Ark's tumour drug is given ODD in the US
Ark Therapeutics' brain tumour drug, EG009, has been conferred with orphan drug designation (odd), by the FDA. Orphan status is conferred on drugs that are used to treat a relatively small number of patients and satisfy a previously unmet need. It gives benefits such as a waiver on application fees for marketing authorisation and an exclusive marketing period.
EG009 has been granted the status because the cancer it combats affects 10,000 people in the US and 16,000 in Europe every year. The average survival time for patients is just eight months and the current treatment involves cutting out the tumour and administering a course of cytotoxic drugs.
The Ark drug works by delivering a gene into the healthy brain cells remaining after the tumour has been removed. These then produce an enzyme that kills the cells trying to divide, preventing a recurrence of a tumour.
The drug is currently in Phase IIB trials in Europe, and the earlier Phase II trials showed that a patient treated with the drug doubled their life expectancy.
In November last year, Ark's Trinam drug, a gene-based product to prevent blood vessels blocking after vascular surgery, was also granted Orphan status by the FDA.
