�Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical test using endovenous administration of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours. The Principal Investigator is Dr. Miguel Villalona-Calero, Professor Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center.
"In this era of personalized malignant neoplastic disease treatment, we are quite a excited about this trial," said Dr. Villalona-Calero. "Although we hold had for some time treatments that target EGFR, K-RAS has been an elusive target. REOLYSIN(R) has the potency to objective K-RAS activated tumors, possibly enhancing the beneficial effects produced by chemotherapy."
"This trial gives Oncolytics the opportunity to treat NSCLC patients in a first-line clinical scope," said Dr. Brad Thompson, President and CEO of Oncolytics. "Assuming we achieve an satisfactory response pace, the combination of REOLYSIN(R) with paclitaxel and carboplatin for NSCLC would be a strong candidate for registration studies."
This trial is a single arm, two-stage, open-label, Phase 2 study of REOLYSIN(R) granted intravenously with paclitaxel and carboplatin every 3 weeks. Patients will receive quartet to six cycles of paclitaxel and carboplatin in conjunction with REOLYSIN(R), at which meter REOLYSIN(R) may be continued as a monotherapy. It is hoped-for that up to 36 patients will be tempered in this trial.
Eligible patients include those with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, wHO have non received chemotherapy treatment for their metastatic or recurrent disease. Patients must get demonstrated mutations in K-RAS or EGFR, or EGFR gene amplification in their tumours (metastatic or primary) in parliamentary procedure to condition for the trial.
The primary objectives of the Phase 2 trial are to determine the documentary response pace of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, and to measure progression-free survival at 6 months. The secondary objectives are to specify the median survival and duration of progression-free endurance in patients, and to evaluate the safety and tolerability of REOLYSIN(R) in combination with paclitaxel and carboplatin in this patient population.
REOLYSIN(R) preferentially replicates in cancer cells that have an activated RAS pathway. Approximately two thirds of all cancers let an activated RAS pathway, including to the highest degree metastatic disease. A large number of mutations, including mutations in EGFR, Her2 or K-RAS along the RAS pathway lead to RAS pathway activation.
Recent clinical studies in NSCLC with EGFR-based therapies have shown that patients with mutations or overexpression of EGFR, which are usually found in NSCLC, derive clinical benefit from these therapies. An agent such as REOLYSIN(R) that selectively replicates in cancers with an excited RAS pathway resulting from EGFR mutations or overexpression may show similar benefit. However, patients with mutant K-RAS, or up to 20% of the more than than 180,000 patients diagnosed every year in the U.S. with NSCLC, do non derive benefit from EGFR-based therapies. The introduction of screening for K-RAS mutations, and the exclusion of K-RAS mutated patients will lead to higher reply rates in EGFR-mutated or overexpressed patients treated with EGFR- based therapies. This excluded patient group is therefore prescreened for RAS pathway activation resulting from mutations in K-RAS, and an agent such as REOLYSIN(R) crataegus laevigata be indicated for this patient mathematical group. This study targets patients with either EGFR-activated tumours or K-RAS mutations.
"Previous preclinical information indicates that reovirus tends to place in the lungs, and we have seen clinical responses in metastatic lung lesions with REOLYSIN(R) as a monotherapy or in combination with paclitaxel and carboplatin," aforesaid Dr. Brad Thompson, President and CEO of Oncolytics. "A pregnant clinical chance for REOLYSIN(R) is in the treatment of patients with metastatic cancers including NSCLC world Health Organization have a mutated K-RAS gene and are unbelievable to respond to treatment with EGF receptor inhibitors."
About Lung Cancer
Lung cancer is the second near common cancer the Crab in workforce and women and is the leading cause of cancer decease. More people die of lung crab than of colon, breast and prostate gland cancers combined. During 2008, there volition be about 215,020 new cases of lung cancer in the U.S., of which 85% to 90% testament be NSCLC. Only around 15% of people diagnosed with lung cancer ar still alive after phoebe years. There is no single, first-line therapy sanctioned for NSCLC in the U.S., just first-line combination treatments include
