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.Celator Pharmaceuticals has announced that the FDA has granted orphan drug designation to CPX-351 liposome injection for the treatment of acute myeloid leukemia.
Subscribe to our email newsletter
Celator is currently preparing to conduct two randomized Phase II studies with CPX-351. The first Phase II study, in newly diagnosed, elderly patients with acute myeloid leukemia (AML) is expected to start enrolling patients before the end of 2008.
The second study, in AML patients who have relapsed following initial treatment, is projected to start enrolling patients in the first quarter of 2009.
CPX-351 is a liposomal formulation of cytarabine and daunorubicin delivered in a 5:1 molar ratio shown to be strongly synergistic in preclinical studies. CPX-351 was developed using Celator’s proprietary CombiPlex technology platform.
Scott Jackson, CEO of Celator, said: “The decision by FDA to grant CPX-351 orphan drug designation reinforces the importance of developing novel products for the treatment of rare diseases and represents another milestone for the company.”