Sophiris Bio shares slide on Phase III results of PRX302

16 December 2014

Biotech company Sophiris Bio (Nasdaq: SPHS) saw shares in the company fall up to almost 80% following an announcement of disappointing results for its PRX302.

Its interim analysis of a Phase III trial indicated that PRX302 would not meet a predefined efficacy threshold as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia. Sophiris said the ongoing PLUS-1 study is unaffected by this, and that the trial will continue until the primary endpoint, the change in the International Prostate Symptom Score (IPSS) from baseline, is evaluated at 52 weeks.

The study was designed to assess safety and efficacy of a single PRX302 dose for the treatment of benign prostatic hyperplasia, with the interim analysis based on the change in PISS from baseline to 12 weeks in all 479 patients treated in the study. The independent data monitoring committee found no safety concerns.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK