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Chimerix Commences Phase 2 Clinical Study of CMX001 for Prevention of Adenovirus Disease in Pediatric and Adult Hematopoietic Stem Cell Transplant Patients
Date:7/13/2011

X001 will be able to make a significant difference."

"We believe CMX001's rapidly evolving antiviral and safety profile provides strong support for this candidate's broad-spectrum, preemptive usage, which includes the often-overlooked pediatric population," said Kenneth I. Moch, Chimerix President and CEO. "To date, CMX001 has been administered to more than 550 subjects and has demonstrated activity against a broad spectrum of dsDNA viruses.  It has been well tolerated and has not shown toxicity in the kidneys or on bone marrow function."  

The AdV HALT Trial/CMX001-202 Design

The primary objective of the Phase 2 clinical study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in hematopoietic stem cell recipients with asymptomatic AdV viremia.  The multi-center, placebo-controlled study, which will be conducted at approximately 30 centers, is expected to enroll 48 pediatric and adult patients who have undergone hematopoietic stem cell transplant and have evidence of infection but no symptoms of disease.  Under the protocol, subjects will be randomized to receive CMX001 or placebo once or twice weekly for at least six, but no more than 12, weeks. The dose of CMX001 or placebo given during the randomized treatment phase will be based upon the age and weight of the subject at the time of enrollment.

The primary endpoint will be "treatment failure", consisting of progression to AdV disease or increasing AdV viremia. Secondary endpoints include safety and tolerability of CMX001, as well as other measurements that include the percentage of subjects who have emergence or progression of cytomegalovirus(CMV), Epstein-Barr virus (EBV), or BK virus (BKV) viremia or disease during therapy.  Drug pharmacokinetics and the development of viral resistance will also be assessed.  

Additional information on study objectives, enrollment cri
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SOURCE Chimerix, Inc.
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Related biology technology :

1. Chimerix Completes Phase I Study and Initiates a Phase II Multi-dose Clinical Trial for CMX001
2. Chimerix Joins International Network of Organizations to Cure Malaria
3. Chimerix, Inc. Appoints Kenneth I. Moch Chief Operating Officer
4. Chimerix Names Wendy Painter, M.D., M.P.H., as Chief Medical Officer
5. Chimerix Names George Painter, Ph.D., Chairman of the Board and Chief Scientific Officer; Appoints Kenneth I. Moch President and Chief Executive Officer
6. Chimerix Initiates Phase 1 Study of CMX157
7. Chimerix to Present at Upcoming Investor Conferences
8. Chimerix Appoints Two New Vice Presidents to Clinical Management Team
9. Chimerixs PIM Conjugate Technology Reduces Risk of Nephrotoxicity for CMX001 and CMX157
10. Chimerix Presents Update on CMX001 Development to the World Health Organization Advisory Committee on Variola Virus Research
11. Chimerix Completes $45 Million Financing to Fund Further Development of Novel Antiviral Therapeutics CMX001 and CMX157
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