Five Prime Therapeutics Announces Completion of Enrollment for the Phase 2 Part of the Ongoing Trial of Cabiralizumab for the...
April 10 2017 - 4:05PM
Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that it
has completed enrollment in the initially planned 30-patient cohort
of the Phase 2 part of the ongoing clinical trial evaluating
cabiralizumab in patients with tenosynovial giant cell tumor,
diffuse type, also known as pigmented villonodular synovitis
(PVNS), an aggressive tumor confined to the synovium.
“Completing enrollment in the Phase 2 part of this
trial marks another important milestone for Five Prime,” said Helen
Collins, M.D., Senior Vice President and Chief Medical Officer of
Five Prime. “PVNS is a rare neoplastic joint disease that can be
associated with significant pain and debilitation. We are
evaluating cabiralizumab, our investigational antibody that blocks
CSF1R, as a potential treatment for this rare disease for which
there are no currently approved medical treatments.”
Five Prime initiated patient dosing in this Phase
1/2 clinical trial of cabiralizumab in July 2015. During the Phase
2 part of the trial, the company is evaluating response rate and
duration, as well as measures of pain and range of motion, in
approximately 30 patients.
The U.S. Food and Drug Administration (FDA) and
European Commission granted Orphan Drug Designation for
cabiralizumab for the treatment of PVNS. The company estimates that
the U.S. prevalence for diffuse PVNS patients may be as high as
25,000 patients.
Five Prime plans to seek regulatory feedback on the
design of a pivotal trial. In addition, the company plans to
present initial data from this clinical trial at 2017 American
Society of Clinical Oncology (ASCO) Annual Meeting.
About PVNS PVNS is a rare, locally
aggressive tumor of the synovium. It is characterized by
local over-expression of CSF-1, which recruits macrophages into the
joints, forming the non-malignant tumor mass. It is associated with
high morbidity, and there are no approved therapies for the
condition. Five Prime is conducting a Phase 1/2 clinical trial
studying cabiralizumab as a treatment for PVNS.
About Cabiralizumab
(FPA008)Cabiralizumab is an investigational antibody that
inhibits the CSF-1 receptor and has been shown in preclinical
models to block the activation and survival of monocytes and
macrophages. Inhibition of CSF1R in preclinical models of several
cancers reduces the number of immunosuppressive tumor-associated
macrophages (TAMs) in the tumor microenvironment, thereby
facilitating an immune response against tumors. Cabiralizumab is
currently in a Phase 2 clinical trial in pigmented villonodular
synovitis (PVNS) and a Phase 1 clinical trial in oncology
indications. Cabiralizumab is being developed under an exclusive
worldwide license and collaboration agreement entered into with
Bristol-Myers Squibb (BMS) in October 2015.
About Five PrimeFive Prime
Therapeutics, Inc. discovers and develops innovative therapeutics
to improve the lives of patients with serious diseases. Five
Prime's comprehensive discovery platform, which encompasses
virtually every medically relevant extracellular protein, positions
it to explore pathways in cancer, inflammation and their
intersection in immuno-oncology, an area with significant
therapeutic potential and a growing focus of the company's R&D
activities. Five Prime has entered into strategic collaborations
with leading global pharmaceutical companies and has promising
product candidates in clinical and late preclinical development.
For more information, please visit www.fiveprime.com.
Cautionary Note on Forward-looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,”
“anticipate,” “estimate,” “intend” and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on Five
Prime’s expectations and assumptions as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Actual results may differ materially from these
forward-looking statements. Factors that may cause actual results
to differ from those expressed or implied in the forward-looking
statements in this press release are discussed in Five Prime’s
filings with the U.S. Securities and Exchange Commission, including
the “Risk Factors” contained therein. Except as required by law,
Five Prime assumes no obligation to update any forward-looking
statements contained herein to reflect any change in expectations,
even as new information becomes available.
Heather Rowe
Investor Relations
415-365-5737
heather.rowe@fiveprime.com
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