Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Yakult Honsha, Aeterna Zentaris' Japanese partner, has commenced Phase 1 trial in multiple myeloma with perifosine, an oral Akt/PI3K inhibitor drug.
Subscribe to our email newsletter
In the two step Phase 1 trial, perifosine is combined with bortezomib (Velcade) and dexamethasone in patients with refractory multiple myeloma who were previously treated with bortezomib.
Aeterna Zentaris president and CEO Juergen Engel said, "Perifosine, also currently in a Phase 3 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, remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs."
The open-label trial will enroll a total of 18 patients (6 in step 1 and 12 in step 2).
Patients will receive perifosine daily (50mg, Days 1-21) in combination with bortezomib (1.3mg/m², 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 response rate, progression-free survival, and time to tumor progression include secondary endpoints.