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Approval for UK reolysin/ paclitaxel and carboplatin trial

Oncolytics Biotech has received a letter of approval from the UK Medicines and Healthcare Products Regulatory Agency for its clinical trial application
Oncolytics Biotech, a TSX-listed Canadian biotechnology company, has received a letter of approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its clinical trial application to test intravenous administration of reolysin in combination with paclitaxel and carboplatin in patients with advanced melanoma, lung and ovarian cancers.

In US studies conducted by the National Cancer Institute (NCI), the combination of reolysin and paclitaxel was uniformly synergistic against six non-small cell lung cancer cell lines examined, including those resistant to paclitaxel or reolysin. Preclinical studies at Cornell University also found that reolysin in combination with platinum drugs enhanced the cytotoxicity of the chemotherapeutic agents.

The first part of the UK trial is an open label, dose-escalating, non-randomised study of reolysin given intravenously with paclitaxel and carboplatin every three weeks. A maximum of three cohorts will be enrolled in the reolysin dose escalation portion. The second part of the trial will immediately follow and will include the enrolment of a further 12 patients at the maximum dosage of reolysin in combination with standard dosages of paclitaxel and carboplatin.

Eligible patients include those diagnosed with advanced or metastatic solid tumours, such as melanoma, lung and ovarian cancers refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the UK trial is to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), recommended dose and dosing schedule and safety profile of reolysin when administered in combination with carboplatin and paclitaxel. Secondary objectives include the evaluation of immune response to the drug combination, the body's response to the combination compared with chemotherapy alone and any evidence of anti-tumour activity.

The principal UK trial investigators are Dr Kevin Harrington of the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust and Dr Geoff Hall of St James's Hospital in Leeds.

Dr Brad Thompson, President and CEO of Oncolytics, said: "The approval of this trial represents an important step forward for Oncolytics, allowing us to move quickly into a treatment combination that could result in a first-line therapy indication for reolysin."

4th January 2007

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