In after-hours trading on Monday shares of Celator Pharmaceuticals (CPXX) soared more than 300% as the company announced positive phase 3 results in a trial with patients with high-risk acute myeloid leukemia. The company’s injectable drug is known as VYXEOS or CPX-351. This drug was being compared to the standard of care regimen of cytarabine and daunorubicin.
The trial was successful because it met the primary end point of the study,which was overall survival. The median overall survival of the VYXEOS group was 9.56 months. On the other hand the standard of care group noted above only had 5.95 months. The hazard ratio of the trial was 0.69 with a p-value of p = 0.005. This p-value represents a 31% reduction in the risk of death versus the placebo compound. That number is obtained by subtracting 1 by the hazard ratio number getting.31 or 31%.
With this result on hand Celator will submit an NDA application to the FDA later this year for marketing approval for VYXEOS in treating these patients with high-risk AML. The company will also file Marketing Authorization Application — MAA — to the European Medicine’s Agency by the first quarter of 2017 for European approval. With positive efficacy results seen to date along with a decent safety profile with Grade 3 events equivalent to current standard of care, there is a high probability that the drug will be approved in both territories.
