Pancreatic Cancer Trial with Gilead’s Simtuzumab, Results of Phase 2

Thursday, September 18, 2014 – Gilead announced today the results of a Phase 2 study that evaluates the effects of simtuzumab, an experimental inhibitor lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine in patients suffering from advanced pancreatic cancer that was not previously treated. The Data of the study will be presented at the congress of the European Society for Medical Oncology in Madrid.

The study reveals using simtuzumab (200 mg or 700 mg) along with gemcitabine did not significantly increased progression-free survival (PFS) compared to placebo plus gemcitabine. PFS was theprimary endpoint of the study. More details on the results will be presented during a session at theconference of the European Society of Medical Oncology (ESMO 2014), which will be held in Madrid,Spain, starting September 26 to 30 (Abstract number 5072 ).

In this randomized, double-blind, placebo-controlled Phase 2, 236 patients with advanced pancreatic cancer receiving gemcitabine IV over the simtuzumab intravenous (200 mg, n = 76; 700 mg, n = 79) or placebo (n = 81) in 28-day cycles. The median PFS of groups receiving simtuzumab 200 mg, simtuzumab 700 mg and placebo was 3.5 months, 3.7 months and 3.7 months, respectively. The difference in level between the SSP simtuzumab and placebo was not statistically significant. The toxicities associated with gemcitabine anticipated were decreased red blood cells (anemia), low blood platelet count (thrombocytopenia), abnormal low number of type of white blood cells called neutrophils (neutropenia), and nausea. There was no difference in adverse effects between patients receiving simtuzumab and those taking the placebo.

“Although simtuzumab did not provide clinical benefit in this study in patients with an advanced pancreatic difficult to treat, we continue to explore the simtuzumab in other areas of unmet medicalneeds, with clinical trials on colorectal cancer, myelofibrosis and lung disease and liver fibroticserious, “said Norbert Bischofberger, PhD, Executive Vice President of Research and Developmentand Chief Scientific Officer of Gilead.

The experimental simtuzumab is a monoclonal antibody that is highly selective for the LOXL2 (lysyl oxidase-like 2), an enzyme that modifies the extracellular matrix promoting the crosslinking of the collagen fibers. LOXL2 is thought to play a significant role in the progression and metastasis of the tumor and the development of fibrotic diseases. Simtuzumab is currently being evaluated in severalPhase 2 trials in progress especially in combination with FOLFIRI for advanced colorectal cancer; in combination with ruxolitinib for myelofibrosis; as monotherapy for idiopathic pulmonary fibrosis, a rare lung disease; and fibrosis of the liver caused by non-alcoholic steatohepatitis (NASH); and primary sclerosing cholangitis (PSC).

Scientist of Gilead are now working on other agents, including momelotinib and GS-5745, which are currently being evaluated in clinical trials for the treatment of pancreatic cancer.

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