Chimerix, Inc. Provides Update on Brincidofovir Pivotal Phase 3 Advise Trial for the Treatment of Adenovirus
January 08, 2015 at 07:00 pm IST
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Chimerix, Inc. 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.
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.
Chimerix, Inc. is a biotechnology company. The Company is focused on developing medicines that address unmet medical needs. The Company's product Imipridones is a cancer therapy that provides ONC201, which is in clinical-stage development for H3 K27M-mutant glioma as its lead indication. In addition, imipridone ONC206 is in dose-escalating clinical trials. Imipridones target specific G protein-coupled receptors (GPCRs) and mitochondrial caseinolytic protease P (ClpP), resulting in cancer cell death. The Company's product Imipridone chemical scaffold provides an opportunity to target GPCRs and ClpP with differential specificity and function. Its ONC212 is an imipridone, an investigational agonist of the orphan GPCR tumor suppressor GPR132, as well as ClpP. Its CMX521 is a nucleoside analog antiviral drug candidate for the treatment of SARS-CoV-2. The Chimerix Chemical Library contains over 10,000 heterocyclic ring systems and nucleosides, also includes approximately 3,500 nucleosides.
CHIMERIX, INC. 
