Thema: Presse: EntreMed commences phase II studies with panzem
Presse: EntreMed commences phase II studies with panzem
Linus[a]
22.01.2006 18:50:40
EntreMed Commences Phase 2 Studies with Panzem(R) NCD - Duke University Medical Center to Conduct Brain Cancer Trial
2006, Jan. 19
PRNewswire
EntreMed, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 2 study for its lead drug candidate, Panzem® NCD (2-methoxyestradiol or 2ME2) in patients with recurring glioblastoma multiforme (GBM). The study will be conducted at the Brain Tumor Center at Duke University Medical Center. David A. Reardon, M.D., Medical Director, Clinical Research at the Brain Tumor Center will serve as principal investigator for the study. The purpose of the single center, 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.
2ME2 is an orally active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor 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 antitumor 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 tumor responses.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, "We are pleased to lead off our Panzem® NCD Phase 2 program with Dr. Reardon and his team of experts at the Duke Brain Tumor Center, a leading center for treating GBM and other brain tumors. 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."
2006, Jan. 19
PRNewswire
EntreMed, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 2 study for its lead drug candidate, Panzem® NCD (2-methoxyestradiol or 2ME2) in patients with recurring glioblastoma multiforme (GBM). The study will be conducted at the Brain Tumor Center at Duke University Medical Center. David A. Reardon, M.D., Medical Director, Clinical Research at the Brain Tumor Center will serve as principal investigator for the study. The purpose of the single center, 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.
2ME2 is an orally active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor 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 antitumor 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 tumor responses.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, "We are pleased to lead off our Panzem® NCD Phase 2 program with Dr. Reardon and his team of experts at the Duke Brain Tumor Center, a leading center for treating GBM and other brain tumors. 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."
Linus[a]
