The drug: NOV-002
The disease: Lung cancer
The company: Novelos Therapeutics
Another promising drug tested, approved and marketed in Russia. Another disaster. NOV-002 was intended to enhance the effectiveness of chemo, but in a study which recruited 903 patients with non-small cell lung cancer in 12 countries, NOV-002 plus chemo failed to improve overall survival rates compared to carboplatin plus paclitaxel.
Late-stage studies are always tricky, but researchers face particularly tough odds when it comes to cancer. "In retrospect, it appears our simulations were inaccurate due to trial data deviating from our statistical model, the impact of censoring patterns, and control arm survival exceeding our expectations based on historical precedents," said Novelos CEO Harry Pamlin at the time. Less than a month later, Novelos shelved the lung cancer program, but held out for mid-stage breast cancer data, which came in with positive data.
Novelos (NVLT) saw its share price dive 81 percent, down to a mere 30 cents a share, after the news hit. Yesterday, the stock opened at five cents a share. The fortunes of Novelos and Medivation also have helped to taint the reputation of clinical trials hosted in Russia, which have produced promising results for two drugs that have taken a painful pratfall in the U.S.
