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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Chimerix Inc | NASDAQ:CMRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.0471 | 4.94% | 1.00 | 0.997 | 1.01 | 1.025 | 0.94 | 0.95 | 365,100 | 19:27:24 |
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
Greater than Ten-Fold Risk of Mortality with Highest AdV Burden
Among pediatric allo-HCT recipients:
Chimerix will share additional findings from the AdVance study in four presentations on Tuesday, March 20, 2018 at EBMT:
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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