Dana-Farber Cancer Institute Commences Phase 1 Trial With EntreMed's Selective Kinase Inhibitor

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 09 May 2008 - 0:00 PDT

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EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, 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."

About EntreMed

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.

Forward Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance (including the timing of royalty revenues and future R&D expenditures), strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need for additional capital and the uncertainty of additional funding; variations in actual sales of Thalomid(R), risks associated with the Company's product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).

EntreMed, Inc.
http://www.entremed.com