DURHAM, N.C., March 24, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq: CMRX ), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced an upcoming presentation on its investigational broad-spectrum antiviral brincidofovir (CMX001) at the 40 th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) being held March 30 – April 2, 2014 in Milan, Italy.
The presentation will summarize safety data from two placebo-controlled studies and an expanded access trial of brincidofovir. Brincidofovir therapy showed no evidence of negative effects on white blood cell production, an important indication of a successful new bone marrow transplant, which is also known as a hematopoietic cell transplant (HCT). The lack of negative impact on the white blood cells or new bone marrow has allowed brincidofovir to begin dosing at the time of the transplant in the Phase 3 trial, SUPPRESS. SUPPRESS is currently enrolling adult allogeneic HCT recipients to determine the safety and efficacy of brincidofovir for the prevention of cytomegalovirus (CMV) infection in high-risk HCT recipients.
"Pre-engraftment Initiation of Brincidofovir (CMX001) in Hematopoietic Cell Transplant Recipients is Supported by Lack of Myeloid Toxicity" will be presented by Marion Morrison, MD, of Chimerix, on Tuesday, April 1, 2014. For more information, please visit EBMT's conference website: www.ebmt2014.org .
The risk of viral infections, especially CMV, is highest in the first three months after bone marrow transplant, while the new immune system is being established. CMV infection remains the most common serious infection following HCT. Available antivirals that have anti-CMV activity are not able to be used as a prevention for CMV infection in at-risk HCT recipients because of the known negative effects on the white blood cells of the immune system. The lack of hematologic toxicity shown in this analysis is an important potential advantage for brincidofovir if the safety profile is confirmed in the ongoing Phase 3 trial.
About the European Group for Blood and Marrow Transplantation (EBMT)
The EBMT is a non-profit organization that was established in 1974 to allow scientists and physicians involved in clinical bone marrow transplantation to share their experience and develop co-operative studies. The EBMT aims to promote all aspects associated with the transplantation of hematopoietic stem cells from all donor sources and donor types including basic and clinical research, education, standardization, quality control and accreditation for transplant procedures. For further information about the EBMT, please visit the website: www.ebmt.org .
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir, has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections caused by DNA viruses. Brincidofovir is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex viruses.
In September 2013, data from Chimerix's Phase 2 trial of brincidofovir in the prevention of CMV in recipients of hematopoietic cell transplants (HCT) were published in The New England Journal of Medicine (N Engl J Med 369:1227-36). Building on these positive Phase 2 results in CMV prevention, Chimerix initiated the Phase 3 SUPPRESS trial in the third quarter of 2013 which, if positive, will be used to support Chimerix's initial regulatory submission for the Accelerated Approval of brincidofovir for prevention of CMV infection in adult HCT recipients.
In late 2013, Chimerix presented data from an exploratory trial of brincidofovir in early AdV infection. A brincidofovir dose of 100 mg twice weekly initiated at the time of detection of AdV in the blood, provided evidence of an antiviral effect, and a numeric decrease in overall mortality. In March 2014, Chimerix initiated an open-label pilot trial of brincidofovir for the treatment of AdV infection in immunocompromised patients.
Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir and CMX157, both of which have potential for enhanced activity and safety in convenient, orally administered dosing regimens. In the third quarter of 2013, Chimerix initiated the Phase 3 SUPPRESS trial of brincidofovir for the prevention of CMV infection in adult HCT recipients, also known as bone marrow transplants. Brincidofovir has shown broad-spectrum in vitro activity against all five families of DNA viruses that affect humans, including CMV, AdV, BKV and herpes simplex viruses. Brincidofovir has received Fast Track designation by the FDA, and the Phase 3 data, if positive, would be used to support Chimerix's initial regulatory submission for the Accelerated Approval of brincidofovir for the prevention of CMV infection in adult HCT recipients. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. Chimerix's second product candidate, CMX157, was licensed to Merck in July 2012 for the treatment of HIV infections. For further information, please visit Chimerix's website, www.chimerix.com .
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Chimerix's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K, its most recently filed Current Reports on Form 8-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. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CHIMERIX CONTACT: Joseph T. Schepers Executive Director, Investor Relations and Corporate Communications 919-287-4125
