The AdVance Study: a Landmark Natural History Study of Adenovirus in Allogeneic Hematopoietic Cell Transplant Shows Strong Co...
March 19 2018 - 7:00AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing
novel antivirals to address unmet medical needs, today announced
data from AdVance, the first large, multi-center study of
adenovirus (AdV) incidence, natural history, management and
clinical outcomes in allogeneic hematopoietic cell transplant
(allo-HCT) recipients. These data will be presented at the 44th
Annual Meeting of the European Society of Blood and Marrow
Transplantation held March 18–21 in Lisbon, Portugal.
Prior to the AdVance study, data and evidence
regarding AdV epidemiology after allo-HCT has been generally
limited to single-center studies. As Chimerix advances its
brincidofovir development program in serious adenovirus infections,
the Company undertook the AdVance study to better characterize the
real-world incidence and outcomes of these infections.
“The AdVance study is the first of its kind to
evaluate the impact of adenovirus infection in the transplant
setting,” said M. Michelle Berrey, MD, MPH, President and Chief
Executive Officer of Chimerix. “This groundbreaking study provides
further evidence of the tremendous unmet need for an effective
treatment for adenovirus, given an infection rate upwards of 32
percent in pediatric allo-HCT recipients and a strong correlation
between adenovirus viral burden and mortality in the first year
post-transplant. These results further strengthen our commitment to
advance brincidofovir as the first potential treatment for serious
adenovirus infections.”
The multi-center, multinational study, conducted
in 2017, examined the incidence, practice patterns, hospitalization
and clinical outcomes of 4,276 (1,738 pediatric, 2,538 adults)
allo-HCT recipients. The population of this study included allo-HCT
performed at 50 centers in Europe from January 2013 to September
2015. The study also assessed AdV plasma viral burden, measured by
time-averaged area under the curve (AAUC), and its correlation with
overall and non-relapse-related mortality.
“The robust findings of the AdVance study are
extremely important for transplant clinicians, as we seek to better
understand the rates and clinical outcomes of adenovirus infection
and assess ways to evaluate antiviral therapies,” said Marco Zecca,
MD, pediatric hematologist and oncologist at Fondazione IRCCS
Policlinico San Matteo and an investigator in the AdVance study.
“Among pediatric allo-HCT recipients in the study, the highest
mortality was observed in those with the greatest adenovirus
burden, with 52 percent mortality in the quartile of highest
adenovirus AAUC, compared to 3 percent mortality reported in the
quartile of lowest AAUC. These data suggest that AdV AAUC is an
appropriate endpoint to assess the potential benefits of antiviral
therapies for the treatment of adenovirus.”
One in Three Pediatric Allo-HCT
Recipients Impacted by Adenovirus
- In the AdVance study, 32 percent of pediatric allo-HCT
recipients developed an AdV infection in the first six months
following allo-HCT.
- Among pediatric allo-HCT recipients, 23 percent developed
detectable AdV viremia (virus in the blood) and 14 percent
developed greater than 1,000 copies/mL, a level previously
associated with negative clinical outcomes.
- In adults, a much lower rate of 6 percent of transplant
recipients were found to have AdV viremia, but only 36 percent of
adult transplant centers employed regular screening protocols
compared with 100 percent of pediatric centers. Thus, AdV
infections in adult HCT may be under-diagnosed and
underreported.
Greater than Ten-Fold Risk of Mortality
with Highest AdV Burden
Among pediatric allo-HCT recipients:
- In patients with AdV viremia over 1,000 copies/mL in the first
six months after transplant, there was an 18 percent mortality rate
of any cause within 6 months.
- In a multivariate analysis, each 10-fold increase in AdV AAUC
(total viral burden) was associated with almost a doubling (1.9
times) of the mortality risk.
- A patient with AdV level in the highest AdV AAUC quartile had a
12 times greater risk of dying than a patient with AdV in the
lowest AAUC quartile.
- The highest mortality was observed in those with the greatest
adenovirus burden, as measured by AdV AAUC. The highest AdV AAUC
quartile had 52 percent 6-month mortality compared to 3 percent
mortality in the quartile of lowest AdV AAUC.
- These data suggest that AdV AAUC is an appropriate endpoint to
assess the potential benefits of antiviral therapies for the
treatment of adenovirus.
- Adenovirus infection in pediatric allo-HCT recipients was also
associated with significantly longer hospital stays.
Chimerix will share additional findings from the
AdVance study in four presentations on Tuesday, March 20, 2018 at
EBMT:
- Incidence of Adenovirus Infections in Pediatric and Adult
Allogeneic Hematopoietic Cell Transplant Recipients in Europe;
Sebastian Voigt, OS-9: Infectious Complications, 18:00 WET,
Auditorium VIII
- Adenovirus Viral Burden is Associated with Mortality in
Pediatric Allogeneic Hematopoietic Cell Transplant Recipients:
Results from the Advance Study; Marco Zecca, OS-9: Infectious
Complications, 18:10 WET, Auditorium VIII
- Adenovirus Viremia is Associated with Substantially Prolonged
Hospitalization in Pediatric Allogeneic Hematopoietic Cell
Transplant Recipients; Antonio Pèrez-Martinez, B073, Infectious
Complications poster session, 9:00 WET, Poster Area / Pavilion
1
- Screening, Monitoring, and Treatment of Adenovirus Infections
in Pediatric and Adult Recipients of Allogeneic Hematopoietic Cell
Transplants: Multicenter Survey of European Transplant Centers;
Kanchan Rao, B043, Hematopoietic Stem Cells poster session, 9:00
WET, Poster Area / Pavilion 1
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 the herpesviruses and adenoviruses. 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 adenovirus, 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.
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 a new clinical
candidate, 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 that there may not be a
viable continued development path for brincidofovir, 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. 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 Annual Report on Form 10-K 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:
ir@chimerix.com or Will O’Connor Stern Investor Relations
Will@sternir.com 212-362-1200
Media: Becky VonsiatskyW2O
Groupbvonsiatsky@w2ogroup.com 413-478-2003
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