Some positive vibes developing in the sector with results pending from a few coys this year..............including Prima..............
"SAN FRANCISCO | Wed Jan 11, 2012 4:05pm EST
SAN FRANCISCO (Reuters) - An interim look at a pivotal trial of Oncothyreon's experimental vaccine for lung cancer, expected this quarter, could signal whether its investment will ever pay off.
Robert Kirkman, chief executive officer of Oncothyreon, said the interim review is triggered when a certain number of patients have died.
"In some sense, the longer it takes the better it is," he said in an interview on Wednesday during the JP Morgan Healthcare conference.
The worst case scenario would be if independent overseers stop the trial after determining that Stimuvax is not working, while the best case would be if they stop the study early because the data shows clear efficacy.
"We would be perfectly content if the decision is to continue the trial to its end," Kirkman said. "We still expect to have top-line data in 2012. If the trial continues, we would have those results in the second half."
Oncothyreon has licensed the vaccine, Stimuvax, to Germany's Merck KGaA, which is conducting the expensive Phase III trial involving 1,514 patients.
The trial is designed to show that Stimuvax improves survival by at least 6 months in newly-diagnosed lung cancer patients who have tumors confined to the chest cavity, but are not eligible for surgery, the CEO said.
Patients are treated with standard therapy of chemo and radiation followed by maintenance with Stimuvax, which is designed to prime a patient's immune system against certain cancer cells.
If Stimuvax is approved by regulators, Oncothyreon would receive $90 million in milestone payments as well as royalties in the mid-teens for North American sales and high single digits for the rest of the world.
"It will be transformative for us and it would be transformative in lung cancer," Kirkman said.
Positive trial results would also be validation for Oncothyreon's wholly owned follow-on cancer vaccine, ONT-10, for which it hopes to start human trials this quarter.
"We own all the rights. So to some extent we are doubling down on Stimuvax," he said.
(Reporting by Deena Beasley; editing by Carol Bishopric)"
.......................................................... "Biovest International (BVTI) and Accentia Biopharmaceuticals (ABPI): Increased Sector Exposure Could Lead To Substantial Gains Posted 12 Jan 2012
Biovest International (PINK:BVTI) and Accentia Biopharmaceuticals (PINK:ABPI) have both been enjoying increased exposure, even if their respective share prices have not shown it yet. Biovest, a majority-owned subsidiary of Accentia, has been developing BiovaxID for the treatment of non-Hodgkin’s lymphoma, an incurable form of blood cancer.
It’s been a rough going for both companies over the past few years following the announcement of positive late stage results for BiovaxID and a bout with bankruptcy, but the tide could be shifting for not just BiovaxID alone, but also for cancer immunotherapy treatments as a whole.
With Dendreon (NASDAQ:DNDN) on a role as a result of positive news from the Provenge sales front and increased exposure from numerous media outlets regarding similar treatments, this could again become a hot sector to watch.
Last month it was announced that BiovaxID was highlighted in the Yale Journal of Biology and Medicine, but it was another article published just this week on the Fox News website that had volume of BVTI inching upwards. Although no parallel move in share price has yet to take place, the volume spike – well more than double the average norm since the article was released – could be worth watching for those that believe that volume precedes price.
The Fox article references BiovaxID as “Kwak’s vaccine”, stating that it has “passed its Phase III trials and is moving toward the final steps of regulatory approval,” and discusses cancer immunotherapeutic treatment as one of the expected medical breakthroughs for 2012.
As attention is again placed on the sector, both BVTI and ABPI could potentially see some significant price appreciation this year as updated approval time lines are announced. Both stocks trade in the thirty cent range, although Biovest is currently carrying a market cap double that of Accentia’s.
Biovax has already been granted an orphan drug designation by the FDA and its progression will be a story worth watching this year, especially since the entire sector looks to be receiving some reinvigorated attention.
While Dendreon provides an example of what can happen with a successful cancer immunotherapy stock, over the short term, keep an eye on shares of both companies, given their modest increases in volume."
(20min delay)