French drugmaker BioAlliance Pharma (Euronext Paris: BIO) has announced the validation by the French drug agency the Afssaps of its application for a Phase I/II clinical trial with Amep in the metastatic melanoma, and the signing of a partnership agreement for the development of its biotherapy with the Department of Oncology of the Herlev Hospital of Copenhagen, Denmark.
Submitted end of January 2012, the Phase I/II clinical trial application follows the positive preliminary results of a first Phase I trial via local administration (intratumoral) in patients with metastatic melanoma. This Phase I/II trial, to be conducted on a European level, aims at evaluating the safety and efficacy profile of the Amep biotherapy via systemic route (intramuscular) in the same indication. The growing incidence of metastatic melanoma and the short survival duration of patients make this cancer a disease with a very strong therapeutic need.
Danish hospital to evaluate Amep in different solid tumors
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