Celator Pharmaceuticals received fast-track designation for its candidate for the treatment of secondary acute myeloid leukemia in elderly patients. CPX-351 is designed to achieve sustained release of the anticancer drugs cytarabine and daunorubicin in a precise ratio.
The fast-track designation means that the company's candidate could be approved more quickly than usual. Celator will now have easier access to FDA officials to discuss CPX-351's development program, and the candidate could be eligible for priority review, depending on the clinical data at the time of the NDA submission.
However, the company's stock was essentially unchanged on the news and remains stuck under $3 on the Nasdaq.
Celator's CombiPlex platform uses a liposome to control the release and distribution of the active ingredients. The company says delivering the constituents of combination therapies in the right ratio is crucial. To that end, Celator's drug delivery complex is supposed to release combination therapies in a precise molar ratio, in this case a 5 to 1 formulation of cytarabine to daunorubicin.
"Our ongoing Phase III study in these patients has completed enrollment, and we expect induction response rate data to be available in the second quarter of this year, and to have overall survival data, the primary endpoint of the study, in the first quarter of 2016. If our Phase III study, comparing CPX-351 to the current standard of care, is successful, the Fast-Track designation may provide an added benefit of facilitating the NDA review process," said Celator CEO Scott Jackson in the release.
The milestone comes on the heels of strong Phase II trial results for use in patients with first-relapse acute AML. Secondary, or high-risk, AML is a different form of the disease that occurs in patients with a previous hematologic disorder, such as aplastic anemia, according to the Cleveland Clinic.
Results from the trial for patients with first-relapse acute AML showed that patients using CPX-351 had a lower 60-day mortality rate than those in the control arm.
Those results did influence the trial for the now-fast-tracked indication of treatment for secondary AML patients. "The insights from this Phase II study were very relevant as we designed our Phase III pivotal study in older patients with secondary AML," said Celator Chief Medical Officer Arthur C. Louie in the release.
- read the release about the fast-track designation
- read the related release about the Phase II trial results