Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology

 News Release - October 25, 2006

EntreMed Commences Clinical Trial for MKC-1 in Lung Cancer Patients

Clinical Study to Evaluate MKC-1 in Combination With Alimta(R) in Advanced Cancer and Non-Small Cell Lung Cancer Patients

ROCKVILLE, Md., Oct. 25 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced commencement of a multi-center study with its drug candidate, MKC-1, in non-small cell lung cancer (NSCLC) patients. The lead institution for this Phase 1/2, open label, dose escalation study will be the Indiana University Cancer Center in Indianapolis, Indiana. Nasser H. Hanna, M.D., Assistant Professor, Department of Medicine, Division of Hematology/Oncology at IUCCI, will serve as Principal Investigator. MKC-1 is being evaluated currently in Phase 1 and 2 clinical studies against breast cancer and in patients with leukemia.

The objective of the Phase 1 portion of this study will be to assess the safety and maximum tolerated dose of MKC-1 when administered orally in combination with pemetrexed (AlimtaŽ). AlimtaŽ is a multi-targeted antifolate, which blocks the activity of folic acid and is approved for the treatment of metastatic NSCLC.

The Phase 2 component of this study will assess the antitumor activity and progression free survival (PFS) in up to 60 patients with non-small cell lung cancer. Patients whose disease has progressed following initial therapy may be eligible to enroll. Patients will receive orally administered MKC-1 in combination with pemetrexed (AlimtaŽ). A secondary endpoint of the Phase 2 study will be to evaluate other parameters of antitumor activity including response duration and overall survival.

MKC-1 is a novel, orally active cell cycle inhibitor with in vitro and in vivo efficacy against a wide range of human solid tumor cell lines, including multi-drug resistant cell lines. MKC-1 has demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple animal models, including paclitaxel-resistant 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. These effects are consistent with a mechanism resulting from MKC-1 binding to multiple intracellular targets, including tubulin and the importin beta proteins. The importin beta family of proteins plays a critical role in nuclear transport and cell division.

Dr. Nasser Hanna commented, "We look forward to initiating this important study to determine the effects that MKC-1 in combination with AlimtaŽ has against lung cancer." Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical Officer, further commented, "We continue to expand our development program for MKC-1. The NSCLC clinical trial represents the third clinical study initiated this year and our first clinical trial combining MKC-1 with an approved therapeutic agent. Dr. Hanna, the study's principal investigator, and his colleagues at the Indiana University Cancer Center participated in the initial clinical study of MKC-1 as a single agent in NSCLC patients. By combining MKC-1 with AlimtaŽ, we hope to improve the clinical benefit over either agent given alone in patients who have failed prior chemotherapy."

For information on this study, visit the Clinical Trials section of the Company's web site at http://www.entremed.com.

AlimtaŽ is a registered trademark of its owner and is not a registered trademark of EntreMed, Inc.

About Non-Small Cell Lung Cancer

For treatment purposes, lung cancer is classified clinically as small cell or non-small cell lung cancer (NSCLC). NSCLC is a disease in which the cells of the lung tissues grow uncontrollably and form tumors and represents approximately 87% of all primary lung cancers. The tumors can reduce the capacity of the lungs or block the movement of air through the bronchi in the lungs. The American Cancer Society estimates that approximately 174,000 new lung cancer cases will be diagnosed in 2006, resulting in approximately 162,000 deaths.

About EntreMed

EntreMed, Inc. (Nasdaq: ENMD ) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. PanzemŽ (2-methoxyestradiol or 2ME2), the Company's lead drug candidate, is currently in Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle regulator, is in Phase 2 studies for metastatic breast cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1 studies in advanced cancers. 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 website 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 ThalomidŽ, risks associated with the integration of Miikana and its 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).


Source: EntreMed

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