EntreMed Inc. has commenced a phase 2 study for its lead drug candidate, Panzem NCD (2-methoxyestradiol or 2ME2) in patients with recurring glioblastoma multiforme (GBM).
The purpose of the single centre, open-label study will be to assess the safety, pharmacokinetics and efficacy profile of Panzem NCD in patients with GBM who have failed initial therapies. Thirty- two refractory/relapsed GBM patients are expected to be enrolled in the study, claims the company release.
2ME2 is an orally active small molecule that attacks tutor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumour cells. Panzem NCD, an oral liquid formulation, has been shown in preclinical studies to significantly increase the drug's bioavailability and activity and has been shown to result in enhanced drug levels of 2ME2 in patients. Phase 1 studies with Panzem NCD have shown that the pharmacokinetic target for anti tumour activity in animals was achieved at a dose of 1000 mg given orally four times each day. Additionally, Panzem NCD had an acceptable toxicity profile at this dose and was associated with stable disease and two minor tumour responses.
Carolyn F. Sidor, EntreMed vice president and chief medical officer, commented, "Based on results from both preclinical experiments and mechanism of action studies, we believe that 2ME2 may be particularly well-suited for this patient population because these tumors are highly angiogenic and frequently harbor pten mutations, which result in high levels of HIF-1alpha protein. EntreMed plans to initiate several additional Phase 2 studies in 2006 in various patient populations, including both single agent and combination studies with other approved anticancer therapies."
The study will be conducted at the Brain Tumour Centre at Duke University Medical Centre. David A. Reardon, Medical Director, Clinical Research at the Brain Tumour Centre will serve as principal investigator for the study.
Approximately 40,000 cases of primary central nervous system (CNS) cancers are diagnosed each year in the United States, of which 17,000 are malignant tumours. Malignant CNS tumours cause approximately 13,000 deaths per year, or about three-fourths of the new annual malignant cases. Glioblastoma multiforme (GBM), also known as grade IV astrocytoma, is the most common and aggressive type of primary brain tumour. GBMs account for approximately 52% of all primary brain tumours. The tumour forms in the glial (supportive) tissue of the brain and invades adjacent tissue.
EntreMed Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation.