EntreMed Initiates Phase 2 Study for ENMD-2076 in Ovarian Cancer
Posted 04-14-2010 at 04:30 PM by admin
No Objection Letter Received from Health Canada
ROCKVILLE, Md., April 13 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD) today announced the initiation of a multi-center Phase 2 study with its lead oncology product candidate, ENMD-2076, in patients with platinum resistant ovarian cancer. The study will be conducted at up to six sites in the United States and Canada. In addition, EntreMed received a No Objection Letter (NOL) from the Therapeutic Products Directorate of Health Canada on its Clinical Trial Application to conduct the Phase 2 clinical trial in ovarian cancer patients. The first study site initiated is Princess Margaret Hospital, University of Toronto, and Dr. Amit Oza, Senior Staff Physician and Professor of Medicine, will serve as principal investigator. Additional sites are expected to join the study during the second quarter.
In this Phase 2 study, patients with platinum resistant ovarian, fallopian or peritoneal cancer will receive ENMD-2076 administered orally as a single agent once a day. The primary objective of the study will be to determine the progression-free survival (PFS) rate of patients at six months. A total of 60 patients are expected to be enrolled in the study. Additional endpoints will include response rate and overall survival.
Ovarian cancer was chosen as the initial indication for a Phase 2 study based on Phase 1 results. In Phase 1, patients (n = 20) with resistant and refractory ovarian cancer treated with single agent, daily, oral ENMD-2076 had a median PFS of 16 weeks. In addition, the combined response rate (using RECIST and CA-125 criteria) is 40% (8/20) with an objective response rate using RECIST of 10% (2/20) and confirmed CA-125 response rate of 30% (6/20). The median number of prior chemotherapy regimens for these patients was 5. Response to ENMD-2076 was independent of prior therapies including prior bevacizumab therapy.
These results compare favorably with agents currently on the market for the treatment of platinum refractory/resistant ovarian cancer such as liposomal doxirubicin and topotecan that have reported a median PFS of 9.1 and 13.6 weeks respectively. Single agent bevacizumab in a less heavily treated group of ovarian cancer patients was associated with a median PFS of between 4.4 and 4.7 months.
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Copyright © 1996-2010 PR Newswire Association LLC. All Rights Reserved.
ROCKVILLE, Md., April 13 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD) today announced the initiation of a multi-center Phase 2 study with its lead oncology product candidate, ENMD-2076, in patients with platinum resistant ovarian cancer. The study will be conducted at up to six sites in the United States and Canada. In addition, EntreMed received a No Objection Letter (NOL) from the Therapeutic Products Directorate of Health Canada on its Clinical Trial Application to conduct the Phase 2 clinical trial in ovarian cancer patients. The first study site initiated is Princess Margaret Hospital, University of Toronto, and Dr. Amit Oza, Senior Staff Physician and Professor of Medicine, will serve as principal investigator. Additional sites are expected to join the study during the second quarter.
In this Phase 2 study, patients with platinum resistant ovarian, fallopian or peritoneal cancer will receive ENMD-2076 administered orally as a single agent once a day. The primary objective of the study will be to determine the progression-free survival (PFS) rate of patients at six months. A total of 60 patients are expected to be enrolled in the study. Additional endpoints will include response rate and overall survival.
Ovarian cancer was chosen as the initial indication for a Phase 2 study based on Phase 1 results. In Phase 1, patients (n = 20) with resistant and refractory ovarian cancer treated with single agent, daily, oral ENMD-2076 had a median PFS of 16 weeks. In addition, the combined response rate (using RECIST and CA-125 criteria) is 40% (8/20) with an objective response rate using RECIST of 10% (2/20) and confirmed CA-125 response rate of 30% (6/20). The median number of prior chemotherapy regimens for these patients was 5. Response to ENMD-2076 was independent of prior therapies including prior bevacizumab therapy.
These results compare favorably with agents currently on the market for the treatment of platinum refractory/resistant ovarian cancer such as liposomal doxirubicin and topotecan that have reported a median PFS of 9.1 and 13.6 weeks respectively. Single agent bevacizumab in a less heavily treated group of ovarian cancer patients was associated with a median PFS of between 4.4 and 4.7 months.
Read the rest of the article here.
Copyright © 1996-2010 PR Newswire Association LLC. All Rights Reserved.
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