The European Medicines Agency's (EMA) Committee for Orphan Medical Products (COMP) recently gave a positive review of enadenotucirev to treat platinum-resistant ovarian cancer.
Also known as ColoAd1, the oncolytic vaccine is in the Phase I/II testing stage to determine its efficacy and safety. Test subjects include ovarian cancer patients throughout the United Kingdom.
Two other clinical studies of enadenotucirev are taking place in Europe. These studies are testing the drug's effectiveness against bladder cancer, colorectal cancer, renal cancer and non-small cell lung cancer.
The COMP must give a positive review before the European Commission decides whether to grant orphan status to treatments.
Orphan drug status is designed to encourage researchers to create therapies that show promise in treating rare illnesses. The EMA considers rare diseases to be chronically debilitating or life-threatening illnesses harming no more than five individuals out of 10,000. The rare disease should also have unsatisfactory treatment options.
Orphan drug status provides manufacturers with 10 years of market exclusivity in Europe.
Enadenotucirev was created by PsiOxus Therapeutics Ltd., a biotechnology company based in Oxford, England. The company is known for its cancer treatments.
“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,” John Beadle, CEO of PsiOxus, said. “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.”