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Zeltia S.A.. (7/23/14). "Press Release: PharmaMar Initiates a Phase I Study with Aplidin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma". Madrid.

Organisations Organisation PharmaMar S.A. (MSE: PHM)
  Group PharmaMar (Group)
  Organisation 2 Chugai Pharmaceutical Co., Ltd.
  Group Roche (Group)
Products Product Aplidin®
  Product 2 clinical research
     


Zeltia (Grupo Zeltia, ZEL.MC) announce today that its oncology subsidiary, PharmaMar SA, has initiated of a Phase I clinical trial with Aplidin® (plitidepsin) in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.

The primary endpoint of this trial is to determine the recommended dose of Aplidin® in combination with bortezomib and dexamethasone and to evaluate the efficacy of the combination in patients with multiple myeloma.

The trial will be conducted in 6 centres in Spain and France and will recruit 30 patients.

Once the trial appropriate dose is determined, an expansion cohort is planned in order to assess the efficacy of Aplidin® for this indication in early stages of treatment.

This trial is part of the company's strategy for the development of Aplidin® as an earlier treatment option for patients with multiple myeloma. The compound is also currently being evaluated in an ongoing Phase III trial for patients with multiple myeloma after the third line of treatment.


About Aplidin®

Aplidin® is an antitumour agent of marine origin, originally isolated from the marine tunicate Aplidium albicans, 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 Food and Drug Administration (FDA) for multiple myeloma (MM). Aplidin® is licensed to Chugai Pharmaceutical for copromotion in Europe.


About PharmaMar

PharmaMar is a biopharmaceutical subsidiary of Grupo Zeltia; it is a world leader in discovering, developing and marketing marine-based drugs to treat cancer. Yondelis® is the first marine-based antitumour drug. PharmaMar has three other compounds in clinical development: Aplidin®, 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 marinebased drugs for use in oncology. 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; Genómica, Spain's leading company in molecular diagnostics based on DNA analysis; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi).


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, contact Grupo Zeltia's Corporate Communications department on +34 91 444 4500.

This note is also available on the PharmaMar web site: www.pharmamar.com and at Zeltia's website:
www.zeltia.com

   
Record changed: 2019-06-09

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