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Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and close to 37,000 die from the disease. The disease is often diagnosed at an advanced stage, and treatment of advanced disease remains challenging.

Gemzar has been a standard chemotherapy drug for the treatment of advanced pancreatic cancer for some time. Not all pancreatic cancers, however, respond to treatment with Gemzar. Moreover the results achieved with Gemzar need to be improved.

Simtuzumab is a monoclonal antibody that inhibits lysyl oxidase like molecule 2 (LOXL2), an extracellular matrix enzyme involved in tumor growth and metastasis.  The drug was determined to be well tolerated as a single agent in patients and when combined with FOLFIRI and appeared promising in patients with colon and pancreatic cancer.

Gilead announced results from a Phase II study evaluating simtuzumab, an inhibitor in combination with current the standard of care, Gemzar. The data show that the addition of simtuzumab (200 mg or 700 mg) to Gemzar did not significantly increase progression-free survival compared to placebo plus gemcitabine.  The time to cancer progression was not improved with the addition of   simtuzumab 200 mg, or  simtuzumab 700. There was no difference in adverse events between patients taking simtuzumab versus placebo, Gilead said, noting that detailed results will be presented at the European Society for Medical Oncology Congress in Madrid next week.

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Although the failure in difficult-to-treat advanced pancreatic cancer patients is a blow, Gilead chief scientific officer Norbert Bischofberger said “we continue to explore simtuzumab in other areas of unmet medical need, with ongoing clinical trials in colorectal cancer, myelofibrosis and serious fibrotic lung and liver diseases”.  Notably, there is randomized, double-blind, placebo controlled phase II study in KRAS mutant CRC ongoing.

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