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GTC Biotherapeutics Reports Results of 2007 Annual Meeting.


Updates of ATryn([R]) Clinical Development and Market Estimates

FRAMINGHAM, Mass. -- GTC GTC

See: Good 'til cancelled order


GTC

See good-till-canceled order (GTC).
 Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB GTCB Gulf Tax Credit Bond (Alabama, Louisiana, Mississippi, USA) ) held its annual meeting of shareholders yesterday. Directors Robert W. Baldridge, James A. Geraghty, and Michael J. Landine were elected to three year terms on the board of directors. In addition, the proposed amendment and restatement of GTC's 2002 Equity Incentive Plan was approved.

During a presentation to shareholders following the business portion of the meeting, GTC updated its progress in the ATryn([R]) program, including updating the estimated market in the acquired deficiency indication of disseminated intravascular coagulation disseminated intravascular coagulation
n.
Abbr. DIC A hemorrhagic disorder that occurs following the uncontrolled activation of clotting factors and fibrinolytic enzymes throughout small blood vessels, resulting in tissue necrosis and
, or DIC DIC diffuse intravascular coagulation; disseminated intravascular coagulation.

DIC
abbr.
disseminated intravascular coagulation


Disseminated intravascular coagulation (DIC) 
, in severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status .

"ATryn([R]) has the potential to become an effective treatment to reduce the current mortality rate, which can be up to 50% in patients with disseminated intravascular coagulation associated with severe sepsis," commented Suzanne Groet, Vice President of Therapeutic Development for GTC. "The needs of the approximately 500,000 patients spread equally between the U.S. and Europe who develop DIC associated with severe sepsis each year are not well met by current treatments. The opportunity for ATryn([R]) is to ultimately demonstrate a significant reduction in mortality and displace the costs associated with current treatment options."

ATryn([R]) is GTC's recombinant form of human antithrombin. Antithrombin, produced in the liver and circulated in blood plasma blood plasma
n.
The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended.
, has both anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting).  and anti-inflammatory properties. The recombinant form is able to be produced using GTC's transgenic production platform, enabling large volume supply. ATryn([R]) has been approved for use in Europe for the prophylactic treatment prophylactic treatment
n.
The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive treatment.
 of deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen.  in hereditary antithrombin deficient patients undergoing surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. . LEO Pharma A/S, GTC's partner in the development and commercialization of ATryn([R]) in Europe, Canada, and the Middle East, is initiating a Phase II dose ranging study in the DIC indication to establish an optimum dose op·ti·mum dose
n.
The quantity of a radiological or pharmacological substance that will produce the desired effect without any unfavorable effects.
 to be used in a subsequent Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  study. Recruitment into the Phase II study is anticipated to begin this quarter and is planned to take about 12 months.

In evaluating the clinical and commercial opportunities in DIC in the U.S., GTC has determined that existing treatment options for severe sepsis are priced at a benchmark of approximately $10,000 per treatment, which if applied to DIC indicates a total potential U.S. market of $2 to 3 billion per year. GTC believes that ATryn([R]) has the potential to achieve in excess of $1 billion of this potential DIC market in the U.S. alone, if successfully developed and approved for DIC associated with severe sepsis.

GTC is also nearing completion of the clinical studies necessary to support the filing of a Biologics License Application for ATryn([R]) in the HD indication planned for the first quarter of 2008. These studies include an evaluation of the incidence of deep vein thrombosis and thromboembolisms in 17 additional hereditary antithrombin deficient patients undergoing surgical and pregnancy procedures that will be treated with ATryn([R]) and a non-inferiority comparison to a total of 35 historical records of patients undergoing similar procedures that have been treated with plasma-derived antithrombin products. GTC plans on releasing top line data from these studies in the fourth quarter of 2007. GTC is in discussions for potential commercial partnering in the US market for ATryn([R]).

The full presentation from the annual shareholder meeting can be accessed at the GTC web site, www.gtc-bio.com.

About GTC Biotherapeutics

GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal Transgenic animal
Animals that have had genes from other species inserted into their genetic code.

Mentioned in: Glycogen Storage Diseases
 technology. In August 2006, ATryn([R]), GTC's recombinant form of human antithrombin, was approved by the European Commission for use in patients with hereditary antithrombin deficiency undergoing surgical procedures. This was the first approval anywhere in the world of a therapeutic protein produced from a transgenic animal. We have developed goats that have the human antithrombin gene linked to a milk-protein promoting gene so that they express this protein in their milk. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, that are difficult to express in economically viable quantities in conventional production systems. In addition, GTC has established a strategic collaboration with LFB LFB Legislative Fiscal Bureau
LFB London Fire Brigade
LFB Linear Frame Buffer
LFB Left Fullback (soccer)
LFB Lyman Frank Baum (The Wizard of Oz author)
LFB Liquid Factor Boiling
LFB Low-Frequency Beacon
 Biotechnologies of France to jointly develop recombinant forms of human plasma proteins and monoclonal antibodies. The first program of the collaboration will be to develop recombinant human factor VIIa as a potential treatment for hemophilia in patients with antibodies to other coagulation factors.

In 2006, GTC was granted a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC's transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as those that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including without limitation statements regarding prospects for clinical development of the DIC indication as well as the ultimate potential market size in the U.S. in that indication. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 and its other periodic reports filed with the Securities and Exchange Commission, including the uncertainties associated with conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of collaboration partners and regulatory agencies. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.
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Publication:Business Wire
Article Type:Financial report
Date:May 24, 2007
Words:987
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