Oncolytics says phase 1 studies show Reolysin as cancer treatment well-tolerated

By E. Janene Geiss

Philadelphia, June 5 - Oncolytics Biotech Inc. announced Monday that interim and final results of two phase 1 clinical trials yielded positive results for Reolysin as a cancer treatment.

The results of the trials and previously completed and reported trials are consistent in showing that Reolysin is well-tolerated and demonstrates activity in tumors when delivered locally or systemically in patients with a wide variety of advanced cancers, officials said in a company news release.

The results were presented during sessions at the American Society of Clinical Oncology annual meeting in Atlanta.

The data cover interim results of the company's phase 1 systemic administration trial being conducted in the United Kingdom and final results of its phase 1 recurrent malignant glioma trial conducted in Canada.

Interim results of the company's U.K. phase 1 systemic administration clinical trial investigating the use of Reolysin to treat patients with advanced cancers indicated that the drug candidate can be delivered systemically to various tumor types and cause virus-mediated tumor responses.

A total of 30 patients have been treated to date in the escalating-frequency and dosage portion of the trial to a maximum daily dose of 1x10(11) TCID50.

To date, these 30 patients have received 65 courses of therapy, for a total of 284 daily treatments. A maximum tolerated dose was not reached and the treatment appears to have been well-tolerated by the patients, officials said.

Of the cohorts whose patients have completed treatment, antitumor activity was noted in patients with colorectal, prostate, pancreatic, bladder, and non small-cell lung cancer.

Two patients with colorectal cancer had tumor stabilization and had CEA tumor marker reduction of 27% and 60%, respectively.

One patient with metastatic prostate cancer had stable disease at four months and had extensive product-induced necrosis with associated intratumoural viral replication in metastatic lesions in the lymph nodes.

One patient with metastatic bladder cancer had stable disease at four months and had a minor tumor response in a metastatic lesion in a lymph node. A patient with pancreatic cancer and a patient with non small-cell lung cancer had stable disease at four months.

The primary objective of the company's U.K. phase 1 trial is to determine the maximum-tolerated dose, dose-limiting toxicity and safety profile when administered systemically to patients.

A secondary objective is to examine any evidence of antitumor activity. Eligible patients include those who had been diagnosed with advanced or metastatic solid tumors that have not responded to standard therapy or for which no curative standard therapy exists.

In the phase 1 Canadian trial for recurrent malignant glioma, results indicated that intratumoural administration of Reolysin was well-tolerated by the patients and a maximum-tolerated dose was not reached. A total of 12 patients were treated with a single, intratumoural injection at dosages of 1x10(7), 1x10(8), and 1x10(9) TCID50 in a delivery volume of 0.9 ml.

The primary objective of the Canadian phase 1 trial was to determine the maximum-tolerated dose, dose-limiting toxicity and safety profile of Reolysin when administered intratumourally to patients.

A secondary objective was to examine any evidence of antitumor activity.

Oncolytics is a Calgary, Alta.-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.

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