when NCT01040221(autism), NCT00645749(RRMS) and NCT01836939(psoriasis) are all ready to release results? These MD/scientists should release the result ASAP, otherwise, no more research.
There should not be 109 efficacy data. It's a phase I/II trial, phase I was for dosing. If no safety concern, goes into phase II with optimum dose. They didn't say the enrollment had finished. Even so, we will have efficacy data long time after, because it's about to measure how long it will block the AML to relapse from first complete remission. It's like watching paint to dry, for years! Not 12 or 24 weeks trials we usually have with TSO.
After the long silent time, the new management have to come out to say something. Anyway, they have to lay out the plan of the year in a few days. And then release the result of HINT2, 2 Crohn's, UC, autism.
If on tomorrow, the monitor board said HCC trial result from 60 patients in 4 months is amazingly good that continuation with the trial is not necessary and unethical to patients on placebo. Will EXEL's price shoot up to $1000 in one hour?
I know it's even more impossible than a daydream. Just food for thought.
They can at least give us some hints about the count of events for COME-1 and EXAM, or are we close to finish enrollment of COMET-2. They use 5th for every question instead.
The answer to the second question is if one group is extremely good comparing to another group or one group is extremely bad, for ethical reasons, DSMB will call off the trial and unblind.
No, I didn't subscribe to that letter. My guess is what they said was 109's transition from phase I into 2. They might already have the data of maximum and optimum dosage and started to dose at one or two optimum dosages. That result won't change share price a lot, IMHO. But at least we can be sure that method didn't cause problems so we had to stop the efficacy trial. Yes, HINT results are almost there. This month should be the last month. And last few months, the remaining patients were already out of TSO. Every month, patients took MRI scan. So, the compiling of data should not take too much time since most data were taken. When they'll make the data public is a question. Publishing on a scientific magazine/conference first, or releasing by CNDO first? Seems it's a UWisc & National MS Society running trial. Hard to tell.
A CNDO-109 question for experts on board: why do we need allogeneic NK instead of autologous? My understanding is that tumor cells evade NK attacks by not present first signal molecules on membrane. NK themselves are not defective. We just want to bypass this step in vitro. Why don't we use self NK and prime them and then infuse them back? Why do we want to risk transplant symptoms? Are there some research comparing these two methods?
Due to the high efficacy of cabo, and half of the patients on drug will live forever until the natural cause, the EXAM and COMET-1 interim will postpone for another year or more...
Just curious, what's the upper and lower limit of recruitment for each site? Of these 66 sites, can one site exceeds 246/66, let's say, 5 patients? Or at least 1 patient for every site? If there are limits, is this requirement for ethnicity diversity?
will this company scrape IBD or TSO as a whole? Seems there is a very violent dispute over there. CEO and CMO all are let go.
KEVIN HORGAN, M.D.
CHIEF MEDICAL OFFICER
Dr. Horgan has served as our Chief Medical Officer since November 2013. Dr. Horgan has more than 25 years of academic and pharmaceutical experience. Prior to joining Coronado, he was at Soligenix, Inc. as Senior Vice President and Chief Medical Officer since 2011. From 2008 to 2011, Dr. Horgan was Head of Internal Medicine at GE Healthcare, a part of General Electric Co. From 2006 to 2008, he was Vice President of Clinical Immunology at Janssen Biotech, Inc. (formerly Centocor Ortho Biotech, Inc.), where he designed and conducted gastroenterology clinical studies for new compounds and indications including REMICADE® (infliximab) and STELARA® (ustekinumab). From 1997 to 2006, Dr. Horgan was Senior Director of Clinical Research at Merck & Co., Inc., where he led the development of the first neurokinin-1 receptor antagonist, EMEND® (aprepitant), to be approved for the prevention of chemotherapy-induced nausea and vomiting. From 1995 to 1997, Dr. Horgan was the Director of the IBD Center at the University of California, Los Angeles (UCLA) . Dr. Horgan graduated in medicine from University College Cork, Ireland and completed his training in internal medicine at the Queen Elizabeth Hospital, Birmingham, United Kingdom and the Johns Hopkins Hospital, Baltimore, Maryland. He did an immunology research fellowship with the National Cancer Institute in Bethesda, Maryland. His research on human T-cell differentiation, activation and migration with emphasis on integrin adhesion molecules provided a framework for subsequent validation of three therapeutic targets. His fellowship training in gastroenterology was at UCLA.
Seems nothing new came out of PGNX trial on ASCO. side effects and safety profile are the same as phase I, trial is on going, blah blah