Oncolytics phase 2 trial shows four patients withOncolytics phase 2 trial shows four patients with PR
Oncolytics Biotech Inc (C:ONC)
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Monday November 14 2011 - News Release
Dr. Brad Thompson reports
ONCOLYTICS BIOTECH INC. ANNOUNCES POSITIVE RESULTS OF U.S.PHASE 2 CLINICAL TRIAL INVESTIGATING REOLYSIN IN COMBINATION WITH PACLITAXEL ANDCARBOPLATIN IN HEAD AND NECK CANCERS
Oncolytics Biotech Inc.'s positive results from a phase 2clinical trial (REO 015) using intravenous administration of Reolysin incombination with paclitaxel and carboplatin in patients with advanced head andneck cancers will be presented at the AACR-NCI-EORTC International Conference onMolecular Targets and Cancer Therapeutics. The conference is being held in SanFrancisco, CA from November 12th to 16th 2011. The Principal Investigator of theU.S. study was Dr. Monica Mita of the Cancer Therapy & Research Center atThe University of Texas Health Science Center at San Antonio (CTRC).
The U.S. trial was a single arm open-label, phase-2 study ofReolysin given intravenously with paclitaxel (175 mg/m2) and carboplatin (AUC 5)every three weeks in patients with platinum-refractory recurrent and/ormetastatic squamous cell cancers of the oral cavity, larynx, or pharynx. Theprimary end point was to determine the objective response rate (completeresponse (CR) + partial response (PR)) of the treatment regimen in the studypopulation. Secondary objectives included the determination of disease controlrate (CR + PR + stable disease (SD)) and the safety and tolerability of thetreatment regimen.
Of the 14 enrolled patients, all had received priorchemotherapy, radiotherapy, or combinations thereof for their metastatic orrecurrent disease. Ten of the 14 patients received prior chemotherapy treatmentwith taxanes. Of the 13 patients evaluable for response, four had PRs, for anobjective response rate of 31%. Six patients had SD or better for 12 weeks orlonger for a disease control rate (SD or better) of 46%. Two of the fourpatients with PRs and both patients with SD had received prior treatment withtaxanes.
"This study was undertaken as a confirmatory trial of anearlier study performed in the UK with a similar patient population (REO 011).It confirmed the high rate of responses observed in the U.K. study, and wasnoteworthy as this U.S. patient population included a higher proportion ofpatients that had failed prior taxane-based therapy," said Dr. Matt Coffey, COOof Oncolytics. "Historically, head and neck cancer has been characterized by avery low rate of success in treatment of patients who have already failedchemotherapy. Standard second-line therapies for platinum refractory head andneck cancer using currently approved cytotoxics have yielded 3 to 7% responserates1."
"These data further confirm the utility of Reolysin in thisindication, even in a heavily pre-treated patient population," said Dr. BradThompson, President and CEO of Oncolytics. "These results are an important steptowards making this potential therapy available to head and neck cancerpatients, and represent a significant milestone for Oncolytics."
1LeA Superscript threen X et al. (2005) A retrospectiveanalysis of the outcome of patients with recurrent and/or metastatic squamouscell carcinoma of the head and neck refractory to a platinum-based chemotherapy.ClinOncol 17: 418-424; Specenier P et al. (2011) Weekly Docetaxel in PatientsWith Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.Am J ClinOncol 34: 472-7.
Conference Call Information
Dr. Brad Thompson, President and CEO of Oncolytics, will hosta conference call and webcast on Monday, November 14th, 2011 at 6:30 a.m. MT(8:30 a.m. ET) to discuss in more depth the presentation covering the U.S. PhaseII head and neck cancer data. To access the conference call by telephone, dial1-647-427-7450 or 1-888-231-8191. A live audio webcast will also be available atthe following link:https://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=3743300 or through theCompany's website at www.oncolyticsbiotech.com. Please connect at least 10minutes prior to the webcast to ensure adequate time for any software downloadthat may be needed. A replay of the webcast will be available atwww.oncolyticsbiotech.com and will also be available by telephone throughNovember 21st, 2011. To access the telephone replay, dial 1-416-849-0833 or1-855-859-2056 and enter reservation number 27729561 followed by the numbersign.
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