EntreMed Initiates ENMD-2076 Clinical Trial in Multiple Myeloma
Phase 1 Trial Supported by Preclinical Data Presented at the American Society of Hematology Meeting
ROCKVILLE, Md., December 9, 2008 - EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has initiated a Phase 1 study of ENMD-2076 in refractory multiple myeloma patients. The study will be conducted at the Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana. Dr. Sherif Farag, Associate Professor, Department of Medicine, will serve as principal investigator.
Primary objectives for the dose escalation study include determining the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ENMD-2076 when administered orally once a day in patients with multiple myeloma who are refractory to other drug therapy. The study will also assess the safety, tolerability, pharmacodynamic effects and activity of ENMD-2076 in this patient population.
Preclinical data supporting the clinical evaluation of ENMD-2076 alone and in combination in multiple myeloma were presented by Dr. Farag earlier this week at the American Society of Hematology Annual Meeting in San Francisco, CA. ENMD-2076 was shown to induce rapid apoptosis (cell death) in multiple myeloma cell lines in vitro. Significant dose-dependent antitumor activity with minimal toxicity was also induced in vivo when ENMD-2076 was administered as a single agent in multiple myeloma models. Combination studies with
ENMD-2076 and lenalidomide (Revlimid(R)) in vitro indicated synergistic cytotoxic activity towards several human multiple myeloma cell lines.
ENMD-2076 was shown, both in vitro and in vivo, to have minimal toxicity towards human and murine hematopoietic progenitor cells, which are essential for maintenance of an active immune system.
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action.
ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to Aurora A kinase and other oncogenic proteins. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers. In addition, ENMD-2076 is relatively selective for the Aurora A isoform in comparison to Aurora B. ENMD-2076 has shown significant cytotoxic activity preclinically towards a variety of human leukemia and myeloma cell lines, as well as towards ex vivo-treated human leukemia patient samples.
EntreMed Vice President of Research, Mark R. Bray, Ph.D., commented, “With our ongoing study in solid tumors progressing well, coupled with the initiation of the multiple myeloma study, our ENMD-2076 program is gaining substantial momentum. The work of Dr. Farag and his colleagues has provided important insights into the mechanism of action of ENMD-2076, and has strongly supported the rationale for clinical investigation of the drug candidate in hematologic malignancies such as multiple myeloma.”
Carolyn F. Sidor, M.D., M.B.A., Vice President and Chief Medical Officer, commented on the Phase 1 study, “Initiation of this Phase 1 study represents continued advancement of the ENMD-2076 clinical program. We are encouraged by the significant preclinical activity we have observed with ENMD-2076 in both solid and hematologic tumors. Based on our cumulative preclinical data, we believe that ENMD-2076 may provide clinical benefit in a broad range of malignancies. We anticipate commencement of a second Phase 1 study in hematological cancers early next year.”
To view a copy of Dr. Farag’s poster, visit the Company’s web site at http://www.entremed.com.
Revlimid(R) a registered trademark of Celgene Corporation and not the Company.
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-2076, a selective angiogenic kinase inhibitor, and ENMD-1198, a novel antimitotic agent 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. 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.
Forward Looking Statements
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