Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY) provided an update on its planned registration program for REOLYSIN®, its proprietary formulation of the human reovirus, at its Annual General Meeting of Shareholders.  The presentation highlights that:

  • The Company will initially focus on pursuing registration for REOLYSIN® in two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma; and
  • The Company will determine further indications and treatment types in which to pursue registration subject to its receipt of data from ongoing single-arm and randomized studies with REOLYSIN®.

“In determining our registration program, we have selected indications and study designs that rely on previous results from our existing preclinical and clinical program and will allow us to move into registration studies immediately after the completion of confirmatory run-in clinical trials,” said Dr. Brad Thompson, President and CEO of Oncolytics.

Planned Registration Program for Muscle-Invasive Bladder Cancer

The Company has filed an Investigational New Drug Application (“IND”) to conduct a small run-in study in patients with muscle-invasive bladder cancer. Pre-operative patients will be treated with a combination of gemcitabine, cisplatin and REOLYSIN® and assessed for histopathological response and safety. Subject to confirmation of histopathological responses attributable to REOLYSIN®, the Company intends to conduct a larger registration study in this indication.

Planned Registration Program for Gliomas

The Company recently announced that the IND containing the protocol titled “MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN®) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors” was active.  The Company intends to conduct a separate small run-in study combining the standard of care (surgery followed by radiotherapy and temozolomide) with REOLYSIN® in adult patients.  Subject to confirmation of responses, the Company intends to conduct a larger registration study using the better therapeutic regime. (Original Source)

Shares of Oncolyticsclosed today at $0.648, down $0.002 or 0.31%. ONCY has a 1-year high of $1.69 and a 1-year low of $0.40. The stock’s 50-day moving average is $0.73 and its 200-day moving average is $0.66.

On the ratings front, Oncolytics has been the subject of a number of recent research reports. In a report issued on March 18, Needham analyst Chad Messer reiterated a Buy rating on ONCY, with a price target of $1.50, which represents a potential upside of 131% from where the stock is currently trading. Separately, on March 17, Canaccord Genuity’s Neil Maruoka reiterated a Buy rating on the stock .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chad Messer and Neil Maruoka have a total average return of 6.1% and 20.2% respectively. Messer has a success rate of 45.9% and is ranked #1068 out of 3612 analysts, while Maruoka has a success rate of 82.8% and is ranked #396.

Oncolytics Biotech Inc is a development stage biopharmaceutical company. It is engaged in the discovery and development of pharmaceutical products for the treatment of cancer.