The Phase III Clinical Trial Using PM1183 in Treating Ovarian Cancer (CORAIL) Continues Following the IDMC's Positive Recommendation
MADRID, February 8, 2016 /PRNewswire/ --
PharmaMar (MSE:PHM) has today announced that the Independent Data Monitoring Committee (IDMC) has notified the company that they recommend continuing, without changes, the phase III clinical trial (CORAIL) currently being carried out using PM1183 on platinum-resistant ovarian cancer patients.
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The recommendation by the IDMC follows analysis of the data obtained from the first 80 patients treated as part of the clinical trial. The pivotal, randomized phase III trial is evaluating the effectiveness of PM1183 compared to standard therapies for this illness, Topotecan or Pegylated liposomal doxorubicin (PLD), in a total of 420 patients.
About PM1183 (lurbinectedin)
PM1183 is an investigational drug from the class of inhibitors of the enzyme RNA polymerase II, which is crucially involved in transcription. By targeting transcription, the drug inhibits the expression of factors important for tumor progression, and impairs the DNA repair system called NER, thereby enhancing tumor cell killing. PM1183 (lurbinectedin) is currently being investigated in different tumor types, including a Phase 3 study for platinum-resistant ovarian cancer, a Phase 2 study for BRCA1/2-associated metastatic breast cancer and a Phase 1b study for small cell lung cancer.
About PharmaMar
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has other three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium and the United States. PharmaMar fully owns other companies: GENOMICA, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
Contact: Media Relations (+34-638-79-62-15) and Investor Relations (+34-914444500)
SOURCE PharmaMar
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