OGXI and ISIS have a very strong relationship with good communications. OGXI is thrilled to be working with TEVA. OGXI could have gotten a better numeric package but not a better total package. OGX-011 is looked upon by TEVA as their beachhead into CA treatments. Upbeat all around at OGXI except they admit to some frustration in their stock price. This info derived from talking to the OGXI people at the ISIS meeting. t
"The difference in PFS between the two arms did not achieve statistical significance (hazard ratio = 0.809) by applying a log-rank test. "
I'm a firm believer in their drug. Going back in a trial to cherry pick results is always frowned upon. The market was very happy with the results and ARQL spiked upon releasing the top line results. Unusual.
I'm guessing the trial was large enough and thus the subgroup large enough to warrant going to a phase III trial with the subgroup. Another phase II trial would be a conservative approach. The c-met trials by multiple pharmas is advancing and delaying for another phase II sounds unlikely. JMHO
What say you?
Correct. I don't think it needs a couple of years for investment in ARQL to payoff. In addition to NSCLC, they are doing several trials to expand 197 to other indications. cMet is valid target in many cancer types, not just NSCLC. Not all of them will work out, but many will. I am very comfortable with their development strategy, top notch. Holding a core position, adding when during major weakness, lighten up during bounce.
On what basis do you call it failed phase II ?
It met it PFS and OS endpoints. Yes they had to do correction for biomarkers, but the results are good (even with patient crossing over). I am happy with the management that they didnt try to pump the stock with flattering PRs like DCTH. They would have published data for patient on ARQ 197+T arm vs T+P arm and let people to believe how great the drug is, but they dont believe in exaggerating the effect.
Anyway, it would a great play within a couple of years. Am I correct JQ ?
Phase II was well designed. We just hope they don't try to include too large patient population in phase III trial. Should follow phase II signal strictly. I believe they will.
I wouldn't call it a failed study, especially in lung cancer. A small randomized phase II trial with clear signal is the best you can hope for because lung cancer is tricky.
cMet is a legitimate target. 197 can be combined with many existing treatments for wide variety of cancers. I just found out today Daiichi Sankyo actually is conducting 197 in combination for colorectal cancer. Combination therapy is the trend for cancer, similar to HIV right now.
By the way, I was long ARQL before trial result. Tried to convince a few to take chance without much success. ARQL is a great example of biotech company who sticks to fact without exeggeration. I'd say it is one of top three small molecule biotech companies who has legitimate chance to become next OSIP and ONXX.
I thought the phase II trial was well designed to reveal a target patient.
Not long ARQL, looks like a long road ahead of it before investable trial results.
Still impressed with the bounce that came from ARQL's failed phase II trial. Somebody other than traders saw something they liked.
Thanks Dr. K...it a nice little gem of a company and i believe its compound will fit in nicely into the combination treatments we see more and more of. That is a way off and several hurdles remain, but the risk/reward value proposition is very attractive at these price levels. I am saving some dollars in case it drops into the 13 range, but have already again added at these levels.
I have confidence in ARQL CEO and CMO making the right decision in phase III patient population. They came from Bayer team who developed Nexavar.
OGXI is on the right track by putting the start of lung cancer trial to next year. I hope they collected tumor tissues from trial patients, are doing lab analysis, hopefully finding markers from responders.
These people don't over promise, which is a good sign.
OGXI will get a bigger bounce if ISIS, MIPO drug has good P3 trial results over the summer. we just get a bounce from the start of -011, P3 trials and than a sell-off.
this stock has no liquidity for the TUTES to trade in/out of. its Market CAP is also not significant enough for most to invest. This company needs to do a 5 for 1 stock spilt.
Management has no clue on how to manage the street as the 18-1 reverse split when they went public has created severe problems for the stock.
ASCO is almost over, Biotech investment CC's are near and end and the summer time biotech doldrums are quickly upon us. In the 18 years i have been trading/investing in this sector we have only had a handfull of summers when the biotech index's traded up thru labor day.