BC Extra | Jun 26, 2019
Company News

June 26 Company Quick Takes: Dupixent approved for nasal polyps; plus Ono/Rafael, Oxford/Santen and more

FDA approves Regeneron's Dupixent in nasal polyps  FDA approved Dupixent dupilumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat chronic rhinosinusitis with nasal polyps. Dupixent is the first drug approved for the indication (see "Phase III...
BC Week In Review | Apr 7, 2017
Clinical News

CPI-613 regulatory update

Based on an end-of-Phase I meeting with FDA, Cornerstone said it plans to advance lead candidate CPI-613 directly from Phase I testing into pivotal trials. This year, the company plans to start 2 pivotal trials...
BioCentury | Mar 25, 2017
Product Development

Pivotal meeting

Cornerstone Pharmaceuticals Inc. was planning a traditional development pathway for CPI-613 in acute myelogenous leukemia and pancreatic cancer, but FDA nudged the company to go from Phase I to pivotal trials for both indications. According...
BC Extra | Mar 23, 2017
Company News

Cornerstone to start pivotal trials in AML, pancreatic cancer

Cornerstone Pharmaceuticals Inc. (Cranbury, N.J.) plans to start two pivotal studies this year of lead candidate CPI-613 to treat relapsed/refractory acute myelogenous leukemia (AML) patients aged 60 and older and stage IV pancreatic cancer patients....
BC Week In Review | Feb 8, 2016
Clinical News

CPI-613: Phase I data

An open-label, dose-escalation, U.S. Phase I trial in 20 patients with metastatic stage IV pancreatic adenocarcinoma showed that IV CPI-613 on days 1 and 3 of each 2-week cycle plus modified fluorouracil, leucovorin, irinotecan and...
BC Week In Review | Jan 5, 2015
Clinical News

CPI-613: Phase I started

Cornerstone began an open-label, dose-escalation, U.S. Phase I trial to evaluate IV CPI-613 in combination with Treanda bendamustine and Rituxan / MabThera rituximab in 4-week cycles for up to 6 cycles. In each cycle, patients...
BC Week In Review | Nov 3, 2014
Clinical News

CPI-613: Phase I started

Cornerstone said the Wake Forest Baptist Medical Center and the NCI began an open-label, dose-escalation, U.S. Phase I trial to evaluate IV CPI-613 in combination with IV Treanda bendamustine in about 14 patients with Hodgkin's...
BC Innovations | Jun 19, 2014
Cover Story

Breaking MYC metabolism

The metabolic enzyme phosphoribosyl pyrophosphate synthetase 2 could represent a tractable way to modulate the notoriously undruggable oncogene MYC. 1 The findings from a University of California, San Francisco team are licensed to Effector Therapeutics...
BC Week In Review | Jun 2, 2014
Clinical News

CPI-613: Phase I data

An open-label, dose-escalation, U.S. Phase I trial in 24 patients with relapsed or refractory ALL showed that 500-2,250 mg/m 2 doses of IV CPI-613 plus cytarabine and mitoxantrone led to an ORR of 54%, including...
BC Week In Review | Nov 11, 2013
Clinical News

CPI-613: Phase II started

Cornerstone said the Comprehensive Cancer Center of Wake Forest Baptist Medical Center (Winston-Salem, N.C.) began a Phase II trial to evaluate IV CPI-613 in 4-week cycles for up to 6 cycles in about 13 patients...
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