CALGARY, Aug. 11 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (“Oncolytics”) has completed patient enrolment in the dose escalation portion of its U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN(R) in combination with docetaxel (Taxotere(R)) in patients with advanced cancers including bladder, prostate, lung and upper gastro-intestinal. The principal investigator is Professor Hardev Pandha of the Royal Surrey Hospital, U.K.
The trial (REO 010) has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN(R) given intravenously with docetaxel every three weeks. Standard dosages of docetaxel were delivered to patients with escalating dosages of REOLYSIN(R) intravenously. The second component of the trial includes the enrolment of a further nine patients at the top dose of REOLYSIN(R) in combination with a standard dosage of docetaxel.
“We have completed the dose escalation stage of the study,” said Prof. Pandha. “Patients enrolled had previously undergone significant treatment with combination chemotherapy. The combination of REOLYSIN(R) and taxotere was safe, well tolerated with no obvious toxicity related specifically to REOLYSIN(R). Efficacy of the combination was encouraging: both objective anti-tumour responses and disease stabilization were observed radiologically.”
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours including bladder, lung, prostate or upper gastro-intestinal cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN(R) when administered in combination with docetaxel. Secondary objectives include the evaluation of immune response to the drug combination, the body’s response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of Phase I/II and Phase II human trials using REOLYSIN(R), its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics, please visit www.oncolyticsbiotech.com
For more information about docetaxel (taxotere(R)) please visit www.taxotere.com
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company’s expectations related to the U.K. combination REOLYSIN(R)/paclitaxel and carboplatin clinical trial and the Company’s belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the tolerability of REOLYSIN(R) outside a controlled test, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.
CONTACT: Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW,
Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403) 283-0858,
cathy.ward@oncolytics.ca; The Equicom Group, Nick Hurst, 325, 300 5th Ave.
SW, Calgary, AB, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916,
nhurst@equicomgroup.com; The Investor Relations Group, Erika Moran, 11
Stone St, 3rd Floor, New York, NY 10004, Tel: (212) 825-3210, Fax: (212)
825-3229, emoran@investorrelationsgroup.com
