EntreMed Commences Phase 2 Study with MKC-1 in Pancreatic Cancer
Multi-Center Study to Focus on Advanced Cancer Patients
ROCKVILLE, MD â€“ December 4, 2007 â€“ EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has commenced a multi-center Phase 2 clinical trial with MKC-1 in patients with advanced pancreatic cancer. The primary objectives of this study will be to determine the antitumor activity of orally-administered MKC-1 in unresectable or metastatic pancreatic cancer patients who have failed at least one prior chemotherapy regimen. The study will also assess the safety, tolerability and overall median survival time of pancreatic cancer patients treated with MKC-1. Massachusetts General Hospital Cancer Center is the lead institution for the study and Eunice Kwak, M.D., Ph.D., Assistant in Medicine, Tucker Gosnell Center for Gastrointestinal Cancers, will serve as the principal investigator.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. Prior preclinical studies have demonstrated that MKC-1 has significant antitumor activity as both a single agent and in combination with an approved epidermal growth factor/epidermal growth factor receptor (EGF/EGFR) inhibitor in pancreatic cancer models. MKC-1 has also demonstrated broad-acting antitumor effects, including tumor growth inhibition or regression, in multiple preclinical models. MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis.
Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief Medical Officer, commented on the study, “Pancreatic cancer patients continue to need more effective and better tolerated treatment options. MKC-1 has shown good activity in preclinical testing against pancreatic tumors, supporting its use in this patient population. Positive results from this clinical trial will provide the basis for designing future randomized Phase 2 studies. With this clinical trial initiation, we are now evaluating MKC-1 as a single agent or in combination in patients with pancreatic cancer, metastatic breast cancer, non-small cell lung cancer (NSCLC), and leukemia.”
About Pancreatic Cancer
Pancreatic cancer is the abnormal cell growth in the tissue of the pancreas. The pancreas is an organ about six inches in length which is located behind the stomach, next to the small intestine. The pancreas produces enzymes that aide in the digestion and absorption of food. Unless pancreatic cancer is detected early, it is difficult to control. At the present time, there is no effective screening for pancreatic cancer and, because the pancreas is hidden by other organs, it is difficult to diagnosis. Pancreatic cancer is the fourth leading cause of cancer death in the United States. The American Cancer Society estimates that approximately 37,000 Americans will be diagnosed with cancer of the pancreas in 2007, resulting in approximately 33,000 deaths.
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 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).
CASI Pharmaceuticals, Inc.