A cancer-focused drug-maker Bioven can now enrol patients in the USA in its international Phase III trial of EGF-PTI, in non-small cell lung cancer (NSCLC).
As the has FDA approved the patients enrolment, Bioven on Thursday said it intends to include around five US study centres in the Phase III trial after FDA’s review of its Investigational New Drug filing.
Bioven’s Phase III trial to test the safety and efficacy of EGF-PTI in inoperable, late-stage NSCLC. A total of 418 patients will take a part in the trial, the primary endpoint of which is overall survival. Up to 30 patients are expected to be enrolled in the USA, Bioven said.
EGF-PTI, which was initially developed in Cuba as CIMAvax-EGF, is an immunotherapy that targets the epidermal growth factor/epidermal growth factor receptor (EGF/EGFR) pathway implicated in tumour growth.
Bioven points out its exclusive rights to EGF-PTI in Europe, ASEAN and Australasia territories, along with the first right of refusal in the Middle East. The company also said that it was talking with Cuba’s CIM in connection with US marketing rights.
Steve Drew, Bioven’s Chief Executive Officer, said: “We are delighted to have received regulatory approval in the USA to enable us to include US patients in our on-going, international Phase III trial of EGF-PTI in non-small cell lung cancer. EGF-PTI is an exciting immunotherapy which in earlier Cuban studies has shown the potential for a significant overall survival benefit in a devastating disease of high unmet medical need.”
Dr Agustin Lage, President of Cuba’s CIMAB SA, which licensed rights to EGF-PTI to Bioven, added: “We are very pleased that our innovative immunotherapy, which was initially developed at the Centre of Molecular Immunology (CIM) in Cuba, is to be trialled in the USA as part of Bioven’s international Phase III study. Our clinical studies of this immunotherapy in Cuba have produced compelling clinical data in non-small cell lung cancer and I look forward to our data being replicated in Bioven’s study.”