ONCOLYTICS BIOTECH INCOTCQX
Oncolytics: Killing Cancer With A Virus
Kanak Kanti De • 30 Comments
Kanak Kanti De • 30 Comments
Thu, Nov. 3, 6:36 AM
Wed, Nov. 2, 7:12 PM
Wed, Aug. 10, 7:40 AM
- Oncolytics Biotech (OTCQX:ONCYF) remains undeterred in its effort to demonstrate a clinical use for lead product candidate REOLYSIN (reovirus variant). Today, it announces additional data from its Phase 2 study, IND 211, in patients with squamous and non-squamous non-small cell lung cancer (NSCLC).
- Non-squamous (adenocarcinoma) patients (n=75) were treated with either REOLYSIN and the chemo agent pemetrexed or pemetrexed alone. Squamous patients (n=76) received either REOLYSIN + the chemo agent docetaxel or docetaxel alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and response-predictive biomarkers.
- Female patients with adenocarcinoma (n=20) treated with REOLYSIN showed a statistically valid improvement in median PFS versus control (5.39 months vs. 3.02 months; p=0.0201). OS also favored the REOLYSIN cohort but has yet to reach statistical significance.
- No PFS or OS benefit was observed in male patients with adenocarcinoma.
- Favorable PFS and OS responses were observed in REOLYSIN-treated patients positive for biomarkers associated with the replication of the reovirus (EGFR, HRAS, KRAS, NRAS, BRAF, p53).
- The data from the squamous group was not sufficient to draw statistical conclusions.
- The company intends to incorporate genetic screening of patients in future study protocols.
- Shares have been in a down trend since May when Oncolytics initially reported disappointing results from IND 211.
- Previously: Oncolytics Bio's REOLYSIN shows mixed results in mid-stage lung cancer study; shares down 18% (May 19)
Thu, Aug. 4, 6:46 AM
Thu, May 19, 12:35 PM
- Thinly traded nano cap Oncolytics Biotech (OTCQX:ONCYF) is down 18% on increased volume in response to the release of tepid preliminary results in two mid-stage trials assessing lead product candidate REOLYSIN (reovirus variant). The first, reported earlier today, was in colorectal cancer. This report will summarize the mixed results in the second, in non-small cell lung cancer (NSCLC). The data will be presented in an abstract at ASCO in Chicago, June 3.7.
- The Phase 2 clinical trial, called IND 211, randomized 152 NSCLC patients into four treatment arms: Arm A: REOLYSIN + pemetrexed (chemo agent); Arm B: pemetrexed alone, both for non-squamous NSCLC patients; Arm C: REOLYSIN + docetaxel (chemo); Arm D: docetaxel alone, both for squamous NSCLC patients.
- Overall, the addition of REOLYSIN failed to demonstrate a statistically valid improvement in progression-free survival (PFS), the primary endpoint, or Overall Survival (OS). It also failed to show much difference in male or female patients. The company combined the arms into "Test" (A+C) and "Control" (B+D). On this basis, patients with the EGFR mutation who received REOLYSIN showed numerical increases in median PFS and median OS versus control, as did patients who expressed the oncogene p53, but the numbers of patients were small (five to eight for EGFR and 21 to 24 for p53).
- The company will need to fine-tune its targeted patients for REOLYSIN if it hopes to succeed in Phase 3.
- Previously: Oncolytics Bio's REOLYSIN falls flat in mid-stage study in colorectal cancer (May 19)
Thu, May 19, 9:46 AM
- Oncolytics Biotech's (OTCQX:ONCYF) REOLYSIN (reovirus variant), in combination with the chemo regimen FOLFOX-6 and Roche's (OTCQX:RHHBY) Avastin (bevacizumab), failed to beat FOLFOX-6 and Avastin alone in a Phase 2 study in patients with advanced/metastatic colorectal cancer (CRC). The data will be presented in an abstract at ASCO in Chicago, June 3-7.
- REOLYSIN showed no statistically valid improvements in any cohorts in terms of objective response rate (ORR), progression-free survival or overall survival. Female patients offered the only ray of hope, in which those receiving REOLYSIN (n=19) showed an ORR of 63.2% compared to 23.8% for control (n=21) (FOLFOX-6 and Avastin alone) (p=0.0054).
- In an apparent attempt to salvage something, the company conducted an additional analysis in patients with liver metastases. The objective tumor response rates favored REOLYSIN 55% (n=40) versus 28.6% (n=42)(p=0.0077). REOLYSIN failed to beat control in patients with no liver metastases.
Fri, May 6, 6:37 AM
- Oncolytics Biotech (OTCQX:ONCYF): Q1 EPS of -$0.03
Thu, Apr. 14, 8:45 AM
- Updated results from a Phase 2 clinical trial evaluating Oncolytics Biotech's (OTCQX:ONCYF) REOLYSIN (reovirus variant), in combination with chemo agents carboplatin and paclitaxel, in metastatic pancreatic cancer patients showed an encouraging long-term treatment benefit compared to carboplatin and paclitaxel alone as measured by overall survival (OS).
- Participants in the open-label, randomized, two-arm study were treated every three weeks. Subjects in the REOLYSIN group received an intravenous dose on days one through five. The chemo agents were administered intravenously on day one only.
- The test arm was REOLYSIN + chemo, the control arm was chemo only and the crossover arm was patients initially treated with chemo only who had REOLYSIN added to their regimen.
- Median OS in the control arm was 6.57 months (n=20). 25% of patients (n=5) survived one year while 0% survived 2 - 3 years. In the test arm, median OS was 7.33 months (n=36) and the proportion surviving one year was 29.6% (27.8% if n=10 or 30.6% in n=11 so unclear on basis for 29.6%), neither statistically significant. Some patients survived longer, however. The proportions of those surviving two and three years were 17.7% (16.7% if n=6) and 8.87% (8.3% if n=3), respectively. At the time of the data cutoff on January 19, there were five total survivors in the test arm and one in the crossover arm.
- In the crossover group, median OS was 10.97 months and the proportions of subjects surviving one, two and three years were 25.0%, 12.5% and 6.25%, respectively.
- The differences between the test arm versus control, the crossover arm versus control and the test are plus the crossover arm versus control were all statistically significant for two-year OS.
- Previously: Reolysin demonstrates modest results in pancreatic cancer trial (Sept. 17, 2014)
Tue, Mar. 22, 8:18 AM
- Results from a Phase 2 clinical trial assessing Oncolytics Biotech's (OTCQX:ONCYF) lead product candidate, reovirus isolate REOLYSIN, in combination with the chemo agent paclitaxel compared to paclitaxel alone in patients with ovarian cancer failed to consistently demonstrate REOLYSIN's efficacy. The data were presented at the Society of Gynecologic Oncology's Annual Meeting on Women's Cancer in San Diego, CA.
- Orphan Drug-tagged REOLYSIN showed its most pronounced effect as measured by the biomarker CA-125, a protein circulating in the blood that is elevated in ovarian cancer. The numbers of full responders, partial responders and those with stable disease in the REOLYSIN + paclitaxel (REO + p) cohort (n=54) were 5 (9.3%), 7 (13.0%) and 12 (22.2%), respectively. The comparable numbers for the paclitaxel alone cohort (n=54) were 1 (1.9%), 9 (16.7%) and 3 (5.6%), respectively. The disease control rate (full responders + partial responders + those with stable disease) was 44.4% (n=24/54) for the REO + p cohort compared to 24.1% (n=13/54) for paclitaxel alone. The differences were statistically valid, but exactly how the responses are defined is not provided other than a reference to modified Rustin's criteria. In a 2011 paper published by the Gynecological Cancer Intergroup, a complete response is defined as a 50% reduction in CA-125 levels from a pretreatment sample that is at least twice the upper limit of the reference range.
- Based on RECIST criteria, however, REO + p (response rate = 17%) failed to perform as well as paclitaxel alone (response rate = 20%). REO + p also failed to match paclitaxel alone in median overall survival (12.9 months versus 15.0 months). Progression-free survival, one of the primary endpoints, was virtually the same: 4.4 months for REO + p versus 4.3 months for paclitaxel alone.
Fri, Mar. 11, 6:33 AM
- Oncolytics Biotech (OTCQX:ONCYF): FY15 EPS of -$0.12
Nov. 18, 2015, 8:13 AM
- A Phase 1b clinical trial assessing Oncolytics Biotech's (NASDAQ:ONCY) REOLYSIN, in combination with Amgen's (NASDAQ:AMGN) KYPROLIS (carfilzomib) and dexamethasone, in patients with relapsed/refractory multiple myeloma in underway. The first stage of the study will enroll three to six patients in two cohorts, each at a different dose.The second stage will enroll up to 12 patients at the maximum tolerated dose determined in the first stage.
- The principal investigator is Kevin Kelly, M.D., Ph.D., from the University of Southern California.
- Multiple myeloma is the second most common type of blood cancer with ~27K new cases in the U.S. each year.
Nov. 5, 2015, 6:44 AM
- Oncolytics Biotech (NASDAQ:ONCY): Q3 EPS of -$0.02
Oct. 29, 2015, 10:48 AM
- Oncolytics Biotech (ONCY -25.3%) will be delisted from the Nasdaq Capital Market effective November 5. It will trade under its current symbol on the OTCQX thereafter.
Oct. 20, 2015, 7:29 AM
- Oncolytics Biotech (NASDAQ:ONCY) is set to submit its IND to the FDA for clearance to begin a Phase 1b study of Merck's (NYSE:MRK) Keytruda (pembrolizumab) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma.
- The open-label study will enroll adult patients with confirmed advanced or metastatic pancreatic adenocarcinoma who failed or did not tolerate first-line treatment. The primary endpoint is the safety and dose-limiting toxicities of REOLYSIN and chemo (gemcitabine or irinotecan or fluorouracil) in combination with Keytruda. Secondary endpoints include overall response rate, overall survival and progression-free survival. There will be an initial six to nine patient safety run-in followed by the enrollment of up to 15 additional participants.
- CEO Dr. Brad Thompson says, "This is the first study examining the effects of REOLYSIN in combination with a checkpoint inhibitor in human patients. It builds on our previous clinical work in pancreatic cancer as well as findings from multiple clinical and preclinical studies indicating the REOLYSIN can upregulate PD-1 and PD-L1.
- REOLYSIN has been designated an Orphan Drug for the treatment of pancreatic cancer by both the FDA and EMA.
Oct. 6, 2015, 11:26 AM
- Oncolytics Biotech (ONCY +1.2%) completes enrollment in its open-label, randomized Phase 2 study assessing the efficacy of REOLYSIN, in combination with docetaxel, versus docetaxel alone in patients with recurrent/metastatic castration-resistant prostate cancer. About 40 evaluable patients are in each arm.
- The primary efficacy endpoint is progression-free survival at 12 weeks.
- The study is being conducted by the NCIC Clinical Trials Group at Queen's University in Kingston, Ontario, Canada.
Aug. 6, 2015, 6:36 AM
- Oncolytics Biotech (NASDAQ:ONCY): Q2 EPS of -$0.03 vs. -$0.05 in 2Q14