- CMX001 demonstrated positive clinical activity against life-threatening adenovirus infection in patients enrolled in the CMX001 Compassionate Use Program
- A significant proportion of patients in the CMX001 Compassionate Use Program had evidence of active infection with more than one virus
DURHAM, N.C., April 29, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today the presentation of the first clinical outcomes data on the use of CMX001 in patients with life-threatening infection with adenovirus (AdV), a disease with no approved therapy. The data were presented at the European Group for Blood and Marrow Transplantation's (EBMT) Annual Meeting held April 7 - 10 in London, England. CMX001 is an investigational oral nucleotide analog lipid-conjugate that has a broad spectrum of antiviral activity against double-stranded DNA (dsDNA) viruses.
"These data from our Compassionate Use Program show that CMX001 has the potential to treat life-threatening infections with AdV, a disease which can be 80% fatal in young adults and children who have undergone a stem cell or bone marrow transplant," said M. Michelle Berrey, MD, MPH, Chief Medical Officer of Chimerix. "CMX001 is being developed as a potential prevention or early treatment for AdV and other viral infections such as cytomegalovirus (CMV) which threaten patients with a weakened immune system. CMX001 is the only investigational antiviral with the potential to treat or prevent viral infections caused by several dsDNA viruses."
These data were presented during the Infectious diseases oral session on Wednesday, April 10, and the Infectious diseases poster session on Tuesday, April 9.
The presentations included:
CMX001 is a potential treatment for AdV infection: preliminary antiviral activity results from an open-label, expanded access study of CMX001 for the treatment of serious or life-threatening diseases caused by dsDNA viruses
Preliminary clinical and viral outcomes data from 57 patients infected with AdV who were treated with CMX001 in an open label, expanded access study. Patients received oral CMX001 twice weekly. The median duration of CMX001 treatment was 12 doses over seven weeks, with the longest duration of treatment of 43 weeks. The level of AdV in the patient's blood was measured at the beginning of therapy, regularly during the treatment period, and at one and four weeks post-treatment. Thirty-four of the 57 patients (79%) had at least a 90% decrease in the amount of virus in the blood at the end of treatment. Patients who had a 90% decrease in AdV blood levels had overall better outcomes, with 9% AdV-associated deaths, compared to a 27% mortality rate for patients who had less than a 90% decrease in viral levels. Patients who began CMX001 therapy earlier in the AdV infection, as soon as virus was detected in the blood and before symptoms were present, had a lower mortality rate of less than 7%, while patients who were treated after virus was detected in the blood and symptoms had developed had a mortality rate of 37% during the one-month follow-up period. Untreated AdV infections in the respiratory tract can have a mortality rate of 80% in children who have received a bone marrow or stem cell transplant. There are currently no approved therapies for AdV infection. CMX001 is in a Phase 2 study as an early treatment for AdV infection in young adults and children who have received a stem cell or bone marrow transplant.
Demographic/baseline characteristics of patients treated with CMX001 for serious or life threatening dsDNA virus infections: predictors of multiple dsDNA virus infections
Demographic and baseline characteristics from 320 patients enrolled in the CMX001 Compassionate Use Program were analyzed using a logistic regression model. To qualify for the program, patients must have had a life-threatening infection with at least one dsDNA virus. This analysis assessed the predictability of demographic and baseline characteristics (gender, age, race/ethnicity, transplant type) on specific viral infections and the likelihood of having more than one viral infection. Approximately one-third of patients enrolled in the Compassionate Use Program had evidence of more than one active infection with a dsDNA virus. The most common co-incident infections in the same patient were CMV and BK virus (BKV), AdV and BKV, and AdV and CMV. Patients enrolled following stem cell transplant, particularly children, had an increased likelihood of multiple dsDNA virus infections. The potential of CMX001 as a broad-spectrum prevention for multiple dsDNA viral infections will be explored in a large Phase 3 study beginning in mid-2013.
About CMX001
Chimerix's lead product candidate, CMX001, is a broad-spectrum oral nucleotide analog that blocks replication of all five families of dsDNA viruses that infect humans, including CMV, AdV, BKV and herpes simplex viruses. In a Phase 2 trial, CMX001 demonstrated potential clinical utility in prevention of CMV infection in high-risk patients who had received a hematopoietic stem cell transplant (HSCT). Chimerix anticipates initiating SUPPRESS, its Phase 3 trial of CMX001 for the prevention of CMV infection in adults undergoing HSCT, in mid-2013. In December 2012, Chimerix completed enrollment of a Phase 2 trial in pediatric and adult HSCT recipients evaluating CMX001 as a preemptive therapy for AdV disease, an often-fatal infection with no approved therapies. Since 2009, Chimerix has made CMX001 available through a Compassionate Use Program to over 80 medical centers worldwide for the treatment of over 430 patients with life-threatening dsDNA viral infections and no alternative treatment.
Chimerix has received Federal funding for the development of CMX001 as a potential medical countermeasure against smallpox from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201100013C.
About Chimerix
Chimerix, a biopharmaceutical company based in Durham, NC, is committed to the discovery, development and commercialization of novel, oral antiviral therapeutics designed to transform patient care in areas of high unmet medical need. Chimerix's proprietary lipid technology has given rise to two clinical-stage lipid acyclic nucleoside phosphonates, CMX001 and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Chimerix's second product candidate, CMX157, an oral nucleotide analog lipid-conjugate for the treatment of HIV infection, was licensed to Merck in July 2012.
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. Such statements include, but are not limited to, statements regarding Chimerix's timing for initiating the Phase 3 SUPPRESS trial, the efficacy of CMX001 and its ability to provide a broad spectrum of antiviral activity and the positive impact of CMX001 on transplant recipients. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Chimerix's estimates regarding its ability to initiate the SUPPRESS trial; the success of the SUPPRESS trial and Phase 2 trials; the demonstrated efficacy of CMX001 in the SUPPRESS trial and Phase 2 trials; the accuracy of Chimerix's estimates regarding expenses and capital requirements; regulatory developments in the United States and foreign countries; Chimerix's ability to obtain and maintain intellectual property protection for CMX001; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Chimerix's filings with the Securities and Exchange Commission, including without limitation its Registration Statement on Form S-1 that was originally filed with the Securities and Exchange Commission on March 8, 2013, and the amendments thereto. 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.