Prednisone is not required for 427. This will become a marketing issue between mdv3100 vs abi war. So it was nice to hear this.
427 has really nice results. The results might get better with time as well. The trial is enrolling nicely. An update will be provided at ASCO (June).
It seems like the new abi trial will be for patients who failed abi and then they plan an abi+/-427 in post chemo. (I might have misunderstood this part. i need to relisten. Maybe later). Then P3 will be probably in prechemo which will be in an untested setting. We are looking at 5-6yr minimum to have p3 results. I guess they didnt hear us saying they should cut the chase and start the P3 in prechemo as monotherapy now.
The most important news for me was that OGX-011 is on track to complete enrollment this year.
PS. Except OGXI, I'm mostly in cash now. Any good biotech ideas?
Oh, as far as other biotechs are concerned, I'm in YMI, which has had a runup lately based on partner/buyout rumors which may or may not be substantiated. I think they're undervalued anyway but as always with biotech who knows.
I'm also in POZN which is sort of a low-tech biotech. They combine two existing drugs to create a new patented entity. They've got combo drugs for migraine and musculoskeletal pain on the market (both partnered) and are developing a combo aspirin + proton pump inhibitor (to prevent GI problems) in late-stage development. Solid cash position and sales of the second marketed drug, while slow, are starting to pick up.
Finally, if you want something you'd be embarrassed to admit you own, there's CVM. They have a drug that supposedly simulates a healthy immune system that's in P3 as a first-line treatment for head & neck cancer. Management is something of a joke (CEO is founder's stepson and given to issuing lots of PRs with vague, dubious claims, never holds CCs), and they don't have enough money to complete the P3 so they do highly dilutive offerings with warrants frequently. But heck, the stock is going for 34 cents and who knows their drug could work, in which case no matter how many shares will be outstanding the stock should be worth many times that.
Agree with your comments including that Dr. Gleave's statement that prednisone is not required for 427 was nice to hear. MDVN and various analysts already seem to be trumpeting the fact that MDV3100 doesn't require it whereas abi does.
Gleave commented on the planned 427 + abi trial at both the end of his presentation and in the Q&A and I had trouble following him both times. But I think he said they plan to do the P2 in the post-chemo setting with patients who have progressed on abi, with the treatment group getting abi + 427 and the controls continuing to get abi alone. He then seemed to say that in the P3 they'd probably want to compare patients getting the combination up front (i.e., before they had progressed on abi) with patients getting just abi, but I think this would still be in the post-chemo setting. He said twice that they hope to complete the P2 and begin the P3 in about a year. That sounds very ambitious but maybe your 5-6 year time frame is too pessimistic. I don't know why they're not going to the prechemo space except that they want to combine with abi and it isn't (yet, anyway) approved there.
I could hear a little of what Scott Cormack was saying in the breakout and one thing was that the other indications -- lung, breast, etc. -- are the subject of so many trials now that enrollment would take forever. I think he said something similar when he announced the initiation of the P2 bladder trial last year. So maybe (given that the 427 patent will expire eventually) they plan to just focus on prostate and bladder, in which case they may not need to partner. However, since the P2 trial with abi is only partially grant-funded and the P3 will be expensive and time-consuming, they're obviously going to need to raise money someday somehow.
BTW the posters are up on the website. The control group in the prostate trial seems to me to be slightly sicker than the 427 group (based on ECOG status and Gleason scores), but not enough to matter.
Agree that Cormack's announcement at the beginning that enrollment in the 011 SYNERGY trial will be completed in 2012 was a positive. FWIW he also said they expect to commence the 011 lung trial in 2012. I realize that's inconsistent with the P1 PK trial you've linked to, with its planned completion date of December, but maybe that trial isn't going forward (maybe they've talked Teva out of doing it), or maybe it will just be supportive. We should find out for sure when they do their Q4 CC in March.