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2004 DEC 2 - (NewsRx.com & NewsRx.net) -- PharmaMar presented new data from its two lead drugs, Yondelis and Aplidin, at the 29th European Society for Medical Oncology Congress (ESMO) held in Vienna, Austria.
Data from two separate studies in patients with solid tumors using Yondelis in combination with the chemotherapy drugs Doxil/Caelyx and carboplatin were presented. The combination of Yondelis with Doxil was shown to be safe and feasible. These trials form the basis for the future development of Yondelis in ovarian cancer as well as in other tumors.
New data was also presented from the preliminary results of a phase II study in Aplidin, which demonstrated evidence of Aplidin's activity in patients with advanced or metastatic melanoma.
The phase I study of Yondelis in combination with Doxil indicates that the combination of Yondelis plus Doxil/Caelyx is well tolerated and feasible, thus allowing the delivery of therapeutic doses of both compounds. Partial responses (reductions in tumor sizes) were observed in patients with ovarian and head and neck cancers as well as in soft tissue sarcomas.
The phase I combination study of Yondelis and carboplatin in advanced solid tumors study's goal of this study is to determine the recommended dose of Yondelis in combination with carboplatin. Preliminary evidence of antitumoral activity has been observed in this trial, although additional clinical research is ongoing.
The preliminary results of a phase II study of Aplidin as a second line therapy in patients with advanced or metastatic melanoma concluded that Aplidin showed activity as a single agent against melanoma in patients previously treated, with an acceptable safety profile. Dr Timothy Eisen, study investigator, concludes that further development of Aplidin in this disease is warranted.
In addition to these presentations of new data, previously reported data were also presented at ESMO, including Yondelis combinations with two other chemotherapy drugs, cisplatin and paclitaxel, a compassionate use programme in Italy, and a pharmacogenomics study on Yondelis.