FibroGen Granted Orphan Drug Designation for Pamrevlumab in the Treatment of Pancreatic Cancer
June 21 2017 - 10:10PM
FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted Orphan Drug Designation status to pamrevlumab,
the company’s first-in-class antibody, for the treatment of
pancreatic cancer.
“This is an important regulatory milestone for FibroGen, as
pamrevlumab continues to show promise in the treatment of
pancreatic cancer,” said Tom Neff, Chief Executive Officer of
FibroGen. “Phase 2 clinical studies of pamrevlumab have produced
initial positive data on median and one-year survival for patients
with advanced pancreatic cancer (88% metastatic). An ongoing study
in locally advanced non-resectable pancreatic cancer has shown
promise in converting pancreatic cancer from non-resectable to
surgically viable. In this current open-label Phase 2 randomized
trial, we are evaluating pamrevlumab in combination with
chemotherapy standard-of-care versus chemotherapy alone. We look
forward to sharing results by early next year.”
Orphan Drug Designation qualifies the sponsor for various
development incentives of the Orphan Drug Act, including tax
credits for qualified clinical testing, to advance the evaluation
and development of products that demonstrate promise for the
diagnosis and treatment of rare diseases or conditions. Orphan Drug
Designation can also convey up to seven years of marketing
exclusivity if the compound receives regulatory approval from the
FDA. FibroGen previously received Orphan Drug Designation for
pamrevlumab for the treatment of idiopathic pulmonary fibrosis
(IPF).
About Pamrevlumab Pamrevlumab (formerly
FG-3019) is an investigational therapeutic antibody developed by
FibroGen to inhibit the activity of connective tissue growth factor
(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 (DMD).
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.
For information about pamrevlumab studies currently recruiting
patients, please visit www.clinicaltrials.gov.
About FibroGen, Inc. FibroGen, Inc.,
headquartered in San Francisco, CA with subsidiary offices in
Beijing and Shanghai, PRC, 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, 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 chronic
kidney disease (CKD) and is entering Phase 3 development for anemia
in lower risk myelodysplastic syndromes (MDS). Pamrevlumab, 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 muscular dystrophy (DMD).
FibroGen is also developing a biosynthetic cornea in China. For
more information, please visit www.fibrogen.com.
Forward-Looking StatementsThis release contains
forward-looking statements regarding our strategy, future plans and
prospects, including statements regarding the development of the
Company's product candidate pamrevlumab, the potential safety and
efficacy profile of our product candidates, and our clinical plans.
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,” “should,” “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 no programs,
including the enrollment and results from ongoing and potential
future clinical trials for pamrevlumab, and other matters that are
described in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2016, and our Quarterly Report on Form 10-Q for
the quarter ended March 31, 2017, 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.
Contact
FibroGen, Inc.
Karen L. Bergman
Vice President, Investor Relations and Corporate Communications
1.415.978.1433
kbergman@fibrogen.com
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