BOSTON ( TheStreet) -- As you read this week's abbreviated Biotech Stock Mailbag, I'm on a Chicago-bound plane to cover the American Society of Clinical Oncology (ASCO) annual meeting. I'll be live-blogging from the ASCO meeting starting tomorrow morning and continuing through Monday, so please check TheStreet's Web site throughout the weekend for all the latest news and buzz on cancer drug stocks from what is the most important cancer drug research meeting of the year. Christian O. emails, "The market doesn't seem to care much about the latest results from the Aastrom BioSciences (ASTM) critical limb ischemia trial. What am I missing here? It seems like the company is giving positive signs that the drug works. I expected the stock to be much higher. Do you have any ideas about what is happening?" Aastrom is developing a personalized, or patient specific, stem cell therapy for the treatment of critical limb ischemia. Patients with chronic CLI have obstructed arteries and reduced blood flow in the arms and legs, which can lead to open wounds and amputation in the most severe cases. Interim, six-month data from Aastrom's phase II study were released last November. Wednesday, the company announced final results from the same study, indicating that ixmyelocel-T (crazy name) demonstrated a statistically significant improvement in time to first occurrence of treatment failure at 12 months compared to placebo -- the study's primary endpoint. Despite what looks like good news, Aastrom's stock was trading relatively flat Thursday as I write this column. A few thoughts on what's going on: Aastrom frustrated investors by not providing any real data in its press announcement of the final study results. The company claims it needs to keep the data under wraps for presentation at a future medical meeting, but c'mon, that excuse doesn't wash. Aastrom was able and willing to divulge plenty of interim numbers from this same trial last fall, so keeping final results secret now isn't justified. If you take Aastrom's words at full face value without actually seeing the data, it seems as if the final results improved over what was presented during the six-month interim analysis. Most importantly, the improvement in amputation-free survival at 12 months trended more favorably in ixmyelocel's direction than the largely equivocal results observed at the previous interim analysis. This is important because amputation-free survival at 12 months will be the primary endpoint of the planned phase III studies. When will the phase III studies start? This might be the real reason why Aastrom shares fell following Wednesday's announcement. The company has been going back and forth with the FDA for nine months to finalize a Special Protocol Assessment (SPA) to govern the design of the phase III studies in CLI.
Aastrom indicated Wednesday that an SPA deal with FDA is very close, which should be welcome news for impatient Aastrom investors. I'd say good news on the SPA for the phase III trials is probably more important to the stock than anything offered up this week since the outcome of the phase II study -- even the final data -- was already a bit stale. Lastly, realize that Aastrom has a long way to go before delivering definitive results on its stem cell therapy. The initial phase III study could take two or three years to complete and report results. Aastrom in the $3-$4 range isn't overvalued at these levels, but it's not particularly undervalued either. Shane F. comments, "Adam, I know you hate Star Scientific (CIGX) but before you make a judgment you should buy some CigRx. It's an incredible anti-inflammatory and is incredibly helpful in helping people quit smoking/dipping. I have chronic arthritis in my foot and CigRx helps with inflammation quite a bit. Also, my brother and cousin both quit dipping using CigRx. You should try CigRx yourself. Give it to people who want to quit smoking. Give it to people with pain problems and arthritis. You will be amazed." I don't hate Star Scientific. I simply do not believe that a company developing retail nutritional supplements derived from naturally occurring compounds in nicotine deserves a $500 million-plus market value. CigRx is a mint-flavored lozenge containing an extract of yerbe mate, a caffeinated herbal tea, and anatabine, a compound found in tobacco plants that may help fight nicotine withdrawal and have some anti-inflammatory effects. Star Scientific peddles CigRx as an alternative dietary supplement for people who want to stop smoking. None of the CigRx claims made by Star Scientific have been reviewed or approved by the U.S. Food and Drug Administration. This isn't a drug, it's a fringe nutritional supplement sold in gas stations, convenience stores and over the Internet. Star Scientific reported first quarter CigRx sales of $47,000. Last March, I wrote about Star Scientific and its relationship with the Roskamp Institute to develop another anatabine-containing nutritional supplement as a potential treatment for Alzheimer's disease. Calling this effort a potential treatment for Alzheimer's is to be incredibly optimistic. Don't count me in that camp. Star Scientific's stock hit a 52-week high of $5.35 on May 31, which is up 32% since I wrote that bearish column in March. What can I say, except that the biotech sector has been going through one of those frothy periods in which speculative investors set aside fundamentals and bid up stocks regardless of quality (or lack of). It's in this kind of biotech bubble market that Star Scientific can achieve a half-billion dollar market valuation, even with a sharp selloff in the stock on Wednesday.
All stock market bubbles burst, and so too, will Star Scientific. Fundamentals do matter, eventually. Evan H. emails a question about BioVest International ( BVTI.PK): "Does the publication of BioVaxID study results in the Journal of Clinical Oncology improve the odds for approval?" No. BioVest's press release Wednesday touts the publication of the BiovaxID phase III study in Journal of Clinical Oncology (JCO) as a validation of its drug and the use of personalized immunotherapy, or cancer vaccine, to treat patients with non-Hodgkin's lymphoma. What BioVest failed to mention in its press release is that an independent editorial in JCO published alongside the study article raises many concerns and questions about the BiovaxID study. The editorial, written by two experts from the Mayo Clinic, concludes that more clinical testing of BiovaxID is necessary and that use of a cancer vaccine in the way BioVest proposes would meet with resistance from doctors who treat lymphoma patients. I have written extensively about the shortcomings in the BiovaxID clinical data and said repeatedly that BioVest has very little chance of gaining FDA approval without conducting another large phase III study. I'm happy to see my bearish opinion shared by two experts from the Mayo Clinic. I've said it before but it bears repeating: If you're looking for the truth, don't place any faith or credit in company-issued press releases. Go directly to the source material, if possible, for the real story. In the example of BioVest, it took me less than five minutes to find both the actual study published in JCO, and more importantly, the accompanying editorial critical of BiovaxID that the company failed to mention. (An innocent omission, I'm sure.) Meantime, BioVest doesn't appear to be in any rush to meet with FDA officials to discuss whether or not the company can even seek regulatory approval of BiovaxID. In its press release Wednesday, BioVest said it was preparing to meet with FDA, but that's exactly what it said last fall -- more than six months ago. What's taking so long? The delay is not a good sign. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.
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