GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Tifacogin – Thanks for your reply. We still have the
unanswered question of why NVS now says an NDA
submission in community acquired pneumonia is
expected in 2008 rather than 2009. Here’s the
most recent PR about the trial, which predates
the acquisition of CHIR by NVS.

http://www.findarticles.com/p/articles/mi_m0EIN/is_2005_Dec_19/ai_n15952030

>>
Interim Analysis Supports Continuation of Phase 3 Trial Of Tifacogin; Pivotal Study of Chiron Drug for Treatment of Severe Community-Acquired Pneumonia Proceeds

Dec 19, 2005

EMERYVILLE, Calif. -- Chiron Corporation (NASDAQ:CHIR) today announced that an independent Data Monitoring Committee (DMC) has recommended the continuation of Chiron's CAPTIVATE study, an ongoing Phase 3 clinical trial of tifacogin for the treatment of patients with severe community-acquired pneumonia. The DMC made its recommendation following a planned interim analysis of clinical data from the study. The study data remains blinded to Chiron, and detailed analysis will not be available until the trial has been completed. No safety concerns were identified by the committee, confirming safety assessments conducted when patient enrollment reached 300 and again at 600.

"We appreciate the careful analysis conducted by the committee and their assessment of the study data on tifacogin," said Stephen Dilly, M.D., Ph.D., chief medical officer of Chiron BioPharmaceuticals. "We look forward to a final analysis of the study data."

The study is expected to enroll 2,100 patients in 200 centers in 19 countries worldwide, and enrollment is expected to be completed in the first half of 2007. The primary endpoint of the study is reduction in mortality at 28 days.

About Tifacogin

Tifacogin, a recombinant form of tissue-factor pathway inhibitor (TFPI), is an investigational drug being evaluated for the treatment of severe community-acquired pneumonia (CAP). Increased expression of tissue factor, a protein, occurs in the lungs of pneumonia patients, where it is believed to directly contribute to activation of blood coagulation and inflammation. Tifacogin interferes with these activities of tissue factor, and the balance of tissue factor and TFPI levels is a key mechanism for the body's control of coagulation. Naturally occurring TFPI levels are not sufficient to compensate for the increase in tissue factor associated with lung infection. Therapeutic administration of tifacogin to restore this balance may be an effective treatment for severe CAP.

About Severe Community-Acquired Pneumonia

Severe community-acquired pneumonia (CAP) is defined as pneumonia contracted outside of a hospital setting that requires the patient's admission to an intensive-care unit. Severe CAP affects approximately 300,000 patients in the United States annually. Approximately 30 percent of patients with severe CAP die. Current therapy includes routine antibiotics and supportive care. However, despite improvements in antibiotic treatment, mortality rates associated with severe CAP have remained approximately constant for the past 50 years. No adjunctive drugs are currently approved for the reduction of mortality in severe CAP.
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