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Oncolytics Biotech (ONCY)
NASDAQ:ONCY
Paclitaxel, Avelumab, Pelareorep
Breast Cancer Metastatic
Phase II
Active Not Recruiting
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
Dec 24, 2019
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Trastuzumab, Letrozole, Atezolizumab, Pelareorep
Breast Cancer
Early Phase I
Terminated
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer
Sep 23, 2019
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Gemcitabine, Cisplatin, Reolysin®
Muscle-Invasive Transitional Cell Carcinoma Of The Bladder
Phase I
Withdrawn
Study of Intratumoral REOLYSIN® in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy in Muscle-invasive Transitional Cell Carcinoma of the Bladder
Mar 24, 2016
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Leucovorin, Gemcitabine, Pembrolizumab, Irinotecan, 5-Fluorouracil, Reolysin®, Chemotherapy
Pancreatic Adenocarcinoma
Phase I
Completed
Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma
Nov 25, 2015
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Bevacizumab, Leucovorin, Irinotecan, Reolysin®, Fluorouracil (5-Fu)
Kras Mutant Metastatic Colorectal Cancer
Phase I
Completed
Study of REOLYSIN® in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer
Jan 07, 2011
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Carboplatin, Paclitaxel, Reolysin
Metastatic Or Recurrent Squamous Cell Carcinoma Of The Lung
Phase II
Completed
A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
Oct 15, 2009
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Carboplatin, Paclitaxel, Reolysin®
Carcinoma, Non-Small Cell Lung
Phase II
Completed
Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin for Non-Small Cell Lung Cancer With KRAS or EGFR Activation
Mar 12, 2009
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Oncolytics Biotech (ONCY) have in its pipeline
ONCY is currently developing the following drugs: Paclitaxel, Avelumab, Pelareorep, Trastuzumab, Letrozole, Atezolizumab, Pelareorep, Gemcitabine, Cisplatin, Reolysin®. These drug candidates are in various stages of clinical development as the company works toward FDA approval.