DURHAM, N.C., Jan. 8, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today provided an update on AdVise, a Phase 3 trial of brincidofovir for the treatment of adenovirus, an infection that can be fatal in people with weakened immune systems. There are currently no approved treatments for adenovirus.
The AdVise trial is enrolling immunocompromised individuals – including allogeneic hematopoietic cell transplant (HCT, or bone marrow transplant) recipients, solid organ transplant recipients and people who are immunosuppressed following chemotherapy. In the planned final study design, patients will receive brincidofovir twice weekly for 12 weeks, with a 12-week follow-up period. Since there are no other treatments for adenovirus, the 24-week survival of each brincidofovir-treated patient will be compared to two historic controls; matched historic controls will be selected from the same participating medical centers, and will include patients with confirmed adenovirus infection who received supportive care and best available therapy prior to the initiation of AdVise.The controls will be matched by cohort (i.e., allogeneic HCT with or without disseminated disease), age, and transplant type. Data from the pilot portion of the AdVise study that was initiated in March 2014 will also be part of the final data analysis.
"We are optimistic about the latest data from the AdVise trial, and are looking forward to evolving the current pilot study into a matched historical control design. AdVise provides an opportunity to more broadly evaluate brincidofovir in adenovirus disease, which we hope will bring us a step closer to having a viable therapy for this life-threatening infection," said Garrett Nichols, MD, MS, Chief Medical Officer of Chimerix.
Brincidofovir for the Treatment of Ebola Virus Disease
A Phase 2 open-label study evaluating brincidofovir in up to 140 patients with confirmed Ebola Virus Disease was initiated on January 2 at Médecins Sans Frontières (MSF)'s ELWA 3 Ebola Management Centre in Monrovia, Liberia. The clinical evaluation is being conducted through a collaboration with the University of Oxford and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) with operational support from MSF and funding provided by The Wellcome Trust. Discussions are ongoing regarding randomized clinical trials of brincidofovir for Ebola Virus Disease.
Brincidofovir for the Prevention of Cytomegalovirus (CMV) in Kidney Transplant Recipients
Chimerix plans to initiate a clinical study of brincidofovir for the prevention of CMV in kidney transplant recipients in the first half of 2015.
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir, is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including viruses in the herpes virus family and adenovirus. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date, side effects that can be treatment limiting with currently available antivirals. Building on the positive Phase 2 results in cytomegalovirus (CMV) prevention, Chimerix initiated the Phase 3 SUPPRESS trial in 2013. If positive, data from SUPPRESS will support Chimerix's initial regulatory submission for brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix is also enrolling AdVise, a Phase 3 trial in adenovirus, which is an often-fatal viral infection with no approved treatment. Chimerix is working with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received Fast Track designation from the FDA for CMV, adenovirus, and smallpox.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary technology has produced brincidofovir (CMX001), a clinical-stage nucleotide analog lipid-conjugate, which has demonstrated potent antiviral activity and safety in convenient, orally administered dosing regimens. Chimerix is currently enrolling SUPPRESS, a Phase 3 study of brincidofovir for the prevention of cytomegalovirus (CMV) in adult hematopoietic cell transplant (HCT) recipients. In addition, Chimerix is enrolling the Phase 3 AdVise trial of brincidofovir for treatment of adenovirus (AdV) infection. Chimerix is working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. 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 Quarterly Report on Form 10-Q, 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.
CONTACT: Joseph T. Schepers
Executive Director,
Investor Relations and Corporate Communications
ir@chimerix.com
919-287-4125
