Pharmacy News Article

Nov 06, 2009 (Datamonitor via COMTEX) NovaRx, a biopharmaceutical company, has successfully negotiated and received FDA approval for a special protocol assessment or SPA protocol amendment to the pivotal Lucanix Phase III clinical trial in patients with non-small cell lung cancer.

The amendment will expand patient eligibility and enable study investigators to treat patients with stable brain metastases. As many as one in three non-small cell lung cancer (NSCLC) patients have such metastases, thus the amendment will make significantly more patients eligible for the trial.

Other approved protocol changes include expanded stratification criteria and the ability for investigators to treat patients with decreased serum albumin levels.

Habib Fakhrai, executive vice chairman of the board and chief scientific officer of NovaRx, said: "The protocol amendment will strengthen the Lucanix Phase III study greatly. We thank the FDA for the speed in which they approved the amendment and look forward to continuing to successfully work with them and our clinical sites throughout this pivotal Phase III trial."

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