There has been a great deal of progress in the past two decades, but more than 40,000 women are still expected to die from breast cancer this year. Sadly, prevalence is still high, with one in every eight women estimated to develop breast cancer during her life.
In 2017, about 252,710 cases of invasive breast cancer are expected to be diagnosed, making it the second most common type of cancer for women, trailing only skin cancer.
Oncolytics Biotech Inc. (TSX:ONC)(OTCQX:ONCYF) wants to do something about those harrowing statistics. The Calgary-based company is developing Reolysin, an intravenously delivered immuno-oncolytic virus that elicits an immune response to fight cancerous cells.
Reolysin has been evaluated as a combination therapy in four, separate trials. Those have including Reolysin with the blockbuster cancer drug Keytruda for late-stage pancreatic cancer; with paclitaxel for late-stage breast cancer; with paclitaxel and carboplatin for metastatic pancreatic cancer; and with gemcitabine for late-stage pancreatic cancer.
Oncolytics stock is charging ahead today on news of a successful End-of-Phase 2 meeting with the Food and Drug Administration regarding the clinical study of the combination of Reolysin and paclitaxel for hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer patients.
Metastatic breast cancer, the advanced stage of disease where it is spreading, affects nearly 155,000 women in the U.S with a five-year survival rate of a paltry 22 percent. Oncolytics is developing Reolysin under an FDA Fast Track designation.
The goal of these meetings is to gain insight from the FDA on what they will want to see for designing a pivotal Phase 3 study in support of a Biologics License Application in the future seeking commercialization of the product if the clinical data warrants it.
Oncolytics CEO Matt Coffey said the agency's feedback was positive and supportive of their planned patient population for a registrational study to build upon compelling data on overall survival from the completed trial.
The Phase 3 trial is expected to enroll 400 patients and have a pre-determined interim analysis, a fact that investors will focus on to cull for signs of efficacy and, thus, possible hints for a favorable future for the therapy.
Given the limited number of successful therapies available today, a safe and effective new biologic treatment would likely be warmly embraced.
Shares of Toronto-listed ONC are up 17.9% in Monday trading at 66 cents as the closing bell nears.
