EntreMed Reports Phase 1 PK and Preclinical Efficacy Results for ENMD-1198
Significant Survival Advantage Shown in Lung Cancer Model
ROCKVILLE, MD â€“ October 25, 2007 â€“ EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of interim Phase 1 pharmacokinetic results for its antimitotic agent, ENMD-1198, together with preclinical antitumor activity results. The data were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held this week in San Francisco, California.
Pharmacokinetic results demonstrate that once a day orally-administered ENMD-1198 has good pharmacokinetic (PK) parameters in cancer patients participating in a Phase 1 clinical study. In the first four cohorts of the dose-escalation trial in advanced cancer patients, ENMD-1198 demonstrated dose proportional PK exposures across the range of 5-30 mg/m2. ENMD-1198, a new chemical entity (NCE) based on a modified chemical structure of 2-methoxyestradiol (2ME2), was designed to decrease metabolism while retaining 2ME2â€™s multiple mechanisms of action, including inducing apoptosis, disrupting microtubules, and inhibiting HIF-1Î±.
ENMD-1198 was evaluated in a preclinical model of non-small cell lung cancer (NSCLC) and demonstrated a three-fold increase in survival compared to Cisplatin, an approved agent for the treatment of this disease. Approximately 80% of the ENMD-1198 treated models remained on study until tumor dissemination evaluation. In prior preclinical studies, ENMD-1198 has been shown to be an orally active, antimitotic agent that leads to arrest of cell division and apoptosis in tumor cells. ENMD-1198 also exerts antiangiogenic activity that further contributes to its overall antitumor effects.
Mark R. Bray, Ph.D., EntreMed Vice President, Research, commented on the results, â€œPreclinical studies with ENMD-1198 continue to highlight its significant antitumor activity. These data demonstrate that ENMD-1198 achieves predictable plasma drug levels after once daily oral dosing in humans, consistent with prior preclinical results.â€
Dr. Bray commented further, â€œThe ENMD-1198 Phase 1 study continues in refractory solid tumor patients with a current dose level that is approaching the maximum tolerated dose in preclinical models without any ENMD-1198-related toxicity. Preclinical studies are continuing to help define Phase 2 indications and assess potential toxicities when used in combination with approved agents. These data further support ENMD-1198â€™s potential for broad application in treating patients with cancer.â€
To view the poster presentation, visit the Companyâ€™s web site at www.entremed.com.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. PanzemÂ® 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. PanzemÂ® 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 â€“ processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Companyâ€™s web site at www.entremed.com and in various filings with the Securities and Exchange Commission.
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