Oncolytics Biotech Inc T.ONC

Rare and Orphan diseases approved w smaller pt trial numbers

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March 27, 2024 - As outlined in the attached link, Pfizer's termination of one of two phase 3 trials assessing a monoclonal antibody designed to treat sickle cell disease, and due to slow recruitment in the general population, doesn’t impact Pfizer's plans for a potential new drug approval from the FDA in 2026, according to a Pfizer spokesperson since  their  monoclonal antibody Inclacumab has received both orphan and rare pediatric disease tags from the federal agency for sickle cell disease. 

Drugs targeting Orphan and Rare diseases are approved early and on small numbers of clinical trial patients. ONCY's pelareorep in the treatment of pancreatic and metastatic breast cancer indications is a candidate for Accelerated Approval in both indications that are considered to have unmet treatment needs. 

Furthermore, pelareorep is a biologic that will be provided 13 years of market exclusivity from the date of FDA approval.

https://www.fiercebiotech.com/biotech/after-terminating-1-2-late-stage-sickle-cell-disease-trials-pfizer-still-expects-fda

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According to ClinicalTrials.gov a trial can report either actual or expected numbers recruited but not both. The anticipated number of patients to be recruited in rare trials is less than that of non-rare disease trials (median, 41[IQR 24–74] vs. 76[40–182]). Similarly, the actual number of patients recruited is less for rare disease trials than in non-rare trials (29[12–60] vs. 62[27–175

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https://www.fda.gov/patients/rare-diseases-fda So when Matt Coffey said that the Phase 3 PanCan study with pelareorep for the treatment of metastatic pancreatic cancer would cost US$80 Million .... he was full of sheet.

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As reported the actual number of patients recruited is less for rare disease trials than in non-rare trials (29[12–60] vs. 62[27–175]) Even at the maximum rare disease numbers reported above 60 as the actual number and 74 as the anticipated number) and  the maxium cost per patient at US$ 200K ex drugs, a post approval Phase 3 confirmatory trial in either pancreatic

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https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?threadid=35763522

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Pancreatic cancer has the highest mortality rate of all the cancer types—accounting for 3% of all cancer deaths in the United States—and is more common among male patients than female patients. - rates of pancreatic head adenocarcinoma—an especially aggressive and fatal tumor situated at the head of the pancreas—appeared to be increasing. https://ascopost.com/news/february-2023/pancreatic