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Old 12-17-2009, 03:00 PM   Nav to Top  #1
dorkytom
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Default NVLT.OB - Novelos

*** Moderator please move to penny stocks... clicked new thread on wrong section of the forum***

As always everything here is solely my opinion… Every person should do their own Due Diligence. I do not claim facts here are accurate.

Ok this is a stock I found on BiomedReports.com usually I don’t trust their headlines, but this stock caught my attention, anyways this is my summary.

Novelos NVLT.ob

This is a spec play based on their likelihood of positive Phase III results expected early 2010.
They have a drug NOV-002 which is currently undergoing Phase III Clinical trials under FDA SPA (Special Protocol Assessment, company met with FDA and designed the clinical trial together) for treatment of Non-Small Cell lung Cancer.

Drug is also Fast tracked by FDA

Non-Small Cell Lung cancer accounts for about 80-90% of all Lung Cancer cases
In the US alone it is estimated for 2009 there will be 219,440 new cases and 159,390 deaths of Lung cancer. So there is a huge market.

Under the clinical trial protocol the company is not allowed to see any of the results until the study ends.

The phase 3 study started in 2006, with full enrollment of 840+ patients in March of 2008. Now here is the critical information per their protocol the clinical trial ends when the 725th treated patient dies. Obviously its been 20 months since they enrolled the final patient and still haven’t hit the 725th death.

Their primary endpoint is median overall survival with target of 12.5 months.

NOV-200 is approved for use in Russia (marketed by Pharma-BAM)

In a controlled randomized U.S. Phase 1/2 clinical trial, advanced NSCLC patients (n=29) treated first-line with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response (p < 0.05) and higher tolerance of chemotherapy (p < 0.01) versus active control (n=15).

Further, in a controlled Russian lung cancer trial, when used in combination with chemotherapy, NOV-002 increased the one year survival rate of patients from 17% (40% in US equivalent) to 63% (p < 0.01), a result that represents an 80% improvement over the 35% survival rate seen with the current standard of care in the U.S.

independent Russian phase 2 trial showed greater than 50% 1-year survival.

Per their Biomedreports interview they have enough cash for about one year.
On November 12th they completed a share offering that resulted in a total of 9 million dollars to Purdue pharma.

They have approximately 117 million shares outstanding, but only 40 million of them on the float.

Currently partnered with Mundipharma (purdue pharma associate) in EU and Japan, and Lee's Pharm in China.

For future reference... i'm documenting that today's share price is 1 dollar


Sources
Next Dendreon? Novelos' CEO Eyeing "Revolutionary" Phase III Results - BioMedReports.com
http://www.novelos.com/docs/novelos%...20overview.pdf
Novelos
http://www.novelos.com/docs/poster%2...%209-18-05.pdf
Unassociated Document
Lung Cancer Home Page - National Cancer Institute
http://www.novelos.com/docs/novelos%...-%20public.pdf
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Last edited by dorkytom; 12-17-2009 at 05:04 PM..
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Old 12-22-2009, 11:21 AM   Nav to Top  #2
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Novelos just hit its 52 week high today up 50% since Thursday.

nvlt.ob






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Old 12-22-2009, 12:06 PM   Nav to Top  #3
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Great call man .. good way to stick to it.
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Old 12-22-2009, 01:28 PM   Nav to Top  #4
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Here is an interesting article from seeking alpha

Microcap Special Situation 12/21/09 - Dr. Mike -- Seeking Alpha


Microcap Special Situation 12/21/09

Novelo Therapeutic's lead drug is NOV-002, which acts as a chemoprotectant and an immunomodulator. NOV-002, a small-molecule formulation of a natural metabolite, is in Phase III development for the treatment of lung cancer, as well as in Phase II development for the treatment of early-stage breast cancer and chemotherapy-resistant ovarian cancer. The company is also developing NOV-205, which acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties.
It's phase III study is for treatment of lung cancer, which is the number 1 cancer, in terms of number of patients, in the U.S.. It's already used in Russia as a treatment with excellent results. The stock had been in a range of .75-.91. It recently popped up, and near the close on Friday it went up and today also. The issue with the study is the following (and this gives the a high chance of success). The study is supposed to terminate when there are 750 deaths. However, the study has been dragging on well beyond the normal timespan for the patient population (which normally lives about 8 to 10 months or less based on the criteria for the study). The efficacy endpoint is to see if the drug can extend life from 10 months to over 12.5 months, and per people knowledgeable about the study, the time for results to show 12.5 month survival for the group using the drug has already passed (which should have occurred in the middle of 2009). Toxicity and side effects aren't a problem based on prior research (the drug is actually the oxidized form of glutathione, which is naturally formed in the body). Since the lung cancer market is so huge, the thought is that once the company has successful phase III results, that it will either partner with a major company or be bought out.
Caveat emptor: what could go wrong? The number 1 possible problem is that the control group could be living longer that the average (though the data on this group is so strong from hundreds of thousands of cases each year that that is unlikely (but possible). Or there could be a FDA delay, etc. However, major financial firms are listing targets for the stock of from $3 to $8. per share (it's up to $1.34 at today's close). It is possible that the stock could for a short time fall into the prior range, but the longer time goes on, the better chances for really excellent study results, and so the high probability for long term multiple returns.


Disclosure: Long NVLT.OB
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Please be aware that there ARE probably factual errors in my posts and any advice I give is probably BAD advice. If I'm posting about a stock/financial strategy, I must have some sort of a financial interest in it... I am most likely either long /short/looking to buy cheap/sell high and thus an extreme conflict of interest definitely exists.

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Old 12-24-2009, 12:33 PM   Nav to Top  #5
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Broke 2 dollars today... trading at 2.17 at this moment.
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Old 12-24-2009, 01:48 PM   Nav to Top  #6
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Good find!!
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Old 01-03-2010, 12:17 AM   Nav to Top  #7
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nvlt continues its gains... last closed at 2.52

New article from biomedreports.com

Pfizer Stops Lung Cancer Study While Novelos' Study Patients Continue to Live Longer - BioMedReports.com

Pfizer Stops Lung Cancer Study While Novelos' Study Patients Continue to Live Longer

In 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).

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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Old 01-04-2010, 06:19 PM   Nav to Top  #8
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Novelos Therapeutics closed at 2.94 today hitting its 52week high of 3.05 at one point today.

To tell the truth in the short term i have no idea how much higher it could go.... There are only about 40 million shares on the float, but the stock has increased by several fold just over the last month.

As soon as the price stabilizes I expect profit taking and also most likely there will be a large increase in short positions, dropping the share price a little bit further.... short position probably won't be that huge, because many people have trouble shorting stocks on OTCBB.

Longer term (maybe 6 months or less) if they meet their primary endpoint I think we may see 10 dollars a share or more. CTIC acheived a market cap of over 1.2 billion at their peak(the day they presented at ASCO), with their drug pixantrone for third line treatment non-hodgekins lymphoma. At 10 dollars NVLT would have a similiar market cap (assuming no dilution, but of course I expect dilution sometime). NVLT's drug is for first line treatement of Non small cell lung cancer, which has a much larger market.

In the US
Non-Hodgkins Lymphoma (CTIC's drug Pixantrone) have about 65000 new cases a year with 19500 deaths.
http://www.cancer.gov/cancertopics/types/non-hodgkin

Lung cancer (NVLT's drug NOV-002)has 219k, with 159k deaths (includes both small cell and non-small cell, non small cell usually about 80-90% of cases)
http://www.cancer.gov/cancertopics/types/lung

If they exceed the primary endpoint of overall survival (12.5 months) by a large margin say 15 months I think we could be seeing a 20 dollar price. Dendreon's provenge extends overall survical by 4 months from 22 to 26months, its market cap is approximately 3 billion, which would make 30 dollars a share for NVLT if they had the same market cap,

http://www.webmd.com/prostate-cancer...n-trial?page=2

In the US alone
Prostate cancer which is what Dendreon's drug treates has about 192 k new cases a year with 30k deaths.
http://www.cancer.gov/cancertopics/types/prostate

NVLT's clinical trial is being done under a special protocol assistance with the FDA, unless there was a significant deviation it would be difficult for FDA to turn down this drug based on efficacy (assuming positive phase III). Of course there are other reasons FDA could reject, but usually there not as dreaded as efficacy, since these often require another clinical trial.

ASCO (American Society of Clinical Oncology) is coming in June 4-8, this may seem like a long time from now, but most bioinvestors know oncology stocks tend to rise significantly as ASCO approaches (then followed by a drop depending on news from ASCO).

http://www.asco.org/annualmeeting/

I'll admit there is a lot of holes in my comparisons of NVLT with CTIC and DNDN, but I made them just to put a little perspective on how important the success of NVLT's phase III results could be.

Below is another interesting article from a blogger, posted a couple days ago.

Update on Microcap Special Situation Novelos Therapeutics 12/27/09 - Dr. Mike -- Seeking Alpha

NVLT.OB Novelos Therapeutics tgt to raised $4 at Rodman and Renshaw following the extension of the Phase 3 data completion date (1.81 )

Rodman and Renshaw is raising their tgt to $4 from
$3 as over the last year, NVLT extended the estimated completion date
for the ongoing Phase 3 study of NOV-002 in non-small cell lung cancer
(NSCLC) by 6-9 months. They view this timeline extension as a positive
development. Prior to the NOV-002 trial timeline extension, they
assumed a 40% probability of success; in light of the timeline
extensions, and assuming that control group survival remains similar to
prior studies, they are increasing their probability of success for this study to 70%. They believe that this is an opportune time to buy NVLT stock for risk-tolerant investors.

This is a treatment for 80.4% of cases of the number 1 cancer in the U.S. (lung cancer), and phase II studies have also shown excellent results for in breast cancer and ovarian cancer patients. Avastin has sales of $800+ million per year. Novelos's treatment, based on safety data so far collected, is much safer. Also, Novelos's treatment appears to both boost the effect of chemotherapy while also facilitating a speedier recovery from chemo, allowing patients to stay on treatment longer & recover quicker. In the studies that led to Avastin's approval as a first line treatment for NSCLC, it had increased survival to a mean of 12.3 months from about 10.3 months for the control group with standard treatment. I think if Novelos's treatment equals that improvement, then it will take market share from Avastin as it so far has a better safety profile, and if it should provide a statistically superior outcome to Avastin's 12.3 month median survival, it could take the vast majority of market share for NSCLC away from Avastin.

I would estimate the probability of success as greater than 90%. The major caveat is that somehow the control group is living much longer than normal, which is highly unlikely to this extent, but possible (that has happened in other drug trials). As always, do your own due diligence and "don't bet the farm on any 1 stock" as unexpected things can happen.

IMHO (in my humble opinion), in terms of trading, the only "downside" to this positive news, is that since results may not be announced for awhile, some "fast money" traders may lose interest which could affect the momentum the stock currently has and temporarily lead to lower prices. Long term, however, the news is very positive for the stock, and since we don't know when the study results will be announced, I think it's best to keep one's money in the stock (that's what I'm doing).


Disclosure: Long NVLT.OB
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Last edited by dorkytom; 01-04-2010 at 07:45 PM..
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Old 01-07-2010, 01:31 PM   Nav to Top  #9
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Novelos Therapeutics Reaches 725th Event in Pivotal Phase 3 Lung Cancer Trial

Novelos Therapeutics Reaches 725th Event in Pivotal Phase 3 Lung Cancer Trial
1/7/2010 8:30:00 AM ET

Business Wire
Trial Conclusion on Track for 1Q 2010

NEWTON, Mass.--(BUSINESS WIRE)-- Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy. The 725th event triggers the steps towards the pre-specified analysis according to the trial's Statistical Analysis Plan (SAP). Top-line trial results are expected to be available later in the first quarter.

This randomized, controlled, open-label Phase 3 trial, being conducted under a Special Protocol Assessment (SPA) and Fast Track designation, has enrolled 903 patients with Stage IIIb/IV NSCLC, which includes all histological subtypes. The trial, conducted across approximately 100 clinical sites in 12 countries, is evaluating NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial is improvement in overall survival. Enrollment commenced in November 2006 and the target enrollment was achieved in March 2008. According to the SAP, a total of 725 events are required to detect a 25% improvement in overall survival (hazard ratio of 0.8) with 85% power and a two-sided significance level of 0.05. No interim analysis was performed.

"We are on track for our pivotal Phase 3 trial to conclude this quarter," said Harry Palmin, President and CEO of Novelos. "Should this registrational trial be positive, we will proceed with filing a New Drug Application (NDA) in 3Q 2010. Thereafter, based on our Fast Track designation, we would project FDA approval for first-line treatment of advanced NSCLC in combination with chemotherapy in 1Q 2011."

This signals the end of the clinical trial and the unblinding of the trial... I would expect the results to be revealed over the next 4-7 weeks.

This is my analysis and opinion that novelos at least hit their primary endpoint (I also posted this on Yahoo Forums).


I'm not attempting to predict Median overall Survival... we'll leave that to the guys with better statistics, but rather support the claim that they likely did at very least hit their primary endpoint (which is nearly identical to the Avastin Primary endpoint) ....

Assuming people die on Novelos in comparable distribution as Avastin and the control group. Not saying they die at the same rate, but rather you see the gradual decline from start of trial to the end of trial... ie not a huge death rate in the beginning for the Novelos group. I believe the posterboards for Nov-002 on the Novelos website can support this at least when comparing to control group in earlier trials...

Just use the comparative 2 year survival data.

At two years we would expect 15% survival for those on the control group, Paclitaxel/Carboplatin per data above.

For Avastin we would expect 23%.

So if we assume their was a trial for Avastin vs. the same control that was the same trial size as novelos, at 2 years we would see 104 survivors in Avastin Group and 67 survivors in control so assuming everyone was enrolled at the same time the 725th even would occurred around approx 22-23 months.

I'm using the Avastin comparison since the primary endpoint of median overall survival is nearly identical I think 12.3 vs 12.5 months.

As of today we have about 178 survivors (vs 171 at 2 years) in the Novelos study... since Full enrollement was completed in March 2008, it is about 21 months ago... so unless nearly all the patients were enrolled from January 2008-March 2008 (We know this isn't the case since the trial was started back in 2006.)... The endpoint has been hit.

Because the trial actually started in 2006 I predict a huge survival advantage on the Novelos group.


By the way am i really the only one that cares about NVLT? Man... I thought there would be a few more investors than just me.....
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Everything I post is merely my opinion... Please perform your own research. I take Absolutely NO responsibility for any actions that you take as a result of my posts.

Please be aware that there ARE probably factual errors in my posts and any advice I give is probably BAD advice. If I'm posting about a stock/financial strategy, I must have some sort of a financial interest in it... I am most likely either long /short/looking to buy cheap/sell high and thus an extreme conflict of interest definitely exists.


Last edited by dorkytom; 01-07-2010 at 01:45 PM..
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Old 02-24-2010, 04:26 PM   Nav to Top  #10
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Denied.

NVLT plummeted today.
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