Canadian biopharmaceutical company Inex said it will have to provide data from randomised Phase III clinical trials before the Canadian regulatory authorities will consider approving Marqibo (sphingosomal vincristine) for non-Hodgkin’s lymphoma and acute lymphoblastic leukaemia.
This is in line with the decision by the US Food and Drug Administration (FDA) in January 2005 to insist on Phase III clinical trial designs using complete response rate as the primary endpoint
Inex said it is now in partnering discussions for the drug with pharmaceutical companies.
Meanwhile, Inex said earlier this month it is planning to spin off its targeted immunotherapy technology and product candidates into a new company that will approach the markets for financing next year.
The aim will be to raise funds for preclinical development of INX-0167, its lead product candidate in this area, enabling it to commence clinical development. INX-0167 seems to boost natural killer cell activity and could be used to boost the activity of antibody-based therapies for cancer.
Inex said the reorganisation would also allow Inex to continue its focus on its late stage targeted chemotherapy platform, including Marqibo, as well as INX-0125 (sphingosomal vinorelbine) and INX-0076 (sphingosomal topotecan).
Inex’ shareholders are due to vote on the proposal at a meeting expected to take place on January 26, 2006.