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news.UK-based biotechnology firm PsiOxus Therapeutics has secured positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) for an orphan medicinal product designation of its oncolytic vaccine, enadenotucirev to treat platinum-resistant epithelial ovarian cancer.
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Enadenotucirev (previously called as ColoAd1) is currently being evaluated in a Phase I/II trial (OCTAVE) in platinum-resistant ovarian cancer patients across multiple UK cancer centres.
The Phase I/II trial is designed to evaluate the safety and efficacy of PsiOxus’ new oncolytic vaccine.
The company said that enadenotucirev is also under investigation in two further European clinical studies in patients with colorectal cancer, bladder cancer, non-small cell lung cancer and renal cancer.
PsiOxus CEO Dr John Beadle said: "Receipt of orphan drug status for enadenotucirev for platinum-resistant epithelial ovarian cancer in Europe has the potential for advancing PsiOxus Therapeutics’ development and commercialisation timeline in this indication.
"We very much appreciate the positive feedback and support of the EMA. The Committee’s positive opinion marks an important milestone in the clinical development of enadenotucirev."
The company is also conducting clinical trials evaluating enadenotucirev’s safety and efficacy through intravenous injection in patients with colorectal cancer.