A Fast Track designation from the U.S. Food and Drug Administration is generally viewed favorably by investors because it comes with certain perks to expedite the expensive and lengthy process of trying to bring a new therapeutic to market. Before Monday's opening bell, Oncolytics Biotech Inc. (TSX:ONC)(OTCQX:ONCYF) said it received the vaunted designation from the FDA for its clinical stage immuno-oncology viral agent, Reolysin, for treating metastatic breast cancer.
Last month, data from Oncolytics' phase 2 trial of Reolysin in combination with the commonly used chemotherapy drug paclitaxel showed that the combo outperformed paclitaxel alone with regards to median overall survival in advanced or metastatic breast cancer patients. The data was presented at the annual meeting of the American Association of Cancer Research (AACR).
More specifically, the Calgary-based biotech said that metastatic breast cancer patients in a specific subset, those with mutations in the tumor suppressor gene p53, saw a particularly substantial improvement. In these patients, median overall survival doubled from 10.4 months to 20.9 months.
Oncolytics intends to initiate phase 3 research evaluating Reolysin plus paclitaxel in metastatic breast cancer patients (with a focus on p53 mutations) subsequent to an End-of-Phase 2 meeting with the FDA to assist with study guidance. One of the benefits of Fast Track status is frequent dialogue with the FDA to discuss clinical trial design, data requirements and the overall drug development plan. The idea is that by consulting with the FDA, the trial will remain on point to evaluate criteria that the FDA deems most important to support a decision for commercialization if endpoints are met.
Shares of ONC had been downtrending for several years , touching a low of 19 cents in December. Advancing Reolysin in the clinic with promising data has helped the stock reverse course, including surging to as high as $1.13 in April. Shares stumbled a bit last week as traders docked some profits from the run, closing Friday at 76 cents each ahead of the Fast Track news.
