Novelos Therapeutics Inc. (NVLT.OB) faces a make or break year in 2010 as the biotechnology company inches towards reporting top-line results from a late-stage trial of NOV-002, its lead product candidate for lung cancer, this quarter.
NOV-002 is already approved in Russia for general medicinal use as an immunostimulant in combination with chemotherapy and antimicrobial therapy and has been available there for over 10 years. It is marketed in Russia by Pharma BAM under the trade name Glutoxim.
The international pivotal phase III trial of NOV-002 is being conducted under a Special Protocol Assessment and Fast Track and has enrolled 903 patients with advanced non small cell lung cancer, or NSCLC. The trial, whose top-line results are expected this quarter, is evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone. Platinum-based chemotherapy regimens like paclitaxel and carboplatin are the most common first-line treatment for advanced NSCLC patients in the U.S, while gemcitabine / pemetrexed and cisplatin are more common in Europe.
The one-year survival rate for patients receiving paclitaxel and carboplatin first-line therapy on average has been found to be about 40%; the weighted average for median survival 9.7 months and the objective tumor response (defined as greater than 30% tumor shrinkage) rate about 27%. Overall, fewer than 5% of advanced non-small cell lung cancer patients survive five years.
According to Novelos, in a U.S. phase I/II clinical trial, advanced NSCLC patients treated with NOV-002 in combination with first-line paclitaxel and carboplatin demonstrated improved objective tumor response and higher tolerance of chemotherapy compared to the active control group.
In a randomized Russian phase II trial, when used in combination with cisplatin-based first-line chemotherapy, NOV-002 increased the one-year survival of advanced NSCLC patients from 17% to 63%; median survival (i.e. 50% of patients dead) was not reached in the NOV-002 arm at 14 months compared to a median survival of 7 months in the active control, according to the company.
In a single arm Russian phase II trial, advanced NSCLC patients treated with NOV-002 in combination with first-line cisplatin-based chemotherapy exhibited greater than 50% one-year survival. According to Novelos, NOV-002, being a chemoprotectant and an immunomodulator, the side effects of chemotherapy is greatly reduced.
Given the safety profile, the company expects NOV-002, if approved, to have advantage over Avastin, which is also used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of non-small cell lung cancer.Avastin is manufactured by Genentech, now wholly owned by Swiss drugmaker Roche Holding AG.
Novelos has a partnership with Mundipharma, an independent associated company of privately held pharmaceutical firm Purdue Pharma, to develop and commercialize NOV-002 in Europe and Asia (excluding China). The collaboration signed last February allows Novelos to receive launch milestones and fixed sales-based payments as well as royalties in the licensed regions. Mundipharma is responsible for certain development activities, regulatory submissions and commercialization of NOV-002 in the licensed areas.
If the late-stage trial results of NOV-002 are positive, the company anticipates being able to file a New Drug Application in the third-quarter of this year and based on its Fast Track designation, expects the FDA decision in the first-quarter of 2011.
NOV-002 is also in a phase II trial for early-stage breast cancer and chemotherapy-resistant ovarian cancer.
Yet another compound in the company's pipeline is NOV-205 for chronic hepatitis C non-responders. The company has completed a phase Ib trial of NOV-205 in the U.S. for that indication.
Novelos shares, which trade over-the-counter, have retraced 36% from their yearly intra-day high of $3.05 set early last month and currently trade around $1.94. The stock has had a good run in the past 52 weeks and has gained over 330% as of Friday's closing price of $1.94.
There could be major upside to Novelos' stock price if top-line results from a late-stage trial of NOV-002, which are expected to be released in the first-quarter, are positive. But that said, since the results of the clinical trial can be a make-or-break event, investing in the stock requires a high tolerance for risk and volatility.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.