EntreMed's ENMD-2076 Demonstrates Promising Activity in a Phase 2 Study in Platinum-Resistant Ovarian Cancer Patients
Primary Endpoint Data Show Clinical Benefit
ROCKVILLE, Md., Oct. 3, 2011 /PRNewswire via COMTEX/ -- EntreMed, Inc. ENMD +18.42% , a clinical stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the final data for the primary endpoint of progression free survival rate at 6 months for its Phase 2 study with ENMD-2076 in platinum-resistant ovarian cancer patients. Data from all 64 patients showed a six-month progression free survival rate of 22 percent. Four patients achieved a partial response as measured by RECIST v1.1. Median overall survival has not yet been reached. The side effect profile was consistent with activity against ENMD-2076's targets, in particular, VEGFR2 and Aurora A.
The study was conducted at 6 major cancer centers across the United States and Canada and the subject of a presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 3 - 7, 2011 in Chicago, Illinois. Details of the presentation are available on our website.
The study was an open-label, single-arm, multi-center-study of 64 patients receiving ENMD-2076 dosed orally as a single agent in patients with platinum-resistant recurrent ovarian, peritoneal or tubal cancer. The primary endpoint for the study was progression-free survival rate at six months. Secondary end-points include safety, response rate, duration of response, and overall survival.
EntreMed's chief medical officer, Carolyn F. Sidor, M.D., M.B.A., added, "These results show an increase in the reported progression free survival rate over the presentation of interim data at ASCO and are very encouraging. We continue to collect data on overall survival and other endpoints. We believe that ENMD-2076 has made an impact on a number of patients with resistant ovarian cancer who have few therapeutic options."
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 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. ENMD-2076 has shown promising activity in Phase 1 clinical trials in solid tumor cancers, leukemia, and multiple myeloma. ENMD-2076 is currently in a Phase 2 trial for ovarian cancer, and preclinical and clinical activities are ongoing in assessing the compound's applicability for other forms of cancer.
EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer. ENMD-2076 is currently in a multi-center Phase 2 study in ovarian cancer and in several Phase 1 studies in solid tumors, multiple myeloma, and leukemia. 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 (the SEC).
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. 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: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; our reliance on a single product candidate, ENMD-2076; the volatility of our common stock; our history of losses and expectation of incurring continued losses; risks relating to the need for additional capital, including the uncertainty of securing additional funding on favorable terms and the risk that we will not be able to drawdown the full amount of funding available under our standby equity distribution agreement; the failure to consummate a transaction to monetize our Thalomid® royalty stream for any reason, including our inability to obtain the required third-party consents; our dependence on a royalty sharing agreement based on sales of a product, Thalomid®, that we do not have control; declines in actual sales of Thalomid® resulting in materially reduced royalty payments; risks associated with our product candidates; results in preclinical models that are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; any lack of progress of our research and development (including the results of our clinical trials); dependence on third parties; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply and other risks); and our ability to compete with larger, better financed biotechnology companies that may develop new approaches to the treatment of our targeted diseases. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the SEC, which are available at www.sec.gov .
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SOURCE EntreMed, Inc.