EntreMed's ENMD-2076 Demonstrates Tumor Regression in Human Colon Cancer Model
ROCKVILLE, Md., October 23, 2008 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of preclinical data for its Aurora A/angiogenesis kinase inhibitor, ENMD-2076. The data were presented by John Tentler, Ph.D., Division of Medical Oncology, , at the 20th EORTC-NCI-AACR Annual Meeting being held this week in Geneva, Switzerland.
ENMD-2076 is a novel kinase inhibitor with potent activity against Aurora A and a number of tyrosine kinases linked to cancer and inflammatory diseases. ENMD-2076 demonstrated strong antitumor effects in a xenograft model of human colon cancer. Tumor stasis was seen at dose levels of 100 mg/kg/day, and tumor regression was observed at doses of 200 mg/kg ENMD-2076 per day. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and post-study histological examination of tumors suggest that the antitumor effects of ENMD-2076 are exerted through a combination of antiangiogenic and antiproliferative actions. Further analysis using positron emission tomography (PET) demonstrated a substantial decrease in tumor metabolic activity in animals treated with ENMD-2076.
ENMD-2076 exerts its effects through multiple mechanisms of action, including antiproliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated substantial dose-dependent efficacy as a single agent, including tumor regression, in multiple xenograft models (e.g. breast, colon, leukemia). Aurora kinases are key regulators of the process of mitosis, or cell division, and are often over-expressed in human cancers. In addition to the Aurora A isoform, ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets. ENMD-2076 is currently in a phase 1 clinical study in advanced cancer patients.
Dr. Mark R. Bray, Vice President Research at EntreMed commented on the presentation, "The exciting work presented by Dr. Tentler and his colleagues underscores the exceptional promise of ENMD-2076 as a novel anticancer therapeutic. Advanced non-invasive imaging using PET and DCE-MRI greatly increased the ability to monitor the antiangiogenic and antiproliferative mechanisms of ENMD-2076. We anticipate employing these techniques in upcoming ENMD-2076 clinical trials. EntreMed is actively pursing development partners for this novel oral anticancer drug candidate."
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1, an oral cell-cycle regulator with activity against the mTOR pathway, is currently in multiple Phase 2 clinical trials for cancer. 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, cell signaling and inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis.
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 EntreMed, Inc. 240.864.2643
Posted: October 2008