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Press Release

PharmaMar Begins a Phase I Study of PM1183 in Japan for the Treatment of Solid Tumors

PharmaMar
Posted on: 29 Nov 16

MADRID, November 28, 2016 /PRNewswire/ --

PharmaMar (MCE:PHM) has announced the start of an open-label, multicenter, Phase I study in Japan to evaluate the recommended dose (RD) of PM1183 (lurbinectedin) in patients with certain types of unresectable/advanced solid tumors.

The main objective of the study is to determine the recommended dose of PM1183 in Japanese patients. Furthermore, the secondary objective will be to evaluate the safety profile, to obtain preliminary information on the antitumor activity along with pharmacokinetic characteristics of PM1183 in Japanese patients when compared to Caucasians.

The study population has to be patients born in Japan or descendants from both Japanese parents that suffer disease progression according to the Response Criteria in Solid Tumors (RECIST v1.1).

As Dr Arturo Soto, director of Clinical Development of PharmaMar's Oncology Business Unit, explains "Three clinical sites in Japan will participate in the trial; the number of patients that are to be included will depend on the tolerability and activity observed in PM1183 and the dose level required to identify the recommended dose in this population".

Contact:
Paula Fernández, Media Relations Manager
+34-638-79-62-15
pfalarcon@pharmamar.com

Investor Relations
+34-914444500

For more information:
www.prnewswire.com/news-releases/pharmamar-begins-a-phase-i-study-of-pm1183-in-japan-for-the-treatment-of-solid-tumors-603379626.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 29/11/2016

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