OXiGENE Inc (NASDAQ:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CA4P for the treatment of platinum-resistant ovarian cancer. 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.
“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. (Original Source)
Shares of Oxigene jumped nearly 21% in pre-market trading. OXGN has a 1-year high of $1.68 and a 1-year low of $0.49. The stock’s 50-day moving average is $0.63 and its 200-day moving average is $0.80.
On the ratings front, H.C. Wainwright analyst Mark Breidenbach initiated coverage with a Buy rating on OXGN, in a report released yesterday. According to TipRanks.com, Breidenbach has a yearly average return of -18.9%, a 34.4% success rate, and is ranked #3633 out of 3828 analysts.
Oxigene, Inc. engages in the development of therapeutics to treat cancer and eye diseases. The company is a clinical-stage, biopharmaceutical company developing novel therapeutics primarily to treat cancer. It offers anti-vascular drugs referred to as vascular disrupting agents. The company was founded in 1988 and is headquartered in South San Francisco, CA.