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PharmaMar S.A.. (5/18/17). "Press Release: PharmaMar Announces New Data with Its Compounds Yondelis and Lurbinectedin during ASCO 2017". Madrid.

Organisations Organisation PharmaMar S.A. (MSE: PHM)
  Group PharmaMar (Group)
  Organisation 2 American Society of Clinical Oncology (ASCO)
Products Product ASCO 2017 Chicago
  Product 2 Yondelis®
Persons Person Soto, Arturo (Zeltia 201506 Director Clinical Development at PharmaMar)
  Person 2 Ortín, Alfonso (PharmaMar 201705 Communications Director)
     


> After the positive results obtained in endometrial cancer with lurbinectedin, PharmaMar plan to initiate a pivotal Phase III study

> The Company has the agreement of the study design in accordance with the FDA


PharmaMar (MSE:PHM) will present data obtained from various clinical studies for its activated transcription inhibitors, Yondelis® and lurbinectedin, during the 53rd Congress of the American Society of Clinical Oncology (ASCO) that will be held from the 2nd to the 6th of June in Chicago (USA).

During this congress, PharmaMar will participate with various presentations for Yondelis® in malignant pleural mesothelioma, along with the data of a prospective study of the combination with radiotherapy in soft tissue sarcoma.

The Company will also present data for lurbinectedin (PM1183) for the treatment of endometrial cancer and BRCA 2-associated metastatic breast cancer. The results will also be presented on a Phase I study that evaluated the combination of lurbinectedin with olaparib in patients with advanced solid tumors.

“After the positive results obtained in endometrial cancer with lurbinectedin, as a single agent and in combination with doxorubicin (abstract 6658), we plan to initiate a pivotal Phase III study. We have reached an agreement with the US FDA on the design of the study”, explains Dr Arturo Soto, Head of Clinical Development at the Oncology Business Unit at PharmaMar. “We will continue with our commitment to finding innovative solutions for cancer patients from compounds of a marine origin that have the characteristic for combating cancer with a novel mechanism of action”, states.

The studies presented during this congress are available on http://abstracts.asco.org


Principle studies to be presented at ASCO 2017

Lurbinectedin

> Activity of lurbinectedin (PM01183) as single agent and in combination in patients with endometrial cancer. (Abstract 5586)
Poster Board: #408. Saturday 3 of June from 13:15 to 16:45. Hall A
Lead author: Martin David Forster, MBBS, MRCP, FRCP, PhD, University College London Hospitals

> Antitumor activity of trabectedin and lurbinectedin in germline BRCA2 carriers with metastatic breast cancer (MBC) as compared to BRCA1 carriers: Analysis of two phase II trials. (Abstract 574)
Poster Board: #174. Sunday, 4 of June from 8:30 to 11:30. Hall A
Lead author: Judith Balmana Gelpi, MD PhD, Hospital Vall d’Hebron

> Phase I study to evaluate the tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of PM01183 (Lurbinectedin) in combination with olaparib in patients with advanced solid tumors. (Abstract 5573)
Poster Board: #395. Saturday, 3 of June from 13:15 to 16:45. Hall A
Lead autjor: Andres Poveda, MD, Clinical Area of Gynecologic Oncology, Instituto Valenciano de Oncología (IVO)

Yondelis® (trabectedin)

> Trabectedin (T) as second line treatment option for patients with epithelioid malignant pleural mesothelioma (MPM) in progression following pemetrexed/platin-derivates chemotherapy: ATREUS trial. (Abstract 8513)
Poster Board: #249. Saturday, 3 of June from 13:15 to 14:30. Hall D2
Laed author: Diego Luigi Cortinovis, MD, Azienda Ospedaliera San Gerardo

> Trabectedin for advanced soft tissue sarcoma: Ten-year real-life perspective. (Abstract 11060)
Poster Board: #383. Sunday, 4 of June from 8:00 to 11:30. Hall A
Lead author: Sivan Shamai, MD, Tel Aviv Medical Center and Sackler School of Medicine

> Trabectedin and radiotherapy in soft-tissue sarcoma (TRASTS) study: An international, prospective, phase I/II trial—A collaborative Spanish (GEIS), Italian (ISG), and French (FSG) groups study. (Abstract 11061)
Poster Board: #384. Sunday, 4 of June from 8:00 to 11:30. Hall A
Laed author: Alessandro Gronchi, MD, Fondazione IRCCS Istituto Nazionale dei Tumori

> Correlation between a new growth modulation index (GMI)-based Geistra score and efficacy outcomes in patients (PTS) with advanced soft tissue sarcomas (ASTS) treated with trabectedin (T): A Spanish group for research on sarcomas (GEIS-38 study). (Abstract 11070)
Poster Board: #393. Sunday, 4 of June from 8:00 to 11:30. Hall A
Laed author: Javier Martinez-Trufero, PhD, Hospital Miguel Servet

> Predictive role of FAS for trabectedin in second lines of advanced soft tissue sarcoma (ASTS): A Spanish group for research on sarcoma (GEIS) study. (Abstract 11071)
Poster Board: #394. Sunday, 4 of June from 8:00 to 11:30. Hall A
Laed author: Javier Martin Broto, MD, PhD, Virgen del Rocio University Hospital, Institute of Biomedicine Research (IBIS)


About YONDELIS® (trabectedin)

YONDELIS® (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights
4
to develop and sell YONDELIS® globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.


About lurbinectedin

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 a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III 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 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, Austria 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 www.pharmamar.com.


Disclaimer

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.


Media Contact:
Alfonso Ortín – Communications Director aortin@pharmamar.com Mobile: + 34609493127
Paula Fernández – Media Relations Manager pfalarcon@pharmamar.com Mobile: +34 638796215
Phone: +34 918466000

Investor Relations:
Phone: +34 914444500
Or please visit our website at www.pharmamar.com

   
Record changed: 2017-05-26

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