Brincidofovir Will Not Be Considered in Further Clinical Trials in Ebola Virus Disease
DURHAM, NC, USA I January 30, 2015 I Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that after discussion with the U.S. Food and Drug Administration, the company is ceasing further participation in all current and future clinical studies of brincidofovir for Ebola Virus Disease (EVD), including the study announced in December in Liberia sponsored by investigators at the University of Oxford and the supportive Phase 2 study of brincidofovir for EVD, Study 205.
Over the last several weeks the number of new cases of confirmed Ebola Virus Disease in Liberia has decreased significantly, with only a handful of patients enrolled to date in the single-arm study of brincidofovir led by the University of Oxford and ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) with operational support from Médecins Sans Frontières (MSF).
The decision to cease further study of brincidofovir in individuals with Ebola Virus Disease does not impact the company’s continued focus on advancing brincidofovir in pivotal studies of CMV prevention in recipients of allogeneic hematopoietic transplant and for the treatment of adenovirus infection in immunocompromised patients.
“We were honored to be able to work with the researchers at University of Oxford and ISARIC together with MSF to initiate the first clinical trial of an investigational agent during an outbreak. The progress in controlling the Ebola outbreak in Liberia is to be commended,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “Chimerix will continue to push forward with our development of brincidofovir for the prevention and treatment of serious viral infections in transplant recipients and other immunocompromised patients.”
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.
SOURCE: Chimerix
Post Views: 159
Brincidofovir Will Not Be Considered in Further Clinical Trials in Ebola Virus Disease
DURHAM, NC, USA I January 30, 2015 I Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that after discussion with the U.S. Food and Drug Administration, the company is ceasing further participation in all current and future clinical studies of brincidofovir for Ebola Virus Disease (EVD), including the study announced in December in Liberia sponsored by investigators at the University of Oxford and the supportive Phase 2 study of brincidofovir for EVD, Study 205.
Over the last several weeks the number of new cases of confirmed Ebola Virus Disease in Liberia has decreased significantly, with only a handful of patients enrolled to date in the single-arm study of brincidofovir led by the University of Oxford and ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) with operational support from Médecins Sans Frontières (MSF).
The decision to cease further study of brincidofovir in individuals with Ebola Virus Disease does not impact the company’s continued focus on advancing brincidofovir in pivotal studies of CMV prevention in recipients of allogeneic hematopoietic transplant and for the treatment of adenovirus infection in immunocompromised patients.
“We were honored to be able to work with the researchers at University of Oxford and ISARIC together with MSF to initiate the first clinical trial of an investigational agent during an outbreak. The progress in controlling the Ebola outbreak in Liberia is to be commended,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “Chimerix will continue to push forward with our development of brincidofovir for the prevention and treatment of serious viral infections in transplant recipients and other immunocompromised patients.”
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.
SOURCE: Chimerix
Post Views: 159
