Celator Pharma Skyrockets on Breakthrough Trial Results

Celator Pharmaceuticals Inc. (NASDAQ: CPXX) was far and away leading the bulls in Tuesday’s session following positive results from its late-stage clinical trial. The company announced positive results from its Phase 3 trial of Vyxeos Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML).

The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival. Data will be submitted for presentation at the American Society of Clinical Oncology 2016 Annual Meeting.

The median overall survival for patients treated with Vyxeos in the study was 9.56 months, compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3.

The percentage of patients alive 12 months after randomization was 41.5% on the Vyxeos arm, compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the Vyxeos arm, compared to 12.3% on the 7+3 arm.
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As a result, the company expects to submit a New Drug Application (NDA) for Vyxeos with the U.S. Food and Drug Administration (FDA) later this year.

Jeffrey E. Lancet, M.D., senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study, commented:

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.

Gail Roboz, M.D., Professor of Medicine and Director of the Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York, added:

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 of Celator were trading up about 350% on Tuesday, at $7.46, with a consensus analyst price target of $18.00 and a 52-week trading range of $1.12 to $8.40.