Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-007 for Treatment of Relapsed or Refractory...
08 December 2020 - 11:00PM
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on
becoming a leader in development and commercialization of
treatments for rare and orphan diseases, today announced that its
Investigational New Drug Application (IND) to study the use of
CERC-007 to treat relapsed or refractory multiple myeloma (MM) has
been accepted by the United States Food and Drug Administration
(FDA) and is now open. The first study will be a U.S. multicenter
Phase 1b clinical trial. Initial data is expected in the first
quarter of 2021.
“Elevated levels of IL-18 are correlated with poor survival in
patients with multiple myeloma1,” said H. Jeffrey Wilkins, MD,
Chief Medical Officer of Cerecor. “Targeting and reducing IL-18
using CERC-007 may substantially benefit relapsed or refractory
multiple myeloma patients. Our first study under this new IND will
give us important information about the pharmacokinetics,
pharmacodynamics, dose, safety and preliminary efficacy that should
illuminate the path forward. We look forward to sharing the data
with the scientific and medical communities in the first quarter of
2021.”
The planned Phase 1b clinical trial is a U.S. multicenter,
open-label, dose-escalation, sequential group study of CERC-007 as
a monotherapy in approximately 30 patients with relapsed or
refractory MM. The primary objectives of the study will be to
determine the safety and tolerability of CERC-007, the recommended
Phase 2 dose, and preliminary efficacy as measured by response rate
in accordance with International Myeloma Working Group (IMWG)
criteria.
About
Multiple
MyelomaMultiple myeloma is the
second most common blood cancer, with approximately 140,000
patients in the United States.2 Multiple myeloma is characterized
by an excess proliferation of plasma cells. Despite increased
availability of new agents, the disease is characterized by a
pattern of recurrent relapses and remains incurable for the
majority of patients, with a 5-year survival rate of approximately
50%.2
About CERC-007CERC-007 is a
fully human monoclonal antibody targeting the proinflammatory
cytokine IL-18. It is in development for multiple auto-immune
diseases, including Still’s disease (adult onset Still’s disease
(AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and
multiple myeloma (MM).
About Cerecor Cerecor is a biopharmaceutical
company focused on becoming a leader in the development and
commercialization of treatments for rare and orphan diseases.
The company is advancing its clinical-stage pipeline of innovative
therapies that address unmet patient needs within rare and orphan
diseases. The company's rare disease pipeline includes
CERC-801, CERC-802 and CERC-803, which are in development for
congenital disorders of glycosylation and CERC-006, an oral
mTORc1/c2 inhibitor in development for the treatment of complex
lymphatic malformations. The company is also developing two
monoclonal antibodies, CERC-002, and CERC-007. CERC-002
targets the cytokine LIGHT (TNFSF14) and is in clinical development
for treatment of severe pediatric-onset Crohn's disease, and
COVID-19 acute respiratory distress syndrome. CERC-007
targets the cytokine IL-18 and is in clinical development for the
treatment of Still’s disease (adult onset Still’s disease (AOSD)
and systemic juvenile idiopathic arthritis (sJIA)), and multiple
myeloma (MM). CERC-006, 801, 802 and 803 have all received
Orphan Drug Designation and Rare Pediatric Disease Designation,
which makes all four eligible for a priority review voucher upon
FDA approval.
For more information about Cerecor, please visit
www.cerecor.com
Forward-Looking StatementsThis press release
may include forward-looking statements made pursuant to the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts. Such
forward-looking statements are subject to significant risks and
uncertainties that are subject to change based on various factors
(many of which are beyond Cerecor’s control), which could cause
actual results to differ from the forward-looking statements. Such
statements may include, without limitation, statements with respect
to Cerecor’s plans, objectives, projections, expectations and
intentions and other statements identified by words such as
“projects,” “may,” “might,” “will,” “could,” “would,” “should,”
“continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,”
“anticipates,” “estimates,” “intends,” “plans,” “potential,” or
similar expressions (including their use in the negative), or by
discussions of future matters such as: the development of product
candidates or products; timing and success of trial results and
regulatory review; potential attributes and benefits of product
candidates; and other statements that are not historical. These
statements are based upon the current beliefs and expectations of
Cerecor’s management but are subject to significant risks and
uncertainties, including: drug development costs, timing and other
risks, including reliance on investigators and enrollment of
patients in clinical trials, which might be slowed by the COVID-19
pandemic; regulatory risks; Cerecor's cash position and the
potential need for it to raise additional capital; general economic
and market risks and uncertainties, including those caused by the
COVID-19 pandemic; and those other risks detailed in Cerecor’s
filings with the Securities and Exchange Commission. Actual results
may differ from those set forth in the forward-looking statements.
Except as required by applicable law, Cerecor expressly disclaims
any obligations or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Cerecor’s expectations with respect thereto
or any change in events, conditions or circumstances on which any
statement is based.
For media and investor inquiriesJames Harrell
Investor RelationsChief Commercial OfficerCerecor
Inc.jharrell@cerecor.com623.439.2220 office
1Nakamura K, Kassem S, Cleynen A et al. Cancer Cell. 2018.
33(4):634-648.e5. 2National Cancer Institute, Cancer Stat Facts:
Myeloma (https://seer.cancer.gov/statfacts/html/mulmy.html)
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