MADRID, Feb. 7, 2011 /PRNewswire/ -- PharmaMar SA (Grupo Zeltia, ZEL.MC) has announced the commencement of a Phase I clinical trial with PM060184 for patients with solid tumors. PM060184 is a marine-derived, synthetically-produced compound which has shown strong in vitro and in vivo antitumor activity and a favorable safety profile in preclinical toxicology studies. PM060184 is PharmaMar's sixth compound in clinical development.
The trials will be performed in hospitals in the U.S., and also in France and Spain. The primary endpoints of this Phase I trial are to identify the dose limiting toxicity (DLT), the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184.
Additionally, the drug's pharmacokinetic profile will be defined and a preliminary evaluation of its antitumor activity in patients will be performed.
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 antitumor drug. Yondelis® is currently approved for STS in 33 countries outside the EEA, and in 10 of those countries for platinum-sensitive ROC as well (including Brazil and Canada). 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 pediatric cancers. PharmaMar has five other compounds in clinical development: Aplidin®, Irvalec®, Zalypsis®, PM01183 and PM060184. 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 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.
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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