From: Doug Skrecky (oberon@vcn.bc.ca)
Date: Fri Dec 21 2001 - 10:18:30 MST
CryoNet - Fri 21 Dec 2001
Message #18202
Oncolytics Biotech Inc. Announces REOLYSIN(R) Phase I
Clinical Trial Interim Results
07:31 EST Thursday, December 13, 2001
CALGARY, AB, Dec. 13 /PRNewswire/ - Oncolytics Biotech Inc.
(TSE: ONC, NASDAQ: ONCY) (Oncolytics) announced interim results
of its Phase I clinical trial of REOLYSIN(R), a potential cancer
therapeutic for RAS activated tumours and cancers.
The Phase I trial was designed as a dose escalation study to
determine the safety and tolerance of REOLYSIN(R) in late-stage
cancer patients who have failed all other treatment options. None
of the patients to date have experienced any serious adverse
events related to the virus nor were there any dose limiting
toxicities detected in any patient. As secondary endpoints,
Oncolytics measured tumour response at both the treated lesion as
well as remote metastatic sites. Evidence of viral activity in
tumours was observed, which ranged from changes in tumour
structure to partial and complete tumour regression in the
injected tumours. 50% of injected tumours in the first four of
six groups (twelve of the eighteen patients) demonstrated
evidence of viral activity. Preliminary evidence of remote tumour
responses were also noted inthe first four groups.
"This positive data rewards the tremendous effort of everyone
involved," said Dr. Brad Thompson, President and CEO of
Oncolytics. "Oncolytics is now in a position to initiate multiple
follow up trials of REOLYSIN(R) to better determine its efficacy
and safety profile. The first of these studies, a T2 prostate
cancer trial, is expected to initiate enrollment in January of
2002.
Other clinical trial protocols are being prepared. We are
pleased that there appeared to be no safety issues with the
administration of REOLYSIN(R) intratumourally, and with the
treated lesion activity that has been observed to date."
The Phase I study enrolled a total of 18 patients in six
groups of three patients each and examined intratumoural (into
the tumour) administration of REOLYSIN(R). The patients had a
variety of primary cancers including breast, head and neck,
melanoma, non-AIDS Kaposi's sarcoma, and others. REOLYSIN(R)was
administered directly into a subcutaneous (underneath the skin)
tumour.
None of the patients were screened for RAS activation of their
tumours before entry into the trial.
Each group received increasing dosages of the virus. Dosages
examined included single injections of 10(7), 10(8), 10(9), and
10(10) PFU (plaque forming units, a measure of live virus
particles), and multiple injections of 10(8) and 10(9) PFU. The
maximum dose tested in the trial was a single injection of 10(10)
PFU (virus particles). Both 10(8) PFU groups and the multiple
10(9) PFU group were added to the original study design when
tumour activity was noted in the 10(7) PFU group, which was
unexpected during the design of the study. Oncolytics had
originally anticipated conducting groups at greater dosages using
multiple injections of 10(10) PFU but Oncolytics determined that
it would not provide any more useful information for the future
development of REOLYSIN(R).
Detailed final results of this study are expected to be
presented next year at an international cancer conference, and
will include final safety, efficacy, and immune data on all the
patients.
About Oncolytics Biotech Inc.... (Standard disclaimer about
forward looking statemennts etc omitted.)
The Phase I Clinical Trial structure has been designed to test 18
patients (from injection through follow-up) in accordance with
the established protocol (an "evaluable patient").
The Trial is designed to follow 6 cohorts with 3 evaluable
patients in each cohort.
Cohort #1 receives one injection at the lowest established
dosage.
Cohorts #2 and #3 both receive single injections with cohort #2
receiving a higher dosage than cohort #1 but less than cohort #3.
Cohorts #4 through #6 receive multiple injections at the maximum
dosage, with cohort #6 receiving the maximum number of injections
at the maximum dosage.
The Trial has also been designed to provide the maximum
protection to the patients involved.
Patient #1 in cohort #1 receives 1 injection and the safety
results from this patient are assessed after being monitored for
2 to 3 weeks. Patient #2 of cohort #1 receives their injection
once the patient #1 assessment indicates progression to the next
patient is appropriate. This procedure is expected to continue
through the first two cohorts. Once these cohorts are completed
and show no significant safety concerns, the subsequent cohorts
are expected to receive their injections concurrently.
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