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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.


TSX:ONC - Post by User

Comment by Noteableon Dec 01, 2023 12:28pm
132 Views
Post# 35763691

RE:RE:Clinical Trial Size in Orphan and Rare Diseases

RE:RE:Clinical Trial Size in Orphan and Rare Diseases ONCYs pelareorep received Orphan status in pancreatic cancer from the EMA in 2015

Some orphan drugs were approved by the European Medicines Agency based on studies with as few as 12 patients.

Studies supporting (post) marketing authorisation (post accelerated approval / Phase 3 confirmatory studies) included several hundred patients.


As stated in the “Guideline on clinical trials in small populations” by the European Medicines Agency/Committee for Medicinal Products for Human Use (EMA/CHMP), most orphan indications submitted for regulatory approval are based on randomised controlled trials (RCT).

ONCY pelareorep is being trialed in Orphan and Rare Diseases/Cancers, such as pancreatic, CRC MSI high, and SCCA, for example, using randomised controlled trials (RCTs).


https://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0597-1

https://www.irdirc.org/wp-content/uploads/2017/12/SPCT_Report.pdf

https://www.ncbi.nlm.nih.gov/books/NBK56176/
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