of its phase I clinical trial of PRX-105, a plant cell expressed pegylated
recombinant human acetylcholinesterase in development for biodefense indications. A copy of the
press release is attached hereto as Exhibit&nbsp;99.1.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;9.01. Financial Statements and 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"><B>(d)&nbsp;<B>Exhibits</B></B></TD>
    <TD width="4%">&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>
</table>

<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<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">99.1</TD>
    <TD width="4%">&nbsp;</TD>
    <TD>Press release dated June&nbsp;8, 2010.</TD>
</TR>




</TABLE>
</DIV>
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</DIV>

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



</TABLE>
</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: June 8, 2010&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>&nbsp;</TD>
    <TD valign="top">Name:&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top">Title:&nbsp;&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>

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y03610exv99w1.htm
<DESCRIPTION>EX-99.1
<TEXT>
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<TITLE>exv99w1</TITLE>
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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 Completes Phase I Clinical Trial for PRX-105</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, June&nbsp;8, 2010 /PRNewswire-FirstCall/ &#151; Protalix BioTherapeutics, Inc. (NYSE-Amex:
PLX) announced today the completion of its phase I clinical trial of PRX-105, a plant cell
expressed pegylated recombinant human acetylcholinesterase in development for biodefense
indications. The trial established the pharmacokinetics of the protein and demonstrated that
single dose, intravenous administration of PRX-105 is safe and well tolerated.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;We are very pleased with the favorable safety and pharmacokinetic results from our phase I
clinical trial of PRX-105,&#148; said Dr.&nbsp;David Aviezer, Protalix&#146;s President and Chief Executive
Officer. &#147;The positive results also provide further validation of the safety and breadth of our
ProCellEx&#153; plant cell based expression system.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Company plans to perform additional safety studies in healthy volunteers and animals in
collaboration with civil and military agencies in the United States and Israel, for which
discussions have been initiated. Given the nature of the biodefense indications for which the
Company is developing PRX-105, efficacy trials of PRX-105 in humans (phase II and phase III) are
not required.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The phase I clinical trial of PRX-105 is a first in human, open label, non-randomized, single-dose
study. PRX-105 is administered intravenously by slow bolus injection to 10 healthy volunteers in
the trial. The trial is being conducted in collaboration with Professor Hermona Soreq, from the
Hebrew University in Jerusalem, Israel, a world leader in the field of acetylcholinesterase
research. The production of PRX-105 is based on patents that were licensed to Protalix Ltd. by
Yissum, the Technology Transfer Company of the Hebrew University, Jerusalem.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Pre-clinical studies have indicated that PRX-105 successfully protects animals exposed to
organophosphate nerve gas agent analogs, in both the prophylactic and post-exposure settings.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About Protalix</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company focused on the development and commercialization of
proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based
expression system. Protalix&#146;s ProCellEx&#153; 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 in an environment free of mammalian components and
viruses. Protalix is also advancing additional recombinant biopharmaceutical drug development
programs. Taliglucerase alfa is an enzyme replacement therapy in development under a Special
Protocol Assessment with the FDA for Gaucher disease.
</DIV>




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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">In August&nbsp;2009, the FDA granted orphan drug status and fast track designation to taliglucerase alfa
for the treatment of Gaucher disease and Protalix filed a rolling NDA submission with the FDA in
December&nbsp;2009. In November&nbsp;2009, Protalix granted Pfizer Inc. exclusive, worldwide rights to
develop and commercialize taliglucerase alfa for the treatment of Gaucher disease, except in
Israel. Protalix retained the right to commercialize taliglucerase alfa in Israel.
</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 material differences include, among others, risks relating to: the
successful completion of our clinical trials; the review process of the FDA, the EMEA, other
foreign regulatory bodies and other governmental regulatory bodies, including the FDA&#146;s and the
EMEA&#146;s review of any filings we make in connection with the treatment protocol for taliglucerase
alfa; delays in the FDA&#146;s, the EMEA&#146;s or other health regulatory authorities&#146; approval of any
applications we file or refusals to approve such filings, including the NDA we filed with the FDA
or taliglucerase alfa for the treatment of Gaucher disease; refusals by such regulatory authorities
to approve the marketing and sale of a drug product even after acceptance of an application we file
for any such drug product; and other factors described in our filings with the Securities and
Exchange Commission. Companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced or late-stage clinical trials, even after obtaining promising
earlier trial results or in preliminary findings for such clinical trials. Further, even if
favorable testing data is generated by clinical trials of drug products, the FDA, EMEA or any other
foreign regulatory authority may not accept or approve an NDA filed by a pharmaceutical or
biotechnology company for such drug product. Failure to obtain approval from the FDA, EMEA or any
other foreign regulatory authority of any of our drug candidates in a timely manner, if at all,
will severely undermine our business and results of operation by reducing our potential marketable
products and our ability to generate corresponding product revenues. The statements in this
release 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>Investor Contact:</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">
Marcy Nanus<BR>
The Trout Group, LLC
</DIV>



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

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Telephone: 646-378-2927<BR>
Email: mnanus@troutgroup.com

</DIV>

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

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">
Brad Miles<BR>
BMC Communications Group, LLC<BR>
Telephone: 212-477-9007 x17<BR>
Email: brad@bmccommunications.com

</DIV>


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