DURHAM, N.C., Feb. 12, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) announced the presentation of preliminary data from the open-label, Phase 3 AdVise trial of brincidofovir for adenovirus infection showing a short-term mortality rate of less than 40 percent. The current analysis is based on the first 85 subjects enrolled and supports the trend seen in the first 48 subjects as presented at the meeting of the Infectious Diseases Society of America (IDSA), IDWeek. Historic mortality rates as high as 80 percent for disseminated adenovirus disease have been reported. These data will be presented today at 4:45 p.m. PT at the 2015 BMT Tandem Meetings, the combined annual meetings of the Center for International Blood and Marrow Transplant Research and the American Society of Blood and Marrow Transplantation, taking place in San Diego, CA. Final trial results will be reported at a later date and will comprise clinical outcomes for trial subjects as compared to matched historical controls.
Adenovirus is a common virus that leads to upper respiratory or gastrointestinal infections in individuals with a healthy immune system, but it can be rapidly fatal in individuals with a weakened immune system, particularly those who have recently undergone a hematopoietic or bone marrow transplant. There is no approved treatment for adenovirus infection. Brincidofovir is an investigational antiviral that has demonstrated in vitro activity against adenovirus and multiple other DNA viruses. Supportive clinical data on the potential utility of brincidofovir were generated from an expanded access study (Study 350), single-patient experiences, and a Phase 2 dose-ranging study in bone marrow transplant patients with adenovirus infection.
The Phase 3 AdVise trial began enrolling in March 2014 and continues to enroll. Immunocompromised patients with asymptomatic, localized, or disseminated adenovirus infection receive brincidofovir for 12 weeks, and are followed for a minimum of 12 weeks after treatment; median observation in this analysis was 10 weeks following the first dose (range: 1 to 34 weeks). Preliminary results from the initial 85 subjects enrolled show a mortality rate of less than 40 percent for bone marrow transplant recipients with disseminated disease and for the patient population overall. This mortality rate has clinical implications for the potential utility of brincidofovir in this indication as compared with the published mortality rates of up to 80 percent for transplant recipients with disseminated disease1. Notably, the high-risk transplant recipients who began brincidofovir with localized or asymptomatic adenovirus infection had a preliminary observed mortality rate of 11 percent (2 of 18 subjects). In addition to these important clinical outcomes, a median 99 percent decrease in the amount of adenovirus in the blood (viral load) was observed.
The preliminary safety and tolerability data in this acutely ill patient population showed a low rate of withdrawal due to brincidofovir-associated adverse events (3/85, 4 percent), with three patients withdrawing from therapy due to lower gastrointestinal events.
"Adenovirus is a severe and often rapidly fatal viral infection in the high-risk bone marrow transplant population, and we currently have no approved treatments," said Michael S. Grimley, MD, Associate Professor of Clinical Pediatrics, Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, who will present the data. "The encouraging data being presented today provide hope that brincidofovir may offer a clinically meaningful treatment option for this life-threatening infection."
Although adenovirus infection has been mostly described in pediatric patients, approximately one-third of subjects enrolled in AdVise were 18 years of age or older, with the oldest patient at 69 years of age. Importantly, over half of the patients who qualified for AdVise had a second significant viral infection in addition to adenovirus; these infections included BK virus (46 percent), cytomegalovirus (28 percent) and Epstein Barr virus (6 percent).
"We're encouraged by these data which support our earlier presentation at IDWeek and reinforce the potential for brincidofovir to improve upon historical survival rates for adenovirus infection and to potentially provide the first approved treatment for this life-threatening infection," said W. Garrett Nichols, M.D., M.S., Chief Medical Officer of Chimerix. "Further, these data underscore the need for an antiviral with activity against multiple viruses given that more than half of the patients who enrolled in AdVise were fighting two or more viral infections."
AdVise is a Phase 3 clinical trial to evaluate the safety and efficacy of brincidofovir for the treatment of adenovirus infection. In March 2014, Chimerix initiated the open-label pilot portion of the study. At least 100 allogeneic hematopoietic cell transplant (HCT) recipients with disseminated adenovirus infection, including those patients who were enrolled in the pilot portion of the study, will receive 12 weeks of treatment with brincidofovir and will be followed for at least 12 weeks post-treatment. Clinical outcomes data including mortality will be compared to data from matched historical controls from the participating medical centers. Disseminated adenovirus disease can be associated with a mortality rate of up to 80 percent in patients who are undergoing hematopoietic cell transplant. There are no therapies approved to treat this infection. Adenovirus causes upper respiratory infections or gastrointestinal symptoms in individuals with a functional immune system, but it can lead to life-threatening infections – including pneumonia and hepatitis – leading to death in those with a weakened immune system, such as patients who have undergone a transplant.
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 potent in vitro antiviral activity against many clinically relevant dsDNA viruses and a favorable safety profile in clinical studies conducted to date. 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 potential medical countermeasure against smallpox. For further information, please visit Chimerix's website, www.chimerix.com.
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.
1Lion T. 2014. Clin. Microbiol. Rev. 2014, 27(3):441-462.
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