Madrid, 28 June 2010: PharmaMar SA (Grupo Zeltia, ZEL.MC) has announced the commencement of a Phase II clinical trial of Aplidin® (plitidepsin) on myelofibrosis patients at centres in the US and Italy.
The trial is designed in two parts. If a positive response is obtained, the company will consult with the competent authorities to convert it into a registration trial.
Myelofibrosis is a myeloproliferative syndrome for which only palliative treatment exists at present. The disease affects an estimated 1.5 out of every 100,000 people.
Aplidin® is an antitumour drug discovered in the Mediterranean tunicate Aplidium albicans and currently produced by chemical synthesis. It is the second most advanced drug in PharmaMar's clinical development pipeline. A pivotal Phase III trial is currently being conducted with Aplidin® on patients with recurrent multiple myeloma.
About PharmaMar
PharmaMar is Grupo Zeltia's biotechnology subsidiary; it is a world leader in discovering, developing and selling marine-based drugs to treat cancer. Yondelis® is Spain's first anti-cancer drug. It is currently approved for STS in 25 countries outside the EEA, and in 5 of those countries for platinum-sensitive ROC as well. Yondelis® is approved for STS and platinum-sensitive ROC in all 30 countries of the EEA; in Switzerland it is approved for STS. Phase II clinical trials with Yondelis® are also under way on prostate, breast, lung and paediatric cancers. PharmaMar has four other compounds in clinical development: Aplidin®, Irvalec®, Zalypsis® and PM01183. PharmaMar also has a rich pipeline of pre-clinical candidates and a major R&D programme.
Important note
PharmaMar, which is headquartered in Madrid (Spain), is a subsidiary of Grupo Zeltia (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.
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