EntreMed Presents Results For Carcinoid Tumor Study

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Carcinoid Tumor

EntreMed presents interim results for its Phase 2 multi-center study combining Panzem NCD with Avastin (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 NCD daily in combination with Avastin 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 NCD and Avastin 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.

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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 NCD and Avastin, in a highly vascular tumor where antiangiogenic agents, including Avastin, have shown activity. By adding Panzem NCD to Avastin therapy, there were no significant differences in the safety profile for these patients as compared to Avastin 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.

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