Next Dendreon? Novelos' CEO Eyeing "Revolutionary" Phase III Results PDF | Print | E-mail
Written by M.E.Garza
Wednesday, 16 December 2009 00:00
"What's interesting about Novelos is that we're in a Pivotal Phase III trial for lung cancer under both SPA and Fast Track for our NOV-002 lead compound," explains Novelos Therapeutics' (OTC: NVLT) Chief Executive Officer, Harry S. Palmin.
The study, a randomized, open-label, Phase 3 Trial of NOV-002 in Combination with Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin alone for the treatment of advanced non-small cell lung cancer is being conducted under the FDA's Special Protocol Assessment. It blinds Novelos from seeing any results as it progresses.
In other words, there is no interim analysis. There is only "one look" and that look occurs once 725 deaths take place during the trial.
"These patients with a median survival of eight to ten months unfortunately die pretty quickly," explains Novelos Therapeutics' Chief Executive Officer, Harry S. Palmin. "One year survival, which is another way to look at this, is just about 40%."
The pivotal study itself began more than three years ago, in November of 2006. By March of 2008, the enrollment target of patients had been reached and now, over a year and a half later, the 725th event has not yet occurred.
It's become pretty obvious, even to the most casual observer, that the patients involved in the trial are living longer than expected and that, in fact, is one of the reasons why Wall Street has begun to take more interest in the company and the study. Originally, most observers, including insiders at the company, expected that the trial might reach a conclusion some time during the middle of this year.
"It's a very unique value proposition," says Palmin. "If you think of Avastin, Roche's drug, it's 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, because our trial is going late, if we assume that the control group does in fact what it's supposed to, around a ten month median survival, and there's historical data on some four-thousand patients with advanced stage lung cancer that have taken our type of chemotherapy (paclitaxel/carboplatin [standard of care in the U.S.]), then 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 II's," explains Palmin. "Same patient population and in two of the trials that were done in Russia, we saw dramatic survival advantages, better anti-tumor effects and in the United States, we saw doubling response rates and better toleration of chemotherapy. So there are three lung cancer trials that were the basis for the pivotal Phase III. We, of course, have applicability to other indications because we're not tumor specific and we're not chemotherapy specific."
That is an important point that has not gone unnoticed. This year, Perdue Pharma has invested over $19 million dollars in Novelos. The company itself, since going public over 5 years ago, has raised over $70 million dollars.
"We had good data out of Russia in non-small cell lung and it is the number one cancer killer, currently; late stage lung cancer," says Palmin. "There are north of two-hundred thousand new patients each year and more than one hundred and sixty thousand deaths and it's a huge market. Just lung cancer is north of a $3.5 billion dollar market.
"Since we have applicability, really, to all solid tumors, in Russia the drug is already approved for general use with chemotherapy. Here in the United States, we've had two positive Phase II results in ovarian and breast cancer. Channel 7 in Miami recently profiled a breast cancer patient that was in our Phase II breast cancer trial and went into complete remission. No signs of cancer. That's based on publicly available information where we've had forty percent of the patients have had no sign of their cancer after treatment of chemo and our drug.
"In addition, the patients that take our drug with the chemotherapy have a much better quality of life while under that treatment, versus being on chemo alone. Plus, very importantly, there is the efficacy improvement. That makes this a very different approach to the treatment of cancer."
BioMedReports: Can you tell us about the mechanism of the drug?
Palmin: "In short, what we do is we regulate redox-sensitive cell signaling pathways that are involved in cancer proliferation, cell-mediated immunity and blood recovery, basically. Recovery from chemotherapy toxicity.
"Some companies tried to use oxidative stress as a way to kill tumors and not surprisingly, that can result in pretty severe side effects for the patient. What we do, is we administer our proprietary formulation of Oxidized glutathione (NOV-002), which induces transient oxidative signal throughout the body and that has pretty profound, different effects in tumor cells versus normal cells. So what we've seen- and this is in patients, in vivo (experimentation using a whole, living organism as opposed to a partial or dead organism), in animals and in vitro experiments (performed not in a living organism but in a controlled environment, such as in a test tube), what we've seen is this different effect on tumor versus normal cells.
"So in tumor cells, we actually potentiate the chemotherapy. 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.'
"We're well funded. We are expecting this Pivotal Phase III outcome in early 2010. We have about a year's worth of funding, so the plan is that as soon as the data is out, we're going to work with a bulge investment bank - like are you familiar with the Dendreon (NASDAQ:DNDN) story?
BioMedReports: Of course.
Palmin: "The idea is to do something very similar as soon as our data is out. So they were a four or five dollar stock that had a positive Phase III in prostate cancer under a similar SPA and Fast Track and, of course, they jumped to a several billion market cap.
BioMedReports: What are you trading at now?
Palmin: "We're trading at around a dollar, we have 117 million shares outstanding (40 million in the float) between common and preferred, which puts us at about $100 million market cap.
"Cougar (Biotechnology) was purchased by Johnson and Johnson for $1 billion in May and that was short of their Phase III results. Our shares at $6 puts us at $1 billion market cap, so our feeling is, that if this Phase III is positive- and there are a lot of reasons to be encouraged even though there are no guarantees- things will play out nicely.
BioMedReports: This sounds like a winner.
Palmin: "I couldn't agree more. Over the past two and a half years I've bought four hundred thousand shares at market.
"There's actually pretty ample liquidity and there's been a fair amount of trading.
"Elemer Piros of Rodman & Ranshaw has covered us with a $3 price target and Raymond Myers, at Emerging Growth Equities has a $5 price target. Our challenge has been to get more coverage on Wall Street and once the Phase III data comes in, of course, that won't be a problem. We already know bulge banks that would want to initiate on us. We do not pay for research. No fees in terms of stock or cash. Even the attention we've gotten thus far has been unsolicited.
"The current approach is to spread the word as much as possible, to get more eyeballs on us so that when the data comes out, to the extent that as people get focused on us earlier, then all the better of course."
Biotech investors know that anything can happen in a single Phase II result. Whats nice about Novelos' situation is that they've had no bad news and lots of positive news.
In their lung cancer studies alone they've had three positive Phase II studies- all prior to starting this large 900 patient Phase III trial.
In other indications, in the U.S., the company announced positive results in breast cancer and ovarian cancer and it's nice to have the validation from Russia across many thousands of patients.
BioMedReports: What are your plans for bringing the drug to market yourself?
Palmin: "I would say that we have a competitive advantage on the clinical and development side and that we have a disadvantage when it comes to on the marketing.
"In the United States, our plan is that as soon as the Phase III data is out for us to hold a competitive auction for the U.S. Rights."
Developing...
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