Oncolytics Biotech seeks to obtain FDA approval in p53 mutated/metatstic breast cancer patients. This group of Reolysin treated mBC patients have demonstrated statistical significance in Overall Survival (OS) of p=0.03
CALGARY, April 5, 2017 /CNW/ - Oncolytics Biotech® Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced data demonstrating a statistically significant (p=0.03) overall survival (OS) benefit for patients with mutated p53 metastatic breast cancer, when treated with REOLYSIN®, an immuno-oncology viral agent, in combination with paclitaxel. Results from IND 213, an open-label, randomized, phase 2 study were presented at the Annual Meeting of the American Association of Cancer Research (AACR), April 1-5, 2017 in Washington, D.C.
FDA "Fast Track" Drug Approval allowed after single small patient size Phase II clinical study.
"Fast track: The FDA’s “fast track” approval designation of 1988 allows drugs that treat life-threatening or debilitating diseases to be approved after a single phase II clinical study."
Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival (OS) Data In KYPROLIS® (Carfilzomib) Label
Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent and Increased Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
THOUSAND OAKS, Calif., July 14, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS® (carfilzomib).
Data submitted to regulatory authorities showed that KYPROLIS, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone (Kd56), reduced the risk of death by 21 percent over Velcade® (bortezomib) and dexamethasone (Vd), resulting in a 7.6 month OS benefit (median OS 47.6 months for Kd56 versus 40.0 months for Vd, HR=0.79; p=0.01). The OS benefit was consistent regardless of prior bortezomib therapy (HR 0.75 for no prior Velcade; HR 0.84 for prior Velcade). These results were presented earlier this year at the 16th International Myeloma Workshop and the 22nd Congress of the European Hematology Association.
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Celegene acquires pre-clinical anti-PD-1 agent from newly created partnership with Chinese company
July 06, 2017
"The prolific dealmaker is paying $263 million upfront to get its mitts on the ex-Asia rights to Beigene’s PD-1 inhibitor BGB-A317 in solid tumors.
BGB-A317 has yet to enter global pivotal trials and has already given up a big head start to rival checkpoint inhibitors from Bristol-Myers Squibb, Merck and the rest of the PD-1/PD-L1 pack. But, while BGB-A317 may arrive too late to make a dent on the monotherapy market, it could still be a useful tool for Celgene as it puts together combinations of cancer drugs to hit solid tumors. "
The board is awfully quiet! Any one have anything to add to the latest news and SP activity?
FDA is transforming the drug approval process. FDA's new drug approval process - is coming out of the 21st Century Cures Act, signed into law last year, which gave the agency $500 million over the next 9 years.
"In the words of the FDA, Cures is designed to speed up the regulatory process while also taking on board the views of patients when it comes to drug development. It also wants to modernize clinical trial designs as well as clinical outcome assessments, which it hopes will help speed up the development and review of new meds."
" .....at ASCO we saw more and more oncolytic virus research coming through the pipeline and more and more data suggesting that oncolytic viruses will be part of the future cocktail of solid tumour treatments."
Interview: Targovax is Bringing Cancer Vaccines & Oncolytic Viruses Back
We talked to CEO Øystein Soug and CMO Magnus Jäderberg of Targovax about why the company’s technologies may succeed where others have failed.
Bailey, do you think we should run our Phase 3 mBC Trial the same way as we ran our Phase 2 with the change of OS as Primary Endpoint of course, OR do you think we should focus our Phase 3 mBC Trial on p53 Mutated patients with mBC as they were the best responders in the Phase 2. In other words, should we limit enrollment to mBC patients with p53 Mutations?
Zack's Research Update on Oncolytics Biotech June 23, 2017
"Since the capital raise, shares on the TSE have declined from the issue price by approximately 34%, despite the company exercising its full allotment option and raising sufficient capital to support clinical trials and operations through the end of 2018 and perhaps slightly longer. Oncolytics is also coming up on its end-of-Phase II meeting with the FDA, which is expected to take place in the first half of August, depending upon scheduling. Following the meeting, the FDA may approve Oncolytics submission of a biologics license application (BLA) or grant breakthrough status, which will allow for priority review and closer collaboration with the FDA. Generally, the FDA takes 60 days to respond to the submission and Oncolytics anticipates making an announcement on the path forward regarding REOLYSIN for metastatic breast cancer in the fourth quarter of 2017. Our estimates take a conservative stance and assume that no special status will be granted and yield a target price of US$2.00. If special status is granted, there is upside to our estimates due to lower costs incurred and faster time to market. We also note that even under our base case scenario, where the Phase III trial is required, our target price will increase upon the start of the trial based on a higher probability of success for candidates that reach Phase III. There has been positive news so far for the company and we note several upcoming potentially positive catalysts as well. "
.32 sucks--- but buy
Market Analysis : The New Biotech Boom Begins NOW
Biotech is blowing every other sector out of the water this week.
Trump administration picks pro-vaccine CDC director | FiercePharma
After fears that President Trump may push for a change in vaccine policy on autism concerns, Brenda Fitzgerald's appointment will likely be a relief to medical professionals.
Several of the reasons that Oncolytics Biotech is establishing a US office in San Diego is because (1) the OV Reolysin is being manufactured and validated by SAFC Carlsbad (Sigma-Aldrich) now Millipore Sigma( a subsidiary of Merck KGaA) located in Carlsbad, California - north of San Diego, CA. AND; (2) both ONCY's VP of Business Development and VP of Investor Relations currently reside in San Diego AND; (3) ONCY CEO Matt Coffey spends considerable time in San Diego and at the Millipore Sigma facilities in Carlsbad completing the FDA's product manufacturing requirements, as ONCY readies itself for a BLA and registration of Reolysin for FDA approval in the treatment of metastatic breast cancer (mBC).
p53 as a molecular marker / biomarker for the detection of cancer.
The p53 gene is the most frequently mutated gene in cancer and accordingly has been the subject of intensive investigation for almost 30 years. Loss of p53 function due to mutations has been unequivocally demonstrated to promote cancer in both humans and in model systems. As a consequence, there exists an enormous body of information regarding the function of normal p53 in biology and the pathobiological consequences of p53 mutation. It has long been recognised that analysis of p53 has considerable potential as a tool for use in both diagnostic and, to a greater extent, prognostic settings and some significant progress has been made in both of these arenas."
"Research in specific cancers indicates that the uses of increasingly well informed p53 mutational analysis are likely to expand to other cancers."
Beating the Odds - Susquehanna International - Jeff Yass - Philadelphia Magazine
LET’S PLAY A game. Let’s say you’re a contestant on Let’s Make a Deal, Monty Hall’s game show from a generation ago. It’s your moment. There are three doors. Behind one door is a brand-new Camaro. Behind each of the other doors, there’s a goat. If yo
Senior Management Appointment in United States - - Oncolytics Biotech Inc. Appoints Andrew de Guttadauro, President of Oncolytics Biotech (U.S.) Inc.
CALGARY and SAN DIEGO, June 29, 2017 /PRNewswire/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company) today announced the appointment of Andrew de Guttadauro as President of its US subsidiary, Oncolytics Biotech (U.S.) Inc. Mr. de Guttadauro, based in the Company's recently opened satellite office in San Diego, California, will primarily be responsible for simultaneously pursuing both global and regional licensing, partnership and commercialization opportunities for REOLYSIN.
Stratified clinical trials in a Subset of patients and FDA approved Enrichment Strategies
"Clinical trials are not designed to demonstrate the effectiveness of a treatment in a random sample of the general population. Instead, sponsors use a variety of strategies to select a subset of the general population in which the effect of a drug, if there is one, can more readily be demonstrated."
Enrichment strategies fall into three broad categories:
1. Strategies to decrease heterogeneity − These include selecting patients with baseline measurements in a narrow range (decreased inter-patient variability) and excluding patients whose disease or symptoms improve spontaneously or whose measurements are highly variable (decreased intra-patient variability). The decreased variability provided by these strategies increases study power (see section III). 2. Prognostic enrichment strategies − choosing patients with a greater likelihood of having a disease-related endpoint event (for event-driven studies) or a substantial worsening in condition (for continuous measurement endpoints) (section IV). These strategies will increase the absolute effect difference between groups but will not alter relative effect. 3. Predictive enrichment strategies − choosing patients more likely to respond to the drug treatment than other patients with the condition being treated. Such selection can lead to a larger effect size (both absolute and relative) and permit use of a smaller study population. Selection of patients could be based on a specific aspect of a patient’s physiology or a disease characteristic that is related in some manner to the study drug’s mechanism, or it could be empiric (e.g., the patient has previously appeared to respond to a drug in the same class) (section V).