FDA Gives Oncolytics Nod on Metastatic Breast Cancer Trial Framework
chart icon APS Pro Bottom Text
Teaching Investors How To Turn Pennies Into Dollars ™

FDA Gives Oncolytics Nod on Metastatic Breast Cancer Trial Framework

By: Tomas Ronolski - AllPennyStocks.com News

Thursday, May 10, 2018

Heading into Thursday, Oncolytics Biotech (TSX:ONC)(OTCQX:ONCYF) was having a good week, trading ahead almost 9 percent to close Wednesday at 74 cents. The increase in value added to a gain of 8 percent in the week prior. In early Thursday trading, shares are climbing even higher following news that an agreement was reached with the the U.S. Food and Drug Administration for a late-stage study of the company's metastatic breast cancer treatment.

Under what is known as a Special Protocol Assessment, or SPA, Oncolytics and the FDA agreed upon the trial's design, endpoints and statistical analysis for a Phase 3 study of Reolysin (pelareorep) for the indication. A SPA is a bit of a comfort blanket, letting a biotech know that the FDA won't have an issue with a pivotal trial's design should the company subsequently file a new drug application seeking marketing approval.

Oncolytics is developing Reolysin, a proprietary isolate of the unmodified reovirus, for metastatic breast cancer under a FDA "Fast Track" designation received last May. The immunotherapy works by inducing selective tumor lysis and promoting an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of solid and liquid cancers. Reolysin only replicates in cancer cells - it is unable to do so in healthy cells for a number or reasons - causing the release of inflammatory cytokines, triggering the immune system to unleash natural killer cell and T-cells in the tumor microenvironment, eliciting cancer cell death.

With the SPA agreement in tow, the Calgary-based company can finalize the work to advance Reolysin into the Phase 3 study.

Shares of Toronto-listed ONC have shot ahead 8.1% to 80 cents just after Thursday's opening bell. U.S.-listed shares of ONCYF are doing even a bit better, up 12.3% at 64 cents ten minutes into the trading session.

Copyright © 2018 AllPennyStocks.com. All rights reserved. Republication or redistribution of AllPennyStocks.com's content is expressly prohibited without the prior written consent of AllPennyStocks.com. AllPennyStocks.com shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Other Canadian Penny Stock Movers