Pamrevlumab is a fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor, or CTGF, a critical mediator in the progression of fibrosis and related serious diseases. Many of these diseases, including idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD) have few, if any, effective therapeutic options. We are currently advancing a number of these promising indications through clinical development. In Phase 1 and Phase 2 clinical studies involving more than 450 subjects, pamrevlumab was well tolerated across a wide range of doses with no dose-limiting toxicities observed to date.
Early on, we observed that pamrevlumab reversed fibrosis in a highly predictive animal model of lung fibrosis. In our Phase 2 IPF clinical studies, pamrevlumab demonstrated the potential for stabilization of disease and, for the first time in human studies, reversal of lung fibrosis in some patients. We anticipate reporting topline results from our Phase 2 randomized, double-blind, placebo-controlled study and a double-blind, active-controlled combination sub-study for the treatment of IPF in the third quarter of 2017.
In pancreatic cancer, we have seen encouraging evidence of clinical activity with the potential to transform advanced and unresectable patients to patients who are surgically resectable. Literature suggests that pancreatic cancer patients who underwent surgical resection tend to have longer survival than those who do not undergo resection. In an open-label Phase 2 pancreatic cancer combination study of pamrevlumab plus gemcitabine and erlotinib, pamrevlumab demonstrated a dose-dependent improvement in one-year survival rate.
Additional information about pamrevlumab trials currently recruiting patients can be found at: www.ClinicalTrials.gov.