Oncolytics Gives Details on Plan for REOLYSIN

Oncolytics Biotech (TSX:ONC, OTCQX:ONCYF) announced its initial registration pathway and clinical development plan for REOLYSIN, their immuno-oncology viral agent.
As quoted in the press release:

The Company’s clinical development plan has two main objectives.  The primary objective is to obtain regulatory approval for REOLYSIN as quickly as possible and is based on the compelling metastatic breast cancer survival data recently presented at the American Academy of Cancer Research (AACR) Annual Meeting, in Washington, D.C.  The second objective is to expand REOLYSIN into commercially valuable new treatment areas that include immunotherapy and immunomodulatory (IMiD) agents in collaboration with pharmaceutical partners.
Registration Path in Metastatic Breast Cancer
At AACR the Canadian Cancer Trials Group (CCTG) presented positive overall survival (OS) data from an open-label, randomized, phase 2 study assessing the therapeutic combination of intravenously-administered REOLYSIN given in combination with the chemotherapy agent paclitaxel versus paclitaxel alone, in patients with advanced or metastatic breast cancer (IND 213). Based on CCTG’s compelling clinical results in this indication, where the combined treatment demonstrated a statistically significantly increase in median OS, the Company has consulted with key opinion leaders to develop a registration strategy.  Management believes that these results are the most compelling data generated by the Company to date and will support a rapid route to market in an important therapeutic area.
The 74-patient study, powered to 90% and designed by the CCTG, reported that in the intention-to-treat patient population there was a statistically significant improvement in median OS from 10.4 months on the control arm to 17.4 months on the test arm (Hazard Ratio 0.65, 80% CI 0.46-0.91, p=0.1). The presentation also indicated that of the 74 patients in the study, 82 percent (61 patients) presented with mutated p53 tumors. The results showed that patients with mutant p53 metastatic breast cancer who were treated with REOLYSIN in combination with paclitaxel (n=30) had a median OS of 20.9 months versus 10.4 months in patients treated only with paclitaxel (n=31) (Hazard Ratio 0.52, 80% CI 0.35-0.76, p = 0.03).
The Company intends to present this data to regulators as part of an End-of-Phase 2 Meeting with a focus on obtaining scientific advice to support a registration pathway. Specific features of any future clinical studies are expected to include: overall survival as a primary endpoint; other exploratory endpoints to identify potential markers of response; and a trial design to ensure a sufficient number of patients are run to reach a statistically significant outcome while balancing the financial resources required.
“We have developed a comprehensive clinical plan for REOLYSIN predicated on its mechanism of action, excellent safety profile with more than one thousand patients treated and the compelling overall survival data recently announced in metastatic breast cancer,” said Dr. Matt Coffey, President and CEO of Oncolytics. “The registration path in the near term will look at combinations of REOLYSIN and chemotherapy agents, beginning with metastatic breast cancer.  In parallel, we intend to look at other pillars of the platform and our long-range focus for REOLYSIN includes establishing collaborations with large pharma to study both immunotherapy and immunomodulatory drug combinations, such as the recently announced collaboration with Myeloma UK and Celgene using Revlimid^®and Imnovid^® in combination with REOLYSIN in myeloma patients.”
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, an immuno-oncology viral-agent, as a potential treatment for a variety of tumor types. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers. Oncolytics’ clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumor lysis; immuno-therapy combinations to produce adaptive immune responses; and immune modulator (IMiD) combinations to facilitate innate immune responses.  Oncolytics is currently planning its first registration study in breast cancer, as well as studies in combination with checkpoint inhibitors and IMID/targeted therapies in solid and hematological malignancies.  For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

Click here to read the full press release.

Source: www.newswire.ca