Yakult, who is sponsoring and conducting the trial in Japan, reported that the first patient has been dosed with perifosine.
The open-label, two step phase I trial in which perifosine is combined with bortezomib (Velcade) and dexamethasone in patients with refractory multiple myeloma who have previously been treated with bortezomib. The trial is expected to include a total of 18 patients (6 in step one and 12 in step two). Patients will receive perifosine daily (50mg, Days 1-21) in combination with bortezomib (1.3 mg/m, Days 1, 4, 8 and 11) and dexamethasone (20mg, Days 1, 2, 4, 5, 8, 9,
11 and 12) according to a three-week cycle (21 days ± 3 days). The primary endpoint is safety while secondary endpoints include response rate, progression-free survival, and time to tumor progression.
"We would like to thank our partner Yakult for their close collaboration in initiating this important phase I trial in multiple myeloma which is necessary at this time in order to comply with Japan's specific registration requirements,” said Juergen Engel, PhD, president and CEO of Aeterna Zentaris. “Perifosine [is] also currently in a phase III trial in other parts of the world in multiple myeloma—for which we expect to reach an interim analysis in the first quarter of next year."