EMA grants positive opinion for orphan drug status for ovarian cancer oncolytic vaccine
OXFORD – 13 January 2015
PsiOxus Therapeutics Ltd. (PsiOxus), an Oxford, UK based biotechnology company developing innovative new treatments for cancer, has been granted a 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 (previously known as ColoAd1) for the treatment of platinum-resistant epithelial ovarian cancer. The positive opinion for the orphan designation was confirmed on 9th January for enadenotucirev described as a chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions.
PsiOxus CEO Dr John Beadle commented: “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.”
Enadenotucirev is currently undergoing phase I/II testing in platinum-resistant ovarian cancer patients across multiple UK cancer centres. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) phase I/II clinical trial aims to assess the safety and efficacy of PsiOxus’ novel oncolytic vaccine. Enadenotucirev is also under investigation in two further European clinical studies in patients with colorectal cancer, bladder cancer, nonsmall cell lung cancer and renal cancer.
The EMA defines rare diseases as life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the EU and where no satisfactory treatment is available. Orphan designation applications are evaluated by the Agency’s COMP, which provides its opinion on whether or not the medicine qualifies as an orphan medicine for the treatment, prevention or diagnosis of a rare disease. If the COMP issues a positive opinion, the European Commission may then grant the medicine orphan status.
The EMA grant an orphan drug designation to promote the development of products that demonstrate promise for the treatment of rare diseases or conditions. Orphan drug designation provides 10 years of market exclusivity in the EU due to various regulatory and economic benefits.
As well as assessing how effective intraperitoneal enadenotucirev is for treating ovarian cancer, PsiOxus is also carrying out clinical studies evaluating its safety and efficacy via intravenous injection in patients with colorectal cancer. The phase I/II EVOLVE study (EValuating OncoLytic Vaccine Efficacy) is currently underway and has shown some promising early results.