Active Biotech and Ipsen have announced that 600 patients have been recruited in the global, pivotal, randomised, double-blind, placebo-controlled Phase 3 study of tasquinimod, used to treat patients with metastatic castrate-resistant prostate cancer (CRPC).
Tasquinimod has a pleiotropic mode of action, which includes immunomodulatory, anti-angiogenic and anti-metastatic activity.
The Phase 3 study is intended to confirm tasquinimod’s efficacy on metastatic CRPC in the pre-chemotherapy setting, with radiological progression-free survival (PFS) as the primary endpoint and overall survival (OS) as the secondary endpoint.
The company said it will enrol around 1,200 patients in more than 250 centres and data from the trial is anticipated to be announced by the end of 2013.
A €10m milestone payment from Ipsen to Active Biotech has been triggered as the planned enrolment has reached an inclusion of 600 patients.
Ipsen chairman and chief executive officer, Marc de Garidel, said the on-schedule recruitment of the 600th patient in the tasquinimod Phase 3 clinical trial is a testimony of the interest of the medical community in the drug’s new and differentiated mode of action.
"Ipsen is now in the final stage of designing the randomised supportive study, to be initiated before year-end, and is getting ready to investigate tasquinimod in additional indications," de Garidel added.
Tomas Leanderson, Active Biotech president and CEO, said the successful recruitment into the ongoing Phase 3 study indicates the level of interest for tasquinimod as an alternative treatment for CRPC.
"The partnership with Ipsen has significantly increased the potential of this novel approach to treat cancer," Leanderson added.
In the previous Phase 2 study, tasquinimod considerably slowed disease progression and improved progression-free survival (PFS) in chemonaïve patients with metastatic CRPC, reporting an acceptable side effect profile.
The six month progression free proportion of patients for tasquinimod and placebo treatment groups were 69% and 37% respectively, with a median PFS of 7.6 versus 3.3 months.