Navigation Links
FDA Grants Chimerix Fast Track Designation for CMX001 for the Prevention of Clinically Significant Cytomegalovirus Infection
Date:3/12/2013

RESEARCH TRIANGLE PARK, N.C., March 12, 2013 /PRNewswire/ -- Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection.  CMX001 is the company's broad spectrum, oral nucleotide analog lipid-conjugate that blocks replication of double-stranded DNA (dsDNA) viruses.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.  Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

CMX001 has completed Phase 2 clinical development for the prevention of CMV infection in adult hematopoietic stem cell transplant (HSCT) recipients.  Chimerix is preparing to initiate SUPPRESS, its Phase 3 study of CMX001 for the prevention of CMV infection in adult HSCT recipients, in 2013.  The company has previously received Fast Track designation for its CMX001 development programs for preemptive treatment of adenoviral disease in patients post HSCT and for the treatment of smallpox.

About Chimerix and CMX001
Chimerix 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.  The Company'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 lead product candidate, CMX001, is a broad spectrum, oral nucleotide analog lipid-conjugate that blocks replication of double-stranded DNA (dsDNA) viruses, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex virus.  CMX001 has completed Phase 2 clinical development for the prevention of CMV in hematopoietic stem cell transplant (HSCT) recipients.  Chimerix is also conducting a Phase 2 study in HSCT recipients which is evaluating CMX001 as a preemptive therapy for AdV disease, an often-fatal infection which has no approved therapies.  Since 2009, Chimerix has made CMX001 available under expanded access regulations to over 80 transplant centers worldwide for the treatment of over 430 patients with life-threatening dsDNA viral infections.  Chimerix anticipates initiating SUPPRESS, its Phase 3 study of CMX001 for the prevention of CMV infection in adults undergoing HSCT, in 2013.   

Chimerix is also developing CMX001 as a potential medical countermeasure against smallpox under a contract from the Biomedical Advanced Research and Development Authority (BARDA). 

Chimerix's second product candidate, CMX157, an oral nucleotide analog lipid-conjugate in Phase 1 development for the treatment of HIV infection, was licensed to Merck in July 2012.   

 


'/>"/>
SOURCE Chimerix, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Pancreatic Cancer Action Network Opposes Sequestration Cuts To National Institutes Of Health & Cancer Research Grants
2. State Food and Drug Administration Grants Approval to Sihuan Pharmaceutical for Clinical Trial of Innovative Drug -- Pinoxacin Hydrochloride
3. Neuralstem Grants Licenses For Central Nervous System Therapy Surgical Devices To Cedars-Sinai Medical Center
4. FDA Grants Orphan Drug Status To Eisais Lenvatinib
5. FDA Grants 510(k) clearance for new Fluke Biomedical ESA615 Electrical Safety Analyzer
6. U.S. FDA Grants Priority Review to Bayers Radium Ra 223 Dichloride NDA for Castration-Resistant Prostate Cancer with Bone Metastases
7. Afraxis Grants Exclusive Global License to Genentech
8. FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)
9. New Jersey Health Foundation Awards First Two Innovation Stage Funding Grants
10. Artemis Diagnostics awarded two grants from Technology Strategy Board to develop cancer imaging technology
11. New Jersey Health Foundation Commits $2 Million to Fund Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/5/2017)... -- Sapheneia and Scannerside received FDA 510(k) clearance to ... third-party Vendor neutral CT product that makes it affordable ... current MITA standards. ... specifically designed to provide CT operators, prior to a ... a predefined threshold. Scannerside Dose Check is intended to ...
(Date:9/5/2017)... Pharmaceuticals Inc. (NASDAQ: ORMP ) (TASE: ORMP) ... the development of oral drug delivery systems, announced today ... U.S. Food and Drug Administration (FDA) regarding ORMD-0801, the ... At the meeting, the FDA gave clear ... would be a Biologics License Application (BLA).  Such a ...
(Date:8/31/2017)... -- PM360,s annual Innovations Issue, published in December, ... happening across the industry. Established six years ago, this ... a comprehensive look at the newest and most exciting ... companies, startups, divisions, products, services, and strategies from the ... in this industry wants to do better—in all facets ...
Breaking Medicine Technology:
(Date:9/20/2017)... ... September 20, 2017 , ... Reflections Recovery ... now accredited by The Joint Commission for chemical dependency and behavioral health services. ... U.S. health care organizations that meet the commission’s rigorous standards. Accreditation by The ...
(Date:9/20/2017)... , ... September 20, 2017 , ... ... Clinical Plus Coating System for clients that rely on safety and cleanliness. This ... of microorganisms. , Silver has been used for centuries for its antimicrobial properties. ...
(Date:9/20/2017)... ... 2017 , ... Renal Support Network’s annual essay contest celebrates ... The theme “Describe a positive decision that you have made about your healthcare” ... one qualification— to have been diagnosed with chronic kidney disease. This year the ...
(Date:9/20/2017)... ... September 20, 2017 , ... ... medical device compliance and commercialization, has just released a new white paper ... is more adamant than ever about medical device, pharmaceutical, and combination product ...
(Date:9/20/2017)... ... September 20, 2017 , ... Demand generation pioneer ... East-coast edition of MarTech: The Marketing Tech Conference October 2–4, at the Hynes ... 40 speakers — representing such thought-leading companies as JP Morgan Chase, GE ...
Breaking Medicine News(10 mins):