DURHAM, N.C., March 14, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) today issued a statement thanking the U.S. Food and Drug Administration (FDA) for its collaboration in developing a protocol for the immediate initiation of a 20-patient pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients.
"Drug development is a complex process. At its best, it is a collaboration between FDA and Sponsors. Chimerix believes that the events of the past week demonstrate what is possible when FDA and Sponsors work closely and collaboratively.
Beginning on Monday, Chimerix and FDA worked jointly to develop a clinical trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients that would be available for Josh Hardy and other similar patients. Making a protocol available by Tuesday evening would not have been possible without the resources that both parties dedicated to this mission. Chimerix appreciates the expertise, advice and guidance that FDA provided.
Chimerix will work with the FDA to address the design of a development program that would incorporate patients similar to those who are participating in the pilot trial, to be able to provide information to support the marketing application for brincidofovir. We join the FDA in its commitment to developing safe and effective drugs for unmet medical needs."
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir, has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections and diseases caused by DNA viruses. Brincidofovir is an oral nucleotide analog that has shown broad-spectrum antiviral activity against all five families of DNA viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex viruses. Brincidofovir has shown a favorable safety and tolerability profile, with no evidence of kidney or bone marrow toxicity in nearly 900 patients dosed to date.
In September 2013, data from Chimerix's Phase 2 trial of brincidofovir in the prevention of CMV in recipients of hematopoietic cell transplants (HCT) were published in The New England Journal of Medicine (N Engl J Med 369:1227-36). Building on these positive Phase 2 results in CMV, Chimerix initiated the Phase 3 SUPPRESS trial in the third quarter of 2013 which, if positive, will be used to support Chimerix's initial regulatory submission for the Accelerated Approval of brincidofovir for prevention of CMV infection in adult HCT recipients.
In late 2013, Chimerix presented data from the first exploratory trial of brincidofovir in early AdV infection. Brincidofovir initiated at the time of detection of AdV in the blood showed encouraging antiviral results and provided new data regarding the risk assessment for immunocompromised patients with AdV infection. A brincidofovir dose of 100 mg twice weekly, the dose being used in SUPPRESS, demonstrated a potent antiviral effect on levels of AdV in the blood, and a numeric decrease in overall mortality. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir and CMX157, both of which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. In the third quarter of 2013, Chimerix initiated the Phase 3 SUPPRESS trial of brincidofovir for the prevention of CMV infection in adult HCT recipients, also known as bone marrow transplants. Brincidofovir has shown broad-spectrum activity against all five families of DNA viruses that affect humans, including CMV, AdV, BKV and herpes simplex viruses. Brincidofovir has received Fast Track designation by the FDA, and the Phase 3 data, if positive, would be used to support Accelerated Approval of brincidofovir for the prevention of CMV infection in adult HCT recipients. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. Chimerix's second product candidate, CMX157, was licensed to Merck in July 2012 for the treatment of HIV infections. For further information, please visit Chimerix's website, www.chimerix.com.
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. Risks are described more fully in Chimerix's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K, its most recently filed Current Reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. 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.