scholarly journals Randomised clinical trial: a phase 1, dose-ranging study of the anti-matrix metalloproteinase-9 monoclonal antibody GS-5745 versus placebo for ulcerative colitis

2016 ◽  
Vol 44 (2) ◽  
pp. 157-169 ◽  
Author(s):  
W. J. Sandborn ◽  
B. R. Bhandari ◽  
R. Fogel ◽  
J. Onken ◽  
E. Yen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Monoclonal Antibody ◽  
Matrix Metalloproteinase ◽  
Phase 1 ◽  
Randomised Clinical Trial ◽  
Matrix Metalloproteinase 9 ◽  
Dose Ranging ◽  
Metalloproteinase 9

Tu1927 Matrix Metalloproteinase 9 (MMP9) Expression in Ulcerative Colitis Is Associated With Histologic Score of Disease Severity

2016 ◽  
Vol 150 (4) ◽  
pp. S979-S980
Author(s):  
William Sandborn ◽  
Scott Lee ◽  
Erik G. Huntzicker ◽  
Guang Chen ◽  
Victoria Smith ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Matrix Metalloproteinase ◽  
Disease Severity ◽  
Matrix Metalloproteinase 9 ◽  
Mmp9 Expression ◽  
Metalloproteinase 9

Updated results of a phase 1 study combining the matrix metalloproteinase 9 inhibitor GS-5745 with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 363-363 ◽  
Author(s):  
Johanna C. Bendell ◽  
Manish R. Patel ◽  
Carrie Baker Brachmann ◽  
Xi Huang ◽  
Julia D. Maltzman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Matrix Metalloproteinase ◽  
Pancreatic Adenocarcinoma ◽  
Phase 1 ◽  
Objective Response ◽  
Locally Advanced ◽  
Matrix Metalloproteinase 9 ◽  
Phase 1 Study ◽  
Metastatic Setting ◽  
Metalloproteinase 9

363 Background: GS-5745 is a monoclonal antibody inhibitor of matrix metalloproteinase 9 (MMP9), an extracellular enzyme involved in matrix remodeling, tumor growth, and metastasis. We present data from patients (pts) with advanced pancreatic adenocarcinoma enrolled in an ongoing multi-indication phase 1 study (NCT01803282) evaluating GS-5745. Methods: Following a monotherapy dose finding stage, pts with locally advanced or metastatic pancreatic cancer received gemcitabine (G) + nab-paclitaxel (Abraxane, A) and GS-5745 800 mg IV every 2 weeks. Treatment continued until disease progression, unacceptable toxicity or withdrawal of consent. Response was assessed every 8 weeks per RECIST version 1.1 criteria. Results: As of April 2016, 36 pts were enrolled (1 continues to receive GS-5745). The most frequently observed adverse events (AEs) of any grade include fatigue (75%), alopecia (55.6%), peripheral edema (55.6%) and nausea (50%). Grade ≥ 3 AEs observed in ≥ 10% of pts included neutropenia (25%), anemia (19.4%) and fatigue (13.9%). The median progression free survival (PFS) for all pts is 7.8 (90% confidence interval (CI) = [6.1, 11]) months (mos), median duration of response (DOR) is 5.8 mos and the objective response rate (ORR) is 44.4%. Of the 31 pts who were treatment naïve in the metastatic setting, median PFS is 9.2 (90% CI = [6.1, 11]) mos, median DOR 5.8 mos and the ORR 51.6%. Median baseline circulating MMP9 was 44.3 (range 12.4-549.6) ng/mL and 31 of 32 patients with post-baseline samples had undetectable MMP9 levels within 8 weeks. Conclusions: GS-5745+GA demonstrated numerically higher ORR and PFS compared to historical data without additional toxicity. Additionally, reductions in circulating MMP9 levels post treatment suggest target engagement by GS-5745 . These results suggest this combination may warrant additional study in first line metastatic pancreatic adenocarcinoma. Clinical trial information: NCT01803282.

Inhibition of Matrix Metalloproteinase 9 Activation by a Specific Monoclonal Antibody

Hybridoma ◽  
1993 ◽  
Vol 12 (4) ◽  
pp. 349-363 ◽  
Author(s):  
NOEMI RAMOS-DeSIMONE ◽  
UTE M. MOLL ◽  
JAMES P. QUIGLEY ◽  
DEBORAH L. FRENCH
Keyword(s):  
Monoclonal Antibody ◽  
Matrix Metalloproteinase ◽  
Matrix Metalloproteinase 9 ◽  
Specific Monoclonal Antibody ◽  
Metalloproteinase 9

The Behavior of Matrix Metalloproteinase-9 in Lymphocytic Colitis, Collagenous Colitis and Ulcerative Colitis

2011 ◽  
Vol 18 (1) ◽  
pp. 85-91 ◽  
Author(s):  
Gábor Lakatos ◽  
Ferenc Sipos ◽  
Pál Miheller ◽  
István Hritz ◽  
Mária Zsófia Varga ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Matrix Metalloproteinase ◽  
Collagenous Colitis ◽  
Matrix Metalloproteinase 9 ◽  
Lymphocytic Colitis ◽  
Metalloproteinase 9
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