Avacta Group PLC (AIM:AVCT), the clinical stage oncology drug company, said the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead drug candidate, AVA6000, for treatment of soft tissue sarcoma.
AVA6000 is a novel form of doxorubicin modified with Avacta's precision delivery platform to improve safety and therapeutic index.
The FDA grants ODD for rare diseases such as soft tissue sarcoma which affects less than 200,000 people in the US, with the designation qualifying the drug developer to receive certain incentives, including seven years of market exclusivity upon drug approval, the company said in a statement.
"This designation provides tax credits and other incentives for drug developers addressing rare diseases," said Alastair Smith, chief executive.
According to the American Cancer Society, 13,190 people in the US will be diagnosed with soft tissue sarcoma this year.
Avacta has an ongoing phase 1 clinical trial to assess the safety and pharmacokinetics of AVA6000 which has potential as a treatment for patients with a range of cancer types, including soft tissue sarcoma.
Shares of the company were trading 6.24% higher at 124.30p in London.