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

Featured jobs

Integrated Brand/ Digital Senior Account Director, London: Excellent package

Principal Medical Writer / Editorial Director – Medical Communic...: £60, 000 - £80, 000

Account Director, Healthcare Communications Agency: £54, 000- £60, 000

Account Director, Healthcare Advertising Agency: Salary TBC

Account Director - Award Winning Healthcare Advertising Agency -...: £50000 - £68000

Market Access Consultant - Greater Manchester: Negotiable

Head of Market Access - International - Based Cambridge: Excellent Basic, Bonus and Flex Benefits

Technical Manager – Developer and Commercial Excellence, Healthc...: Excellent package

Science Writer, Healthcare Advertising Agency: £40, 000 - 45, 000 DOE benefits,

Healthcare PR Senior Account Manager: Salary TBC

Healthcare PR Director: £100, 000 – £120, 000 benefits

Senior Account Manager – Healthcare Advertising: Salary TBC

Senior Account Manager / Account Director - Medical Education – ...: Salary TBC

Account Manager: Negotiable

Senior Strategist/ Planner, Healthcare Marketing, London: Excellent package

Graduate Scientific Editor: DOE

Senior Writer, Healthcare Advertising, London: Excellent package

Scientific Director – Medical Communications - New York or Remot...: $100000 - $150000

Associate Scientific Director: Salary TBC

Account Manager, Healthcare Advertising: £30 - 38, 000 (or -)

Account Manager- 4 days per week or full-time: Salary TBC

Senior Medical Writer, Principal Medical Writer, Scientific Dire...: £40000 - £75000 Bonus Benefits

Medical Writer - Creative and Scientific Projects: DOE

Senior Medical Writer: Salary is DOE

Account Manager, MedicalCommunications/ Healthcare PR: benefits

PM Society Digital Awards – the power of together: Our chief executive, Emma Statham, writes about the value of awards and the power of together....
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’....