Landmark AdVance Study Shows Adenovirus Burden Correlates with Mortality in Pediatric Allogeneic Hematopoietic Cell Transplan...
October 04 2018 - 7:00AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing
novel antivirals to address unmet medical needs, today announced
the full analysis of adenovirus (AdV) viral load dynamics and
all-cause mortality in pediatric patients. These data from the
AdVance study, the first large, multi-center study of AdV
incidence, natural history, management and clinical outcomes in
allogeneic hematopoietic cell transplant (allo-HCT) recipients will
be presented at IDWeek™ 2018, held October 3-7 in San Francisco,
CA.
Prior to the AdVance study, the epidemiology of
AdV after allo-HCT has been generally understood via single-center
studies, with little data on the correlation between AdV viral load
and risk of mortality. Historically, acceptance of virologic
endpoints as surrogates for clinical outcomes such as survival have
been important in progressing antiviral development in other viral
diseases.
“AdVance represents a significant step forward in our
understanding of the impact of adenovirus on allo-HCT recipients.
Although clinicians have long held anecdotal correlations of high
adenovirus measures and mortality in the six months after
transplant, we now have data from transplant centers across
Europe that support the correlation of AdV viral
burden and mortality,” said Garrett Nichols, MD, MS, Chief
Medical Officer of Chimerix. “AdVance shows for the first
time that viral burden measured as adenovirus area under the
curve is predictive of short-term survival. These
data further validate the use of this primary
endpoint in our ongoing AdAPT trial of
brincidofovir in pediatric allo-HCT recipients.”
The AdVance natural history study was a multi-center,
multinational analysis conducted in 2017 that examined the
incidence, practice patterns, hospitalization and clinical outcomes
of 4,276 (1,738 pediatric, 2,538 adults) allo-HCT recipients. At
IDWeek in San Francisco, an analysis will be presented which
further explores the relationship between pediatric (<18 years)
AdV viral load dynamics and all-cause mortality. Notably, 241
patients had AdV viremia ≥1,000 copies/mL within six months of
allo-HCT. Eighteen percent (18%, 43/241) of pediatric patients died
within six months of experiencing their first plasma AdV ≥1000
copies/mL.
The statistical
analyses explored the
relationship between six different dynamic AdV viral load measures
and all-cause mortality, including:
- AdV time-averaged area under the curve (AAUC)
- Peak AdV viremia
- AdV viral load over time
- Two-week change in AdV viremia
- Days of viremia <1,000 copies/mL
- Days of undetectable AdV viremia
Key findings include a greater than
ten-fold risk of mortality with highest AdV burden.
- Patients in the highest quartile of AdV AAUC had a mortality
hazard ratio of 11.6 relative to those in the lowest quartile,
showing that AAUC is a clinically useful indicator for AdV
infection outcome.
- Peak AdV viral load and persistence of AdV viremia were
associated with stepwise increases in mortality, even after
adjusting for immune reconstitution.
- AdV AAUC incorporates both viral peak and persistence, with
each log10 increase in AdV AAUC associated with approximately a
doubling of mortality risk.
- In multivariate analyses, all AdV viral dynamic measures were
shown to be significantly associated with, and independent
predictors of, all-cause mortality.
Oral presentation details:
- Abstract Title: Adenovirus Load Dynamics Are
Consistently Correlated with Risk of Mortality in Pediatric
Allogeneic Hematopoietic Cell Transplant Recipients: Findings from
the Landmark AdVance Study (1732)
- Oral Abstract Session: Transplant and
Immunocompromised Hosts: Emerging Issues
- Location & Time: Room W 2002; Saturday,
October 6, 2018, 9:15 a.m. PDT (12:15 p.m. EDT)
About Brincidofovir
Chimerix's lead product candidate,
brincidofovir, is a nucleotide analog that has antiviral activity
against all five families of DNA viruses that affect humans,
including adenoviruses and variola virus, the virus that causes
smallpox. Brincidofovir has a high barrier to resistance, no
myelosuppression and a low risk of nephrotoxicity. Brincidofovir
has received Fast Track designation from the FDA for
cytomegalovirus (CMV) and smallpox. Brincidofovir has also received
Orphan Medicinal Product Designation from the European
Commission for the treatment of adenovirus, for the prevention
of CMV disease, and for the treatment of smallpox, and Orphan Drug
Designation from the FDA for the treatment of smallpox.
About Chimerix
Chimerix is a biopharmaceutical company
dedicated to discovering, developing and commercializing medicines
that improve outcomes for immunocompromised patients. Chimerix's
proprietary lipid conjugate technology and compound library have
produced brincidofovir (BCV, CMX001); CMX157, which was licensed to
ContraVir Pharmaceuticals; and CMX521, the first clinical-stage
direct-acting antiviral for the treatment and prevention of
norovirus. For further information, please visit Chimerix's
website, www.chimerix.com.
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other factors, including the possibility our current or future
clinical trials of brincidofovir may not be successful, that
FDA and other regulatory authorities may not approve
brincidofovir or brincidofovir-based regimens, and that marketing
approvals, if granted, may have significant limitations on their
use. As a result, brincidofovir may never be successfully
commercialized. In addition, Chimerix may be unable to
file for regulatory approval for brincidofovir with other
regulatory authorities. Similar risks and uncertainties apply to
the Company’s development of CMX521. These risks, uncertainties and
other factors could cause actual results to differ materially from
those expressed or implied by such forward-looking statements.
Risks are described more fully in the Company's filings with
the Securities and Exchange Commission, including without
limitation the Company's most recent Quarterly Report on Form 10-Q
and other documents subsequently filed with or furnished to
the Securities and Exchange Commission. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. The Company undertakes no obligation
to update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
CONTACT:Investor Relations: Michelle
LaSpaluto(919) 972-7115ir@chimerix.com or Will O’Connor Stern
Investor Relations Will@sternir.com 212-362-1200
Media: Laurie MasonsonW2O Grouplmasonson@w2group.com(917)
459-6164
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Sep 2023 to Sep 2024