EntreMed Presents Interim Results for Phase 2 Carcinoid Tumor StudyCombination of Panzem(R) NCD and Avastin(R) May Slow Tumor Growth
ROCKVILLE, Md., January 28, 2008 /PRNewswire-FirstCall/ -- EntreMed, Inc. , 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 multi-center study combining Panzem(R) NCD with Avastin(R) (bevacizumab) in patients with advanced or metastatic carcinoid tumors. The data were presented by principal investigator, Matthew Kulke, M.D., from the Dana-Farber Cancer Institute, during the 2008 Gastrointestinal Cancers Symposium being held in Orlando, Florida.
Thirty-one patients received oral Panzem(R) NCD daily in combination with Avastin(R) administered intravenously every other week. Of the 29 evaluable patients, 27 patients (87%) had stable disease and 2 patients (7%) had progressive disease as their best response. Fourteen of the 31 patients have been treated for at least six months, and 9 of the 14 have been treated for over one year. Results demonstrate that the combination of Panzem(R) NCD and Avastin(R) is well tolerated in advanced carcinoid tumor patients. The current analysis includes median follow up time over 8 months. Median progression-free survival and overall survival have not yet been reached. Enrollment in the trial is closed and 9 patients remain on study.
Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical Officer, commented on the results, "This study was designed to evaluate the combination of two antiangiogenic agents, Panzem(R) NCD and Avastin(R), in a highly vascular tumor where antiangiogenic agents, including Avastin(R), have shown activity. By adding Panzem(R) NCD to Avastin(R) therapy, there were no significant differences in the safety profile for these patients as compared to Avastin(R) alone. Additionally, we are encouraged by the length of progression free time that patients have remained on treatment. Once the median progression free survival is established, we will evaluate the data to determine how we should proceed with this combination."
About Carcinoid Tumors
Carcinoids are tumors of neuroendocrine origin. Approximately 85% of carcinoid tumors develop in the gastrointestinal tract between the stomach and the rectum. Approximately half of these originate in the appendix, and may metastasize to the liver, while the remaining half develop in the intestine, rectum and lung. Approximately 6,000-7,000 cases of carcinoid cancer are diagnosed in the U.S. annually and their incidence has been increasing over the past 30 years. It is common for more than one tumor to develop in the small intestine and the presence of a carcinoid tumor increases the probability of other cancers in the digestive system.
Carcinoid tumors often release certain hormones into the bloodstream that cause symptoms such as facial flushing, wheezing, diarrhea, and a fast heartbeat. These symptoms are grouped together and called the "carcinoid syndrome." Carcinoid tumors can release hormonally active peptides into the blood that cause symptoms throughout the body, as contrasted with other tumor types that produce symptoms at the site of the primary tumor or its metastases. Chemotherapy may be indicated in patients with aggressive tumors, progressive liver metastases, partial or complete intestinal obstruction, or severe symptoms uncontrollable by other treatment methods. Standard cytotoxic therapy offers limited benefit to patients with metastatic carcinoid tumors. Neuroendocrine tumors are known to be highly vascularized, suggesting the use of antiangiogenic drugs as potential treatment options.
Avastin(R) is a registered trademark of its owner and is not a registered trademark of EntreMed, Inc.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an oral cell-cycle regulator with activity against the mTOR pathway. Panzem(R) (2-methoxyestradiol) NCD is also in multiple Phase 2 studies in oncology patients. Additionally, ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. The Company has approved IND applications for Panzem(R) in rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora- angiogenesis inhibitor, 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.
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: January 2008