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.
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 ThalomidÂ®, risks associated with the Companyâ€™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).
Metabolism and Pharmacokinetics of ENMD-1198, and Orally Bioavailable Microtubule Destabilizing Agent, in Rats, Dogs and Humans
CASI Pharmaceuticals, Inc.