Celator Pharmaceuticals (NASDAQ:CPXX) stated Monday evening good outcomes from the Stage 3 trial of VYXEOS (cytarabine:daunorubicin) Liposome for Injection (additionally called CPX-351) in patients along with high-threat (secondary) acute myeloid leukemia (AML) compared to the standard of treatment program of cytarabine and daunorubicin called 7+3. The trial complied with its primary endpoint demonstrating a statistically substantial improvement in total survival. Data will certainly be submitted for presentation at the American Society of Health care Oncology 2016 Annual Meeting. The median total survival for patients treated along 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. Based regard these outcomes the business expects to submit a Brand-new Drug Application (NDA) for VYXEOS along with the U.S. Meals and Drug Administration (FDA) later this year and submit a promotional Authorization Application (MAA) along with the European Medicines Company (EMA) in the very first quarter of 2017.
The stock is up 364.88% or $6.13 after the news, hitting $7.81 every share. Concerning 8.03M shares traded wrists or 1690.28% up from the average. Celator Pharmaceuticals Inc (NASDAQ:CPXX) has actually declined 33.19% due to the fact that August 6, 2015 and is downtrending. It has actually underperformed by 30.24% the S&P500.
Celator Pharmaceuticals, Inc., a Health care phase biopharmaceutical company, establishes treatments to address cancer. Its proprietary drug ratio technology platform, CombiPlex, allows for the rational make and rapid evaluation of optimized combinations incorporating traditional chemotherapies, too as molecularly targeted reps to deliver increased anti-cancer activity. The companyÂ’s product pipeline entails CPX-351, a liposomal formulation of cytarabine:daunorubicin, which joins Stage III study for the therapy of acute myeloid leukemia; and CPX-1, a liposomal formulation of irinotecan:floxuridine that has actually completed Stage II study for the therapy of colorectal cancer. Its preclinical phase product candidate is CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation for vitro and vivo studies. The business was founded in 1999 and is headquartered in Ewing, Brand-new Jersey.
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