PharmaMar announces new advances in oncology at ASCO 2015 for compounds YONDELIS® and PM1183

2015-05-14

(Press-News.org) This news release is available in Spanish.

Compelling clinical activity of PM1183 in second line, achieving 67% response rate and a progression-free survival of 4.7 months in patients with small cell lung cancer (SCLC), a type of tumor with very limited treatment alternatives

Data from an interim analysis from the pivotal Phase 3 trial of YONDELIS® in soft tissue sarcoma, SAR-3007, will be presented in an oral presentation

Phase 2 data showcase activity of YONDELIS® in malignant pleural mesothelioma, a rare form of lung cancer that is largely related to asbestos exposure and for which effective therapies are lacking

Madrid, May 14, 2015: PharmaMar announces that it will present several clinical studies to showcase the data obtained in various tumor types, including SCLC, soft tissue sarcoma and mesothelioma during the 51st American Society of Clinical Oncology meeting in Chicago (ASCO; May 29-June 2). Abstracts have been selected for oral presentation, poster discussion session and general poster presentation. The studies presented by the Company will include the first-in-class drug YONDELIS® (trabectedin), and the second-generation of this class, PM1183 (lurbinectedin). PM1183 is an inhibitor of the transcriptional machinery and a DNA repair complex, which have proven to be crucial in different tumor types, including SCLC, soft tissue sarcoma and ovarian cancer. In addition, these drugs have been shown to have an effect on the tumor microenvironment by targeting tumor-associated macrophages, which is relevant for cancers such as mesothelioma and ovarian cancer, in which chronic inflammation seems to be a hallmark of the disease.

"PharmaMar continues to advance cancer care through the development of innovative anticancer drugs that target tumors in a way that no one is doing. We are identifying new ways to tackle the root of the disease, and our new class of drugs shows efficacy even in difficult-to-treat tumors, such as small cell lung cancer, mesothelioma and soft tissue sarcoma", says Nadia Badri, MD, VP Medical Affairs, PharmaMar. "The events that will take place this year are crucial for PharmaMar as we move forward in the oncology arena, and this forum is the perfect scenario to feature our clinical programs"

Meeting abstracts are available at http://abstracts.asco.org/

Studies highlighted at ASCO 2015

YONDELIS® (trabectedin) Interim data for trabectedin in soft tissue sarcoma, as well as clinical results in mesothelioma will be presented in 4 studies in oral and poster presentations.

SAR-3007: A Randomized Phase 3 Study of Trabectedin (T) or Dacarbazine (D) for the treatment of patients (pts) with Advanced Liposarcoma (LPS) or Leiomyosarcoma (LMS). (Abstract 10503) - sponsored by Janssen Products
Oral Abstract Session: Sarcoma Presentations (3:00 PM - 6:00 PM). Monday, Jun 1 at 4:00 PM - 4:12 PM at S504
Lead Author: George Demetri, MD et al. Dana-Farber Cancer Institute, Boston, MA, USA.

OVC-3006: A Phase 3 Study of Trabectedin (T) plus Pegylated Liposomal Doxorubicin (PLD) versus PLD for Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer. (Abstract TPS5606) - sponsored by Janssen Products
General Poster Session: Gynecologic Cancer. Saturday, May 30 from 1:15 PM - 4:45 PM at S Hall A Poster Board 163b
Lead Author: Robert L. Coleman, MD The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Activity and Safety of Trabectedin in Patients with Sarcomatoid/Biphasic Malignant Pleural Mesothelioma. (MPM) (Abstract 7561) - sponsored by MaNGO
General Poster Session: Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers. Monday, June 1 from 8:00 AM to 11:30 AM at S Hall A Poster Board 309
Lead Author: Diego Luigi Cortinovis, MD Università degli Studi di Milano-Bicocca, Monza, Italy.

Time to secondary resistance (TTSR) after rechallenge with trabectedin (T) in myxoid round cell liposarcoma (MRCLPS) patients. (Abstract #10566)
General Poster Session: Sarcoma. Sunday, May 31 from 8:00 AM to 11:30 AM at S Hall A Poster Board 210
Lead Author: Roberta Sanfilippo, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.

PM1183 (lurbinectedin) Two PharmaMar-sponsored studies will be featured at ASCO. Data from the clinical trial of PM1183 in SCLC will be further highlighted at a Poster Discussion Session that will be followed by time for networking with panelists.

Lurbinectedin (PM01183) with doxorubicin (DOX), an active treatment as second-line therapy in small cell lung cancer (SCLC). (Abstract #7509)
General Poster Session: Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers. Monday, June 1 from 8:00 AM to 11:30 AM at S Hall A Poster Board 256 This poster will be discussed at the Poster Discussion Session on Monday, June 1 from 1:15 PM - 2:30 PM at E Hall D2
Lead Author: Martin Forster, MD University College Hospital, London, UK.

A multicenter phase II basket clinical trial of lurbinectedin (PM01183) in selected advanced solid tumors. (Abstract #TPS2604)
General Poster Session: Trial in progress - developmental Therapeutics-Clinical Pharmacology and Experimental Therapeutics. Saturday, May 30 from 8:00 AM to 11:30 AM at Poster Board 318b
Lead Author: Mariano Provencio Pulla, MD PhD Hospital Universitario Puerta de Hierro, Madrid, Spain.

INFORMATION:

About YONDELIS® (trabectedin) YONDELIS® (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery. It is approved in 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). Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights 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 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 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.

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 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

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PharmaMar announces new advances in oncology at ASCO 2015 for compounds YONDELIS® and PM1183

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