Celator’s shares jump on positive late-stage trials for leukaemia drug
pharmafile | March 16, 2016 | News story | Business Services, Research and Development, Sales and Marketing | Celator Pharmaceuticals, EMA, US FDA, Vyxeos, drug trials, phase III
Shares in trial-stage Celator Pharmaceuticals (Nasdaq: CPXX) soared gaining over four times in value as the company announced late-stage trials for its leukemia drug met its primary endpoint.
The company said following the trial results it will file a New Drug Application (NDA) for its drug compound Vyxeos (cytarabine/daunorubicin) with the US Food and Drug Administration (FDA) later in the year and submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first quarter of 2017.
Jeffrey Lancet, the principal investigator for the study, says: “The overall survival advantage seen with CPX-351 compared to 7+3, along with a superior response rate and no increase in serious toxicity indicates that we’ll likely have a new standard of care for treating older patients with secondary AML. This represents a major step forward for a very difficult-to-treat patient population.”
The company said the trials showed Vyxeos significantly improved overall survival in patients with high-risk acute myeloid leukaemia (AML) versus standard of care in a Phase III study.
Dr Gail Roboz, says: “These findings confirm that Vyxeos provides the first opportunity we’ve had in decades to extend survival for patients with high-risk AML. Also, more patients in remission means more who are eligible for potentially curative therapy.”
Shares in the company closed up $7.26 at $8.94, Tuesday on the Nasdaq.
Anjali Shukla
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