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

Phase II Lucanix(R) study and the investigator-initiated Phase II trial.

"This is a very promising approach to cancer treatment, and results reported so far are beyond anyone's expectations. I am very excited to be a part of this confirmatory effort, and to be able to offer this unique treatment option to my patients," said Dr. Lyudmila Bazhenova, principal investigator of the STOP trial at the Rebecca and John Moore's Cancer Center of UCSD. "Traditional chemotherapy for stage IV NSCLC still yields disappointing results, and my hope is that this trial will improve the natural history of the disease." The FDA granted NovaRx Fast-Track approval for the Lucanix(R) trial in March of 2007, and Special Protocol Assessment approval in January of 2008.

According to the American Cancer Society, in 2008 there will be an estimated 215,000 new cases of lung cancer diagnosed, and 162,000 deaths caused by this disease in the United States alone. Lung cancer is the number one cause of cancer death throughout the world. "The statistics for global lung cancer deaths are staggering. I am confident that this Phase III trial will establish Lucanix(R) as a viable treatment option for patients with this dreaded disease," said Dr. Habib Fakhrai, president and co-founder of NovaRx.

In Phase II testing, 50 percent of patients entering the trial with stable disease who received Lucanix(TM) following one frontline regimen of chemotherapy lived more than 44 months, compared to less than 10-12 months for such patients under the current standard of care. In addition, patients with advanced disease who received Lucanix(TM) after zero to five prior chemotherapy treatments demonstrated a one-year survival of 61 percent and a two-year survival of 41 percent. Such late-stage patients typically demonstrate one-year survival of less than 30 percent. Lucanix(TM) was shown to produce only insignificant side effects.

"In addition to significantly increased survival," Fakhrai co
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SOURCE NovaRx Corporation
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