Oncolytics Biotech Inc. Announces Filing for Orphan Drug Designation with the U.S. FDA for Pancreatic and Ovarian Cancers
Dec 2 14
Oncolytics Biotech Inc. announced that it has submitted applications for Orphan Drug Designation to the U.S. Food and Drug Administration for REOLYSIN® for the treatment of pancreatic and ovarian cancers. 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.
Oncolytics Biotech Inc. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 08:35 AM
Nov 18 14
Oncolytics Biotech Inc. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 08:35 AM. Venue: The Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Bradley G. Thompson, Executive Chairman, Chief Executive Officer and President.
Oncolytics Biotech Inc. Announces Consolidated Earnings Results for Third Quarter and Nine Months Ended Sept. 30, 2014
Nov 6 14
Oncolytics Biotech Inc. announced consolidated earnings results for third quarter and nine months ended Sept. 30, 2014. For the quarter, the company reported operating loss of $4,677,213, loss before income taxes of $4,637,276, net loss of $4,636,608, net comprehensive loss of $4,536,147 or $0.05 per basic and diluted share cash used in operating activities of $4,415,215, acquisition of property and equipment of $113,782 compared to the operating loss of $6,224,129, loss before income taxes of $6,113,650, net loss of $6,113,650, net comprehensive loss of $6,147,163 or $0.07 per basic and diluted share cash used in operating activities of $6,509,872, acquisition of property and equipment of $103,512 for the same quarter a year ago.
For the year to date, the company reported operating loss of $15,011,671, loss before income taxes of $14,833,494, net loss of $14,840,222, net comprehensive loss of $14,731,780 or $0.17 per basic and diluted share cash used in operating activities of $16,359,528, acquisition of property and equipment of $131,001 compared to the operating loss of $18,030,973, loss before income taxes of $17,740,167, net loss of $17,740,167, net comprehensive loss of $17,666,041 or $0.21 per basic and diluted share cash used in operating activities of $20,029,692, acquisition of property and equipment of $250,814 for the same period a year ago.
Oncolytics Biotech Inc. Announces Overall and KRAS-Mutated Patient Data from U.S. Randomized Phase 2 Pancreatic Cancer Study
Sep 16 14
Oncolytics Biotech Inc. announced overall and KRAS-mutated patient data from a two-arm randomized phase 2 study of carboplatin, paclitaxel plus REOLYSIN (test arm) versus carboplatin and paclitaxel alone (control arm) in the first line treatment of patients with recurrent or metastatic pancreatic cancer (NCI-8601). The trial is sponsored by the U.S. National Cancer Institute (NCI) through a clinical trials agreement between the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis and Oncolytics. Oncolytics provided clinical supplies of REOLYSIN for the study and paid for the immune and genetic testing of the patients. The overall objectives of the study were to determine the progression free survival of the overall patient population and the patient population according to KRAS mutation status. The study enrolled 73 patients, 37 were in the control arm, 36 were in the test arm. The median progression free survival for the control arm was 5.16 months (95% confidence interval (CI) = 2.267 to 6.176) versus 5.26 months for the test arm (95% CI = 3.187 to 6.307). KRAS mutated patient population: As part of the study design, patients were screened for KRAS status at codon 12. Of the 60 patients where KRAS status could be determined (mutant versus wild type), 44 (73%) had mutations in the KRAS gene (n = 23 in the control arm, n = 21 in the test arm). Median progression free survival in the test arm was 5.72 months (95% CI = 3.187 to 6.767) versus 4.11 months in the control arm (95% CI = 1.938 to 6.176). This translates into a 1.61 month (39%) improvement in median progression free survival in the test arm versus the control arm. Three patients on the test arm and one on the control arm had not progressed as of the time of analysis. Kaplan-Meier plot of the Progression Free Survival (PFS) of the control arm versus the test arm of the KRAS mutated patient population.