EntreMed Receives Orphan Drug Designation for ENMD-2076 in Leukemia
ROCKVILLE, MD, February 16, 2010 â€“ EntreMed, Inc. (Nasdaq: ENMD), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Companyâ€™s lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML).
The FDA accepted EntreMedâ€™s application upon review of preclinical data as well as initial data from its ongoing Phase 1 clinical study with ENMD-2076 in patients with relapsed or refractory acute myeloid leukemia (AML).Â As previously presented, initial results from the Phase 1 study demonstrated that ENMD-2076, administered orally as a single agent, was well tolerated in this patient population.Â The data for 15 evaluable AML patients showed that one patient achieved a CRi (complete remission with incomplete hematological recovery) and two patients achieved a morphologic leukemia-free state (MLFS). Three additional patients participating in the study experienced 11%, 14%, and 65% reductions in marrow blast count.
Carolyn F. Sidor, M.D., EntreMed Vice President and Chief Medical Officer commented on the designation, â€œWe are pleased to have received orphan drug designation for ENMD-2076 in leukemia.Â Results from our Phase 1 studies along with the preclinical data continue to support the development of ENMD-2076 in both solid and hematological cancers. We previously received orphan drug designation in ovarian cancer, the initial solid tumor indication planned for Phase 2.â€
Orphan drug is a designation by the U.S. 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. EntreMed received orphan drug designation previously for ENMD-2076 in the treatment of multiple myeloma and ovarian cancer.
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.
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a cancer of the blood or a blood forming organ.Â The American Cancer Society estimates that approximately 13,000 new AML cases will be diagnosed in the United States in 2009, resulting in approximately 9,000 deaths.Â AML generally affects older people, average age of 67, and is less prevalent in adults under the age of 40.Â Men are at a slightly higher risk for developing AML (1 in 250) than women (1 in 300).
EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing primarily ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer.Â ENMD-2076 is currently in Phase 1 studies in advanced cancers, multiple myeloma, and leukemia.Â Additional information about EntreMed is available on the Companyâ€™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.Â 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 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 ThalomidÂ® resulting in reduced revenues; risks associated with the Companyâ€™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).
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