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FDA awards grant for cancer drug study

The US FDA has awarded a $1.6m grant under its orphan drugs programme to a Alabama-based biotech company Egen to help the company with clinical trials of a potential new therapy for ovarian cancer

The US Food and Drug Administration (FDA) has awarded a $1.6m grant under its orphan drugs programme to a small, Alabama-based biotech company called Egen to help the company with clinical trials of a potential new therapy for ovarian cancer.

The four-year grant is intended to assist in the phase II clinical development of the privately held company's lead product, Egen-001, which is being developed for the treatment of advanced recurrent ovarian cancer.

The drug is an interleukin-12 (IL-12) gene formulated with a biocompatible delivery polymer. IL-12 enhances the body's immune system against cancer and inhibits tumour blood supply, according to Egen.

The product has completed two phase I trials: one as monotherapy in platinum-resistant ovarian cancer patients, and the other in combination with carboplatin/docetaxel chemotherapy in platinum-sensitive ovarian cancer patients.

The FDA granted orphan drug status to Egen-001 in 2005. The status, which is reserved for drugs intended to treat diseases that affect fewer than 200,000 Americans, carries a number of benefits, including seven years of US marketing exclusivity, tax breaks and eligibility for help with clinical trial costs.

This is Egen's second grant for the drug from the FDA. The first, totaling $1m, was awarded in 2005.

3rd February 2011

PME Digital Edition

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