"Celator Pharmaceuticals Inc. Nasdaq CPXX httpstudio.financialcontent.comprnewsPageQuoteTickerCPXX today announced positive results from the Phase  trial of VYXEOS cytarabine daunorubicin Liposome for Injection also known as CPX in patients with highrisk secondary acute myeloid leukemia AML compared to the standard of care regimen of cytarabine and daunorubicin known as . 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  Annual Meeting. The median overall survival for patients treated with VYXEOS in the study was . months compared to . months for patients receiving  representing a . month improvement in favor of VYXEOS.  The hazard ratio HR was . p. which represents a  percent reduction in the risk of death versus .   The percentage of patients alive  months after randomization was . on the VYXEOS arm compared to . on the  arm.  The percentage of patients alive  months after randomization was . on the VYXEOS arm compared to . on the  arm. The overall survival advantage seen with CPX compared to  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 LeukemiaMyelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study. This represents a major step forward for a very difficulttotreat patient population. VYXEOS also demonstrated a statistically significant improvement in induction response rate CRCRi of . versus . p. and this significance was maintained for the analysis of CR alone CR of . versus . p..   Sixtyday allcause mortality was . versus . in favor of patients treated with VYXEOS.  No substantial difference in Grade  or higher adverse events was observed between VYXEOS and . In the intenttotreat population Grade  or higher hematologic adverse events were similar for overall infections febrile neutropenia and bleeding events. In the intenttotreat population Grade  or higher nonhematologic 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 highrisk 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 YorkPresbyterian 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 .   The successful outcome of this Phase  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.  The clinical trial was conducted in partnership with The Leukemia  Lymphoma Society http LLS through its Therapy Acceleration Program TAP which has supported the clinical development of VYXEOS beginning in Phase . Conference Call Information Celator will host a conference call and live audio webcast on Tuesday March   at am EDT to discuss the results of the Phase  trial. To participate in the conference call please dial  domestic or  international and refer to conference ID . The live webcast of the call can be accessed in the Investors section of Celators website at  http An archived webcast will be available on Celators website beginning approximately two hours after the event. About VYXEOS VYXEOS cytarabinedaunorubicin Liposome for Injection also known as CPX is a nanoscale coformulation of cytarabine and daunorubicin at a synergistic  molar ration.  VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic antitumor activity are encapsulated in a nanoscale liposome in order to maintain the desired ratio following administration. VYXEOS was granted orphan drug status by the FDA and the European Commission for the treatment of acute myeloid leukemia AML.  VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML.  In addition to the Phase  trial Celator published results from two randomized controlled Phase  trials with VYXEOS. The first trial was conducted in newly diagnosed elderly AML patients and the second trial was conducted in patients with AML in first relapse.  Phase  Trial Design The randomized controlled Phase  trial Protocol NCT httpclinicaltrials.govctshowNCT enrolled  patients at  sites in the United States and Canada and compared VYXEOS to the conventional cytarabine and daunorubicin treatment regimen commonly referred to as  as firstline therapy in older  years of age patients with highrisk secondary AML. Patients were stratified for age  to  and  to  years of age and AML type treatmentrelated AML AML with documented history of MDS with prior treatment with hypomethylating agent therapy AML with documented history of MDS without prior hypomethlyating agent therapy AML with a documented history of chronic myelomonocytic leukemia CMMoL and de novo AML with a karyotype characteristic of myelodysplastic syndrome MDS.  Patients were randomized  to receive either VYXEOS or .  Patients could receive one or two inductions and responding patients could receive one or two consolidations.  First induction for VYXEOS was um days   and  by minute infusion and for the control arm was cytarabine mgmday by continuous infusion for  days and daunorubicin mgm on days   and  . Second induction for VYXEOStreated patients was um on days  and  and the control arm was cytarabine mgmday by continuous infusion for  days and daunorubicin mgm on days  and  .   Only patients with documented CR or CRi were eligible to receive chemotherapy consolidation.  Consolidation for VYXEOStreated patients was um on days  and  and the control arm was cytarabine mgmday by continuous infusion for  days and daunorubicin mgm on days  and  . About AML Acute myeloid leukemia AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. AML is generally a disease of older adults and the median age of a patient diagnosed with AML is about  years. The American Cancer Society estimates that there will be  new cases of AML and  deaths from AML in the U.S. in .  In Europe the number of new cases is estimated to be  and in Japan the number is . The Company estimates that nearly  percent of AML patients are over the age of  and approximately  percent are intermediate or high risk.  Furthermore approximately half of those patients are considered suitable for intensive treatment.   Even with current treatment overall survival for AML is poor.  In patients over  years of age the  year survival rate is less than .  In highrisk secondary AML overall survival is lower resulting in an acute need for new treatment options for these patients. About Celator Pharmaceuticals Inc. Celator Pharmaceuticals Inc. with locations in Ewing N.J. and Vancouver B.C. is an oncologyfocused biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer. Celators proprietary technology platform CombiPlex enables the rational design and rapid evaluation of optimized combinations of anticancer drugs incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anticancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens as well as the challenges inherent in combination drug development by identifying the most effective synergistic molar ratio of the drugs being combined in vitro and fixing this ratio in a nanoscale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor. Celators pipeline includes the lead product VYXEOS also known as CPX a nanoscale liposomal formulation of cytarabinedaunorubicin being studied for the treatment of acute myeloid leukemia CPX a nanoscale liposomal formulation of irinotecanfloxuridine studied in colorectal cancer and a preclinical stage product candidate CPX a hydrophobic docetaxel prodrug nanoparticle formulation. The Company is advancing its CombiPlex platform and broadening its application to include molecularly targeted therapies. The Company is seeking research and development collaborations with other biotechnologypharmaceutical companies where its proprietary technology may provide benefit. For more information please visit Celators website at  http Information on ongoing trials is available at  http ForwardLooking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator they are forwardlooking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of . Words such as may will expect anticipate estimate intend and similar expressions as well as other words or expressions referencing future events conditions or circumstances are intended to identify forwardlooking statements. Examples of forwardlooking statements contained in this press release include among others statements regarding the safety potential efficacy therapeutic potential and commercial potential of VYXEOS also known as CPX our expectations regarding the timing of our regulatory filings our expectations regarding our research and development programs and advancing our CombiPlex platform and the potential to establish research and development collaborations applying our proprietary technologies with other biotechnologypharmaceutical companies. Forwardlooking statements in this release involve substantial risks and uncertainties that could cause our development programs future results or achievements to differ significantly from those expressed or implied by the forwardlooking statements. Such risks and uncertainties include among others the uncertainties inherent in the conduct of clinical studies whether clinical study results obtained to date will be predictive of future results whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates. Celator undertakes no obligation to update or revise any forwardlooking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forwardlooking statements as well as risks relating to the business of the company in general see Celators Form K for the year ended December   subsequent reports on Form Q and K and other filings by the company with the U.S. Securities and Exchange Commission. Related Links http"