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Gilead's simtuzumab fails pancreatic cancer trial

Showed little difference in progression-free survival compared to placebo results
Gilead Sciences

Gilead Sciences has suffered a setback after its cancer candidate simtuzumab failed to achieve a survival benefit in a pancreatic cancer trial.

The phase II study of simtuzumab (GS-6624) - an inhibitor of lysyl oxidase-like-2 (LOXL2) - showed that the drug was unable to improve progression-free survival in a phase II study of patients with previously untreated advanced pancreatic cancer.

LOXL2 is required for normal processes that come into play during tissue development and wound healing but is over-expressed in various cancers and fibrotic disease states.

In the trial, 236 patients with pancreatic cancer were given either intravenous simtuzumab (200mg or 700mg) or a placebo on top of standard chemotherapy with intravenous gemcitabine in 28-day cycles.

The median progression-free survival was 3.5 months for the low dose and 3.7 months for the higher dose of simtuzumab, versus 3.7 months for placebo, said Gilead, noting that that detailed results from the study will be presented at the European Society for Medical Oncology (ESMO) congress later this month.

Simtuzumab - which was acquired by Gilead when it bought Arresto Biosciences for $225m in 2010 - is also in phase II trials for idiopathic pulmonary fibrosis, myelofibrosis, non-alcoholic steatohepatitis (NASH) and colorectal cancer, with data due from the middle of 2015.

The failure in pancreatic cancer is a minor setback for the project as the drug could still have considerable potential if it shows its worth in fibrotic diseases such as NASH and IPF, according to analysts.

Meanwhile, Gilead is riding the crest of a wave as its hepatitis C virus drug Sovaldi (sofosbuvir) eclipses all launch records for a pharmaceutical product.

Norbert Bischofberger, Gilead's chief scientific officer, said: "Although simtuzumab did not provide clinical benefit in difficult-to-treat advanced pancreatic cancer patients in this study, we continue to explore simtuzumab in other areas of unmet medical need.”

Other companies developing LOXL2 inhibitors include Pharmaxis and InterMune, which have small-molecule candidates in early-stage development.

Article by
Phil Taylor

18th September 2014

From: Research

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