EntreMed's ENMD-2076 Demonstrates Significant Anti-Cancer Activity in Multiple Myeloma Preclinical Models
Study Results Published in British Journal of Haematology
ROCKVILLE, Md., July 13 /PRNewswire-FirstCall/ -- EntreMed, Inc. (NASDAQ: ENMDD) , today announced the publication of preclinical data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor, which demonstrated significant activity against multiple myeloma (MM) cell lines and in MM models in vivo. Results of the study, conducted by EntreMed's collaborator, Sherif Farag, M.D., Ph.D., and colleagues at the Indiana University School of Medicine, were published in the on-line version of the British Journal of Haematology on June 15, 2010 and are scheduled to be published in print in the August 1, 2010 issue. Dr. Farag is the Principal Investigator for the ongoing Phase 1 study with ENMD-2076 in multiple myeloma patients. The Company recently initiated a Phase 2 study for ENMD-2076 in ovarian cancer patients. Ovarian cancer was selected as the initial Phase 2 indication based on results from the Phase 1 study in patients with solid tumors where the clinical benefit of ENMD-2076 was observed in this patient population. Six sites are participating in the Phase 2 study and all are actively recruiting patients.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )
In the recently published preclinical data, ENMD-2076 was shown to have significant cytotoxicity against MM cell lines as well as against primary MM cells taken from human patients, with minimal toxicity seen towards haematopoietic progenitor cells, which are essential for the production of normal blood cells. ENMD-2076 was observed to exert its activity through multiple mechanisms important to MM growth and survival, including inhibition of the phosphoinositide 3-kinase/AKT pathway, and downregulation of X-linked inhibitor of apoptosis seen as early as six hours after treatment. G2/M cell cycle arrest and inhibition of the Aurora A and B kinases were seen after 24 to 48 hours of exposure. In murine models implanted with H929, a human plasmacytoma cell line, oral treatment resulted in dose-dependent inhibition of tumor growth with concomitant reduction in mechanism-specific markers of ENMD-2076 activity including phospho-histone H3, Ki-67, angiogenesis, and phospho-FGFR3. These data on ENMD-2076's mechanism of action provide additional support for ENMD-2076's potential therapeutic applicability in a broad range of oncology indications. ENMD-2076 has been the subject of multiple Phase 1 studies and is currently in a multi-center Phase 2 study in ovarian cancer patients.
In addition to the publication of these preclinical data, Dr. Sherif Farag's laboratory at the Division of Hematology and Oncology, Department of Medicine, Indiana University School of Medicine and the Indiana University Melvin and Bren Simon Cancer Center, has been awarded a research grant for $319,550 sponsored by the National Cancer Institute to continue his efforts to assess the mechanisms of action of ENMD-2076 and its potential use as a therapeutic to treat MM, an incurable cancer with current treatment.
Dr. Mark R. Bray, Vice President Research at EntreMed commented, "Dr. Farag's work has generated important additional insights into the mechanism of action of our multi-kinase inhibitor. ENMD-2076 is shown to target multiple myeloma cells through several mechanisms that are vital to their growth and survival. Data from Dr. Farag's laboratory expands and validates our knowledge regarding how ENMD-2076 acts to kill cancer cells, and thereby increases our understanding of how best to continue to utilize the compound in the clinic to treat patients. We are very encouraged by the data generated and the correlation of these findings with our clinical work and will continue to advance our Phase 2 development of ENMD-2076."
"We are pleased to have these preclinical results published as they further support ENMD-2076's potential to treat patients with hematological and solid tumors," commented Dr. Carolyn F. Sidor, EntreMed's Vice President and Chief Medical Officer. "Additional preclinical evaluations, as well as data complied from our ongoing clinical studies, provide further insight into the scope of ENMD-2076's activity and aide in the process of selecting additional Phase 2 indications."
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.
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).
Associate Director, Corporate Communications & Investor Relations
Source: EntreMed, Inc.
CONTACT: Ginny Dunn, Associate Director, Corporate
Investor Relations of EntreMed, Inc., +1-240-864-2643
Web Site: http://www.entremed.com/
Posted: July 2010