The AML trial ongoing is open label. Doctors are more willing to keep patients on drug if they know that they are actually on experimental drug and not placebo. In MDS case the placebo is also an active drug.
They just need to educate the doctors that the patients on combo need to weather the side-effects until complete remission occurs. I think there's still hope for the MDS indication. Once the data is analyzed and those removed from the analysis who withdrew early due to side-effects (not progressive disease) the efficacy of the drug will be demonstrated.
Seems like stock never recovered from the big biotech down day a few trading days ago. Company sitting on $150M in cash and 3 drug candidates, 2 heading for phase 3. What a steal at these levels.
2 years is an eternity for small cap biotech
THey've already stated that AML data is positive. This trial is open label. What will be more important is how many discontinuations there are and how the side-effects were managed until remission could occur.
Good article on bioworld with MEI CEO:
AS AML BID WITH HDAC INHIBITOR GOES ON
Educate docs, switch dose and/or schedule: Fix for MEI phase II 'bomb' with pracinostat?
What CEO Daniel Gold called a "ticking time bomb" apparently went off in the 102-patient phase II trial testing MEI Pharma Inc.'s histone deacetylase (HDAC) inhibitor pracinostat in combination with Vidaza (azacitidine, Celgene Corp.) against previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS), as top-line data show the pair performed no better than Vidaza by itself.
Shares of San Diego-based MEI (NASDAQ:MEIP) closed Monday at $1.93, down $4.37, or 69.4 percent, a new 52-week low.
Gold's "bomb" reference related to the fact that Vidaza and the HDAC inhibitor cause, at first, a worsening of the condition – blocked maturation of red blood cells, platelets, and neutrophils – that they're designed to help in the end.
Unusually high dropout rates turned up, too. An earlier, 10-patient study at MD Anderson Cancer Center provided the impetus for the experiment, and "the indication was from the pilot study that if the patients stayed on the drug long enough, they finally did recover and had a very good outcome," Gold told BioWorld Today. "If nothing else, what we've learned is that when you're running a larger, blinded study, the rules are probably different for the investigator in terms of their willingness to brave it with their patients in the face of adverse events."
MEI "tried to be pretty open from the very beginning, when we started the MDS study, that the purpose was not to prove that the 10-patient study was right," Gold said. "It was to rigorously determine what the true benefit was – response, transfusion, progression-free survival [PFS]. That was our number one goal. I think the [jury] is still out" on those matters, he said.
Actually from hearing what management has said it appears that they did not hit endpoint due to discontinuations in treatment arm. The combo treatment starts with a worsening of symptoms before resolving and complete remission. Pilot study was conducted at MD Anderson where they are familiar with how to progress patients past the side-effects until complete remission occurs. WIll be very interesting to see the response rates if those that discontinued treatment early due to side-effects in both arms are removed. I wouldn't give up on MDS indication quite yet.
Not true, drug is protected by 2 patents. One is expires next year the other not for another decade.
Well the AML Phase II clinical trial has no placebo arm and they've basically already said the data is good and re-affirmed that in the MDS press release. To me, the main reason I think AML has a better shot is because there as been complete responses seen when just treating with Pracinostat single agent. I think with MDS they only have seen a complete response when treating with the combo.
My thought is basically any good news at this point will pop the stock. Apparently management will provide more data at April Needham conference. Also June AML data will be good.