MEIP had a very good data update on the single arm elderly AML Phase II trial at ASH but the stock went down ? The trial was a combination of Vidaza and pracinostat. They reported a 14.3+ month OS (still counting) with a high complete response rate of 42%. Anything over 12 months would be a win and 14 months a big win and they still haven’t reached median overall survival on the whole cohort (median OS for patients with high risk genetics was 13.3 months again a big win in my book). The best results for Vidaza as single agent in elderly AML is about 10-12 months OS. The negative is that this was a single arm trial and patients probably had a slightly lower blast count than in the comparative Vidaza trials.. MD Anderson is acting as the PI and that is a bit of a problem for since they MD Anderson always seems to get better results than can be repeated in a controlled trial. But even given that caveat the results look substantially better than what one would have expected from Vidaza as single agent. Management has guided to a Phase III registration trial to begin 2nd H ’16. Current market cap is only $46 million with a strong cash position of $53 million and no debt. How does the stock price make sense in light of the clinical data? There are only 34 million outstanding shares and the float is 29 million—this all looks pretty good to me. Is nobody is paying attention here?. The company did take a hit in 2015 on an MDS trial which was plagued by a high dropout rate due to toxicity. This was not nearly as big a problem in the AML trial when you are dealing with a quickly fatal disease.
Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "Since the unblinding of our randomized study in front-line MDS, we have learned that the combination of Pracinostat and azacitidine resulted in a high rate of discontinuations due to adverse events compared to azacitidine alone. These discontinuations occurred predominantly within the first two cycles of treatment and often before a response assessment could be performed, leading to a higher complete response (CR) rate overall with azacitidine alone. However, exploratory sensitivity analyses among patients who were able to tolerate treatment for at least four cycles (n=54) suggest that patients treated with Pracinostat plus azacitidine appear to derive benefit compared to azacitidine alone, with hazard ratios for progression progression-free survival (0.37), event-free survival (0.33) and overall survival (0.59) all favoring the Pracinostat plus azacitidine arm.
"The data from our open-label study in elderly patients with newly diagnosed AML," continued Dr. Gold, "demonstrate that many patients are achieving responses within the first two cycles and continue to improve with ongoing therapy, with fewer discontinuations due to adverse events than in our MDS study. Overall, 54% of patients (27 of 50) have achieved a clinical response with 42% (21 of 50) achieving a CR. The 60-day mortality rate in the study is 10% (5 of 50) and the one-year survival rate is estimated at 60%. All of these data points compare favorably to a recent study of azacitidine alone in this population1. Median overall survival, the most important measure in determining the development path forward for this combination, still has not been reached. We will continue to follow these patients and look forward to the presentation of updated overall survival data at ASH next month."
I have been investing Biotech since 2002.. Lots of winners and some blows up overall I have done pretty well....I have about 50 plus biotechs in my profilio ...spreading the risk....but right now of course this has been a challenimg time in the world of Biotech investing ...but I am sticking with it ....
thank you ! chinaman I appreciate your comments... fyi... fwiw my biggest postion in bio is ARRY..
In the new trial, patients will be randomised in a 2:1 ratio to receive either 120mg of gilteritinib or salvage chemotherapy consisting of LoDAC, azacitidine, MEC (mitoxantrone, etoposide, and intermediate-dose cytarabine), or FLAG-IDA (fludarabine, cytarabine, and granulocyte colony-stimulating fac
tor with idarubicin).
A parallel multi-dose expansion group was started based on the efficacy seen in the dose escalation phase.
Preliminary data from the Phase I/II trial showed a 57.5% overall response rate and a 47.2% composite complete response (CR) rate. The results were based on 106 patients with FLT3 mutations, who
received doses at 80mg and over.
The BLRX 8040 was only 50 mil mc so I would say that 8040 is far from dead in the water ... Certainly a combination is plausible.
Well, Jim, I can answer that from a BI standpoint. As Rick has said, we're not prepared on this call to give guidance into the first quarter on a revenue basis, but as you look at BIs, which have traditionally been a leading indicator for us, January/February has been very encouraging as it relates to BIs coming through. Some of that is J-code, as Boris mentioned, warehousing, if you will. But if you just take new patient BIs, which is of course the demand created by the sales force being in the office, and the issuance of the permanent J-code, we've certainly seen an uptick of new patients over the previous quarter. In addition, of course we've got the lag of patients who came out of January.
Right now if you look at what we think is kind of the leading indicator of demand, from that standpoint we're pretty close to what we expected to see as demand in January and February. So that's the good news. As I said earlier, and as Rick has reiterated, the conversion of that "demand" that's pretty much on track where we expect it into actual revenue, has been a little bit slower than we anticipated. So I guess if I can look at the quarter without getting into the actual numbers, right now I think we feel pretty good about the demand creation per our expectations. But certainly we would have to confess that we were a little more optimistic that with the permanent J-code, the system would be more fluid, and we would see those patients moving through
with less of a lag time.
I was traveling ...Is that what they said on CC? ..January and February below expectation .? Thx
Get an injection in the eye every 45 to 60 days for current treatment or
Get an injection in the eye with ALIM's compound every 2 to 3 years ...???
The sales here should ramp up very nicely moving forward ... Especially with the J Code now in place.
Having invested in Biotech for 25 years they swing and are volatile. Hang tough the science is pretty good here so until that changes you have to stay the course.
Socialist countries are no growth stagnant societies. ?? Who in the heck wants that?
Oh brother I stand corrected again had to scroll further down the 13G filing BVF for 7 million plus shares of ARRY .. They all ready had a position however