On March 30, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CA4P for the treatment of platinum-resistant ovarian cancer (Press release, OXiGENE, MAR 30, 2016, View Source [SID:1234510177]). Schedule your 30 min Free 1stOncology Demo! Companies with Fast Track designation are able to benefit from more frequent meetings and communications with the FDA regarding development plans to support product registration, and may also be eligible for priority review of New Drug Applications, which shortens FDA’s standard review timeline.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The FDA’s granting of Fast Track status to CA4P is a significant acknowledgement of the potential for CA4P to provide a new and better treatment option for women with platinum-resistant ovarian cancer," stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. "I am pleased that we now have the opportunity to work closely with FDA to expedite our CA4P development program in ovarian cancer, as we seek to bring this promising product candidate to patients."
OXiGENE’s Fast Track application included data showing that CA4P is a novel investigational agent that has been shown in a randomized controlled trial to provide improved response rates and improved progression-free survival to patients with recurrent ovarian cancer when used in combination with bevacizumab (combination anti-vascular therapy) compared to bevacizumab alone, outcomes which were especially prominent in a subgroup of patients with platinum-resistant ovarian cancer.