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NovaRx Corporation Announces FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix(R) Study in Non-Small Cell Lung Cancer (NSCLC)
Date:11/4/2009

nix®:

In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, Lucanix® induces the patient's immune system to specifically target the cancer.

Lucanix® consists of four non-small cell lung cancer cell lines that have been gene-modified to block a molecule called transforming growth factor-beta (TGF-beta), which is commonly produced by cancer cells. The molecule allows cancer to hide from the body's natural immune system. When TGF-beta is blocked, the immune system can see, find, and destroy the cancer naturally.

United States Food Drug Administration granted NovaRx Fast-Track approval for the Phase III Lucanix® trial in March of 2007, and Special Protocol Assessment approval in January of 2008. The Phase III study commenced in August 2008 and over 90 global clinical sites are expected to enroll NSCLC patients in the trial.

Lucanix® is currently under clinical investigation and has not been approved for use in the United States, Canada, Europe or elsewhere. Any claims of safety and efficacy can only be made after the FDA reviews the data and approves all labeling claims for Lucanix®'s intended use.

About NovaRx Corporation

NovaRx Corporation is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel cell-based therapeutic vaccines for the treatment of cancer. The company's headquarters and manufacturing operations are in San Diego, California. The proprietary core technology upon which Lucanix® is based has been exclusively licensed to NovaRx on a worldwide basis. Lucanix® is a registered trademark of NovaRx Corporation.

Although the company's current clinical trials are for the treatment of advanced non-small cell lung cancer, the majority of other forms of cancer are expected to be susceptible to NovaRx's vac
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SOURCE NovaRx Corporation
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