AEterna Zentaris has announced that the US Food and Frug Administration has granted fast-track status to step up development of its new treatment for relapsed/refractory multiple myeloma.
The fast-track programme is signed to boost the development and accelerate the review process for new drugs to treat serious or life-threatening conditions, such as relapsed/refractory multiple myeloma, for which median survival ranges can be as little as six to nine months.
The company is in the development phase for the PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), in partnership with Keryx Biopharmaceuticals.
AEterna Zentaris president and CEO Juergen Engel said that the company looks forward to the emergence of the data from the forthcoming Phase III clinical trial.
“We believe that this North American clinical development programme will also be very useful to support the development and registration of perifosine in the rest of the world,” Engel said.
A Phase III trial to investigate perifosine in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma is expected to begin by the end of the year.