ENMD-2076 Clinical Program Adds Leukemia Clinical Study and Orphan Drug Designation
ROCKVILLE, Md., May 15 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced presentations for three of its clinical-stage drug candidates at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 29 - June 2, 2009 in Orlando, Florida. Presentations include both poster and discussion sessions and are listed below.
The Company has further expanded its clinical development efforts for ENMD-2076 and has commenced a Phase 1 study in patients with relapsed or refractory leukemia. The study will be conducted at the Princess Margaret Hospital in Toronto, Ontario and Karen Yee, M.D., will serve as Principal Investigator. Although the primary endpoints of the study include defining the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ENMD-2076 administered orally in patients with relapsed or refractory leukemia, the study will also evaluate pharmacodynamic effects of ENMD-2076 by collaborating with Dr. David Hedley, Department of Molecular Oncology, Ontario Cancer Institute (OCI).
Dr. Mark R. Bray, EntreMed Vice President, Research commented, "We are very excited to be working with Dr. Hedley and his staff, who have considerable experience in evaluating the mechanistic effects of kinase inhibitors like ENMD-2076 in cancer patients. The close proximity of EntreMed scientific personnel based in Toronto to our clinical collaborators at the OCI will facilitate our ability to obtain the maximum value from this study and its correlative components."
In addition, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for ENMD-2076 for the treatment of ovarian cancer. Several ovarian cancer patients participated in the ENMD-2076 Phase 1 study in solid tumors and will be included in the data presentations at ASCO. Orphan drug is a designation by the Food and Drug Administration indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Sponsors of drugs granted orphan designation qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act. Previously EntreMed had received orphan drug designation for ENMD-2076 for multiple myeloma.
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented, "The clinical development program for ENMD-2076 is expanding with the addition of the myeloma clinical study announced earlier and with this new study in patients with leukemia. Also, plans are underway to expand the solid tumor study at the maximum tolerated dose of ENMD-2076 to further define the objectives of safety, pharmacokinetics and antitumor activity. We believe the current clinical program allows us to quickly add new patients to establish the potential of ENMD-2076 and provide a focus for Phase 2 development. These data serve as a foundation to continue discussions with potential development partners for 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 demonstrate 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 Aurora A kinase and other oncogenic proteins. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers. ENMD-2076 targets a defined set of kinases, including Flt-3 and FGFR3, which have been shown to play important roles in the pathology of hematological cancers.
EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing primarily ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer. ENMD-2076 is currently in Phase 1 studies in advanced cancers and multiple myeloma. The Company's other therapeutic candidates include MKC-1, an oral cell-cycle regulator with activity against the mTOR pathway currently in multiple Phase 2 clinical trials for cancer, and ENMD-1198, a novel antimitotic agent currently in Phase 1 studies in advanced cancers. The Company also has an approved IND application for Panzem(R) in rheumatoid arthritis. 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 (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
|SOURCE EntreMed, Inc.|
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