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Sunday, December 04, 2011 10:11:48 PM
Murrstir
In this case interim results were released because the 33 patient trial met its goal after only 13 patients. This is quite a good result in an indication with such low life expectancy.
Your earlier question about general Phase III trial length is difficult to answer because of the variability of many factors... How many are planned to be enrolled, how tight the enrollment criteria is, how available are patients in the locations you are running trials and competition from other trials. Oncolytics has chosen to dramatically increase the centers running trials to speed up the enrollment. Unfortunately the CEO has not given updates to the number of enrolled patients so its very hard to predict how long until we reach the 80th patient in our Phase III H&N trial. If we have 60 centers enrolling, you only need 1.3 per center to reach 80.
After we reach 80 then we will most likely wait to open the data to allow the response time to be evaluated for the 80th patient which may be a few months, the the analysis which may take a few months. So the uncertainty of when we will get to see data remains today until we get the 80th patient enrolled press release.
The problem with waiting on the sidelines is that news of a partnership or some other unexpected positive event could move this very fast.
Next up is lung cancer, both NSCLC (Dr Villalona) and SCCL (Dr. Monica Mita) results are expected this year so that a decision can be made on a Phase III in one of these two indications... at least that is what the expectations were. How fast these trials are moving now is also uncertain as we have been given no recent updates beyond the July NSCLC results which brought to light the agonizingly slow pace of enrollment in NSCLC.
We also have Phase I colorectal results from Dr Sanjay Goel to see as well as Melonama from Dr Monica Mita at some point. The other panc trial using Carbotax has a while yet to go although this has the outside potential to be one trial that could be stopped early if they are seeing results like to Mayor Brennan.
As others have said we need patients and patience.
A summary of the trials can be found here... http://clinicaltrials.gov/ct2/results?flds=Xt&flds=a&flds=b&flds=c&flds=f&flds=g&flds=h&flds=j&flds=k&flds=l&flds=o&flds=p&flds=q&flds=s&term=reolysin&show_flds=Y
Does this help out at all?
onco_investor
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