Oncolytics starts conformity testing for ReolysinOncolytics starts conformity testing for Reolysin
Oncolytics Biotech Inc (C:ONC)
Shares Issued 71,239,918
Last Close11/18/2011 $4.28
Monday November 21 2011 - News Release
Dr. Matt Coffey reports
ONCOLYTICS BIOTECHATRADEMARK INC. ANNOUNCES START OFCONFORMITY TESTING WITH SAFC
SAFC, a division of Sigma-Aldrich Corp., has commencedvalidation activities designed to demonstrate the manufacturing process for thecommercial production of Reolysin, Oncolytics Biotech Inc.'s proprietaryformulation of reovirus, is robust and reproducible. Process validation isrequired to ensure that the resulting product meets required specifications andquality standards and will form part of the company's submission to regulators,including the United States Food and Drug Administration (FDA), for productapproval.
"Process validation is a critical piece of thecommercialization process for Reolysin assuming our clinical studies areultimately successful," said Dr. Matt Coffey, chief operating officer ofOncolytics. "We have worked diligently to advance our manufacturing program inparallel with our clinical efforts to ensure we have sufficient quantities forboth late-stage clinical testing and commercial launch."
Oncolytics's broad clinical program currently has more than 10trials enrolling patients including a phase III study in head and neck cancerusing a protocol agreed by the FDA under the special protocol assessment processand randomized phase II studies in ovarian and metastatic pancreaticcancers.
We seek Safe Harbor.
© 2011 Canjex Publishing Ltd.