Novelos finalizes phase 3 trial protocol for NOV-002 in non-small cell lung cancer with FDA

By Lisa Kerner

Erie, Pa., May 30 - Novelos Therapeutics, Inc. said it has finalized a Special Protocol Assessment (SPA) with the Food and Drug Administration for a single pivotal phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy.

The company expects to begin patient enrollment in the third quarter of 2006, according to a company news release.

The randomized, open-label, international study will evaluate NOV-002 in combination with paclitaxel and carboplatin compared to paclitaxel and carboplatin alone.

A total of 840 patients with stage 3b/4 NSCLC will be enrolled in the trial at 100 clinical sites in 10 countries. The primary efficacy endpoint is improvement in overall survival.

"What is agreed to during the SPA process is binding on the FDA's review division and Novelos," vice president of regulatory, quality and compliance said in the release.

"As such, it removes much of the uncertainty as to whether our pivotal Phase 3 trial design for advanced NSCLC will be adequate and sufficient to support NOV-002 approval."

Novelos, a Newton, Pa.-based biotechnology company, develops therapeutics to treat cancer and hepatitis.

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