PharmaMar (MSE:PHM) today announced the start of a multicenter, prospective, pivotal study to analyze the efficacy of the antitumoral compound of marine origin, plitidepsin in patients with relapsed and refractory angioimmunoblastic T-cell lymphoma. As this is classified as a rare disease, and in consultation with the US Food and Drug Administration (FDA), the study has been designed with only one study arm.
The primary objective is to analyze the efficacy of plitidepsin in terms of overall response rate, to be evaluated by an independent committee following the Lugano classification response criteria. The secondary endpoint will be to evaluate other efficacy parameters such as duration of response, progression free survival and overall survival; the pharmacokinetic characteristics, the safety profile of plitidepsina and the identification of possible biomarkers that help to identify the predictive activity of the compound.
"This pivotal clinical trial will include 60 patients from approximately 25 investigative sites", stated Dr Arturo Soto, Director of Clinical Development at PharmaMar´s Oncology Unit. "After the recent announcement of the positive results obtained with plitidepsin in patients with multiple myeloma, we are continuing with the development of this molecule in other hematological tumors such as angioimmunoblastic T-cell lymphoma".