"Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer"
The number of trial centers has doubled from 3 to 6. The three new cancer centers have been just posted to this trial on July 25 - all are recruiting.
The trial started in Dec 2010 and is now getting 3 new centers - that's a tantalizing indication that they might be seeing some good results IMO.
Winship Cancer Institute of Emory University, Atlanta Georgia, ranked #5 in Georgia, high performing in Cancer
Montefiore Medical Center, Bronx New York, ranked #11 in New York, high performing in Cancer
Oklahoma Cancer Center, Oklahoma City, Oklahoma, not ranked
For those who are new to Oncolytics the first anecdotal evidence we had of possible effectivness of Reo in Panc cancer was Bexley Mayor John Brennan. Bexley Mayor Brennan who was put in the randomized Carb/pac/Reo Pancreatic trial was also diagnosed with Stage IV cancer and lived just about a year from diagnosis. He died in January 2012. He was originally randomized to the Carb/Pac control arm and was failing rapidly on that arm and then crossed over to the Reo/Carb/Pac arm where he stabilized, gained weight and fared much better with metastatic leisions shinking. He survived much longer than most Stage IV patients.
>>>Yet the patient was able to survive 9 months notwithstanding his suboptimal treatment with Reolysin.>>>
Besides the 9 months survival, its important to point out that the patient's quality of life had also improved>>>
>>>He's gone from having extreme discomfort from eating most foods (to the point of requiring a fairly large dose of opiates simply to sleep) to being able to eat just about anything except non-ground beef (he can eat ground beef). >>>
Note that the patient was not on the standard dosing of Reolysin. He was on a much lower dose to accommodate his blood counts.
"His current treatment regimine is reolysin + gemcitabine every other week (RBC and WBC counts are too depressed to do the standard 2 weeks on, 1 week off treatment)"
Yet the patient was able to survive 9 months notwithstanding his suboptimal treatment with Reolysin.
He lived till May 28 - 9 months. That's a lot longer than would be anticipated - "The amount of time a person has left to live with stage IV (Panc) cancer can be limited to a couple of days or up to six months".
The enrollment by company for any trial seem slow for a blockbuster cancer therapy. At this rate it will take at least 2 more full years for treatment to reach the market. This assuming H&N pending data is good. The earliest I see Pancreatic in the market using the company treatment is beyond 2015.
This make me wonder that employees (including BT) of the company try to prolong the existence of the company as long as they can. It is a job for them as the expense of investors.
I am not that pessimistic about the timing of Panc. (i.e.2015) They have probably been planning this and talking to the FDA for at least six months. When they announce it and start the trial they will be much wiser about the number of centers to get on study. There won't be a 6-9 month lag like H&N to get the centers on study. The Gem reo enrolled at 4.5 pt/center per year. The CPR panc is enrolling faster based on the PI's comments. If they are able get 40 centers on study (there are about 120 centers using reo now) and they only needed 120 pts for the trial, this could be enrolled in 7 months. If they started preparing sites after the endpoint of the CPR trial in Feb. they could have 40 sites ready to go before the end of the year. The trial could make its endpoint next year.
"The earliest I see Pancreatic in the market using the company treatment is beyond 2015"
If Reo gets approved for H&N and if the PH II Gem and/or Carb/Pax panc results are spectacular or even just good - you will most likely see off label use of Reo in panc before 2015 and before a panc PH III completes IMO.
>think it is the other pancreatic trial (with Gemcitabine) where results are next expected after H & N results..<<
Since Montefiore is recruiting for both reo trials one might also speculate that the gemzar trial may be about to be completed.
Wasn't this the trial mentioned at the AGM as the next trial after H&N to report an update? That would seem to indicate that enrollment is progressing well. If that is the case why join a trial nearing full enrollment, or for that matter why would ONCY add sights, if not in anticipation of a follow on Phase III?
" that's a tantalizing indication that they might be seeing some good results IMO."
I guess I tend to think more conservatively, rather than allow myself to think to the extreme, which I think you are doing here.
Obviously a difference of thinking/thought processes here, but it's just as easy to read into the fact that the number of recruiting trial centers that has doubled from 3 to 6 is because of really slow recruiting. This idea is certainly not out of the realm from what we've experienced in other trials, no?
I've been accused of being D2Fox in the past because of my more conservative thinking regarding Oncy progress(obviously Fox is not a political conservative) but regarding investments we both tend to look at all sides of the cube, not just the one that benefits us the most.
Let the bashing begin!!
"Obviously a difference of thinking/thought processes here, but it's just as easy to read into the fact that the number of recruiting trial centers that has doubled from 3 to 6 is because of really slow recruiting. This idea is certainly not out of the realm from what we've experienced in other trials, no?"
What you say is true you could look at it that way that's why I qualified what I said with a might.
But tell me if you were running a center and were asked to begin a new trial that has already been running for a year and a half wouid you do it blindly or would you ask to see how it is going in the centers where it is already. I think before you would lock your center into the trial you would want to see some evidence of it succeeding - wouldn't you? Remember this trial is randomized but open label, it is not blinded - so they can ask how it is going with the patients getting the Reo vrs those who aren't. Montefiore and Emeory at least are big, fully endowed cancer centers - they don't need to run a trial just to get some income.