DURHAM, N.C., Dec. 23, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today provided a year-end recap of 2014 highlights for the investigational oral broad-spectrum antiviral brincidofovir.
M. Michelle Berrey, M.D., M.P.H., President and CEO of Chimerix, said, "2014 was a pivotal year for brincidofovir and for Chimerix. In March we initiated the AdVise study in children with life-threatening adenovirus infection; in October we presented our initial clinical outcomes data from the first 48 subjects enrolled in AdVise, and showed the potential benefit of BCV on survival in this otherwise deadly viral infection. In late August the U.S. Centers for Disease Control and Prevention shared results of their independent studies showing in vitro activity of brincidofovir against Ebola virus. Through the last few months Chimerix has partnered with global health organizations and government agencies to advance the critical clinical studies which will help us understand the potential role of brincidofovir in treating Ebola Virus Disease, and in treating or preventing multiple life-threatening viral infections in at-risk patients. Chimerix is now poised to deliver on significant corporate and development milestones in 2015."
- Brincidofovir for CMV: SUPPRESS – Data in Second Half 2015
Results from the 450-patient Phase 3 SUPPRESS trial for the prevention of cytomegalovirus (CMV) infection in hematopoietic cell transplant recipients are expected in the second half of 2015. If positive, these data would support the first regulatory submission for brincidofovir for the prevention of CMV infection following stem cell transplantation. There is currently no approved therapy for the prevention of CMV in these patients.
- Brincidofovir for Adenovirus: AdVise – Additional Clinical Outcomes Data in 2015
Additional clinical outcomes data from the pilot portion of AdVise have been accepted for oral presentation at the 2015 BMT Tandem Meetings in February. There is currently no approved treatment for adenovirus infection, a too-often fatal infection in patients with compromised immune systems.
- Brincidofovir for Ebola Virus Disease – First Clinical Study to begin in Liberia
The critical clinical evaluation of brincidofovir for Ebola Virus Disease is advancing through a collaboration with the University of Oxford and ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) with operational support from Médecins Sans Frontières and with funding provided by The Wellcome Trust. The World Health Organization and relevant European and African health authorities are also participating in this important clinical research. This initial clinical evaluation of brincidofovir will be a Phase 2 open-label study of up to 140 patients with confirmed Ebola Virus Disease; survival for patients who receive brincidofovir will be compared with survival for patients in the period leading up to this study. A second, controlled trial comparing brincidofovir to another potentially active investigational therapeutic is under development for conduct in Liberia or Sierra Leone through the collaboration with WHO and Oxford University.
Following the administration of brincidofovir to several patients with Ebola Virus Disease through Emergency Investigational New Drug Application (IND) or single-patient protocol, the U.S. Food and Drug Administration (FDA) authorized Study 205, a single-arm study to evaluate the safety and antiviral activity of brincidofovir in patients with confirmed Ebola Virus Disease. At this time, additional clinical or preclinical data and further discussion with the FDA are required before brincidofovir can be administered for Ebola Virus Disease via Study 205 or Emergency IND. In early 2015, Study 205 will be open at multiple medical centers in Europe and may be accessible to patients with confirmed Ebola Virus Disease.
About Brincidofovir (BCV, 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 herpesvirus family and adenoviruses. In over 1,000 patients treated to date, brincidofovir has not been associated with kidney or bone marrow toxicity, side effects that can be treatment-limiting with available antivirals. Building on the positive Phase 2 results in the prevention of cytomegalovirus (CMV) infection, Chimerix initiated the SUPPRESS Phase 3 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. In March 2013 Chimerix initiated AdVise, a Phase 3 trial in disseminated adenovirus infection, an often-fatal infection in immune-compromised children and adults. Chimerix has a longstanding collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received FDA Fast Track designation 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 (BCV, 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. Chimerix is enrolling the Phase 3 AdVise trial of brincidofovir for treatment of adenovirus (AdV) infection. Chimerix has a longstanding collaboration with BARDA to develop brincidofovir as a medical countermeasure for smallpox. For further information, please visit Chimerix's website: www.chimerix.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, Dr. Berrey's statements in the second paragraph of the press release, and the information provided regarding (i) Chimerix's intended regulatory submissions, (ii) Chimerix's request for priority review and (iii) Chimerix's planned Expanded Access program for patients with disseminated adenovirus infection. While Chimerix believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of factors that could cause actual events or results to differ materially from those indicated 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.