EntreMed’s ENMD-2076 Active in Solid and Hematological Cancers
Responses Demonstrated in Leukemia and Ovarian Cancer Patients
ROCKVILLE, MD, November 16, 2009 - EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the presentation of data for the Phase 1 study for its Aurora A/angiogenic kinase inhibitor, ENMD-2076, in leukemia patients. The Company also announced that it has selected ovarian cancer as an initial Phase 2 indication.
Phase 1 Leukemia Data
Initial data for the Phase 1 clinical study with ENMD- 2076 in patients with relapsed or refractory acute myeloid leukemia (AML) were presented by principal investigator, Dr. Karen Yee, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held this week in Boston, Massachusetts.Â Early results for the study in hematological cancers demonstrated that ENMD-2076, administered orally as a single agent, was well tolerated.Â Data for 15 evaluable patients showed that one patient achieved a CRi (complete remission with incomplete hematological recovery) and two patients achieved a morphologic leukemia-free state (MLFS).Â Three additional patients experienced 11%, 14%, and 65% reductions in marrow blast count.Â The AML study continues to enroll patients and pharmacodynamic and pharmacokinetic activity is being monitored.
Ovarian Cancer â€“ Initial Phase 2 Indication
While early Phase 1 data from the leukemia study are encouraging, the Company has selected ovarian cancer as its initial Phase 2 indication.Â This decision is supported by data from the ongoing Phase 1 study with ENMD-2076 in patients with solid tumors where of the 20 ovarian cancer patients, tumor and tumor marker responses were demonstrated in 45% of patients. In addition, another 15% have shown clinical benefit including reductions in tumor size, improvement in symptoms, or both. The decision is further supported by robust preclinical data and the need for additional active agents for ovarian cancer patients who have failed current standard of care.
These clinical data combined with the known mechanisms of ENMD-2076, including its antiangiogenic properties and activity against several targets important in the pathogenesis of ovarian cancer, support the selection of this indication to begin the Phase 2 program. EntreMed has received orphan drug designation for the use of ENMD-2076 in ovarian cancer patients and the Phase 2 study is expected to commence in the second quarter of 2010.
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, MD, MBA commented, â€œAlthough the leukemia study remains ongoing, data so far are very encouraging.Â ENMD-2076 alone was able to induce remission in an acute leukemia patient with aÂ Flt-3 mutation.Â Â Â Additionally, some patients without this mutation achieved significant hematological improvements withÂ reductions in blast percentages and/orÂ the need for transfusions.Â It isÂ possible that some of ENMD-2076â€™s targets other than Flt-3 play a role in its activity and this is under active investigation.Â We areÂ expanding the AML study to include additional patients that may benefit from ENMD-2076 therapy.â€
Dr. Sidor continued, â€œWe are pleased to have selected a Phase 2 indication as it represents an important next step in advancing our clinical program for ENMD-2076.Â As reported earlier this year, ovarian cancer patients participating in the Phase 1 study in solid tumors were among those who demonstrated marked clinical benefit from ENMD-2076 administered orally as a single agent.Â We anticipate commencement of a Phase 2 study that will further define the activity of ENMD-2076 in relapsed or refractory ovarian cancer patients.Â We will continue to determine other potential uses for ENMD-2076 in cancer therapy by evaluating the results from our solid tumor Phase 1 study.Â Clinical data presented to date support the compoundâ€™s activity in a variety of solid and hematological cancers, including patients who have failed prior antiangiogenic treatments.â€
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 The Companyâ€™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.Â The Company also has an approved IND application for PanzemÂ® in rheumatoid arthritis.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 (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 ThalomidÂ®, 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; 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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