Orphan Drug Application Filed for NOV-002 for Treating Refractory Ovarian Cancer
Jun 17, 2005 - 9:55:38 AM
Novelos Therapeutics, Inc. (OTC BB: NVLT), a biotech company focusing on oxidized glutathione for use in fighting cancer and hepatitis, today announced that it has filed an orphan drug application with the U.S. FDA for the Company's lead compound, NOV-002. The application focuses on the investigation of combination therapy of NOV-002 with standard chemotherapy for treating refractory (chemotherapy resistant) ovarian cancer. A response from the FDA is expected by mid August.
In the U.S., an orphan drug designation may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 U.S. persons. Such designation provides a company with seven years of marketing exclusivity along with regulatory assistance and reduced fees.
Refractory ovarian cancer patients -- those who do not respond to chemotherapy -- have a very poor prognosis because they are faced with inadequate therapeutic options. Response rates from second-line treatments, such as doxorubicin and topotecan, are typically less than 12%; re-exposure to cisplatin-based treatment will typically have less than 15% response rate.*
In Russian clinical studies, NOV-002 has sensitized previously resistant ovarian cancers, substantially raising the patient response rate to chemotherapy treatment.
In 2005, ovarian cancer is expected to be diagnosed in approximately 22,220 U.S. women, and be responsible for 16,210 deaths. Standard first-line treatment for ovarian cancer patients is carboplatin and paclitaxel chemotherapy combination. Doxorubicin (Doxil) and topotecan (Hycamtin) alternate as second- and third-line chemotherapy treatments.*
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