Oncolytics Biotech Inc. (ONCY: Quote,ONC.TO: Quote) Wednesday said it plans to expand enrollment in the first stage of its Phase III trial of Reolysin in combination with carboplatin and paclitaxel for the treatment of head and neck cancers or REO 018. This will take additional time to follow the patients and obtain mature progression free survival data. The company's stock is plunging over 28 percent in pre-market activity.
Providing an update on the REO 018 study, the firm said it held an internal analysis of the blinded combined clinical data for all 80 patients enrolled in the first stage of the study.
The median evolving progression free survival or PFS of the 80 patients, comprising the combined control and test groups, was greater than expected, and so was the best response rate.
However, it was found that patients for whom only metastatic disease was being measured by clinicians, were responding differently to treatment than patients who had local regional head and neck disease. Metastatic disease is the spread of a disease from one organ or part to another non-adjacent organ or part.
Patients in whom only metastatic disease was measured had a median evolving PFS of 120 days, which was statistically much greater than those patients with a noted local regional head and neck tumor.
Oncolytics believes it has now identified two distinct patient groups; patients with local recurrent disease, with or without metastases, and those with distal metastases. Patients from both groups are being enrolled in the study.
Each group contains patients from both the control and test arms of the study. Oncolytics believes these two groups of patients must be considered to be different for the purpose of analysis and investigation.
The company consulted with its principal investigators and the independent statistician for the study and met with the U.S. Food and Drug Administration on Monday. Based on the discussions, the company plans to expand enrollment in the first stage of the study to include 160 patients. All these patients have now been enrolled.
Oncolytics plans to introduce an additional segregation to distinguish between patients with local recurrent disease, with or without metastases, and patients with distal metastases. Based on the analysis of the 160 patients, Oncolytics expects to generate randomized data from two discrete patient populations.
Oncolytics intends to treat this expanded first stage of the REO 018 clinical trial as a separate supportive study to a planned registration study. This will be similar to, and take the place of, the original second stage of the REO 018 clinical trial.
It will require additional time to follow the expanded group of patients and allow the evolving PFS data to mature, Oncolytics said.
Brad Thompson, president and CEO of Oncolytics said, ''Segregating and separately evaluating the two identified patient groups means we will be able to obtain our first randomized data in these two patient populations, including one with only metastatic disease...Patients with metastatic disease represent a large potential market."
ONCY, which closed at $2.82 on Tuesday, is declining 28.37 percent in pre-market activity.
ONC.TO settled at $2.73 on Tuesday.
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by RTT Staff Writer
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