Epizyme reports initial findings from EPZ-5676 study, shares fall


Shares of Epizyme (EPZM -34.3%) sink after the company outlines initial findings from a Phase 1 study of EPZ-5676 in heavily pre-treated advanced hematological malignancies.

EPZM says the treatment has been well-tolerated with no dose-limiting toxicities. There was one adverse event-related treatment discontinuation, but the company says it wasn't related to the drug.

Treatment effect observed in four of eight MLL-r acute leukemia patients.

No treatment effects observed in non-MLL-r patients.

The company now plans to initiate a Phase 1 "MLL-r only expansion stage with an 80 mg/m2/day administration schedule without a drug holiday and with possible continued dose escalation." (PR)

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Comments (9)
  • MDHJr
    , contributor
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    Can anyone explain the big negative here that warrants such a huge drop in the stock?
    14 Nov 2013, 12:20 PM Reply Like
  • Matija Snuderl
    , contributor
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    as mentioned in a previous discussion, I dont understand why great Phase I data caused such a massive drop. I would expect to see something like this if the drug killed one or two of trial patients... In my opinion, results are better than great (unless i am missing some insider story here). There is n otoxicity, that's the key. It works against geneticlaly defined subtypes. And most amazingly, it works after HEAVY previous therapy. That's quite amazing if you think what is the goal of the Phase I = prove that the drug doesnt kill and establish MTD. The fact that they saw therapeutic response and could follow it with a biomarker is really good. It also (somehow surprisingly) shows that after all that therapy (which has been damaging the cancer cell) DOT1 is stil l the cancer cell growth driver. If you look at the abstract they will present at ASH how the compound synnergistically works with chemo, together news are great. I think either someone who doesnt understand Phase I trials hit the panic button when they saw "4/8 response", or there is something that is not being said.
    14 Nov 2013, 12:27 PM Reply Like
  • Ryan Sullivan
    , contributor
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    An overreaction. I think there was some hope out there (not from me, but from some in the investment community) that the drug might have an effect on the non-MLL-r patients as well, potentially opening the effects up to other leukemias.

     

    I think the investment community is overlooking the line "Additionally, some MLL-r patients experienced resolution of leukemia-related symptoms and manifestations, including fevers, cachexia, and leukemia cutis." That's huge for patients that had failed all types of treatment up until that point.

     

    Perhaps some are worried about expiration lockups and were holding to this point to see the results before selling? I'm not sure.

     

    I'm holding at this point, I'll consider buying more after lockups expire on the 27th, looking for good results presented at ASH.
    14 Nov 2013, 01:49 PM Reply Like
  • Matija Snuderl
    , contributor
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    you might be right, but that would be completely contrary to what the company is trying to achieve and would frankly mean they cannot predict who will and who wont respond to the drug. I like it as a imatinib/CML story. Clearly defined population with good response. This is targeted therapy at its best and without toxicity. Trading volumes are quite interesting to watch.... -40% drop was actually caused by relatively small volumes that came in quickly one after another. And each buy was quickly overran by a few sells. Now even a recent massive 300k order doesnt push it up much. Remember a few weeks ago where a couple of thousand shares buy order would send a stock up 4%? I wouldn be surprised if this panic is used now by smart ones to suck out shares that were dumped in panic. Wouldnt be surprised if we are at ~$22-23 by the end of today.
    14 Nov 2013, 02:01 PM Reply Like
  • Matija Snuderl
    , contributor
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    damn I wish I had free money at 18...
    14 Nov 2013, 02:07 PM Reply Like
  • Matija Snuderl
    , contributor
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    so this is funny, this was suggested as the reason for drop: "Drop May Reflect Maximum Tolerated Dose Not Reached" how can you reach MTD if you dont have any dose limiting toxicities...? Maximum tolerated dose is the dose which can be given safely without toxicity. If you reach the maximum planned dose for the Phase I and you dont see dose limiting toxicites, it means you (still) didnt reach the maximum tolerated dose. It might be twice as much as the highest dose, or three times, or 10 times. Gotta be some trading robot that sells based on MTD not reached :).
    14 Nov 2013, 02:14 PM Reply Like
  • MDHJr
    , contributor
    Comments (84) | Send Message
     
    Thank you
    14 Nov 2013, 02:34 PM Reply Like
  • stocknerd
    , contributor
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    Phase 1 testing (generally) is: Does the treatment/product have adverse affects like death or dangerous other side affects.
    14 Nov 2013, 04:27 PM Reply Like
  • Matija Snuderl
    , contributor
    Comments (335) | Send Message
     
    exactly, that's why 50% response rate should be welcomed by champagne, not by 40% drop :). bet yo uthere is a robot that is supposed to sell if the word NOT appears anywhere in the wire associated with the company
    14 Nov 2013, 04:42 PM Reply Like
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