Results Demonstrate Durable Single Agent Responses
ROCKVILLE, Md., Sept. 10 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of interim results for its Phase 2 clinical study of MKC-1 in patients with metastatic breast cancer (MBC). The data were presented by EntreMed collaborators during the 2007 Breast Cancer Symposium "Integrating Emerging Science into Clinical Practice," held September 7-8, 2007 in San Francisco, California. Dr. Kathy D. Miller, Associate Professor, Indiana University Cancer Center, Indianapolis, Indiana is the first author.
The Phase 2 single-agent study is being conducted at multiple centers across the United States to evaluate the safety and efficacy of MKC-1 in metastatic breast cancer patients who have failed therapy with anthracyclines and taxanes. Results from the first stage of the single-agent study demonstrate that orally-administered MKC-1 is well-tolerated without evidence of cumulative toxicity in anthracycline/taxane refractory metastatic breast cancer patients. Of the 35 evaluable patients, one complete response (CR), two partial responses (PR), and three stable diseases (SD) of greater than four months were observed. This study has proceeded to the second stage and is continuing to enroll up to 53 evaluable patients to confirm safety and assess the extent of objective responses in this patient population.
MKC-1 is a novel, orally-active, small molecule cell cycle inhibitor with a unique mechanism of action, which involves inhibition of the Akt-mTOR pathway, binding importin-b and tubulin, cell cycle arrest, and apoptosis. MKC-1 arrests mitosis by inhibiting an intracellular target important in cellular trafficking that has been shown to be involved in cell division. MKC- 1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase of the cell cycle, and induce apoptosis in multiple cell lines, consistent with a mechanism in which MKC-1 blocks the nuclear uptake of proteins essential to cell replication.
Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical Officer, commented on the results, "MKC-1 is showing good antitumor activity in metastatic breast cancer patients who had failed conventional anthracycline and taxane chemotherapy. In addition, the study has passed a second Data Safety Monitoring Board (DSMB) review without any study modification. This study is an important milestone for our MKC-1 clinical development program as it confirms that MKC-1 does have single-agent activity and is well-tolerated by these advanced breast cancer patients. An additional MKC-1 single-agent study is underway in hematological cancers and a combination study is underway with pemetrexed (Alimta(R)) in non-small cell lung cancer. We plan to evaluate our options for either randomized single- agent or combination studies in breast cancer once this study is complete."
To view the poster presentation, visit the Recent Presentations section of the Company's web site at http://www.entremed.com.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2) is currently in multiple Phase 2 clinical trials for cancer. MKC-1, an oral cell-cycle regulator, is in multiple Phase 1 and 2 studies for cancer. ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. Panzem(R) is also in preclinical development for rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, is in preclinical development for cancer. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell-cycle regulation and inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's web site at http://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).
Associate Director, Corporate Communications & Investor Relations
|SOURCE EntreMed, Inc.|
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