Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients
Recently Expanded Clinical Program Now Includes Solid and Hematological Malignancies
ROCKVILLE, Md., June 1 /PRNewswire-FirstCall/ -- EntreMed, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the presentation of clinical data for its Aurora A/angiogenic kinase inhibitor, ENMD-2076, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held this week in Orlando, Florida. Data were presented in both oral discussion and poster sessions.
ENMD-2076, a small molecule, oral kinase inhibitor that targets Aurora A and other kinases critical to angiogenesis, cellular growth and proliferation, was studied in patients with refractory solid tumors. Data from the 25 patients who participated demonstrated that ENMD-2076 administered orally in daily doses is associated with clinical benefit as determined by reductions in tumor volume, reductions in tumor markers, and improvement in cancer-related symptoms. These benefits were demonstrated in patients with a variety of tumor types including melanoma, renal cell, ovarian and colorectal cancer. ENMD-2076 was well-tolerated when administered daily.
In addition, plasma soluble KDR (VEGFR2), a marker of effect against the VEGF receptor, was reduced in all patients when compared to baseline. Side effects included hypertension and low blood counts, consistent with the known targets of ENMD-2076. Plasma concentrations at the higher dose levels evaluated were within the range of where there was excellent antitumor activity in preclinical models.
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented, "Plans are underway to expand this study and evaluate additional patients with a variety of cancers as well as specifically those with colorectal and ovarian cancers. These additional data will guide our selection of the most promising solid tumor indications for further study in Phase 2. The recent initiation of Phase 1 studies in multiple myeloma and leukemia will allow us to extend the possible indications for ENMD-2076 into hematological malignancies where preclinical data have been encouraging. These data and the initiation of additional studies have added significant value to the program and, in line with the Company's strategy to accelerate the clinical development of ENMD-2076, partnering discussions continue."
To view a copy of the poster and slide presentations, visit Scientific Presentations under the Therapeutic Pathways section of the Company's web site at www.entremed.com.
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 Flt-3 and FGFR3, kinases 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).
Posted: June 2009