oncolytics biotech inc (ONCY) Key Developments
Oncolytics Biotech Inc. Announces Phase 1 Study in Pediatric Patients with Brain Tumors
May 19 15
Oncolytics Biotech Inc. announced that submission to the U.S. Food and Drug Administration 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 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.
Oncolytics Biotech Inc. Announces Unaudited Consolidated Earnings Results for First Quarter Ended March 31, 2015
May 7 15
Oncolytics Biotech Inc. announced unaudited consolidated earnings results for first quarter ended March 31, 2015. For the quarter, the company reported operating loss of $3,608,273, loss before loss taxes of $3,551,838, net loss of $3,551,838, net comprehensive loss of $3,326,247 or $0.04 basic and diluted per share, cash used in operating activities of $2,747,189, acquisition of property and equipment of $11,940 compared to the operating loss of $5,569,588, loss before loss taxes of $5,481,601, net loss of $5,485,451, net comprehensive loss of $5,504,145 or $0.06 basic and diluted per share, cash used in operating activities of $6,164,078, acquisition of property and equipment of $15,980 for the same quarter a year ago.
Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Status from the EMA for Pancreatic Cancer
Apr 29 15
Oncolytics Biotech Inc. announced that the European Medicines Agency has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of pancreatic cancer. The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU, and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant benefit to those with the condition. Following Orphan Designation, sponsors can access a number of incentives including protocol assistance, market exclusivity for a ten-year period following approval and potential fee reductions. The receipt of Orphan Designation does not change the regulatory requirements or process for obtaining marketing approval. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.
Oncolytics Biotech® Inc. Receives Extension To Regain Compliance From Nasdaq
Apr 28 15
Oncolytics Biotech® Inc. announced that it has received a letter from the NASDAQ OMX Group (Nasdaq) determining that the company is eligible for an additional 180-calendar day period, until October 26, 2015, to regain compliance with the minimum $1.00 per share required for continued listing under Listing Rule 5550(a)(2). Per the notice of deficiency received on October 29, 2014, Oncolytics had a period of 180-calendar days, or until April 27, 2015, to regain compliance with the minimum bid price requirement. Following a review, Nasdaq determined that the company was eligible to receive an additional 180-day period on the basis that Oncolytics still met the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and had provided written notice of its intention to cure the minimum bid price deficiency during the second 180-day compliance period by effecting a reverse stock split, if necessary. The company's shares continue to trade on the Toronto Stock Exchange (TSX) and are in full compliance with TSX listing requirements. The company's listing on the TSX is completely independent of, and will not be affected by, the status of its Nasdaq listing. If compliance cannot be demonstrated by October 26, 2015, Nasdaq staff will provide written notification that the company's securities will be delisted. At that time, the company may appeal Nasdaq staff's determination to a Hearings Panel.
Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Malignant Gliomas
Apr 17 15
Oncolytics Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for its lead product candidate, REOLYSIN, for the treatment of malignant glioma. The company applied for an ODD for pediatric high grade gliomas (HGG), however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages. In three previous brain cancer studies including gliomas, REOLYSIN has been shown to infect a variety of brain tumors when delivered intravenously. The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.