CMX001 Shows Antiviral Activity in Immunocompromised Transplant Patients With Severe Adenovirus Infection
Clinical Data Highlighted in Oral Presentation at the 24th Annual ICAR Meeting
DURHAM, N.C., May 11, 2011 /PRNewswire/ -- Chimerix, Inc., a pharmaceutical company developing oral antiviral therapeutics, today presented data showing that the majority of immunocompromised patients with severe adenovirus infections who were treated with Chimerix’s lead antiviral compound, CMX001, had a > 99% decrease in viral load compared to baseline after two weeks of therapy. These CMX001 clinical data, described in an oral presentation today at the 24th Annual International Conference on Antiviral Research (ICAR) held in Sofia, Bulgaria, demonstrate the unique activity of CMX001 against adenovirus (AdV), a life-threatening viral infection without an approved treatment.
“In the most challenging and urgent of Emergency IND cases, CMX001 has demonstrated antiviral activity against a full spectrum of double-stranded DNA infections including AdV,” said Wendy Painter, MD, Chief Medical Officer for Chimerix. “The results presented in this oral session today further support our efforts to advance CMX001 as a much-needed therapeutic for critically ill transplant patients, including pediatric post-stem cell transplantation patients with life-threatening adenovirus infections. We also believe that this data will contribute to broader development of CMX001 against the breadth of double-stranded DNA viruses.”
Chimerix’s CMX001 is in development as a potential broad-spectrum antiviral agent with promising activity against all classes of double-stranded DNA (dsDNA) viruses that can infect humans. CMX001 is currently in clinical studies against multiple infections including cytomegalovirus and advenovirus, and has the potential to meet a significant unmet medical need for patients at risk of these dsDNA life-threatening viral infections.
The oral presentation provided an analysis of twenty-two patients with adenovirus viremia who had received at least two doses of CMX001, had measurable plasma viremia at baseline, and had viral load data available at > 2 weeks after the first dose of CMX001. The majority of CMX001 treated patients had a > 99 percent decrease in viral load compared to baseline after two weeks of therapy. There was a median -2.5 log10 change in viremia from baseline by the last timepoint (range -6.0 to +0.3 log10). Patients who had either sensitive virus or no proven resistance had a median decrease of almost 1000-fold (-2.9 log10) from baseline. In patients with pre-existing resistance to CDV, attributable to prior suboptimal cidofovir (CDV) therapy, antiviral activity of CMX001 was a median -0.55 log10 decrease from baseline. Additionally, higher plasma exposure to CMX001 appeared to correlate with a more rapid response.
These data were presented by Randall Lanier, PhD, Senior Director of Virology, Chimerix, at the 24th Annual International Conference on Antiviral Research in an oral presentation titled “CMX001 (Hexadecyloxypropyl Cidofovir) Antiviral Activity against Adenovirus in Patients Correlates with Drug Levels and Viral Sensitivity” (Abstract # 33).
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 475 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 treatment 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 builds on Chimerix’s extensive experience working with clinicians at over 60 leading institutions in the United States, Canada, Europe and Israel who have sought CMX001 for the treatment of more than 175 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.
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.
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