Entremed (ENMD)

[Rocky I]

EntreMed's MKC-1 Meets Primary Efficacy Endpoint in Non-Small Cell Lung Cancer Clinical Trial



Phase 2 Randomized Study Under Consideration



ROCKVILLE, Md., Nov. 10 /PRNewswire-FirstCall/ -- EntreMed, Inc.

(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has met the primary endpoint for the efficacy portion of the open label Phase 1/2 study of MKC-1 in combination with pemetrexed (Alimta(R)) in non-small cell lung cancer patients.

(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )

The Phase 1/2 study was designed to first evaluate a dose of MKC-1 to be used safely in combination with Alimta(R) to treat patients with advanced NSCLC. Patients were subsequently enrolled into the Phase 2 portion where the primary endpoint was tumor response. The primary endpoint has been met and EntreMed is considering options for further studies in NSCLC patients. Options include the continuation of the current single arm study or a randomized Phase 2 study in the same patient population.

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. Data from previous studies with MKC-1 demonstrate 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. Furthermore, MKC-1 inhibits the Akt-mTOR signaling pathways, which may occur through inhibition of the mTOR/rictor pathway. The Akt-mTOR pathway is the most frequently mutated pathway in human tumors and mutations have been shown to promote tumor progression and decrease survival in cancer patients. EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented on the study, "We are pleased to have met the primary efficacy endpoint in the first stage of this study. We are now considering whether to continue the current study or pursue additional options such as a randomized Phase 2 study in patients with non-small cell lung cancer. We will continue to collect data over the next few months from patients participating in this trial to determine the most efficient path forward in this indication."