Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Life Healthcare Communications

Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics