Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that the Cancer Therapy Research Center at the University of Texas/org> Health Science Center (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with metastatic melanoma. The Principal Investigator is Dr. Devalingam Mahalingam, M.D., Ph.D., MRCP(UK), MRCP(I), clinical investigator in GI/thoracic oncology and drug development at the CTRC.
"We have seen some very encouraging results in our clinical trials using REOLYSIN in combination with other therapies in metastatic melanoma patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "For example, of nine evaluable melanoma patients treated intravenously in our combination REOLYSIN and chemotherapy trials, five had stable disease or better (two partial responses and three stable disease).
"In our local administration REOLYSIN and radiation studies, all of the evaluable melanoma patients (10) had stable disease or better in the target lesion, (three partial responses, one significant minor response and six stable disease). These results, combined with preclinical work demonstrating that in vivo combination treatment resulted in markedly reduced tumour growth compared to single agent treatments, provided the rationale for our collaborators to explore a Phase 2 combination study for patients with metastatic melanoma."
"Today, few effective treatment options exist for patients with advanced malignant melanoma," said Dr. Mahalingam. "We welcome this collaboration with Oncolytics, and are excited to have started patient enrolment for this Phase II investigator-initiated study at the CTRC. We are hopeful this novel agent will continue to show promising results."
The trial (REO 020) is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. It is anticipated that up to 43 patients will be treated in the study.
Eligible patients include those with metastatic, malignant melanoma who have failed one or more prior therapies, or those who are not considered to be a candidate for standard, first-line treatment.
The primary objective of the Phase 2 trial is to measure the objective response rate (partial response (PR) and complete response (CR)) to the treatment combination. The secondary objectives are to assess progression-free survival (PFS) and overall survival (OS) for the treatment regimen in the study population, to assess disease control rate (CR + PR + stable disease (SD)) and duration in the study population, and to assess the safety and tolerability of the combination treatment.
This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.