X-Message-Number: 18202 Date: Thu, 20 Dec 2001 21:21:32 -0800 From: Olaf Henny <> Subject: Phase I Clinical Trials Reovirus References: <> Hi All: Can anybody please help me to make sense out of the interim results below? Specifically, I have no idea what to make of those figures relating to the plaque forming units, i.e. 10(7), 10(8) etc. If that helps I have posted the outline of the trial structure at the bottom of this post. Best, Olaf 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. Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=18202