Chimerix Presents Data Supporting Brincidofovir as a Potential Treatment for Smallpox at 2020 American Society for Microbiolo...
January 29 2020 - 8:00AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on
accelerating the development of medicines to treat cancer and other
serious diseases, today announces that data in support of
brincidofovir (BCV) as a potential treatment for smallpox were
highlighted in an oral presentation and poster at the 2020 American
Society for Microbiology (ASM) Biothreats Meeting taking place
January 28-30, 2020 in Arlington, Virginia. Chimerix is developing
BCV as a medical countermeasure against smallpox.
The poster titled, “Brincidofovir Treatment Efficacy in Two Well
Characterized Orthopoxvirus Infection Models of Smallpox,” can be
accessed on the Investor page of the Chimerix corporate
website.
Independent experiments were performed in two lethal animal
models of smallpox. In these studies, either rabbits or mice were
inoculated with rabbitpox or ectromelia virus, respectively, to
determine the survival benefit of BCV in animals acutely infected
with these orthopoxviruses. These animal models are being studied
in connection with the FDA Animal Rule to determine the utility of
BCV as a medical countermeasure against the human orthopoxvirus
disease, smallpox. Animals were randomized to receive either
placebo or BCV treatment at varying intervals post infection. In
both studies, animals that received BCV, regardless of time
post-infection, demonstrated a statistically significant survival
advantage relative to placebo.
Based on the increased survival evident in both studies, the
authors concluded, “These studies show that treatment with BCV post
exposure results in a statistically significant survival benefit in
two well-characterized orthopoxvirus infection models for smallpox.
These studies also provide a scientific rationale for therapeutic
intervention with BCV in the event of a smallpox outbreak when
vaccination is contraindicated or when diagnosis follows the
appearance of clinical signs and symptoms.”
“We are delighted to present the data from these two
confirmatory trials that demonstrate BCV’s significant survival
benefit in both orthopoxvirus infection models of smallpox. These
compelling data underscore the potentially life-saving benefit of
BCV and support the rationale for the Biomedical Advanced Research
and Development Authority (BARDA) to stockpile BCV as a
countermeasure in the event of a smallpox outbreak,” said Mike
Sherman, President and Chief Executive Officer of
Chimerix.
“We continue to look forward to conducting a pre-NDA meeting
with the U.S. Food and Drug Administration (FDA) and to our
planned submission of applications for approval of BCV in
mid-2020,” added Mr. Sherman.
About Chimerix
Chimerix is a development-stage biopharmaceutical company
dedicated to accelerating the advancement of innovative medicines
that make a meaningful impact in the lives of patients living with
cancer and other serious diseases. The two clinical-stage
development programs are dociparstat sodium (DSTAT) and
brincidofovir (BCV).
Dociparstat sodium is a potential first-in-class
glycosaminoglycan biologic derived from porcine heparin that has
low anticoagulant activity but retains the ability to inhibit
activities of several key proteins implicated in the retention and
viability of AML blasts and leukemic stem cells in the bone marrow
during chemotherapy (e.g., CXCL12, selectins, HMGB1).
Mobilization of AML blasts and leukemic stem cells from the bone
marrow has been associated with enhanced chemosensitivity and may
be a primary mechanism accounting for the observed increases in EFS
and OS in Phase 2 with DSTAT versus placebo. Randomized Phase 2
data suggest that DSTAT may also accelerate platelet recovery
post-chemotherapy via inhibition of platelet factor 4, a negative
regulator of platelet production that impairs platelet recovery
following chemotherapy. BCV is an antiviral drug candidate in
development as a medical countermeasure for smallpox. For further
information, please visit the Chimerix website,
www.chimerix.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Forward-looking
statements include those relating to, among other things,
Chimerix’s ability to develop BCV as a medical countermeasure for
smallpox; Chimerix’s ability to submit and/or obtain regulatory
approvals for BCV; and Chimerix’s ability to enter into a
procurement contract for BCV as a medical countermeasure. Among the
factors and risks that could cause actual results to differ
materially from those indicated in the forward-looking statements
are risks that BCV may not obtain regulatory approval from
the FDA or such approval may be delayed or conditioned;
risks that development activities related to BCV may not be
completed on time or at all; Chimerix’s reliance on a sole source
third-party manufacturer for drug supply; risks that ongoing or
future trials may not be successful or replicate previous trial
results, or may not be predictive of real-world results or of
results in subsequent trials; risks and uncertainties relating to
competitive products and technological changes that may limit
demand for our drugs; risks that our drugs may be precluded from
commercialization by the proprietary rights of third parties; risks
related to procurement of brincidofovir for the treatment of
smallpox and additional risks set forth in the Company's filings
with the Securities and Exchange Commission. These
forward-looking statements represent the Company's judgment as of
the date of this release. The Company disclaims, however, any
intent or obligation to update these forward-looking
statements.
CONTACT:Investor
Relations:
Michelle LaSpaluto 919 972-7115 ir@chimerix.com Will O’Connor Stern
Investor Relations will@sternir.com 212-362-1200
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