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ENMD-2076 Demonstrates Preclinical Antitumor Activity in Colorectal Cancer

June 2, 2010

ROCKVILLE, Md., June 2 /PRNewswire-FirstCall/ — EntreMed, Inc. (Nasdaq: ENMD), today announced the publication of preclinical results for its clinical-stage Aurora A/angiogenic kinase inhibitor, ENMD-2076, in human colorectal cancer xenograft models. The results of the study, conducted by EntreMed collaborators at the University of Colorado School of Medicine, were published in the June 1, 2010 issue of Clinical Cancer Research (Vol. 16, Issue 11). ENMD-2076, EntreMed’s lead oncology drug candidate, is currently in a multi-center Phase 2 study in ovarian cancer patients.

(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )

ENMD-2076 demonstrated robust antitumor activity against murine xenograft models of human colorectal cancer (CRC) established from both cell lines and primary human samples. Advanced imaging techniques including dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and 18FDG-positron emission tomography (18FDG-PET) were employed in the study, and revealed the strong antiproliferative, antiangiogenic, and antimetabolic activities of ENMD-2076 towards tumor cells. ENMD-2076 induced regression of tumors in a xenograft model derived from the HT29 human colorectal cell line. In addition, ENMD-2076 induced strong growth inhibition of tumors that were grown in murine models from KRAS mutant cancer tissue taken directly from primary or metastatic sites in CRC patients. In contrast to cetuximab (Erbitux®), ENMD-2076 appears to be effective in both KRAS mutant and wild-type CRC tumors and therefore may represent a potential option for the enlarging population of patients with KRAS/BRAF/PI3K mutated tumors. Results from this preclinical study, along with data from the Phase 1 study in patients with solid tumors, suggest that ENMD-2076 may have potential therapeutic benefit in the treatment of colorectal cancer.

Dr. John Tentler, Division of Medical Oncology, University of Colorado School of Medicine, commented on the results, “We are very excited about the preclinical efficacy of ENMD-2076 against our murine models of CRC. While the antitumor effects of this compound on the human colon cancer xenografts were readily apparent, we were pleased that the imaging studies of these tumors also indicated profound changes in their vasculature and metabolism in response to ENMD-2076. It is our hope that these results translate to the patients in future clinical trials.”

Dr. Mark R. Bray, Vice President Research at EntreMed commented on the paper, “In addition to demonstrating the substantial efficacy of ENMD-2076 in xenograft models of colorectal cancer in their excellent and comprehensive study, Dr. Tentler and his colleagues have illustrated the potential utility of advanced, non-invasive imaging techniques such as DCE-MRI and PET in evaluating the compound’s antitumor and antiangiogenic capabilities. These results provide invaluable information regarding the mechanism of action of ENMD-2076, and further support our goals for the clinical development of the compound. In the Phase 1 study in which ENMD-2076 was used to treat patients with solid tumors, colorectal cancer patients were among the participants who showed clinical benefit by reductions in tumor volume and tumor markers. We continue to evaluate the therapeutic potential of this potent compound in both solid and hematological cancers and recently initiated a multi-center Phase 2 study in ovarian cancer patients.”

About ENMD-2076

ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. Preclinical studies with ENMD-2076 demonstrated significant antitumor activity, including tumor regression, in multiple solid and hematological malignancies. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases which have been shown to play important roles in the pathology of several cancers. While ENMD-2076 is currently in a Phase 2 trial in ovarian cancer, preclinical and clinical activities are ongoing in assessing the compound’s applicability in other forms of cancer.

About EntreMed

EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer. ENMD-2076 is currently in a multi-center Phase 2 study in ovarian cancer and in several Phase 1 studies in solid tumors, multiple myeloma, and leukemia. 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, 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 the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the failure to consummate a transaction to monetize the royalty stream for any reason, including our inability to obtain the required third-party consents; declines in actual sales of Thalomid® resulting in reduced revenues; 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, including delays to the commencement of such 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

SOURCE EntreMed, Inc.


Source: newswire



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