Biotech is where you find the most fun stories in investing, it has always called me like the sweet song of the mermaid. Antigenics brings a whole new sense of weird into play. They are among a set of companies hoping to bring the first cancer vaccine to market. Well AGEN got stiffed by the FDA and at the time I read the clinical reports and it was one of those 1.7 year survival studies that's easy to shirk off unless of course you have cancer. My mom has had breast and my step father is simmering now with MM so I keep an ear to the ground in this arena perhaps more so than semiconductors!Who cares about them! Anyway tiny AGEN can't fund a new study but they believe if they can stretch that survival rate somehow they would have a winner and so naturally they turn to Russia! In a first, Russia has approved AGEN'S kidney cancer drug Oncophage. It's the first so-called therapeutic cancer vaccine to win full-out approval anywhere in the world. This is not a traditional preventive vaccine where you'd get a shot to stave off coming down with something. Therapeutic means you'd unfortunately have to get the cancer first and then your own cells are mixed with the "vaccine" to empower your body's immune system to fight off the disease. In Russia AGEN enrolled 125 patients in the same clinical trial. And after a 10-month process, AGEN won approval of the drug there making Russia the first country in the world to allow a therapeutic cancer vaccine onto the market..... I have not as of yet been able to get the exact numbers of the russian trial..... a Dr not paid for by the co was quoted on cnbc.com..... Over the phone he told me, "Absolutely no question about it (that the drug works). I've looked at the data," he said, "and there's clear activity in the intermediate risk subgroup." That means he believes the drug works on patients whose tumors are of a certain size and confined to the kidney and the fatty tissue around the organ. If it has spread then this drug, he said, is not for you. Dr. Wood says he and his colleagues have just submitted the study for possible publication in a major, but unidentified, peer-reviewed medical journal. That could give the drug even more cred. Motley Fool chirped in with this- This isn't a vaccine in the traditional sense -- it doesn't keep patients from getting cancer. Cancer vaccines induce the patient's immune system to attack the tumor after the patient has already been afflicted with cancer. There's apparently a very simple reason that Antigenics went to Russia to gain approval for Oncophage: There's no way that the U.S. would approve the treatment given its current data. Its phase 3 trial failed to show that Oncophage could slow down the recurrence of kidney cancer after surgery. The company reanalyzed the data and found that a subset of patients -- those who have lower-stage tumors and thus a better prognosis of survival without treatment -- responded well to the drug. Oncophage improved the chance of cancer not recurring in this subset of patients by 45%. However, the FDA doesn't accept subset analyses for support of marketing applications. Such analysis is just an observation, not actually testing of a hypothesis. Of course, the company's observation could become a testable hypothesis. If Oncophage were to be tested in just these better-prognosis subjects in another trial, it could lead to FDA approval. Instead, Antigenics decided to try to get the drug approved in Russia and, possibly, the European Union. Whether they have a different scientific method in Russia or they're just willing to take a flier on an unproven treatment, I don't know. Either way, Antigenics plans to begin selling the drug starting in the second half of this year. Hopefully, it'll be able to use the money it makes off treatments in Russia and fund another trial. Until then, U.S. kidney cancer patients will just have to stick with proven conventional treatments like Pfizer's (NYSE: PFE) Sutent and Onyx Pharmaceuticals' (Nasdaq: ONXX) Nexavar. Or fly to Moscow for the unproven stuff. Nice reporting, if they can get a 45% anything the stock is going to soar so if it's a smaller subset so be it... already we are talking a smallish overall market, so maybe Antigenics is not the play... then again the Russians seem to want to fund a new study and just the expectation between now and the FDA date will cause the stock to double... that's the trouble with these biotechs.... AGEN did secure new financing by the way 7 million shares sold to private investors at $3! no discount. Who else can benefit from this new found attention to vaccines? Cell Genesis comes to mind; they just recently got a financing deal, $33 million up front I think, I have to double check- possible $300 mill deal. Let's keep an eye on CEGE.... they retained NA marketing rights (DD this) Of course there is DNDN, I'm sick of their story at this point. GERON is up nice today on volume folks! Trust me I'm not the only one thinking this way... Geron could be bought here and with Bush leaving shortly, it's only a matter of time before the stem cells take off.... That's not a bad call.... other names Vical, Favrille......... ~ stoney
Wow check this insider action out on AGEN in Jan... Officer 1,426 Direct Acquisition (Non Open Market) at $2.28 per share. $3,251 9-Jan-08 ARMEN GARO H Officer 1,166,667 Indirect Purchase at $3 per share. $3,500,001 9-Jan-08 ARMEN GARO H Officer 542,050 Direct Purchase at $3 per share. $1,626,150 Ok for the Armen dude that's a HUGE increase in holdings folks.... They are buying at $3, selling to new investors at $3 and options to buy more at $3.75... and the stock is $2.60.... opportunity knocking?
I bought 75k yesterday at 2.75. It seems BAM Opportunity fund took down 6 mill of the shares offered on tues night at $3. Thats Dimitry's group.
Thanks for that restricted! I'm feeling this trade more and more as always timelines are important- but how many times have you seen options given for a whole boatload of stock offered at below the price? This time it's real clean for such a small co. A flurry of press releases about re submission to the FDA and this gets to $5 quite easily.... as is the case with DNDN 2 years is 2 years that's a lot of hugs the FDA has to lighten up especially with this new info about early stage clump junk.... very interesting and potentially rewarding stuff. I would expect a press release to be generated by those very same buyers any day now.... CEGE is mentioned favorably in that link so I'm a going there too, so lets have some drinks and make sure I really feel this way! Tomorrow should be interesting.... AGEN,CEGE,CBLI,GERN, are all at the top of my action list. ~stoney
If this is such a lay-up how come AGEN's offering stock so damn cheap? Insiders knew about this offering in advance. That's fairly obvious the day the announced the news. In addition, they're strapped for cash and if they were optimistic about it they'd add a little more support to this thing. I don't think this is going to be the waterfall of profits you're hoping for. Just my 2 pennies
Do you think that resubmission news will drive the price up? Usually the headline has to have "FDA" and "approval" in it or it's ho-hum....
maxpi I take your point... sometimes as happened with labopharm DDSS the company gets foreign approval and merrily sells their wares there and it doesn't make one iota of a difference to the FDA. This case is different (1) because Russia has embarrassed them to some degree and (2) the particular subset that they will provide to the panel will have almost no chance of failing.... this brings us down to the murkier area of how broad an approval and this is where we may stub our toe.... the trick is by the time that happens will the stock already have had an earnings report showing sales and possibly a survivor going longer than the 1.7 years extra? If the side effects are low just who is the FDA looking out for? Like I said above 1.7 years of hugs from grandchildren is longer than those wonks at the FDA would have you think.... it's the DNDN problem. There is now the chance of showing much longer survival times when given to patents in early stage non spread out cancer and if nothing else provides a healthy basis for more drug combinations with Antigenics's compound.~ stoney
Well I've put in the time (all night) and read more damn clinical studies than I ever hope to again and I've got to say for a number of reasons which I will outline in a future thread I think I am going with CELL GENESIS as a LT play today! CEGE.... ~ stoney