ROCKVILLE, Md., May 2 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announced today that it has commenced a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and clinical benefit of its novel tubulin binding agent, ENMD-1198, in patients with advanced cancer. Patients with advanced cancer whose disease has failed to respond to existing therapies or where no approved therapy is available are expected to be enrolled in the study. The single-center, dose-escalation study will be conducted at the University of Colorado at Denver and Health Sciences Center in Aurora, Colorado. D. Ross Camidge, M.D., Ph.D. will serve as Principal Investigator for the study.
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ENMD-1198, a new chemical entity (NCE) based on a modified chemical structure of 2-methoxyestradiol (2ME2), is designed to decrease metabolism while retaining 2ME2’s multiple mechanisms of action, including inducing apoptosis, binding microtubules, and inhibiting HIF-1alpha. In preclinical studies, ENMD-1198 has been shown to be an orally active, microtubule disrupting agent that leads to arrest of cell division and apoptosis in tumor cells. In addition, ENMD-1198 also exerts antiangiogenic activity that further contributes to its overall antitumor effects. Preclinical results for ENMD-1198 support its potential for broad application in cancer. ENMD-1198 was discovered at EntreMed and the intellectual property belongs exclusively to the Company.
“We are excited to move into clinical studies with this novel compound and to continue our relationship with the University of Colorado,” said Carolyn F. Sidor, M.D., M.B.A., EntreMed’s Vice President and Chief Medical Officer. “Results from preclinical studies with this compound highlight its significant antitumor activity and multiple mechanisms of action, including inhibiting three transcription factors, HIF-1alpha, NF-kappaB and Stat3, known to promote tumorigenesis. With the initiation of this study, EntreMed now has three product candidates, Panzem(R) NCD, MKC-1 and ENMD-1198, in clinical trials for cancer patients, with additional trials planned for later this year.”
Preclinical data demonstrate that oral administration of ENMD-1198 leads to pronounced in vivo antitumor activity in several cancer models, resulting in a reduction in tumor burden and/or an increase in survival equivalent to cyclophosphamide, the positive control in the studies. Preclinical toxicology studies demonstrate that ENMD-1198 affects cell populations with a high proliferative rate, including bone marrow, gastrointestinal tract and lymphoid organs. These effects are common with approved cancer agents and can be monitored in the clinic.
For more information on the Phase 1 study with ENMD-1198, visit the Clinical Trials section of EntreMed’s web site at http://www.entremed.com.
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) (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 also in Phase 2 studies 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 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, 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; the integration of Miikana and its product candidates; the early stage of our products under development; that 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; our dependence on third parties; and regulatory risks.
CONTACT: Ginny Dunn EntreMed, Inc. Associate Director Corporate Communications & Investor Relations 240-864-2643
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CONTACT: Ginny Dunn, Associate Director, Corporate Communications &Investor Relations of EntreMed, Inc., +1-240-864-2643
Web site: http://www.entremed.com//
