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- Aplidin(R) is PharmaMar’s second most advanced compound in clinical development
- Preliminary results from Phase II studies in patients with Peripheral T-cell Lymphoma presented at the 50th congress of the American Society of Hematology (ASH) have shown excellent results, with a response rate of 27%.
- Aplidin(R) is a new antitumoral agent discovered in the Mediterranean tunicate Aplidium albicans, currently obtained by chemical synthesis
Madrid, Spain | January 15, 2009 | PharmaMar, a biotechnology company of the Zeltia Group, announces the extension of Phar II trial with Aplidin® (plitidepsin), a novel antitumoral compound of marine origin, after the excellent preliminary results obtained in a Phase II trial.
Aplidin®, currently obtained by chemical synthesis, is PharmaMar’s second most advanced compound in clinical development. Aplidin is being evaluated in preclinical studies and Phase II clinical trials in hematological and solid tumors in Europe and the United States.
Preliminary results confirmed the activity of Aplidin® against Peripheral T-Cell Lymphoma in a multicenter trial with 17 patients. During the study, prolonged remissions of the disease were observed, with a response rate of 27%. The toxicity of the drug was not relevant.
In face of the excellent results obtained, PharmaMar has increased the number of patients participating in this trial for this indication. Also, the new design of the study involves the participation of new eight European and American hospitals.
About Aplidin®
Aplidin® (plitidepsin) is a new anti-tumor agent discovered in the Mediterranean tunicate aplidium albicans and currently obtained by chemical synthesis. Aplidin is the second most advanced compound in clinical development of PharmaMar. Aplidin induces apoptosis rapidly and persistently, secretion of vascular endothelial growth factor 1 (VEGF1) and blocks the cell cycle. Aplidin is being evaluated in preclinical studies and Phase II clinical trials in hematological and solid tumors in Europe and the United States. Clinical data have shown antitumor activity in multiple myeloma, renal cancer, and aggressive lymphomas. Since the end of 2005, studies of Aplidin® in combination with other antitumoral drugs are ongoing, as a basis for prospective phase III registration studies.
PharmaMar
PharmaMar is the world-leading biopharmaceutical company of the Zeltia Group, committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines. Yondelis® is the first Spanish antitumoral compound, currently marketed in the European Union for the treatment of soft tissue sarcomas in adults after the failure of standard therapy. Last December 4th, 2008 PharmaMar submitted a Registration Dossier of Yondelis® in relapsed ovarian cancer (ROC) to the EMEA. A decision on the approval for this indication is expected to take place by mid-2009. PharmaMar has four novel compounds in clinical development: Yondelis® is also in Phase II studies in prostate, breast and pediatric cancers. Aplidin ®, Zalypsis ®, and Irvalec ® are new marine-derived agents in clinical development. PharmaMar also has an extensive portfolio of products in preclinical research and a sound R&D program.
Important note
PharmaMar, based in Madrid, Spain, is a company of the Zeltia Group (Spanish Stock Exchange, ZEL) that has been listed on the Spanish Stock Exchange since 1963. This document is a press release, not a brochure. This document does not constitute nor is it part of any offer or invitation to sell or issue any application of purchase, offer, or shares subscription of the Group. Likewise, this document nor its distribution is part or can be of base for any contract or investment decision and does not constitute any kind of recommendation in relation with the shares of the Company.
SOURCE: PharmaMar |
