Pamrevlumab Included in Pancreatic Cancer Action Network’s Adaptive Clinical Trial Platform
FibroGen (NASDAQ: FGEN) announced the activation of an experimental arm in the Pancreatic Cancer Action Network's Precision Promise trial. This trial aims to expedite approval of therapies for metastatic pancreatic cancer by integrating multiple stakeholders. The new arm tests FibroGen's pamrevlumab with standard chemotherapy treatments. Patients may receive pamrevlumab as a first-line treatment in the trial, aiming to enhance patient outcomes. Currently, the trial is enrolling at 15 sites nationwide, with plans for additional sites in early 2022.
- Activation of pamrevlumab experimental arm in Precision Promise trial.
- Opportunity for patients to receive first-line treatment with pamrevlumab.
- Partnership with PanCAN to accelerate drug development.
- None.
SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced activation of an experimental arm in the Pancreatic Cancer Action Network's (PanCAN) Precision PromiseSM adaptive trial platform evaluating pamrevlumab [and standard of care] for patients with metastatic pancreatic cancer. The objective of Precision Promise is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities.
“We are inspired by the mission of the Pancreatic Cancer Action Network and are excited to partner with them,” said Mark Eisner, MD, Chief Medical Officer. “We share PanCAN's goal of accelerating the development of new treatment options for pancreatic cancer patients.”
“By partnering with FibroGen to bring a first-line experimental treatment arm into Precision Promise, we are expanding options for the patients enrolling in this trial,” said Anne-Marie Duliege, MD, PanCAN’s Chief Medical Officer. “It is one of PanCAN’s major objectives to continue to bring innovative, experimental drugs like FibroGen’s pamrevlumab into this study in order to accelerate drug development and hopefully bring new therapies to market faster. Pancreatic cancer patients can’t afford to wait.”
The new experimental treatment arm tests FibroGen’s pamrevlumab in combination with standard of care chemotherapy treatments for pancreatic cancer, gemcitabine and Abraxane®. The combination therapy is offered to patients with metastatic pancreatic cancer as either a first- or second-line treatment option, marking the first experimental treatment arm to be offered as a first-line treatment in PanCAN’s innovative Precision Promise trial. With this addition, a newly diagnosed patient enrolling in Precision Promise has the opportunity to be randomized onto an experimental therapy as their first-line treatment, and then onto another experimental therapy as their second-line treatment if they maintain eligibility while the first treatment becomes no longer effective.
PanCAN’s Precision Promise aims to revolutionize the clinical development paradigm in pancreatic cancer by enabling a faster, more efficient, and patient-centric approach to developing new treatment options and improving outcomes for pancreatic cancer patients. The novel clinical trial platform requires fewer patients to understand if a potential new therapy is working and can accelerate late-stage development by up to two years. The statistical design of Precision Promise was led by renowned statistician Dr. Donald Berry of Berry Consulting, designer of the I-SPY breast cancer trials.
Precision Promise is currently open and enrolling at 15 Clinical Trial Consortium sites nationwide and PanCAN expects to add five additional sites in early 2022. For more information on the trial, please see clinical trials.gov: Precision Promise Trial
About Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive.
About Metastatic Pancreatic Cancer
In Stage IV, or metastatic, pancreatic cancer, the patient’s cancer has spread to another part of the body. At this stage, the cancer cannot be removed by surgery and patients usually receive a treatment such as chemotherapy that travels through the bloodstream to reach cancer cells that are in many places throughout the body. The five-year survival rate for metastatic pancreatic cancer is 3 percent1.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 filed with the Securities and Exchange Commission (SEC), 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.
References: 1. American Cancer Society. Cancer Facts & Figures 2021. Atlanta: American Cancer Society; 2021.
Contacts:
FibroGen, Inc.
Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
mtung@fibrogen.com
Media:
Jillian Scholten, Senior Public Relations Manager
Pancreatic Cancer Action Network
Direct: 949-244-2561| E-mail: jscholten@pancan.org
GCI Health
FibroGenMedia@gcihealth.com
FAQ
What is the purpose of the Precision Promise trial involving FGEN?
What are the treatment options for patients in the Precision Promise trial?
When will additional sites for the Precision Promise trial open?
What is pamrevlumab and its role in the trial?
How does the Precision Promise trial change pancreatic cancer treatment development?
