Celator Pharmaceuticals Inc. (NASDAQ:CPXX) announced positive results from the Phase 3 trial of VYXEOS™ (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. 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 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 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.
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 well likely have a new standard of care for treating older patients with secondary AML, said 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. This represents a major step forward for a very difficult-to-treat patient population.
VYXEOS also demonstrated a statistically significant improvement in induction response rate (CR+CRi of 47.7% versus 33.3%; p=0.016) and this significance was maintained for the analysis of CR alone (CR of 37.3% versus 25.6%, p=0.040).
Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.
No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3 or higher, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3 or higher, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.
These findings confirm that VYXEOS provides the first opportunity weve had in decades to extend survival for patients with high-risk AML, added 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. Also, more patients in remission means more who are eligible for potentially curative therapy.
Based on these results the company expects to submit a New Drug Application (NDA) for VYXEOS with the U.S. Food and Drug Administration (FDA) later this year and submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first quarter of 2017.
The successful outcome of this Phase 3 trial represents an important advance for AML patients, their families and clinicians, said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. It also marks a major milestone for Celator, for VYXEOS, and for our CombiPlex® platform. We offer our sincere thanks to the patients and investigators who participated in this study and we will work closely with regulatory authorities to make this new treatment available to the AML community as soon as possible.
Celator Equity Analysis
Celator Pharmaceuticals Inc. (NASDAQ:CPXX) opened trading today as $9.38 and is trading in the range of 8.50-10.25 today. Celator’s current market cap stands at $324.04 Million.
Celator is currently covered by 3 Wall Street analysts. The mean target price is $18.33 according to First Call. This presents a solid upside to the current price of the equity. The Mean Recommendation sits at 1.7 which is based on 3 Buy ratings.
The most recent analyst actions consisted of Argus downgrading the stock on March 17th and FBR initiating coverage with an outperform rating back in November.
The current quarter EPS consensus estimate is -0.12. Celator reported actual earnings last quarter of -0.15 which beat the -0.16 consensus estimate, a 6.30% surprise.
Celator Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, develops therapies to treat cancer. Its proprietary drug ratio technology platform, CombiPlex, enables the rational design and rapid evaluation of optimized combinations incorporating traditional chemotherapies, as well as molecularly targeted agents to deliver enhanced anti-cancer activity. The companys product pipeline includes CPX-351, a liposomal formulation of cytarabine:daunorubicin, which is in Phase III study for the treatment of acute myeloid leukemia; and CPX-1, a liposomal formulation of irinotecan:floxuridine that has completed Phase II study for the treatment of colorectal cancer. Its preclinical stage product candidate is CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation for vitro and vivo studies. The company was founded in 1999 and is headquartered in Ewing, New Jersey.