Analyst Research

Report Title Price
Provider: New Constructs, LLC
$25.00
Provider: Thomson Reuters Stock Report
$25.00
Provider: MacroRisk Analytics/EconomicInvestor
$25.00
Provider: Edison Investment Research
$10.00

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

Threshold Pharmaceuticals Inc And Merck KGaA's Merck Serono Announce Initiation Of TH-302 Phase 3 MAESTRO Study In Patients With Locally Advanced Or Metastatic Pancreatic Adenocarcinoma


Friday, 25 Jan 2013 04:00am EST 

Threshold Pharmaceuticals Inc announced that Threshold's partner Merck KGaA, Darmstadt, Germany, through its division Merck Serono, initiated the global Phase 3 MAESTRO study assessing the efficacy and safety of investigational hypoxia-targeted drug TH-302 in combination with gemcitabine in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma. The initiation of the Phase 3 MAESTRO study resulted in Threshold earning a $30 million payment from Merck KGaA pursuant to the terms of Threshold's license and co-development agreement with Merck KGaA, which includes an option for Threshold to co-commercialize in the U.S. MAESTRO stands for TH-302 in the treatment of MetastAtic or unrESectable pancreaTic adenocaRcinOma. MAESTRO is a randomized, placebo-controlled, international, multi-center, double-blind Phase 3 trial of TH-302 plus gemcitabine compared with placebo plus gemcitabine and is expected to enroll 660 patients. The primary efficacy endpoint is overall survival; the secondary endpoints include efficacy measured by progression-free survival (PFS), overall response rate and disease control rate, as well as assessments of safety and tolerability, pharmacokinetics and biomarkers. The study is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). 

Company Quote

2.9
-0.04 -1.36%
28 Nov 2014