|Higher pamrevlumab exposure associated with improved survival
SAN FRANCISCO, Feb. 03, 2017 (GLOBE NEWSWIRE) -- FibroGen, Inc., (NASDAQ:FGEN), a science-based biopharmaceutical company, today announced that clinical results from the company’s open-label, dose-escalation Phase 1/2 study (FGCL-MC3019-028) of pamrevlumab in pancreatic cancer were published in the Journal of Cancer Clinical Trials (Picozzi et al., J Cancer Clin Trials 2017, 2:123). The published results support a dose-related increase in survival in advanced pancreatic cancer, and that pamrevlumab can be safely combined with chemotherapy. Pamrevlumab is first-in-class fully human monoclonal therapeutic antibody that inhibits connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders.
“The data showing improved survival with pamrevlumab suggest a role for CTGF in the interactions of cancer cells and stroma responsible for tumor proliferation in PDAC,” said Vincent J. Picozzi, Jr., M.D., Director of the Pancreas Center, Virginia Mason Hospital & Seattle Medical Center and lead author. “These results provide further support for the clinical evaluation of pamrevlumab in combination with chemotherapy, and evidence that pamrevlumab can be safely combined with chemotherapy without incremental toxicity in advanced pancreatic cancer patients.”
In the 028 trial, the safety and efficacy of increasing doses of pamrevlumab were evaluated in combination with two chemotherapy agents, gemcitabine and erlotinib, in 75 patients with previously untreated Stage III or Stage IV pancreatic ductal adenocarcinoma. Pamrevlumab was well tolerated with no dose-limiting toxicity observed and no dose-related trends observed in type or incidence of serious adverse events. Toxicity, tumor response by CA19-9 and CT scan-based RECIST criteria, progression-free survival (PFS) and overall survival (OS) were assessed. In a post-hoc analysis, FG-3019 trough plasma levels (a measure of exposure) on Day 15 (D15Cmin) and baseline CTGF levels were correlated with clinical outcomes. High FG-3019 exposure (D15 Cmin ≥150 μg/mL) was associated with improved median OS (9.0 vs 4.4 months, (D15 Cmin <150 μg/mL), p=0.024), and one-year OS rate (34.2% vs. 10.8%, respectively, p=0.026), respectively. Plasma CTGF showed potential as a prognostic biomarker, as low baseline CTGF levels (<10 ng/mL) were associated with improved OS (10.1 vs 4.4 months (≥10 ng/mL), p=0.028).
About Pancreatic Ductal Adenocarcinoma and Connective Tissue Growth Factor
Pancreatic ductal adenocarcinoma (PDAC), or pancreatic cancer, is the fourth leading cause of cancer deaths in the United States. According to the National Cancer Institute, in 2016, there were approximately 53,000 new cases of pancreatic cancer projected in the United States alone. Pancreatic cancer is aggressive and typically not diagnosed until it is largely incurable. Most patients are diagnosed after the age of 45, and overall five-year survival is about 7%, due to many factors, including advanced stage at diagnosis and limited response to currently available therapies (http://seer.cancer.gov/statfacts/html/pancreas.html). PDAC tumors often exhibit a high degree of desmoplasia, characterized by extensive connective tissue stroma and elevated levels of Connective Tissue Growth Factor (CTGF). Cancer-stroma interactions affect tumorigenesis, angiogenesis, resistance to therapy and metastatic spread of tumor cells. CTGF is overexpressed in PDAC and facilitates local desmoplasia, tumor progression and metastasis in animal models.
Pamrevlumab (FG-3019) is an investigational therapeutic antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy.
In desmoplastic, or fibrotic, cancers such as pancreatic cancer, CTGF in the extensive fibrous stroma associated with the tumor promotes abnormal proliferation of stromal cells and tumor cells.
About FibroGen, Inc.
FibroGen, Inc., headquartered in San Francisco with subsidiary offices in Beijing and Shanghai, is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat (FG-4592), the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity in Phase 3 clinical development for the treatment of anemia in CKD. Pamrevlumab (FG-3019), a fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), is in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne’s muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding the potential benefit of pamrevlumab (FG-3019) to patients with pancreatic cancer including in combination with chemotherapy agents and in future clinical studies, and the potential for pamrevlumab to demonstrate safety or efficacy, including in combination with chemotherapy agents without incremental toxicity. Our actual results may differ materially from these early data and any forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
Karen L. Bergman
Vice President, Investor Relations and