Dana-Farber and Colorado Treating Patients with ENMD-2076
ROCKVILLE, Md., May 8 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that Dana-Farber Cancer Institute has joined the University of Colorado Cancer Center in conducting a Phase 1 study of ENMD-2076 in advanced cancer patients. Dr. Geoffrey Shapiro, Dana-Farber Cancer Institute, and Dr. Wells Messersmith, University of Colorado Cancer Center, will serve as co-principal investigators for the study.
Safety and tolerability of orally administered ENMD-2076 in refractory cancer patients will be assessed in this Phase 1 study. A secondary objective for the study will be to determine a dose-dependent response to treatment with ENMD-2076 through the evaluation of pharmacokinetic parameters.
ENMD-2076 is a novel, selective kinase inhibitor with potent activity against Aurora A and tyrosine kinases linked to the promotion of cancer and inflammatory diseases. ENMD-2076 acts through multiple pathways, resulting in both antiproliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated substantial, dose-dependent efficacy as a single agent in multiple preclinical models, including tumor regression in breast, colon, and leukemia models. Importantly, ENMD-2076 is an oral agent that has shown an acceptable toxicity profile in preclinical studies without cardiovascular toxicity.
Carolyn F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical Officer commented on the study, "Both clinical trial sites are now enrolling and treating patients with our selective kinase inhibitor. We believe that this product candidate has substantial potential as both a single agent and in combination with other approved cancer drugs. ENMD-2076 is unique-in-class because it not only inhibits Aurora A selectively, it also inhibits a cluster of kinases that are important for tumor growth, particularly growth factor receptors critical to angiogenesis. ENMD-2076 has potent antitumor activity in multiple preclinical models, including both solid tumors and hematological cancers."
James S. Burns, EntreMed President & Chief Executive Officer commented, "Further development of ENMD-2076 is consistent with both our focus on investing behind oncology drug candidates with strong single-agent activity and our continuing interest in kinase inhibitors. In keeping with our 2008 goals of cash preservation and rigorous resource management, we intend to pay the $2 million Phase 1 milestone to Miikana shareholders in shares of EntreMed common stock. Our goals for this program over the next twelve months are to complete the clinical trial in solid tumor patients, initiate a clinical trial in patients with hematological cancers, and secure a pharmaceutical partner to help accelerate the development of ENMD-2076."
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an oral cell-cycle regulator with activity against the mTOR pathway. ENMD-1198, a novel antimitotic agent, and ENMD-2076, a selective kinase inhibitor, are in Phase 1 studies in advanced cancers. The Company also has an approved IND application for Panzem(R) in rheumatoid arthritis. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell-cycle regulation and inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's web site at http://www.entremed.com and in various filings with the Securities and Exchange Commission.
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Associate Director, Corporate Communications & Investor Relations
|SOURCE EntreMed, Inc.|
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