Oncolytics Biotech, Inc. (USA)  (NASDAQ:ONCY) announced that following submission to the U.S. Food and Drug Administration (“FDA”) for review, the Investigational New Drug Application 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” is now active.  The study sponsor is Mayo Clinic based in Rochester, Minnesota, and the Study Chair is Dr. Richard Bram of Mayo Clinic.

“This is the first time we have been able to assess this treatment combination in patients,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Pediatric patients with high grade primary brain tumors have few, if any, treatment options so we are eager to determine if this regimen can make a difference for a group with poor survival outcomes.”

The study is an open-label Phase I trial to clarify the safety, and determine possible efficacy, of GM-CSF given prior to administration of intravenous REOLYSIN® for children with malignant high grade brain tumors. GM-CSF will be administered on days one and two of each cycle with REOLYSIN® administered on days three, four and five. Cycles will be given every 28 days for up to 12 cycles if patients remain without evidence of tumor progression and without intolerable toxicity.  The primary outcome for the nine to 18 patients of the Phase 1 study will be safety and tolerability. Secondary goals include median progression free and overall survival in this patient population.

Eligible patients include those between the ages of 10 and 21 with histologically confirmed high grade (grade 3 or 4) primary brain tumor either classified as a glioma (including astrocytoma, anaplastic oligodendroglioma and glioblastoma multiforme), medulloblastoma, atypical teratoid/rhabdoid tumor or primitive neuroectodermal tumor. Patients must have no known curative therapy available and can have had up to two chemotherapy regimens for the brain tumor previously.

Oncolytics has conducted three previous clinical studies in adults with brain cancers including gliomas, and has found that REOLYSIN® can infect a variety of brain tumors when delivered intravenously. In April 2014, the Company announced the findings from a clinical study showing that intravenously delivered REOLYSIN® can cross the blood brain barrier and a pre-clinical study in animals examining the synergies associated with treatment with GM-CSF prior to administering REOLYSIN®. The Company has received Orphan Drug Designation from the FDA for the use of REOLYSIN® in the treatment of malignant gliomas.

According to the US Central Brain Tumor Registry an estimated 4,620 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed in pediatric and adolescent patients in 2015. In patients between zero and 19 years old, the overall total incidence of HGG (including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma, and malignant glioma) is approximately 0.8 per 100,000. (Original Source)

Shares of Oncolytics closed yesterday at $0.7099 . 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 $0.67.

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 implies an upside of 111.3% from current levels. 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 -1.5% and 16.0% respectively. Messer has a success rate of 36.5% and is ranked #3046 out of 3606 analysts, while Maruoka has a success rate of 69.2% and is ranked #683.

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.