Selective Kinase Inhibitor Phase 1 Trial in Advanced Cancer Patients
ROCKVILLE, Md., April 9, 2008 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), 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.
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.
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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Company's proposed products (such as marketing, safety, regulatory, patent,
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Associate Director, Corporate Communications & Investor Relations
|SOURCE EntreMed, Inc.|
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