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news.Biotech firm Novelos Therapeutics has filed an orphan drug application with the FDA for the company's lead compound, NOV-002. The application focuses on the use of NOV-002 as an adjunct to standard chemotherapy for treating refractory ovarian cancer.
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In the US an orphan drug designation may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 US persons. Such designation provides a company with seven years of marketing exclusivity along with regulatory assistance and reduced fees.
Refractory ovarian cancer patients have a very poor prognosis because they are faced with inadequate therapeutic options. According to Novelos, response rates from second-line treatments, such as doxorubicin and topotecan, are typically less than 12%.
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 US women, and be responsible for 16,210 deaths, according to America’s National Cancer Institute. Standard first-line treatment for ovarian cancer patients is carboplatin and paclitaxel chemotherapy combination.
NOV-002, marketed in Russia by an unrelated entity under the trade name GLUTOXIM, has been administered to over 5,000 patients, yielding excellent safety and promising efficacy data.
Novelos is currently investigating the potential of the therapy for both ovarian and lung cancer.