Protox believes the drug's unique mechanism of action could change the way patients with enlarged prostate are treated. It said that the drug, PRX302, could be used to treat men under local anesthetic without the need for surgery.
The objective of this phase I trial will be to examine the safety and tolerability of PRX302. Secondary endpoints will include evidence of therapeutic activity, pharmacokinetic data and antibody response to PRX302. The study is designed to determine the therapeutic dose in male patients with symptomatic benign prostatic hyperplasia who are not currently taking oral medication for their condition.
“The use of PRX302 to treat histological BPH will eliminate hospital stay, reduce the morbidity of formal transurethral resection surgery and eliminate the sexual side effects common to this type of surgery,” said Dr Peter Pommerville, director of Research at Can-Med Clinical Research.