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<SEC-DOCUMENT>0000891092-07-001499.txt : 20070418
<SEC-HEADER>0000891092-07-001499.hdr.sgml : 20070418
<ACCEPTANCE-DATETIME>20070418115928
ACCESSION NUMBER:		0000891092-07-001499
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20070418
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20070418
DATE AS OF CHANGE:		20070418

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:		07772739

	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>e27007_8k.txt
<DESCRIPTION>FORM 8-K
<TEXT>

                                  UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 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): April 18, 2007

                         Protalix BioTherapeutics, Inc.
             (Exact name of registrant as specified in its charter)

            Florida                   000-27836               65-0643773
   -------------------------      ----------------      ----------------------
        (State or other              (Commission             (IRS Employer
        jurisdiction of              File Number)         Identification No.)
        incorporation)

                                 2 Snunit Street
                                  Science Park
                                     POB 455
                              Carmiel, Israel 21000
               ---------------------------------------------------
               (Address of principal executive offices) (Zip Code)


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

Registrant's telephone number, including area code: +972-4-988-9488

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):

|_|   Written communications pursuant to Rule 425 under the Securities Act (17
      CFR 230.425)
|_|   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
      240.14a-12)
|_|   Pre-commencement communications pursuant to Rule 14d-2(b) under the
      Exchange Act (17 CFR 240.14d-2(b))
|_|   Pre-commencement communications pursuant to Rule 13e-4(c) under the
      Exchange Act (17 CFR 240.13e-4(c))


<PAGE>

Item 8.01. Other Events

On April 18, 2007, Protalix BioTherapeutics, Inc. (the "Company") issued a press
release announcing that had received written notice from the United States Food
and Drug Administration that it may initiate a Phase III clinical trial in the
United States of its lead product candidate, prGCD.

Item 9.01. Financial Statements and Exhibits

(d)   Exhibits

99.1  Press release dated April 18, 2007

                                   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.

                                                PROTALIX BIOTHERAPEUTICS, INC.


Date: April 18, 2007                            By:    /s/ David Aviezer
                                                       -----------------------
                                                Name:  David Aviezer, Ph.D.
                                                Title: President and
                                                       Chief Executive Officer


                                       2

</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>e27007ex99_1.txt
<DESCRIPTION>PRESS RELEASE
<TEXT>

                                                                    Exhibit 99.1

                Protalix BioTherapeutics, Inc. Receives Approval
          from the FDA to Initiate a Phase III Clinical Trial of prGCD

                  Phase III clinical trial may commence shortly

Carmiel, Israel - April 18, 2007 - Protalix BioTherapeutics, Inc. (AMEX: PLX)
today announced that it has received written notice from the United States Food
and Drug Administration (FDA) that it may initiate a Phase III clinical trial in
the United States of its lead product candidate, prGCD, a proprietary plant cell
expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment
of Gaucher Disease, a lysosomal storage disorder in humans.

The FDA has allowed the Company to directly initiate Phase III based upon the
results of the Company's pre clinical and Phase I clinical trials of prGCD. The
Company presented the completed data from its Phase I clinical trial at the
European Working Group of Gaucher Disease (WEGGD) in Cambridge, United Kingdom
in July 2006.

The Company hopes to commence the Phase III clinical trial shortly. The trial
will take place in centers in the United States, Israel, where approval from the
Israeli Ministry of Health has been received, and other locations worldwide. The
study will initially consist of male and female adult patients with Gaucher
Disease.

David Aviezer, Ph.D., President and Chief Executive Officer of Protalix
BioTherapeutics, commented, "The receipt of the FDA's approval to initiate a
Phase III clinical trial of prGCD represents an important milestone in the
development of this product, and we are excited about the progress we have made
thus far. Following the success of our Phase I trial and our promising pre
clinical and biochemical data, we believe that we will continue to see positive
results from our patients in Phase III."

Dr. Aviezer continued, "We remain deeply committed to the development of a
treatment for Gaucher Disease and are excited by the opportunity to commence the
Phase III trial and working with the medical experts and patient community."

About Protalix BioTherapeutics, Inc.

Protalix's proprietary technology is based on its plant cell culture and
bioreactor system, which provides an effective and scaleable cell system for
industrial production of recombinant biopharmaceuticals. Protalix is pursuing
advanced clinical studies for its enzyme therapy for Gaucher Disease and intends
to advance additional recombinant biopharmaceutical drug development programs.
The Company believes its plant-based expression has significant advantages over
more traditional mammalian and bacterial expression technology with respect to
patient safety, cost and scalability.


<PAGE>

Safe Harbor Statement

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 inherent risks and uncertainties
in developing drug platforms and products of the type we are developing; delays
in our preparation and filing of applications for regulatory approval; delays in
the approval or potential rejection of any applications we file with the FDA, or
other health regulatory authorities; lack of progress of our research and
development (including the results of clinical trials being conducted by us);
obtaining on a timely basis sufficient patient enrollment in our clinical
trials; the impact of development of competing therapies and/or technologies by
other companies; our ability to obtain additional financings required to fund
our research programs; our ability to establish and maintain strategic license,
collaboration and distribution arrangements and to manage our relationships with
collaborators, distributors and partners; potential product liability risks and
risks of securing adequate levels of product liability and clinical trial
insurance coverage; the possible disruption of our operations due to terrorist
activities and armed conflict, including as a result of the disruption of our
subsidiary, our manufacturing facilities, collaborative partners, licensees, and
clinical trial sites; and other factors described in our filings with the
Securities and Exchange Commission. The statements are accurate only as of the
date hereof and we disclaim any obligation to update this information, except as
required by law.

For additional information, contact:

Protalix Investor relations: investors@protalix.com
++972-4-988-9488

AMEX IR Alliance for Protalix:

Lee Roth / David Burke
212-896-1209 / 212-896-1258
lroth@kcsa.com / dburke@kcsa.com
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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