Merck KGaA to conduct Stimuvax clinical trial

Merck KGaA is to conduct a phase III clinical trial of Stimuvax (BLP25 liposome vaccine) in patients with non-small cell lung cancer (NSCLC).

The stimulating targeted antigenic responses to NSCLC (Start) trial will analyse the safety and efficacy of the treatment in patients with unresectable stage III NSCLC, Biomira has announced.

Biomira states that the phase III trial has been designed taking into consideration advice from the European Medicines Agency/Committee for Medicinal Products for Human Use.

The Start trial will involve patients with NSCLC who have previously exhibited a response or stable disease following treatment with two cycles of platinum-based radio-chemotherapy.

“Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC,” Biomira reports.

The company adds that the trial will include 1,300 patients in 30 countries worldwide, with enrolment now open in 12 countries.

Merck will conduct this trial together with EMD Pharmaceuticals, as laid out in the partnership agreement between itself and Biomira and, when the first patient is enrolled into the phase III clinical trial, Merck will grant Biomira a milestone payment.

Last month, Merck announced that the EC had approved its proposed acquisition of Serono.