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Efficacy and Safety Follow-Up Results 3 - 7 1/2 Years After Single Treatment With Transrectal NX-1207 in Multi-Center Prospective Blinded Randomized Controlled Studies of Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Neal Shore1, Sheldon Freedman2, Barton Wachs3, Barrett Cowan4
1Carolina Urologic Research Center, Myrtle Beach, SC;2Sheldon Freedman, MD LTD, Las Vegas, NV;3Atlantic Urology Medical Group, Long Beach, CA;4Urology Associates, Englewood, CO
Introduction: NX-1207 is an investigational prostate selective therapeutic protein drug for BPH which causes controlled atrophy of prostate tissue. NX-1207 2.5 mg is injected transrectally bilaterally into the transition zone. In 4 U.S. Phase 1-2 and Phase 2 studies NX-1207 efficacy measures reached statistical significance at 90 days. Subjects from these studies were assessed in blinded follow-up studies to determine long-term efficacy.
Methods: All available unselected subjects and controls were included. AUASI scores were measured at intervals of 7 years (Phase 1-2) and 3-5 years (Phase 2).
Results Obtained: Overall in separate followup studies at 3 to 7 ½ years after a single dosage of NX-1207, 37 to 58% of subjects required no surgical treatments or medication for their BPH. After 7 ½ years, 58% of available Phase 1-2 subjects had no drug or surgical treatment for their BPH and had a mean improvement of 11.7 points in their AUASI scores. All Phase 2 follow-up study efficacy Results reached statistical significance. There were no sexual side effects or significant adverse safety events attributable to study drug.
Conclusions: NX-1207 treatment offers an office based transrectal ultrasound guided injection procedure for the treatment of LUTS due to BPH. Follow-up Results after a single treatment indicate significant symptomatic improvement with an acceptable safety profile.
This research was supported by Nymox Corp.
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