AEterna Zentaris Inc, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.
A phase III trial investigating perifosine in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, perifosine had received orphan drug designation in the United States for the treatment of multiple myeloma.
Perifosine is a novel oral anticancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies.