Constellation Pharmaceuticals Receives FDA Fast Track Designation for CPI-0610 in Treatment of Myelofibrosis
01 Novembre 2018 - 12:00PM
- Recently Expanded and Enhanced MANIFEST Phase 2 Trial Ongoing
with Proof of Concept Data Expected Mid-2019
Constellation Pharmaceuticals, Inc. (NASDAQ:CNST), a
clinical-stage biopharmaceutical company using its expertise in
epigenetics to discover and develop novel therapeutics, today
announced that it has received Fast Track designation from the
United States Food and Drug Administration (FDA) for CPI-0610 in
treatment of myelofibrosis (MF) based on preliminary results from
the Company’s Phase 2 study, MANIFEST.
Constellation is developing CPI-0610 with the goal of providing
a new treatment option for patients with MF who have experienced
disease progression after treatment with Jakafi (ruxolitinib), the
only approved therapy for MF. Enrollment is ongoing in the Phase 2
portion of the open-label Phase 1/2 MANIFEST clinical trial, which
is exploring CPI-0610’s potential both as a monotherapy and as a
combination therapy with Jakafi. As previously reported,
preliminary data demonstrated clinical activity, such as spleen
volume reduction, symptom improvement, increase in hemoglobin
levels, and conversion to transfusion independent status in a
patient who was transfusion dependent. Constellation recently
expanded the MANIFEST study to include a third cohort, designed to
evaluate CPI-0610 as a first-line therapy in combination with
ruxolitinib in JAK 1/2-inhibitor-naïve MF patients.
“We believe there is an opportunity to improve the standard of
care for MF patients with agents that modify the underlying
disease,” said Adrian Senderowicz, Senior Vice President and Chief
Medical Officer of Constellation Pharmaceuticals. “This Fast Track
designation highlights CPI-0610’s potential to address a
significant unmet need. Based on promising early data and our
progress with site initiation and patient enrollment, we continue
to expect to determine proof of concept in mid-2019.”
The FDA grants Fast Track designation to facilitate the
development and expedite the review of drugs to treat serious or
life-threatening diseases and fill unmet medical needs. A drug that
receives Fast Track designation is eligible for more
frequent meetings with the FDA to discuss the drug's development
plan and ensure collection of appropriate data needed to support
drug approval, more frequent written communication about the design
of the proposed clinical trials and use of biomarkers, eligibility
for accelerated approval and priority review, and rolling
review.
About Myelofibrosis
MF is part of a collection of progressive blood cancers known as
myeloproliferative neoplasms and is associated with significantly
reduced quality of life and shortened survival. As the disease
progresses, the bone marrow produces fewer red blood cells. Within
one year of diagnosis, the incidence of thrombocytopenia (a
condition characterized by low platelet counts in the blood) and
severe anemia (a condition characterized by low red blood cell
counts) and the need for red blood cell transfusion increase
significantly. Among other complications, most patients with MF
have enlarged spleens, as well as many other physical symptoms,
including abdominal discomfort, bone pain, and extreme fatigue.
About CPI-0610
CPI-0610 is a potent and selective small molecule designed to
promote anti-tumor activity by selectively inhibiting the function
of BET proteins to decrease the expression of abnormally expressed
genes in cancer. Constellation’s epigenetics platform includes a
deep understanding of the biological contexts in which BET proteins
operate, including cancer pathways that are highly sensitive to
CPI-0610. The results from preclinical studies, as well as
translational insights from the successful first-in-human study of
CPI-0610, led to prioritizing the clinical development of CPI-0610
in myelofibrosis (MF). Enrollment is ongoing in the Phase 2 portion
of the open-label Phase 1/2 MANIFEST clinical trial of CPI-0610,
either as a monotherapy or in combination with ruxolitinib, in
patients with MF who are refractory or intolerant or have relapsed
or lost response to the standard of care. MANIFEST also includes a
third cohort designed to evaluate treatment with CPI-0610 in
combination with ruxolitinib as a first-line therapy in JAK
1/2-inhibitor-naïve MF patients. The company expects to determine
proof of concept for CPI-0610 in MF in mid-2019.
About Constellation Pharmaceuticals
Constellation Pharmaceuticals is a clinical-stage
biopharmaceutical company developing novel therapeutics that
selectively modulate gene expression to address serious unmet
medical needs in patients with cancer. The Company has a deep
understanding of how epigenetic and chromatin modifications in
cancer cells and in the tumor and immune microenvironment play a
fundamental role in driving disease progression and drug
resistance. Constellation is driving development of the EZH2
inhibitors CPI-1205 and CPI-0209 for the treatment of metastatic
castration-resistant prostate cancer and other cancers as well as
the BET inhibitor CPI-0610 for the treatment of myelofibrosis. The
Company is also applying its broad research and development
capabilities to explore other novel targets that directly and
indirectly impact gene expression to fuel a sustainable pipeline of
innovative small-molecule product candidates.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties, including
statements regarding the development status of the Company’s
product candidates, the anticipated benefits of the changes to its
clinical trial protocols and its anticipated achievement of
milestones, including determination of proof of concept. All
statements, other than statements of historical facts, contained in
this press release, including statements regarding the Company’s
strategy, future operations, future financial position, prospects,
plans and objectives of management, are forward-looking statements.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in,
or implied by, such forward-looking statements. These risks and
uncertainties include, but are not limited to, risks associated
with Constellation’s ability to: obtain and maintain necessary
approvals from the FDA and other regulatory authorities; continue
to advance its product candidates in clinical trials; replicate in
later clinical trials positive results found in preclinical studies
and early-stage clinical trials of CPI-1205, CPI-0610 and its other
product candidates; advance the development of its product
candidates under the timelines it anticipates, or at all, in
current and future clinical trials; obtain, maintain or protect
intellectual property rights related to its product candidates;
manage expenses; and raise the substantial additional capital
needed to achieve its business objectives. For a discussion of
other risks and uncertainties, any of which could cause the
Company’s actual results to differ from those contained in the
forward-looking statements, see the “Risk Factors” section, as well
as discussions of potential risks, uncertainties, and other
important factors, in the Company’s most recent filings with the
Securities and Exchange Commission. In addition, the forward-
looking statements included in this press release represent the
Company’s views as of the date hereof and should not be relied upon
as representing the Company’s views as of any date subsequent to
the date hereof. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. CPI-1205, CPI-0610, CPI-0209,
and other product candidates are investigational in nature and have
not yet been approved by the FDA or other regulatory
authorities.
Jakafi® is a registered trademark of Incyte Corporation.
Contact
Ronald Aldridge Investor RelationsConstellation
Pharmaceuticals+1
617-714-0539ron.aldridge@constellationpharma.com
Lauren ArnoldMedia RelationsMacDougall Biomedical
Communications+1 781-235-3060larnold@macbiocom.com
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