Navigation Links
Disseminated Adenovirus Infection Eradicated in a Pediatric Hematopoietic Stem Cell Transplantation Recipient Who Received Chimerix's Lead Antiviral CMX001
Date:2/24/2011

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New Clinical Study Shows RyMed InVision-Plus® IV Connector Dramatically Reduced Catheter-Related Bloodstream Infections by Over 92%
2. Reportlinker Adds Bone and Joint Infection Market to 2016 - Medical Imaging and PCR Methods to Facilitate Early Diagnosis and Treatment
3. Instead of Preventing Infections, Silver Coated Needleless IV Connectors May Actually Cause Them, a Nationally-Recognized Expert Tells National Conference on Cancer Nursing Research
4. Optimer Pharmaceuticals and Astellas Announce Collaboration to Commercialize Fidaxomicin for Clostridium difficile infection (CDI) in Europe and Certain Other Countries in Middle East, Africa and CIS
5. Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
6. Chimerix Commences CMX001 Open-Label Clinical Study for the Treatment of Patients With Life-Threatening or Serious dsDNA Viral Infections
7. Optimer Pharmaceuticals Receives Orphan Drug Designation for Fidaxomicin for the Treatment of Pediatric Clostridium difficile Infection
8. Crothall Healthcare Selects 3M™ Clean-Trace™ for Infection Control Verification
9. Adeona Acquires Access to Clinical Data Supporting Oral Zinc for Prevention of Infections in the Elderly
10. Sage Products and 3M Infection Prevention Announce Agreement
11. Telbivudine Given to Mothers With Hepatitis B Reduces Infection Rate in Infants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... April 20, 2017  Cogentix Medical, Inc. (NASDAQ: ... providing the Urology, Uro/Gyn and Gynecology markets with ... Keswani has joined the Company as Senior Vice ... created position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has ...
(Date:4/20/2017)...  RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage ... unmet medical needs, today announced that it will ... development program, based on its proprietary self-delivering RNAi ... (SID) 76 th Annual Meeting.  The SID ... relevant to skin health and disease through education, ...
(Date:4/20/2017)... April 20, 2017  AbbVie (NYSE: ABBV), a ... (n=145/146) of chronic hepatitis C virus (HCV) infected ... 6 and compensated cirrhosis (Child-Pugh A) achieved sustained ... ) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir ... seen following 12 weeks of G/P treatment without ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... An April 24th article on Yahoo! Beauty discusses ... with the help of a weight loss surgery. The woman, declaring “I will not hate ... been left following her dramatic weight loss. Dr. Feiz & Associates notes that, while it ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... ... its new partnership with the Home Care Association of America (HCAOA). This agreement ... Private Duty Accreditation services, as well as discounts on Accreditation University (AU) educational ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... ... to announce the integration of Microsoft(R) Word(TM) Online(TM), which enables sleep physicians to ... since it streamlines the reporting process and provides a familiar interface that does ...
(Date:4/28/2017)... ... ... Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ) announced today that ... as “stable.” At the same time, the ratings agency cautioned that the company’s rating ... “capital adequacy” thresholds required for its strong rating. , “Horizon is committed to being ...
(Date:4/28/2017)... ... April 28, 2017 , ... GlycoMark, Inc. announced today ... throughout the Northeast U.S. , GlycoMark is the only clinically available blood ... provides a clinically proven one- to two-week measure of hyperglycemic excursions, often related ...
Breaking Medicine News(10 mins):