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Chimerix Announces Exclusive Worldwide License of Phase 3 Ready CX-01 for Development in Acute Myeloid Leukemia
Transformational Transaction Provides Key Program in First-Line Acute Myeloid Leukemia with Fast Track and Orphan Drug Designations and Potential Utility as a Platform Technology
Phase II Randomized Data Presented at
Company Plans to Initiate Phase 3 Registrational Trial in mid-2020
Conference Call at
“We are pleased to have made such rapid progress in repositioning the company and transforming our pipeline with this important cancer therapy. We are excited to advance this promising product candidate in AML as it has shown compelling activity across multiple endpoints in first-line patients as opposed to later lines of therapy where most of the recent advances in this disease area have occurred. With more than 21,000 new cases of AML diagnosed annually in the U.S. alone and a five-year survival rate of less than 30%, the patient need is clear. CX-01’s mechanism of action, targeting multiple proteins involved in protecting and supporting the growth of cancer cells, provides opportunities for potential development across a range of hematologic malignancies,” stated Mike Sherman, Chief Executive Officer of Chimerix. “This transaction exemplifies our commitment to pursuing and accelerating programs where we can quickly address unmet patient needs with a meaningful clinical benefit.”
“While several new agents have been recently approved for AML, a backbone of cytotoxic chemotherapy continues to be necessary for treatment with curative intent. If our results are confirmed, combining CX-01 with chemotherapy has the potential to have a significant impact on the outcomes of patients suffering from one of the most challenging hematologic malignancies,” said
CX-01 is a new chemical entity derived from unfractionated heparin with very low anticoagulant activity. CX-01 targets key protein pathways important for AML blast cell migration to the bone marrow and retention of these cells in the marrow where they are protected from chemotherapy. CX-01 also binds with proteins involved in chemotherapy resistance and the delay in platelet recovery after chemotherapy. Together, these activities are understood to sensitize AML blasts to chemotherapy and improve clinical responses. These mechanisms of action support the potential for development in myelodysplastic syndrome, multiple myeloma, and lymphomas.
In a recently completed Phase II study, 75 patients over 60 years of age with newly diagnosed AML were randomized 1:1:1 to one of two doses of CX-01 (0.125 mg/kg/hr or 0.250 mg/kg/hr) plus standard 7+3 chemotherapy (7 days of cytarabine, 3 days of anthracycline) or to the control arm of standard 7+3 chemotherapy alone. Data presented at the 2019
CX-01 was well tolerated with adverse events similar across all treatment arms. The most common serious adverse event was febrile neutropenia with three cases in each CX-01 treatment group and one case in the control group.
Under the terms of the agreement,
|Chimerix management will host a conference call today at 8:30AM ET. To participate, please dial:|
|US and Canada:||(877) 354-4056|
A live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the
Cantex is a clinical stage biopharmaceutical company focused on developing and commercializing proprietary compounds that enhance the efficacy and safety of the treatment of cancer and other life-threatening disorders. CX-01, is a multi-targeted new chemical entity in development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. Cantex's other clinical stage product, Dicopp®, a proprietary combination of disulfiram + copper, is currently in a clinical trial for metastatic pancreatic cancer. For more information, please visit www.cantex.com.
This press release includes 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 potential benefits to be derived from the license agreement with
Source: Chimerix, Inc.