CMX001 Study 201 is a randomized, placebo-controlled Phase 2 study of CMX001 as prophylaxis for CMV in hematopoietic cell transplant recipients. 230 subjects were randomized (3:1) to receive CMX001 or placebo in five sequential, dose-escalating cohorts. Subjects were dosed either once weekly (QW) or twice weekly (BIW) for nine to 11 weeks until post-transplant week 13, with a four-to-eight week follow-up period.
To date, more than 700 patients have been dosed with CMX001 in placebo-controlled clinical trials and open-label treatment protocols. Recently presented data from 183 patients who received CMX001 within a compassionate setting indicated that CMX001 showed no indication of the myelosuppression or nephrotoxicity associated with currently available antiviral therapies.
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health. Utilizing proprietary lipid conjugate technology, the company's two clinical stage compounds have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved drugs.
In addition to the company's development of its lead candidate, CMX001, for transplant recipients, CMX001 is also being developed as a medical countermeasure in the event of a smallpox release, with the potential to provide an important therapeutic option for the 80 million people in the U.S. currently estimated to be immunocompromised, or a household contact of a contraindicated individual, and thus not candidates to receive a smallpox vaccine (for additional information, please see http://www.bt.cdc.gov/agent/s
|SOURCE Chimerix, Inc.|
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