Biotech Values

[AlpineBV_Miller]

These data are from Oncolytics Biotech (ONCY) REO-002 trial. Here's an except from what we wrote about this trial in June 2005 when we initiated coveraged on ONCY.

A total of 45 patients were to be enrolled, but the histopathological data was clear enough after six patients that the trial was stopped.

Trial design was approved in May of 2001. The first patient was enrolled in April of 2002. Data were provided in March of 2003.

Men scheduled for prostatectomy (surgical removal of the prostate) received one intra-tumoral injection of Reolysin. Three weeks later, the prostate was removed and extensively biopsied.

All but one patient had viral activity in the harvested prostate. 4/6 patients had clear histopathological evidence of tumor cell apoptosis (cell death). The fifth patient with viral activity has no apoptosis, but his tumor shrank by 67% and his PSA dropped 53%. We would expect this was coincidental to Reolysin since there was no apoptotic activity.

Close examination of tumor and normal prostate cells revealed no healthy cells saw permissive replication of the reovirus. Permissive replication was found only in tumor cells. This is important data inside an intact human system.

This whole trial is important. Men with T2 prostate cancer are essentially healthy and have intact immune systems. A few had some fevers and chills, but otherwise no ill effects from Reolysin treatment.

We were very puzzled as to why the company did not keep dosing patients given the IND specified a 40-patient target. Management told us they learned enough after six patients and didn’t need to do any more. That rings hollow to us as the ability to conduct additional studies of dosed tissue and collect safety data in this population is invaluable.

Study of the prostate tissue has been ongoing since the end of dosing some time in 2002. Papers are being prepared with detailed examination of the effect of Reolysin on the prostate tissue.