Healthcare Industry News: NSCLC
News Release - January 23, 2007
Safety Monitoring Board Recommends Continuation of EntreMed's MKC-1 Phase 2 Breast Cancer StudySupply Agreement Also Completed With Roche for MKC-1 Drug Substance
ROCKVILLE, Md., Jan. 23 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced a favorable review of MKC-1 safety data by an independent Data Safety Monitoring Board (DSMB). The review was undertaken to assess the safety of MKC-1 in a Phase 2 multi-center clinical trial in patients with advanced or metastatic breast cancer who have failed conventional therapies.
The DSMB concluded that the apparent risk, based on the current safety data review for MKC-1, was appropriate for the population under study. The DSMB also felt that the study did not require any modification, and that the Phase 2 study in patients with metastatic breast cancer should continue as currently designed. The study is being conducted at multiple centers across the United States and is evaluating the safety and efficacy of MKC-1 in metastatic breast cancer patients who have failed therapy with anthracylines and taxanes.
EntreMed also announced that it recently completed the purchase of all remaining bulk quantities of the active pharmaceutical ingredient (API) for MKC-1 from Roche. EntreMed has a worldwide, exclusive license from Roche to develop and commercialize MKC-1. In addition to the clinical trial in metastatic breast cancer, MKC-1 is currently in Phase 1 and 2 clinical studies in patients with non-small cell lung cancer (NSCLC) and hematological (blood) malignancies.
James S. Burns, EntreMed's President and Chief Executive Officer, commented, "Given questions about the toxicity of MKC-1 observed in prior clinical studies using higher doses and shorter schedules, it was important for us to demonstrate MKC-1's safety and tolerability using the 14-day schedule. The DSMB's recommendation that the MKC-1 clinical study in patients with metastatic breast cancer proceed without modification will allow us to continue evaluation of the efficacy of MKC-1 in this patient population. We are continuing to enroll patients in leukemia and non-small cell lung cancer trials, and we expect to report preliminary results from the metastatic breast cancer clinical trial during the first half of this year. Furthermore, the Roche supply agreement provides EntreMed with the means to pursue its clinical development program for MKC-1 with sufficient GMP material at a reasonable cost in anticipation of future pivotal clinical trials."
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. In previous studies, MKC-1 demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical 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 mechanisms 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.
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 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).
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.