NOVELOS BEGINS ENROLLMENT IN LUNG CANCER STUDY

Novelos Therapeutics announced that the first patient has been enrolled in the pivotal Phase III trial in advanced non-small-cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy.

This randomized, open-label, international trial is being conducted under a special protocol assessment and will study 840 patients with Stage IIIb/IV NSCLC. It will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone. The trial, with a primary efficacy endpoint of improvement in median overall survival, will be conducted across approximately 100 clinical sites in 10 countries. Novelos is planning for patient enrollment to be completed in the first quarter of 2008.

NOV-002 is a small-molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. In a controlled, randomized Phase I/II clinical trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response and higher tolerance of chemotherapy versus the control group. In a controlled, randomized Russian trial, when used in combination with cisplatin-based chemotherapy, NOV-002 increased the one-year survival of advanced NSCLC patients from 17 percent to 63 percent.