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NovaRx gets approval to expand study

NovaRx Corp. announced Wednesday that the company has expanded patient eligibility for one of its clinical trials.

The San Diego company, which is developing cell-based vaccines for cancer, received FDA approval for a Special Protocol Assessment (SPA) Protocol Amendment to its Lucanix Phase 3 clinical trial in patients with non-small cell lung cancer (NSCLC).

Lucanix is a treatment designed to target only cancer cells, unlike conventional cancer therapies that kill normal cells, as well as tumors.

The amendment will expand patient eligibility and enable researchers to treat patients with stable brain metastases. As many as one in three NSCLC patients have such metastases, so the amendment would make significantly more patients eligible for the trial, according to NovaRx.

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

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