Orphan Drug Designation Recommendation: PsiOxus Therapeutics’ Vaccine For Ovarian Cancer
PsiOxus Therapeutics is an Oxford, UK-based biotechnology developing treatments for oncology. The company announces January 13th that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) grants a positive opinion for an orphan medicinal product designation for its oncolytic vaccine, Enadenotucirev (previously known as ColoAd1) for platinum-resistant epithelial ovarian cancer.
EMA COMP opinions are forwarded to the European Commission (EC). The EC will then decide whether to grant an orphan designation in question. A public summary of the opinion will be available on the EMA website following adoption of the respective decisions on orphan designation by the EC.
Enadenotucirev is currently undergoing Phase I/II clinical trials in Platinum-resistant ovarian cancer in several UK cancer centers. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) Phase I/II clinical trial has the objective of assessing the safety and efficacy of the oncolytic vaccine. Enadenotucirev is also under investigation in 2 additional European clinical studies for :
• Colorectal Cancer
• Bladder Cancer
• Non-Small Cell Lung Cancer (NSCLC)
• Renal cancer.
Please Note : “Vaccine” by John Keith (Photographer) [Public domain, NIH], via Wikimedia Commons | Wikimedia Commons.
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