News

Masitinib study misses endpoint
Enlarge image

Clinical trailsFrance

Masitinib study misses endpoint

01.11.2012 - French AB Science’s cancer drug Masitinib failed to improve overall survival in a Phase III study. But certain patient groups might benefit from the treatment.

The double-blind, international Phase III trial enrolled 348 patients with pancreatic cancer and compared masitinib plus Gemzar treatment with Gemzar treatment alone. There was no significant change in the overall survival time of the patients (7.7 vs. 7 months, p=0.74), said the French drugmaker. But in a subgroup of patients with an undisclosed genetic biomarker which is thought to be indicative of aggressive disease progression, the orally administered tyrosine kinase inhibitor masitinib plus Gemzar significantly improved median overall survival vs. placebo plus Gemzar (11 vs. 5 months, p=0.000038). In a second subgroup of patients with a pain intensity level above an undisclosed threshold at baseline, the orphan drug plus Gemzar also significantly improved median overall survival vs. placebo plus Gemzar (8.1 vs. 5.4 months, p=0.01). These two independent patient populations represented 65% and 45%, respectively, of the overall population, according to AB Science.

AB Science also announced that the European Medicines Agency (EMA) has accepted to review the Marketing Authorization Application (MAA) for conditional approval of masitinib in combination with Gemzar in the treatment of non-resectable, advanced adenocarcinoma pancreatic cancer „ on the basis of results from a Phase III study that showed masitinib in combination with Gemzar significantly extends overall survival in two independent patient populations having the worst prognosis.“ Masitinib targets the stem cell factor (SCF) receptor tyrosine kinase (CD117).

Masitinib has been available in Europe since the second part of 2009 as a treatment of mast cell tumors in animals (Masivet), specifically dogs. In the US it is distributed under the name Kinavet by AB Science and has been available for veterinaries since 2011.

© eurobiotechnews.eu/bk

http://www.european-biotechnology-news.com/news/news/2012-04/masitinib-study-misses-endpoint.html

2014EU

19.12.2014 We took a look back at 2014: which European Biotechnology News stories topped the charts this year?

R&DEUBelgium

18.12.2014 IMI has launched a €115m call for proposals involving a project in collaboration with the Bill and Melinda Gates Foundation to improve vaccines against whopping cough in children.

PoliticsEUPolandItalySpainUK

16.12.2014 Two consortia combined of 144 European companies, research institutes and universities have been selected for funding by the EIT in the areas of health and raw materials. Both clusters are set to acquire €1.1bn over the next seven years.

M&ALuxembourg

11.12.2014 Luxembourg bio-analytical testing company Eurofins Scientific has signed an agreement to acquire Boston Heart Diagnostics Corp. for an initial €112m.

StudySwitzerlandEU

10.12.2014 When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.

FinancingUKSpain

09.12.2014 British drug delivery specialist Midatech Pharma plc floated on the London stock market. It is the third biotech IPO on the AIM market this year.

CooperationAustria

05.12.2014 Austrian contract research company VTU has entered into a development and commercialisation agreement with US company RCT. The partners want to combine both companies' Pichia pastoris protein production technologies under VTU's roof.

FinancingDenmark

03.12.2014 Danish biotech pharma Ascendis has successfully completed a €48m Series D financing round. The funding is expected to support its late-stage clinical trials to push its lead drug into Phase III trials.

Events

All Events

Current issue

All issues

Product of the week

Products