Oncolytics phase 2 trial shows benefit rate of 62%Oncolytics phase 2 trial shows benefit rate of 62%
Oncolytics Biotech Inc (C:ONC)
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Friday December 02 2011 - News Release
Dr. Matt Coffey reports
ONCOLYTICS BIOTECHATRADEMARK INC. ANNOUNCES PHASE 2 CLINICALTRIAL OF REOLYSIN IN COMBINATION WITH GEMCITABINE IN PANCREATIC CANCER REACHESPRIMARY ENDPOINT
Oncolytics Biotech Inc.'s interim data from a phase 2 clinicaltrial using intravenous administration of Reolysin in combination withgemcitabine (Gemzar) in patients with advanced pancreatic cancer (REO 017) hasindicated that the clinical study has successfully reached its primary endpoint, and that the drug combination is active.
To date, eight patients of 13 evaluable patients in the studyhad stable disease (SD) for 12 weeks or longer, for a clinical benefit rate(complete response (CR) + partial response (PR) + SD) of 62%. An additionalpatient had an unconfirmed PR of less than six weeks.
The study is using a one sample, two-stage design. In thefirst stage, 17 patients were to be enrolled, and best response noted. If lessthan three responses (defined as CR or PR or SD for 12 weeks or more) wereobserved, the study would have concluded that the combination was inactive andbeen terminated. If three or more responses were observed among the 17 patents,the study would enroll an additional 16 patients for a total of 33 evaluablepatients. As previously disclosed, this initial endpoint was met after sixevaluable patients were enrolled. If at least eight responses were observed outof 33 patients, the study would have reached its primary endpoint and concludethat the drug combination is active.
"These results far exceeded our initial expectations, havingmet the primary endpoint in a study designed to enroll 33 patients with justover a third of enrolment completed," said Dr. Matt Coffey, Chief OperatingOfficer of Oncolytics. "We will continue to enroll in this study to evaluate theprogression free survival of the patient group, and will continue testingREOLYSIN with various chemotherapeutic agents including gemcitabine andcarboplatin/paclitaxel across multiple trials to further understand itspotential in the treatment of pancreatic cancer."
About Pancreatic Cancer
The American Cancer Society estimates that 44,030 Americanswill be diagnosed with pancreatic cancer and 37,660 Americans will die from thedisease in 2011, making this type of cancer the fourth leading cause of cancerdeath for both men and women in the United States. For more information aboutpancreatic cancer, please go to www.cancer.org.
We seek Safe Harbor.
© 2011 Canjex Publishing Ltd.