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Brincidofovir demonstrated a statistically significant survival advantage in two well-characterized animal models of lethal orthopoxvirus infection
DURHAM, N.C., Jan. 29, 2020 (GLOBE NEWSWIRE) -- Chimerix (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.
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.