Oncolytics releases phase I trial results for Reolysin
Oncolytics Biotech Inc ONC
Shares issued 19,191,395 Mar 20 2002 close $3.040
Thursday Mar 21 2002 News Release
Dr. Matt Coffey reports
ONCOLYTICS BIOTECH INC. ANNOUNCES REOLYSIN(R) PHASE I CLINICA ...
Oncolytics Biotech has released summary results from its phase I clinical trial of Reolysin, a potential cancer therapeutic for Ras activated tumours (interim results were previously released on Dec. 13, 2001).
The study examined the administration of escalating dosages of Reolysin directly into a subcutaneous (underneath the skin) tumour in 18 terminal cancer patients with progressive (actively growing) cancer that had failed to respond to conventional therapies.
The primary outcome of the trial was safety. None of the patients receiving Reolysin experienced any serious adverse events related to the virus, nor were there any dose-limiting toxicities detected in any patient.
The secondary outcomes measured in the study relate to tumour responses. Tumour responses were measured at both the treated lesion as well as remote tumour sites. Viral activity is defined as a transitory or lasting tumour regression of at least 30 per cent measured in two dimensions against the tumour size prior to injection on the first day of treatment. Evidence of viral activity was detected in 11 of 18 patients (61 per cent), with the tumour regression ranging from 32 per cent to 100 per cent.
Clinically, tumour response is typically classified in one of four ways: progressive disease means tumour growth of greater than 25 per cent, stable disease means the change ranges from growth of less than 25 per cent to a reduction of less than 50 per cent, a partial response means a reduction of greater than 50 per cent but there is still detectable tumour and a complete response means no tumour can be detected. Patients are considered to be evaluable for clinical response only if they return for all followups. In 11 of 17 evaluable patients, the injected tumours were classified as stable disease on day 28 after the first, and in some cases the only, injection of Reolysin. By day 98, five of 10 evaluable patients still had tumour responses (four stable disease, one partial response). In addition, evidence of remote tumour responses was also noted in several patients.
"Reolysin demonstrated an extremely positive safety profile in this study," said Dr. Brad Thompson, president and chief executive officer of Oncolytics. "In addition, while this comparison is not statistically significant, the percentage of patients that showed evidence of viral activity correlates well with the level of Ras activation expected in a randomly selected group of cancer patients, which is expected to be between 50 per cent and 70 per cent. The phase I results are very promising and consistent with the safety and efficacy that has been observed in the animal models we have conducted to date."
The company will be hosting a conference call to discuss the Reolysin phase I summary results on Thursday, March 21 at 10 a.m. ET. The call will be audiocast live and archived for 90 days at www.oncolyticsbiotech.com.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
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