PharmaMar completes the patient recruitment for the Phase 3 pivotal study with PM1183

October 18, 2016

PharmaMar (MSE:PHM) announces today that the patient recruitment for the randomized and pivotal Phase III "CORAIL" study with lurbinectedin (PM1183), for the treatment of platinum-resistant ovarian cancer, has been successfully completed. Four hundred and forty-three patients from more than 100 hospitals from Europe and USA were included in the study.

The "CORAIL" study evaluates the efficacy of PM1183 in comparison with topotecan or pegilated lyposomal doxorrubicin, standard of care for this pathology. As Dr Arturo Soto, Director of the Clinical Department of PharmaMar´s Oncology Business Unit, explains "the study has been completed three months ahead of schedule, which reflects the interest in the drug and in the study and also a necessity by the investigators for a new therapeutic alternative for these patients".

About lurbinectedin (PM1183)

PM1183 is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including this Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a pivotal Phase III study for small cell lung cancer.

About ovarian cancer

It is estimated that about 240,000 cases will be diagnosed worldwide and about 150,000 women will die of ovarian cancer. Among gynaecological malignancies, it is the second most common cancer and the one causing more deaths . Most patients with ovarian cancer have late-stage disease, in which the cancer has spread, at the moment of diagnosis . Debulking surgery to remove most of the tumor is usually followed by chemotherapy; however, about 80% of women will relapse after treatment with platinum or a taxane and they may benefit from other therapeutic alternatives .
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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 three other 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.

Bibliography

iii Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on 15 April 2015.

ivhttp://www.cancer.org/cancer/ovariancancer/

v Ann Oncol (2013) 24 (suppl 10):x69-x76.doi: 10.1093/annonc/mdt475

Pharmamar

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