CALGARY, June 8, 2011 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC), (NASDAQ:ONCY) (“Oncolytics”) today announced that an abstract covering interim preliminary results from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours is available on the International Association for the Study of Lung Cancer World Conference on Lung Cancer website at http://www.2011worldlungcancer.org/index.html. The conference is being held in Amsterdam, the Netherlands from July 3rd - 7th 2011.
The abstract, entitled “Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors”, authored by Villalona-Calero et al, indicated that as of the date of submission of the abstract 21 patients had received Reovirus (REOLYSIN) (3 x 1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Initial doses used were carboplatin AUC 6 on day one, and palitaxel 200 mg/m2, on day one of each 21-day cycle. Due to exacerbation of prior gastrointestinal conditions and febrile neutropenia (one each) in first two patients, doses were reduced to paclitaxel 175 mg/m m2 and carboplatin AUC 5. Overall, 85 cycles (per patient median four, range one to eight) were administered. Grade 3-4 adverse events included grade 4 neutropenia (four patients), anemia, fatigue, electrolyte abnormalities, diarrhea, (two patients), and single cases of nausea, vomiting, and sepsis. Molecular tumor demographics included: eight Kras mutant, three EGFR mutant, 15 EGFR amplified. Response evaluation to date in 20 patients showed six partial responses (PR) (30%), 12 stable disease (SD)(60%), two progressive disease (PD)(10%). This translates into a clinical benefit rate (complete response (CR)+PR+SD) of 90% and a response rate (CR+PR) of 30%.
“Although preliminary, this data is very encouraging. Once we have data from our ongoing Phase II trial in squamous cell carcinoma lung cancer, we will decide which lung cancer indication will proceed into a randomized clinical study,” said Dr. Brad Thompson, President and CEO of Oncolytics.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the implication of the materials to be presented at the IASLC 14th World Conference on Lung Cancer with respect to REOLYSIN; the Company’s belief as to the potential of REOLYSIN as a cancer therapeutic; the Company’s expectations as to the success of its research and development programs in 2011 and beyond, the Company’s planned operations, the value of the additional patents and intellectual property; the Company’s expectations related to the applications of the patented technology; the Company’s expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.
