Close
Close
Treatment News

PharmaMar Announces the Start of a Pivotal Study With plitidepsin in angioimmunoblastic T-cell lymphoma

3.0
3.2 from 10 votes
Tuesday, June 14, 2016

Learn more about:

Access Programs

MADRID - PharmaMar (MCE: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."

Contact
Media Relations: 638-79-62-15
Investor Relations: 914444500

Source: PharmaMar
3.0
3.2 from 10 votes
Free Newsletter
Trending News
Related Videos