NVLT.OB

[la-onda]

very bullish chart, plus summarization

Novelos Therapeutics' (NVLT.OB) CEO Is Eyeing "Revolutionary" Phase III Study Results
Wednesday, December 16, 2009 06:48ET
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LOS ANGELES, CA -- (Marketwire) -- 12/16/09 -- BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, has published an exclusive interview with the CEO of Novelos Therapeutics, Inc. (OTCBB: NVLT), Harry S. Palmin.

It's become pretty obvious, even to the most casual biotech sector observer, that patients involved in Novelos' pivotal Phase III trial for lung cancer are living longer than expected.

"These patients with a median survival of eight to ten months unfortunately die pretty quickly," explains Palmin. "One year survival, which is another way to look at this, is just about 40%."

But Wall Street has begun to take more interest in the company and the study since over a year and a half after the enrollment target of patients was reached, the number of the expected deaths has not yet occurred.

In the interview, Palmin reveals:

"...Avastin is the only drug in non-small cell lung cancer, first line treatment, that showed a survival advantage. They showed a two month survival advantage, 12.3 months versus 10.3, but the drug has severe toxicities associated with it on top of the chemotherapy toxicities and it's very expensive. It's also only available to very few lung cancer patients because the histology it works for is non-squamous.

"The point that I'm trying to make is that given our current statistical projections, we should be on track to achieve or possibly even exceed our possible twelve and a half month median survival target.

"By way of background, we started the pivotal Phase III on lung cancer on the back of three Phase IIs," explains Palmin. "We saw dramatic survival advantages, better anti-tumor effects and in the United States, we saw doubling response rates and better toleration of chemotherapy."

The complete interview is available now at BioMedReports.Com:

http://biomedreports.com/component/content/article/56-top-leading-news/22199-novelos-eyeing-qrevolutionaryq-phase-iii-cancer-study-results.html

[la-onda]

 
Novelos' (NVLT.OB) Study Patients Continue to Live Longer as Pfizer Stops Lung Cancer Study
Thursday , December 31, 2009 09:55ET
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LOS ANGELES, CA -- (Marketwire) -- 12/31/09 -- BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, is reporting Pfizer Inc. has announced that it has decided to discontinue the late-stage study of its lung cancer candidate figitumumab (CP-751,871) while Novelos' (OTCBB: NVLT) pivotal Phase 3 trial, with a primary efficacy endpoint of improvement in median overall survival, continues across approximately 12 countries and 100 clinical sites.

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 lung cancer.

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

"We actually potentiate the chemotherapy," said Palmin in a recent interview with BioMedReports. "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.'"

The complete report is available now at BioMedReports.Com: http://biomedreports.com/articles/most-popular/23144-pfizer-stops-lung-cancer-study-while-novelos-patients-continue-to-live-longer.html

[la-onda]

another stellar day, I have locked som profits, still holding core postition 

[la-onda]

fyi:
Charles B. writes, "I believe Novelos Therapeutics(NVLT.OB Quote) will shape up to be a Dendreon -like (DNDN Quote) story in the first quarter. It's interesting that their lead compound [NOV-002] is such a simple molecule -- oxidized glutathione, a readily available compound, which is not tumor specific. Good, bad, or ugly, this promises to be a wild ride. You have Russians involved, an overzealous, inexperienced CEO promoter, a common laboratory chemical, a Massachusetts General Hospital-directed phase III study in non-small cell lung cancer, and a frenzied, pimpled fan boy. Get the word processor ready. This promises to be entertaining, and perhaps (just perhaps) the biggest biotech story of the year."

Charles is right, but I have only one question: Will Novelos be the good Dendreon of April 2009 or the bad Dendreon of May 2007?

Novelos shares have tripled in the past month (the stock closed Thursday at $2.24) because the phase III study of NOV-002 in lung cancer patients appears late to finish. Study results, initially expected last fall, are now to be released in the current quarter. The company said Thursday that the NOV-002 study just reached the 725 death events needed to conduct the final analysis.

Novelos CEO Harry Palmin hasn't been shy about attributing what he says is a longer-than-expected trial duration to a possible survival benefit from NOV-002.

The NOV-002 study is blinded to Palmin and the company, so he only knows that ALL patients in the study seem to be living longer than expected. But he assumes that patients in the study's control arm treated for chemo alone will report a median survival in the range of 10 months - that's in line with previously reported phase III studies in non-small cell lung cancer.

If that turns out to be true, patients treated with NOV-002 plus chemo could report median survival exceeding 12 months -- enough for the study to be a huge success, said Palmin in a December interview with a Web site devoted to penny-stock promotion.

I don't want to sound unduly critical, but Palmin's comments make me cringe. Not because I'm 100% confident he's dead wrong, but because even if he's right, he shouldn't be out there making such bold predictions so close to the study's completion.

[la-onda]

still holding