FibroGen Announces Publication of Pamrevlumab (FG-3019) Clinical Data in Pancreatic Cancer Showing Safety and Improved Surviv...
February 03 2017 - 11:06AM
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.
About Pamrevlumab
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.
Contact Information
Karen L. Bergman
Vice President, Investor Relations and
Corporate Communications
FibroGen, Inc.
kbergman@fibrogen.com
(415) 978-1433
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