I beg to differ in your description of the route to approval that a drug must take in the U.S.
Phase I trials test the drug candidate for safety. Phase II trials test dose escalation and efficacy (does the drug work). Phase III trials are large scale efficacy tests prior to applying for approval.
Note: a "pivotal" trial is one that will lead to marketing approval, generally it is a phase III trial, but some companies have used a pivotal phase II trial to gain approval
Also of interest is that generally in clinical trials phase I consists of delivering the drug to healthy volunteers, however, due to the disease, phase I trials for cancer drugs can use actual cancer patients.
In Oncolytics' case, the phase I trial used 18 patients for whom all other therapy had failed, giving them an expected lifespan of 3-4 months. Several survived much longer than that.
Currently, ONCY is nearing the end of a phase II prostate trial that is designed to gather scientific information on the method of action of the drug. The primary endpoint is a histopathological review of the prostate gland post-resection.
Also, ONCY is past the mid-point in a phase I dose escalation trial in patients that have recurrent brain tumours. (This patient population has an estimated lifespan of 3 months.) At a recent Healthcare conference, the CEO stated that of the initial 5 evaluable patients, 3 had survived longer than 1 year (13 mo, 14 mo, 15 mo). While not statistically significant, it does point towards them having received a benefit from the single dose of REOLYSIN injected into their tumour. (Of note is that these patients received a sub-clinical dose of the drug, some of them receiving 1/10th of the dose used on mice.)
If anyone is serious about following up on ONCY (from either a scientific or investment point of view), I'd recommend the Yahoo message board. There are several high quality contributors and newcomers are welcome (http://messages.yahoo.com/bbs?action=t&type=r&boa rd=yahoo.83.0a.1600781469).
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I beg to differ in your description of the route to approval that a drug must take in the U.S.
a rd=yahoo.83.0a.1600781469).
Phase I trials test the drug candidate for safety.
Phase II trials test dose escalation and efficacy (does the drug work).
Phase III trials are large scale efficacy tests prior to applying for approval.
Note: a "pivotal" trial is one that will lead to marketing approval, generally it is a phase III trial, but some companies have used a pivotal phase II trial to gain approval
Also of interest is that generally in clinical trials phase I consists of delivering the drug to healthy volunteers, however, due to the disease, phase I trials for cancer drugs can use actual cancer patients.
In Oncolytics' case, the phase I trial used 18 patients for whom all other therapy had failed, giving them an expected lifespan of 3-4 months. Several survived much longer than that.
Currently, ONCY is nearing the end of a phase II prostate trial that is designed to gather scientific information on the method of action of the drug. The primary endpoint is a histopathological review of the prostate gland post-resection.
Also, ONCY is past the mid-point in a phase I dose escalation trial in patients that have recurrent brain tumours. (This patient population has an estimated lifespan of 3 months.) At a recent Healthcare conference, the CEO stated that of the initial 5 evaluable patients, 3 had survived longer than 1 year (13 mo, 14 mo, 15 mo). While not statistically significant, it does point towards them having received a benefit from the single dose of REOLYSIN injected into their tumour. (Of note is that these patients received a sub-clinical dose of the drug, some of them receiving 1/10th of the dose used on mice.)
If anyone is serious about following up on ONCY (from either a scientific or investment point of view), I'd recommend the Yahoo message board. There are several high quality contributors and newcomers are welcome (http://messages.yahoo.com/bbs?action=t&type=r&bo
Cheers,
P.D.T.