ZELTIA SA 
By Stage 1 of Phase 3 study completed
Stage 2 of Phase 3 study will enrol additional 190 patients
Madrid, 18th December: The Independent Data Monitoring Committee (IDMC) has notified PharmaMar, a biopharmaceutical subsidiary of Grupo Zeltia (ZEL.MC), that it recommends completion of the on-going Phase 3 trial of Aplidin® (ADMYRE) in patients with relapsed/refractory multiple myeloma. The two-stage, 2:1 randomized Phase 3 study is evaluating Aplidin® in combination with dexamethasone versus dexamethasone alone. The IDMC recommendation follows a comprehensive analysis of efficacy and safety data from the 60 patients required in the first stage of the Phase 3 trial in which the study comfortably met the established efficacy threshold.
PharmaMar will enroll an additional 190 patients in the second stage of the Phase 3 trial. The number of centers initially planned will be doubled in order to accelerate the recruitment process. The Primary endpoint of the phase 3 study is a 60% improvement in progression free survival. Enrollment of Stage 2 of this phase 3 is anticipated to begin in Q12013.
About Aplidin®
Aplidin® is an antitumour agent of marine origin, originally isolated from the marine tunicate Aplidiumalbicans, and currently obtained by chemical synthesis. Aplidin® is PharmaMar's second most advanced compound. It is currently in phase II clinical trials for solid and haematological malignant neoplasias like T cell lymphoma and in phase III clinical trials for multiple myeloma. Aplidin® has been designated an orphan drug by the European Commission (EC) and the FDA for multiple myeloma (MM).
About PharmaMar
PharmaMar is a biopharmaceutical subsidiary of Grupo Zeltia; it is a world leader in discovering, developing and selling marine-based drugs to treat cancer. Yondelis® is Spain's first antitumour drug. It is currently approved for soft tissue sarcoma (STS) in 39 countries outside the EEA, and for platinum- sensitive relapsed ovarian cancer (ROC) in 25 of those countries plus Brazil. Yondelis® is approved for STS and platinum-sensitive ROC in all 30 countries of the EEA. Yondelis® is also undergoing Phase II trials on breast and paediatric cancers. PharmaMar has four other compounds in clinical development:
Aplidin®, Zalypsis®, PM01183 and PM060184. PharmaMar also has a rich pipeline of pre-clinical candidates and a major R&D programme
About Zeltia
Zeltia S.A. is a world-leading biopharmaceutical company specialised in the development of marine- based drugs for use in oncology and central nervous system illnesses. Grupo Zeltia consists mainly of the following companies: PharmaMar, the world-leading biotechnology company in advancing cancer care through the discovery and development of innovative marine-derived medicines; Noscira, a biotech firm focused on discovering and developing new drugs against Alzheimer's disease and other neurodegenerative diseases of the central nervous system; Genomica, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical division comprising Zelnova and Xylazel, two highly profitable companies that are leaders in their respective market segments.
Important note
PharmaMar, which is headquartered in Madrid (Spain), is a subsidiary of Zeltia, S.A. (Spanish stock exchange: ZEL), which has been listed on the Spanish Stock Exchange since 1963 and on Spain's Electronic Market since 1998. 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.
For more information +34 91 444 4500
This note is also available on the PharmaMar web site:www.pharmamar.comand atZeltia's website:
www.zeltia.com
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