Proteon drug candidate gets fast-track designation

Proteon Therapeutics Inc., a privately held Waltham biopharmaceutical company, said today that it has received fast-track designation for a drug candidate from the Food and Drug Administration.

The drug candidate is PRT-201, which is being investigated for its ability to improve vascular access in patients currently on or being prepared for hemodialysis, said the company, which noted that the FDA's fast-track designation is intended to facilitate development and expedite review for drugs that treat serious diseases and fill unmet medical needs.

PRT-201 is a recombinant human elastase that is being studied for its ability to improve surgery outcomes in patients requiring chronic hemodialysis, the company said.

"This is a very important milestone for us as we prepare to initiate clinical trials with PRT-201 this year," Timothy P. Noyes, president and chief executive of Proteon, said in a statement.
(By Chris Reidy, Globe staff)