Pfizer Stops Lung Cancer Study While Novelos' Study Patients Continue to Live Longer Print E-mail
By M.E.Garza   
Thursday, 31 December 2009 08:01

NovelosIn case those of you following the incredible developing story at Novelos Therapeutics (OTC:NVLT) missed it, Pfizer Inc. (NYSE: PFE) has announced that it has decided to discontinue the late-stage study of its lung cancer candidate figitumumab (CP-751,871).






Next Dendreon? Novelos' CEO Eyeing "Revolutionary" Phase III Results

WSVN in Miami recently profiled Novelos' NV-002, which is also being studied for use against breast and ovarian cancer

Quick Fact:
Purdue Pharma (of
OxyContin® fame) is making a concerted push in cancer treatments and recently completed a $9M private placement in NVLT in exchange for the exclusive rights to negotiate for the US opportunity to NOV-002 through the end of Phase III. Mundipharma AG has the NOV-002 rights in EUR & Asia (ex-China).

The decision reportedly followed an analysis, which revealed that the candidate was unlikely to meet the main goal of improving overall survival. The study was designed to evaluate the candidate as a first-line treatment in patients suffering from advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).

Yesterday, it was reported that an independent data monitoring committee found by analyzing data from Pfizer's late-stage study that the addition of figitumumab to a combination of older medications - paclitaxel and carboplatin - was unlikely to meet the primary endpoint of improving overall survival compared to the combination of paclitaxel and carboplatin alone.

Meanwhile, Novelos' randomized, open-label, international, pivotal Phase 3 trial continues evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in approximately 900 patients with Stage IIIb/IV NSCLC.

NVLT's trial, with a primary efficacy endpoint of improvement in median overall survival, is being conducted across approximately 12 countries and 100 clinical sites. Novelos commenced the trial in November 2006, and reached target enrollment of 840 patients in March 2008. It was supposed to have come to an end several months ago (once 725 deaths took place during the trial), but it's still going stong. Many, including NVLT's Chief Executive Officer, Harry S. Palmin, think this is a very big tell.

After studying all the information and recent filings by Novelos, it's easy to see that insiders at the company are very excited about their drug compound.

Again, it's become pretty obvious that Novelos' patients involved in the trial are living longer than expected. Meanwhile, Pfizer's decision to halt thier own study follows a halt in new patient enrollment for the late-stage trial three months ago, when the data monitoring committee found that Pfizer's patients treated with figitumumab were suffering from a greater number of adverse events, including death.

This is yet another reason why investors have taken more interest in Novelos and their pivotal Phase 3 study, which is now expected to conclude during the first half of 2010 at the latest.

Last week, Novelos Therapeutics target share price was quietly raised to $4 from $3 at Rodman & Renshaw. This news also ahead of the Phase 3 study results for NOV-002. The firm continues to believe that now is an opportune time for risk-tolerant investors to get into shares and keeps an Outperform rating on the stock.

Other drugs like
motesanib, by Takeda Pharmaceutical and Amgen (Nasdaq: AMGN) and Nexavar, from Bayer and Onyx Pharmaceuticals (Nasdaq: ONXX), have shown negative effects in that cell type, leaving the market wide open for Novelos' (OTC: NVLT) NOV-002.

"We actually potentiate the chemotherapy," said Palmin in a recent BioMedReports interview. "We make the cancer cells more sensitive to chemotherapy and we also inhibit the cancer's ability to metastasize (spread), so there are all sorts of interesting effects that happen at the tumor level. However, on the normal cells- for example bone marrow cells and blood cells- which of course get damaged by chemotherapy- we don't stop the damage but we do help the recovery from that damage. In the words of big pharma, 'if this Phase III trial is positive, this will be revolutionary for the cancer field.'"




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