PharmaMar Initiates a Phase III Registration Trial with Aplidin(R) in Multiple Myeloma Patients
MADRID, June 8 PharmaMar SA (Grupo Zeltia, ZEL.MC) today announced that a registration trial in relapsed/refractory multiple myeloma patients has been initiated with Aplidin(R) (plitidepsin) in combination with dexamethasone versus dexamethasone alone.
This pivotal, international, multicenter Phase III clinical trial, called ADMYRE, will enroll 300 patients in 60 medical centers across 20 countries (including the U.S., Europe, Asia and South America), with an estimated recruitment period of 24 months. The primary objective of ADMYRE is Progression Free Survival (PFS).
Aplidin(R) is an anti-tumor agent originally isolated from the Mediterranean tunicate Aplidium albicans and currently obtained by chemical synthesis. Aplidin(R) is the second most advanced compound in clinical development at 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(R) is Spain's first anti-cancer drug. It is currently approved for soft tissue sarcoma (STS) in 25 countries outside the EEA, and in 5 of those countries for platinum-sensitive recurrent ovarian cancer (ROC) as well. Yondelis(R) 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(R) are also under way on prostate, breast, lung and pediatric cancers. PharmaMar has four other compounds in clinical development: Aplidin(R), Irvalec(R), Zalypsis(R) and PM01183. PharmaMar also has a rich pipeline of pre-clinical candidates and a major R&D program.
Zeltia S.A. is a world-leading biopharmaceutical company specialized 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 central nervous system diseases; 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.
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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