I did some dd here! Got in at 2.07 and it caught fire two days later. Sold all my shares on the run in the threes. I couldnt hold another biotech losing all my cash. And as usual here we are below my old entry point. Ok so whats the real deal with ceplene. Did the fda say no to it with out another trial? Did the company do some sort of trial and if so why not refile fda app? I mean give me something good here. I am itching to get back in. There is alot here and think this could be great!!!!!!!!! Ok enough im out, Green
Finally a reasonable post here. thegreenservan, try to ignore the hypers here with yahoo ids less than a week old. They'll claim I am ten other people I am not and the ususal ps which is thrown at somebody who posts a negative viewpoint.
Here is the quick scoop on Ceplene. Ceplene was run in a phase III clinical trial by the former company Maxim, which was acquired by EPCT when the bank finally was tapped out. In combination with IL-2, ceplene showed positive results in patients with AML. However, the trial was rejected by the FDA because an IL-2 alone arm was not run in that clinical trial. Essentially, Maxim couldn't prove that the effect was coming from the known FDA approved anti-cancer IL-2. The FDA asked Maxim to repeat the whole study with an Il-2 alone control, but the money had dried up by them.
IL-2 was later published not to have an effect in an academic study in AML run by someone at the Univeristy of Chicago. here is a link to the study:
Do the math yourself, the Chicago study was run with a different dosing regime and for a time period substancially shorter than the Maxim study. The reason for Maxim not running the IL-2 alone arm is likely due to the significant cost of the daily dose of IL-2 (~$20K)/person. EPCT is betting on the EU filing will be accept using the Chicago data as the IL-2 alone control arm.
Will the Eu regulatory agencies accept the Chicago data or not. That is the gamble. NP-1, the topical pain cream is a joke. They have only shown that it doesn't get into the blood stream to date. No clinical trial establishing an effect in people completed. Their only other cancer drug EP2407, even with their claims of "accelerated enrollment phase I" is many many years away from approval.
The huge spike on April 20 amazingly coincided with a repeating of MYGN press release on a compound that they sold to MYGN:
The amazing coincidence was that Domain Public Equity Partners L P, a venture fund owning EPCT, unloaded a huge number of EPCT shares on April 20th - the day the stock went from 2 and change to almost 5 bucks. DPEP got out in the high 4 range. Coincidence? Sure....
thank you, rlertr, for the informative post. regarding ceplene, you cite to one study that shows il-2 alone does not show positive results, but weren't there two studies? both appeared in "blood," one was the children's cancer group, the other was cancer and lukemia group b. check out slide 10 of 28 in the canacord adams analyist presentation last week. i listened to that presentation, and the ceo sounded quite positive about the status of the emea application -- the quote was something like "very positive feedback to date" -- from memory. i give it a 50-50 chance on ceplene. they had some other new data in that presentation (about quality of life, etc.) that they said would be included in the application and be presented at the upcoming ash convention. all in all, he sounded quite positive. however, couple the positive statements with a forward looking statement warning, and that plus a couple of bucks will get you a ride on the subway...
again, thanks for the info. regarding the history of what happened at the fda. one question still remains for me, though...why didn't the company go back to the fda armed with the two third-party studies once they came out? do they think they have a better shot at the fda with emea approval, was it cost, did the fda say don't come back unless you perform the study yourself, was it something else? again, appreciate your thoughts.