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Former Eli Lilly Veteran Brings Deep Oncology Clinical and Regulatory Expertise
DURHAM, N.C., June 22, 2020 (GLOBE NEWSWIRE) -- Chimerix (CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced the appointment of Allen Melemed, M.D., M.B.A., as Chief Medical Officer.
“We are delighted to welcome Dr. Melemed as a key member of our management team. We look forward to leveraging his considerable clinical and regulatory experience as a distinguished pharmaceutical executive. His vast experience bringing oncology therapeutics through development and approval across multiple modalities will be invaluable as we initiate our dociparstat sodium (DSTAT) Phase 3 trial in first line acute myeloid leukemia (AML), our ongoing Phase 2/3 trial to combat acute lung injury (ALI) in COVID-19 patients, and finalize our rolling New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox,” said Mike Sherman, Chief Executive Officer of Chimerix.
“I am particularly pleased to be joining Chimerix at such an important juncture in its growth trajectory. DSTAT’s potential to improve survival in newly-diagnosed AML patients is critically important in a disease where five-year survival rates remain far too low, particularly in older populations. Furthermore, DSTAT’s broad mechanism to manage inflammation and hematologic disorders offers promise to treat ALI in COVID-19 patients and underpins its mechanism of action in ALI beyond the current pandemic. I look forward to working with the team to advance our pipeline of important therapies and to bringing these life-saving treatments to patients in need,” said Dr. Melemed.
Dr. Melemed joins Chimerix from Eli Lilly and Company, where he spent more than 20 years dedicated to the clinical development and approval of oncology medicines across a broad range of tumor types including VERZENIO®, CYRAMZA®, LARTRUVO® , ALIMTA® and RETEVMO® among others. Most recently, he served as a Distinguished Medical Fellow and Senior Director of Regulatory Affairs Oncology, North America. In addition to his role at Eli Lilly, Dr. Melemed was an attending physician in pediatric oncology at Indiana University (IU) School of Medicine, Riley Children’s Hospital from 1996 to 2012.
Dr. Melemed holds a B.S. in Genetics and Cell Biology from the University of Minnesota and a M.D. from the University of Minnesota School of Medicine. In addition, he completed his residency in pediatrics at the University of Wisconsin, Madison and fellowship in pediatric hematology/oncology at IU School of Medicine. He earned an M.B.A. from the University of Chicago Booth School of Business. Dr. Melemed has authored dozens of scientific and clinical publications.
Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Its two clinical-stage development programs are DSTAT and BCV.
Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that may be dosed at much higher levels without triggering bleeding complications. In vitro and in vivo animal model data support DSTAT’s potential to reduce the inflammation and cellular infiltration associated with ALI and address coagulation disorders associated with COVID-19 pathology of high mobility group box 1 (HMGB1) and platelet factor 4 (PF4). Separately, DSTAT inhibits the activities of several key proteins implicated in the viability of AML blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1, elastase). Randomized AML Phase 2 data suggest that DSTAT may also accelerate platelet recovery post-chemotherapy via inhibition of PF4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy. The company is conducting a randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure. The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose. A formal analysis of all endpoints, including supportive biomarkers will be performed at the conclusion of the Phase 2 portion of the study. Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 450 subjects.
BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the mechanism of action of DSTAT and its potential; Chimerix’s ability to develop DSTAT, including the initiation of a Phase 3 trial in AML and the ongoing Phase 2/3 clinical trial for DSTAT as a potential treatment for ALI associated with COVID-19; Chimerix’s ability to submit and/or obtain regulatory approvals for DSTAT and BCV; and the timing and receipt of a potential procurement contract for BCV in smallpox. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that DSTAT may not achieve the endpoints of its clinical trials; risks that DSTAT may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that development activities related to DSTAT may not be completed on time or at all; Chimerix’s reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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