Disseminated Adenovirus Infection Eradicated in a Pediatric Hematopoietic Stem Cell Transplantation Recipient Who Received Chimerix's Lead Antiviral CMX001
— Emergency IND Case Report of Broad-Spectrum Antiviral CMX001 Published in Journal of Clinical Virology —
DURHAM, N.C., Feb. 24, 2011 /PRNewswire/ -- Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of the first reported case in which adenovirus (AdV) infection was successfully eradicated following treatment with its broad-spectrum antiviral drug, CMX001. Oral CMX001 was administered under an Emergency Investigational New Drug Application (EIND) to a severely immunocompromised pediatric stem cell patient following the patient's failure to respond to prior treatment with intravenous cidofovir. Data from this case report were published in the February edition of the Journal of Clinical Virology.
"Cases such as this highlight the life-saving potential of CMX001 to successfully and safely resolve severe viral infections. Data generated from Chimerix's clinical studies and numerous EIND cases in which CMX001 has been used to combat the full spectrum of double-stranded DNA viruses have greatly informed our late-stage clinical development plans," said Wendy Painter, M.D., Chief Medical Officer of Chimerix. "We see a unique opportunity to develop this drug for the prevention and treatment of viral infections that are frequently fatal to transplant patients. In particular, the lack of viable treatment options in the pediatric patient population must be rapidly addressed and we are preparing to initiate a Phase 2 clinical study in pediatric and adult transplant patients with adenovirus infections."
CMX001 is being developed by Chimerix for dual-use as a broad-spectrum antiviral for the treatment of life-threatening viral infections in immunocompromised patients and as a medical countermeasure in the event of a smallpox release. Chimerix is currently conducting a Phase 2 dose-defining clinical study of CMX001 in immunocompromised hematopoietic stem cell transplant patients at risk of life-threatening infection with cytomegalovirus. Chimerix is initiating a Phase 2 clinical study in immunocompromised pediatric and adult hematopoietic stem cell transplant patients with AdV infections. An open label study is also underway for the treatment of any of 12 different dsDNA viral infections, including adenovirus, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses.
Emergency IND Case Study of Disseminated Adenovirus Infection
The study was carried out under an EIND granted by FDA in a severely immunocompromised twelve-year-old bone marrow transplant patient. The patient presented with diarrhea, AdV viremia, AdV enteritis and positive cultures for AdV in the lung. Despite a reduction in immunosuppressive medications, the patient's AdV viremia continued to increase. Her clinical condition worsened, with severe gastrointestinal (GI) bleeding, hepatitis and respiratory failure. Initial treatment with intravenous cidofovir did not control the infection.
Once CMX001 treatment was initiated, a prompt and continued reduction in plasma adenovirus load was noted. Within five weeks of initiating treatment with oral CMX001, the patient's viral load was reduced to undetectable levels, while renal and hepatic function improved. Within eight weeks, the patient was transferred out of intensive care, hemodialysis was discontinued, and the patient's GI bleeding and renal impairment were resolved. Following resolution of AdV viremia and clinical signs and symptoms of disease, the patient was maintained on CMX001, which was well tolerated and no drug-related serious adverse events were observed.
The case report was published under the title " Eradication of disseminated adenovirus infection in a pediatric hematopoietic stem cell transplantation recipient using the novel antiviral agent CMX001 " in the February issue of the Journal of Clinical Virology (Paolino K, et. al., 2011; Vol. 50, issue 2, pg. 167-170).
About Chimerix and CMX001
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health.
The company's lead candidate, CMX001, is being developed as a potential broad spectrum antiviral agent for the treatment of life-threatening double-stranded DNA (dsDNA) viral diseases. Over 350 people have received CMX001 to date, with a growing body of evidence supporting the drug's antiviral activity in humans.
Clinical studies of CMX001 include an ongoing Phase 2 study of the prevention/control of cytomegalovirus (CMV) in hematopoietic stem cell transplant patients (CMX001-201), a Phase 2 study being initiated for the pre-emption of adenovirus (AdV) infection in pediatric and adult hematopoietic stem cell transplant patients (CMX001-202), and an Open-Label Study (CMX001-350) for the treatment of any of 12 different dsDNA viral infections, including AdV, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses. The Open-Label Study, which is designed to provide supportive data for CMX001's pivotal studies, builds on Chimerix's extensive experience working with clinicians at over 55 leading institutions in the United States, Canada, Europe and Israel who have sought CMX001 for the treatment of more than 150 immunocompromised patients under Emergency INDs. CMX001 has been well tolerated in all studies.
CMX001 is also being developed as a medical countermeasure in the event of a smallpox release. Chimerix has received significant federal funding for the development of CMX001 as a medical countermeasure against smallpox from the National Institute of Allergy and Infectious Diseases under Grant No. UO1-AI057233 in addition to new funding 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.
Chimerix's second clinical-stage antiviral compound, CMX157, a potent nucleoside analogue with in vitro activity against HIV and hepatitis B, has the potential to directly address several limitations of current HIV therapies. Chimerix is developing CMX157 for the treatment of HIV infection including those caused by multi-drug resistant viruses. A Phase 1 clinical study has been completed demonstrating that the compound is well tolerated and that the active antiviral, TFV-PP, was measurable in peripheral blood mononuclear cells (PBMCs) after a single dose and remained detectable for six days, indicating that it may be suitable for once-weekly dosing.
Led by a world-class antiviral drug development team, Chimerix is also leveraging the company's extensive chemical library to pursue new treatments for hepatitis C virus, flu, malaria and other global public health needs. For additional information on Chimerix, please visit http://www.chimerix.com.
SOURCE Chimerix, Inc.
CONTACT: Kenneth I.
Moch, President and Chief Executive Officer of Chimerix, Inc.,
+1-919-313-2961; or Susan M. Pietropaolo or Michelle Corral, both
of BCC Partners, +1-201-923-2049 or +1-415-794-8662
Web Site: http://www.chimerix.com
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Posted: February 2011