ROCKVILLE, Md., April 9, 2008 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has commenced a Phase 1, dose-escalation study for its selective kinase inhibitor, ENMD-2076, in advanced cancer patients. Dr. Wells Messersmith, University of Colorado Cancer Center, will serve as co-principal investigator for the study. Additional centers are expected to join Colorado as study sites this quarter.
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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 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.
The Phase 1 study will assess safety and tolerability of orally administered ENMD-2076 in refractory cancer patients. In addition, pharmacokinetics will be assessed to determine a dose-dependent response to treatment with ENMD-2076.
Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical Officer, commented on the study, "Commencement of this Phase 1 study marks the achievement of a critical milestone in our clinical development program and further supports our strategy of focusing on orally-administered, small molecule drugs with multiple mechanisms of action. Data from preclinical studies with ENMD-2076 demonstrate its significant antitumor potential as a single agent in a variety of tumor types. Through this Phase 1 study, we expect to not only determine ENMD-2076's safety profile and appropriate Phase 2 dosing schedule, but which tumor types may be better suited for this compound. We plan to initiate a second Phase 1 study in patients with hematological cancers later this year."
James S. Burns, EntreMed President & Chief Executive Officer commented, "ENMD-2076 is an exciting selective kinase inhibitor with potent single agent activity that has induced tumor regression in multiple preclinical models. ENMD-2076, developed internally, is consistent with our focus on investing behind oncology drug candidates with strong single-agent activity and with our continuing interest in selective kinase inhibitors. In parallel with the clinical trial, we will seek a pharmaceutical or biotech partner to help accelerate the development of our novel selective kinase inhibitor."
The administration of ENMD-2076 to the first patient in this important Phase 1 study will trigger a milestone payment by EntreMed pursuant to EntreMed's acquisition of Miikana Therapeutics, Inc. in January 2006. Under the terms of the merger agreement with Miikana, the dosing of the first patient triggers a $2 million payment to the former Miikana stockholders, either in cash or shares of EntreMed common stock.
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 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).
CONTACT: Ginny Dunn, Associate Director, Corporate Communications &
Investor Relations of EntreMed, Inc., +1-240-864-2643
Web site: http://www.entremed.com/
