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8:02 AM, Nov 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Sangamo delays readout for hemophilia A gene therapy

Sangamo Therapeutics Inc. (NASDAQ:SGMO) said on its 3Q18 earnings call on Nov. 8 that it will not submit a late-breaking abstract to present Phase I/II data for its hemophilia A gene therapy at next month's...
8:02 AM, Nov 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Solid moves up timeline for IGNITE DMD readout

Solid Biosciences Inc. (NASDAQ:SLDB) expects preliminary data from the Phase I/II IGNITE DMD trial of microdystrophin gene transfer therapy SGT-001 to treat Duchenne muscular dystrophy (DMD) in 1Q19, up from 1H19 that was guided previously....
8:01 AM, Nov 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Bayer's Stivarga first to enter adaptive brain cancer trial

Bayer AG (Xetra:BAYN) and the Global Coalition for Adaptive Research (GCAR) said Stivarga regorafenib will be the first therapy to enter the adaptive Phase II/III GBM AGILE trial, which has been designed to more rapidly...
12:52 PM, Nov 02, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

NIH pauses stem cell trial after Brigham calls to retract 'fabricated' foundational research

NIH's National Heart, Lung, and Blood Institute (NHLBI) said Oct. 29 it will pause the Phase II CONCERT-HF trial testing a cardiac stem cell therapy as recent calls for retraction of journal articles in related...
12:49 PM, Nov 02, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Gilead discontinues gastric cancer candidate andecaliximab

Gilead Sciences Inc. (NASDAQ:GILD) announced in its 3Q18 earnings that it discontinued development of andecaliximab for gastric cancer. The company said a Phase III trial showed a lack of benefit on the primary endpoint of...
2:21 PM, Oct 26, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Vertex discontinues development of spinal cord injury compound VX-210

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) discontinued development of acute spinal cord injury candidate VX-210 after a DSMB recommended stopping a Phase IIb trial for futility following an interim analysis. Vertex has rights to VX-210 from BioAxone BioSciences...
2:18 PM, Oct 26, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Castle Creek discontinues Phase II of epidermolysis bullosa compound

Castle Creek Pharmaceuticals LLC (Parsippany, N.J.) discontinued the Phase II DELIVERS trial evaluating topical 1% diacerein (AC-203, CCP-020) to treat epidermolysis bullosa simplex (EBS). According to ClinicalTrials.gov, an IDMC said the trial will not meet...
12:40 PM, Oct 26, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Alphamab Oncology, 3DMed start Phase II of PD-L1 antibody in solid tumors

Alphamab Oncology (Suzhou, China) and 3D Medicines Corp. (Shanghai, China) began a Phase II trial of KN035 in previously-treated patients with locally advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma...
12:26 PM, Oct 26, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Alphamab Oncology, 3DMed start Phase III for PD-L1 antibody in cholangiocarcinoma

Alphamab Oncology (Suzhou, China) and 3D Medicines Corp. (Shanghai, China) began a Phase III trial of KN035 plus gemcitabine and oxaliplatin to treat cholangiocarcinoma. The open-label, Chinese trial will enroll about 390 patients. The trial's...
11:34 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Apellis pauses Phase III trials after single lot of APL-2 causes inflammation

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) voluntarily paused dosing in Phase III trials of intravitreal APL-2 to treat geographic atrophy due to eight reported cases of non-infectious inflammation in patients treated from a single manufacturing lot of...

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