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NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
Date:8/21/2008

SAN DIEGO, Aug. 21 /PRNewswire/ -- NovaRx Corporation announced today that the company initiated its pivotal Phase III clinical trial of Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC). The first patient enrolled in the study was treated by Dr. Lyudmila Bazhenova the trial's principal investigator at the University of California, San Diego School of Medicine.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080821/LATH009-a)

(Photo: http://www.newscom.com/cgi-bin/prnh/20080821/LATH009-b)

The study is designated as the STOP trial because of its expected endpoints: Survival; Tumor-free, Overall; and Progression-free. It is an international, multicenter, randomized, double-blind study involving up to 700 individuals with advanced stage NSCLC, and will be conducted at approximately 90 clinical sites in the U.S., Canada, India, and Europe.

In a Phase II clinical trial, two-year survival among patients with stages IIIB and IV disease who received Lucanix(R) was significantly longer than that of individuals being treated with the current standard of care. A second, investigator-initiated phase II study supported these results.

In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, the therapeutic vaccine developed by NovaRx induces the patient's immune system to specifically target the cancer. In phase II clinical studies to date, the side effects of this treatment have included redness or soreness at the injection site.

"In medical research, you see something like this once in a lifetime," said John Nemunaitis, M.D., executive director at the Mary Crowley Medical Research Center in Dallas, TX and principal investigator of both the
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SOURCE NovaRx Corporation
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