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FibroGen Announces Early Phase 2 Data From a Clinical Study of FG-3019 in Combination With Chemotherapy as Neoadjuvant in Locally Advanced, Unresectable Pancreatic Cancer

SAN FRANCISCO, Jan. 27, 2016 (GLOBE NEWSWIRE) -- FibroGen, Inc. (FibroGen) today announced early results from a Phase 2, randomized, open-label study of FG-3019, an investigational anti-fibrotic antibody, in combination with gemcitabine and nab-paclitaxel (chemotherapy) compared to those chemotherapy agents alone for the treatment of patients with locally advanced pancreatic ductal adenocarcinoma (PDAC) who have failed resection scoring and are characterized as inoperable. The tumors in 3 of the first 4 evaluable subjects randomized to FG-3019 plus chemotherapy were converted from inoperable to operable condition. In contrast, 1 of the first 4 evaluable subjects treated with chemotherapy alone was considered operable. Treatment with FG-3019 in combination with chemotherapy was generally well tolerated. There were no complications from laparoscopy or biopsies that were clinically significant or delayed dosing, and to date there have been no safety imbalances between treatment arms. The data were presented at the 2016 American Society of Clinical Oncology (ASCO) GastroIntestinal Cancer Meeting in a poster session on January 22, 2016, Abstract Number 4138.

In this study (NCT02210559), patients with inoperable locally advanced pancreatic cancer, assessed by CT scans, are carefully staged with PET scans, endoscopic tissue biopsies, and laparoscopy. Subjects are randomized to six cycles of chemotherapy with gemcitabine and nab-paclitaxel with or without FG-3019. The study is targeted to enroll a total of 42 subjects, so these data represent an early assessment. 

Twelve subjects out of the total target of 42 have been enrolled to date. Among the 6 randomized to FG-3019 plus chemotherapy, 2 are still on treatment, 1 discontinued treatment due to complications of chemotherapy and 3 completed treatment. Tumors in the 3 subjects who completed treatment were considered operable after treatment. Two subjects had complete tumor removal (R0) and one subject had microscopic tumor remaining after surgery (R1). Among the 6 subjects randomized to chemotherapy alone, 2 are still on treatment, 2 subjects discontinued treatment due to tumor progression during the course of the study, and two subjects completed treatment. Of the two subjects who completed treatment, one was considered to have operable cancer and had a complete tumor removal (R0). After 2 cycles of treatment in these first 12 subjects, plasma levels of CA19.9, a non-specific tumor marker, showed a mean reduction of 78.3% with FG-3019 plus chemotherapy compared to 48.7% with chemotherapy alone. An additional advantage of the study is that it will provide tumor biopsy samples with which we plan to assess changes in biomarkers of the tumor, stroma, and inflammatory cells.

“Stromal tissue associated with pancreatic tumors provides vital support for tumor growth and metastases, and our preclinical and clinical data to date suggest that connective tissue growth factor (CTGF) plays a central role in the stroma of pancreatic cancer,” said Dr. Frank Valone, FibroGen’s Chief Medical Officer.  “We believe that FG-3019, which targets CTGF, can provide benefit to patients with pancreatic cancer. We are encouraged by these early clinical data in which we achieved complete tumor removal in some subjects who had inoperable tumors prior to receiving FG-3019 plus standard chemotherapy.”  Patients in whom locally advanced pancreatic tumors can be resected may have a substantial survival benefit compared to those in whom the tumors remain unresectable (Heestand et al. (2015) J Clin Oncol 33:1770-1778). 

In a previous study, increasing doses of FG-3019 were combined with gemcitabine plus erlotinib for treatment of subjects with advanced pancreatic cancer. That study (N=75) indicated a dose-related increase in survival.  At the lowest doses of FG-3019, no subjects survived for one year, while at the highest doses approximately 30% of subjects survived one year.  The study further demonstrated a relationship between blood levels of FG-3019 and survival.

About Pancreatic Cancer

Pancreatic ductal adenocarcinoma, or pancreatic cancer, is the fourth leading cause of cancer deaths in the United States. According to the National Cancer Institute, in 2014 in the United States, there were projected to be approximately 47,000 new cases of pancreatic cancer. Pancreatic cancer is aggressive and typically not diagnosed until it is largely incurable.  Most patients are diagnosed after the age of 45, and 94% of patients die within five years from diagnosis (American Cancer Society).

About FG-3019

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 FG-3019 in idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy. While the safety and efficacy of FG-3019 have not been established, it has been well tolerated to date, with no apparent safety signals in ten Phase 1 and Phase 2 clinical studies and more than 350 treated patients to date.

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, induces extracellular-matrix, or ECM, deposition that provides a substrate for tumor cell adherence, promotes angiogenesis, and promotes metastasis by enhancing cell motility, invasion, and survival. Studies in a transgenic mouse model of pancreatic cancer indicate that treatment with FG-3019 in combination with chemotherapy may enhance the efficacy of chemotherapy and improve survival.

About FibroGen, Inc.

FibroGen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. We have capitalized on our extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate multiple programs targeting various therapeutic areas. Our most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule HIF prolyl hydroxylase (HIF-PH) inhibitor, in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD). Our second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy. For more information about FibroGen, please visit www.fibrogen.com.

Forward Looking Statements

This release contains forward-looking statements, including statements regarding the potential benefit of FG-3019 to patients with pancreatic cancer, the usefulness of tumor biopsies, the survival benefit of tumor resection, and the potential for continued safety or efficacy in this and other studies. 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

Leanne C. Price
FibroGen, Inc.
lprice@fibrogen.com
415.978.1740

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FibroGen, Inc.