Topotarget says belinostat pivotal trial meets primary endpoint

26 September 2012

Denmark’s Topotarget (Nasdaq OMX: TOPO) said that the primary endpoint has been met for the pivotal trial with its potential blockbuster cancer drug candidate belinostat for patients with peripheral T-cell lymphoma (PTCL), causing the company’s shares to rocket 135% to 2.42 Danish kroner.

The pivotal BELIEF study (PXD101-CLN-19) evaluating the efficacy and safety of belinostat for the treatment of patients with relapsed/refractory PTCL met its primary endpoint. A Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data from the trial are being further analyzed and are expected to be communicated during Q4 2012.

US biotechnology firm Spectrum Pharmaceuticals (Nasdaq: SPPI) licensed the rights to belinostat for North America and India, and an option for China, in exchange for an upfront cash payment of $30 million, potential milestone payments of up to $320 million (The Pharma Letter February 3, 2010).

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK