FDA Grants Fast Track Designation to Reolysin for Metastatic Breast Cancer


“The FDA granted fast track designation to pelareorep for the treatment of metastatic breast cancer, according to the drug’s manufacturer.

“Pelareorep (Reolysin, Oncolytics Biotech) is an immuno-oncology viral-agent designed to induce selective tumor lysis, and promote an inflamed tumor phenotype through innate and adaptive immune responses, according to a company-issued press release.

“An open-label, randomized phase 2 study evaluated the addition of IV pelareorep to paclitaxel for patients with advanced or metastatic breast cancer.”

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Oncolytics Biotech® Inc. Reports Additional Data from Randomized Phase II Study of REOLYSIN® in Non-Small Cell Lung Cancer


“Oncolytics Biotech Inc. …today announced additional data from IND 211, a randomized, Phase II clinical study of REOLYSIN® in patients with non-small cell lung cancer (“NSCLC”). The study enrolled patients with both non-squamous (adenocarcinoma) and squamous cell histology. Those with adenocarcinoma (n=75) were treated with REOLYSIN® in combination with pemetrexed in the test arm versus pemetrexed alone in the control arm. Those with squamous cell histology (n=76) were treated with REOLYSIN® in combination with docetaxel in the test arm versus docetaxel alone in the control arm. The study’s primary objective was progression free survival (“PFS”). Its secondary objectives included overall survival (“OS”), safety, and measurement of biomarkers that may be predictive of response.”

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New Cancer Drug Reolysin Shrinks Lung Tumors

Interim results from a phase II clinical trial of the new cancer drug Reolysin in squamous cell carcinoma (SCC) of the lung, a type of non-small cell lung cancer (NSCLC), show that tumors shrank in 23 of 25 patients. The patients had SCC that had spread from its original site, or recurred after treatment, and were treated with the chemotherapy drugs Paraplatin (carboplatin) and Taxol/Abraxane (paclitaxel) in addition to Reolysin. Ten patients experienced tumor shrinkage and 13 experienced stable disease, while the cancer progressed in 2 patients. On average, tumors shrank by a third of their original size. Reolysin consists of a modified form of a virus that selectively attacks cancer cells, while producing no symptoms in most healthy people.

Viral Drug Helps Shrink Melanomas in Early Trial

Initial results of a phase II trial suggest that melanoma tumors shrink when treated with both chemotherapy and an experimental drug called Reolysin. Developed by the pharmaceutical firm Oncolytics Biotech, Reolysin is a virus that that doesn’t harm healthy cells, but kills cancer cells with RAS mutations, which have defective antiviral defenses. The researchers treated 14 melanoma patients with the drug combination and found that tumors shrank in 3 of them and did not get bigger in 7 more. Next, the researchers will test Reolysin combined with drugs that target melanomas with BRAF mutations.

Oncolytics Cancer Drug Meets Mid-Stage Trial Goal, Shares Rise

“Oncolytics Biotech Inc said preliminary data from a mid-stage trial showed that its cancer drug, Reolysin, met the main goal of reducing the size of tumors in patients with metastatic melanoma, a type of skin cancer.”

Reolysin Continues to Show Promise for Lung Cancer Treatment

An ongoing phase II clinical trial of the novel cancer treatment Reolysin has shown promising results for lung cancer. Reolysin, which is produced by Oncolytics Biotech, is a form of reovirus, a virus that infects and destroys cancer cells. The clinical trial studied patients with advanced squamous cell carcinoma (SCC) of the lung, a type of non-small cell lung cancer (NSCLC), who received Reolysin in combination with chemotherapy. Nine of 21 patients showed a partial beneficial response, while another 9 patients had no disease progression; the cancer worsened in the remaining 3 patients. Similar response rates to Reolysin had been observed during the first stage of this trial last year. Oncolytics press release: http://www.oncolyticsbiotech.com/news_items/details?press_release_id=1929

Oncolytics lung cancer drug effective in mid-stage trial, shares up

Oncolytics Biotech Inc said its experimental lung cancer drug was found to be more effective in a mid-stage trial study, sending its shares up more than 10 percent.”

A Retrospective Analysis of VeriStrat Status on Outcome of a Randomized Phase II Trial of First-Line Therapy with Gemcitabine, Erlotinib, or the Combination in Elderly NSCLC Patients

In a multicenter randomized phase II trial of gemcitabine (arm A), erlotinib (arm B), and gemcitabine and erlotinib (arm C), similar progression-free survival (PFS) and overall survival (OS) were observed in all arms. We performed an exploratory, blinded, retrospective analysis of plasma or serum samples collected as part of the trial to investigate the ability of VeriStrat (VS) to predict treatment outcomes.

Gemcitabine is the superior treatment for elderly patients with VS Poor status. First-line erlotinib for elderly patients with VS Good status may warrant further investigation.

Quantitative Chemical Proteomics Profiling Differentiates Erlotinib from Gefitinib in EGFR Wild-type Non-small Cell Lung Carcinoma Cell Lines

Although both erlotinib and gefitinib target the epidermal growth factor receptor (EGFR), erlotinib is effective in patients with EGFR wild-type or mutated tumors, whereas gefitinib is only beneficial for patients with activating mutations. To determine whether these differences in clinical outcomes can be attributed to their respective protein interaction profiles, a label-free, quantitative chemical proteomics study was performed. We propose that, in an EGFR wild-type context, erlotinib may have a complementary mode of action by inhibiting integrin-linked kinase (ILK), -parvin and PINCH (IPP) complex activities, resulting in the slowing down of the metastatic process of epithelial tumors.