Pharmamar Completes Patient Recruitment Of Phase III Registration Trial (ADMYRE) With APLIDIN(Plitidepsin) In Multiple Myeloma
MADRID, June 1, 2015 /PRNewswire/ --
PharmaMar announced today that the patient recruitment for the pivotal Phase III trial of APLIDIN® (plitidepsin) for the treatment of multiple myeloma, denominated ADMYRE, has been successfully completed. The study, which originally planned to include 250 patients, has enrolled 255 patients in 71 medical centers worldwide, including the US, Europe, Asia, South America, Australia, and New Zealand. An application for marketing authorization in Europe is planned to be submitted in 2016.
(Logo: http://photos.prnewswire.com/prnh/20150203/727958-b )
(Logo: http://photos.prnewswire.com/prnh/20150203/727958-a )
ADMYRE is a prospective, pivotal, randomized (2:1), open-label, multicenter study that compares plitidepsin in combination with dexamethasone versus dexamethasone alone in patients who have relapsed or refractory multiple myeloma after at least three prior therapies, but no more than six. Patients must have previously received bortezomib and lenalidomide. In an interim analysis, the Independent Data Monitoring Committee (IDMC) recommended completion of the Phase III ADMYRE unmodified given that no safety issues were reported and the study comfortably met the established efficacy threshold upon evaluation of data from 60 evaluable patients.
In this registration trial, the primary endpoint is progression-free survival (PFS), which will be used to compare the efficacy of plitidepsin plus dexamethasone versus dexamethasone alone. Secondary endpoints will evaluate tumor response rate, duration of response and overall survival.
"Our compound represents a first-in-class drug in the therapeutic paradigm of multiple myeloma," said José María Fdez. Sousa-Faro, PhD, Chairman of PharmaMar. "We are on track now to bring this innovative therapeutic advance a step closer to these patients."
About PharmaMar
Headquartered in Madrid, PharmaMar is the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. YONDELIS® is the first anticancer drug of marine origin and is commercially available in 81 countries for the treatment of advanced soft tissue sarcomas as a single-agent, and for relapsed platinum-sensitive ovarian cancer in combination with DOXIL®/CAELYX®. PharmaMar develops and commercializes YONDELIS® in Europe and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
Media Inquiries:
Carolina Pola - Communications Director
Sara García - Media Relations
Phone: +34-91-444-45-00
Mobile: +34-608-93-36-77
Investor Relations:
Phone: +34-914444500
Or please visit our website at http://www.pharmamar.com and http://www.zeltia.com
SOURCE PharmaMar
Help employers find you! Check out all the jobs and post your resume.
PharmaMar announced today that the patient recruitment for the pivotal Phase III trial of APLIDIN® (plitidepsin) for the treatment of multiple myeloma, denominated ADMYRE, has been successfully completed. The study, which originally planned to include 250 patients, has enrolled 255 patients in 71 medical centers worldwide, including the US, Europe, Asia, South America, Australia, and New Zealand. An application for marketing authorization in Europe is planned to be submitted in 2016.
(Logo: http://photos.prnewswire.com/prnh/20150203/727958-b )
(Logo: http://photos.prnewswire.com/prnh/20150203/727958-a )
ADMYRE is a prospective, pivotal, randomized (2:1), open-label, multicenter study that compares plitidepsin in combination with dexamethasone versus dexamethasone alone in patients who have relapsed or refractory multiple myeloma after at least three prior therapies, but no more than six. Patients must have previously received bortezomib and lenalidomide. In an interim analysis, the Independent Data Monitoring Committee (IDMC) recommended completion of the Phase III ADMYRE unmodified given that no safety issues were reported and the study comfortably met the established efficacy threshold upon evaluation of data from 60 evaluable patients.
In this registration trial, the primary endpoint is progression-free survival (PFS), which will be used to compare the efficacy of plitidepsin plus dexamethasone versus dexamethasone alone. Secondary endpoints will evaluate tumor response rate, duration of response and overall survival.
"Our compound represents a first-in-class drug in the therapeutic paradigm of multiple myeloma," said José María Fdez. Sousa-Faro, PhD, Chairman of PharmaMar. "We are on track now to bring this innovative therapeutic advance a step closer to these patients."
About PharmaMar
Headquartered in Madrid, PharmaMar is the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. YONDELIS® is the first anticancer drug of marine origin and is commercially available in 81 countries for the treatment of advanced soft tissue sarcomas as a single-agent, and for relapsed platinum-sensitive ovarian cancer in combination with DOXIL®/CAELYX®. PharmaMar develops and commercializes YONDELIS® in Europe and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
Media Inquiries:
Carolina Pola - Communications Director
Sara García - Media Relations
Phone: +34-91-444-45-00
Mobile: +34-608-93-36-77
Investor Relations:
Phone: +34-914444500
Or please visit our website at http://www.pharmamar.com and http://www.zeltia.com
SOURCE PharmaMar
Help employers find you! Check out all the jobs and post your resume.