BioXell Initiates Phase IIb Trial of BXL628 in Benign Prostatic Hyperplasia

08-Jul-2005

BioXell S.p.A. announced initiation of a Phase IIb clinical trial evaluating the efficacy of its lead compound BXL628 in benign prostatic hyperplasia (BPH).

Coordinated by the Division of Urology at the San Raffaele Hospital in Milan, the study will enroll more than 500 patients in 60 urology centres across Italy. Using a double-blind, randomised, placebo controlled, parallel group design, the trial's primary objective is to confirm the ability of BXL628 monotherapy to reduce prostate volume after 24 weeks of treatment. Secondary endpoints are severity of symptoms, urinary flow rate, sexual function and Quality of Life. In addition, the study will evaluate the effectiveness of a fixed combination of BXL628 and tamsulosin, currently the "gold standard" alpha-blocker therapy for BPH.

BioXell successfully completed a Phase IIa clinical trial in September 2004. Comprehensive data from that study demonstrated that the drug significantly reduced prostate volume without affecting the androgen levels, thus avoiding the negative sexual side effects associated with current therapies. In particular, the data showed that after only three months of treatment, 29% of patients treated with BXL628 experienced a clinically significant reduction of prostate volume, vs. none of the patients who had received placebo. The drug was also shown to be extremely well tolerated and accepted by patients.

BPH is commonly treated by orally administered 5 alpha reductase inhibitors and alpha 1 receptor antagonists, both of which are associated with tolerability issues, specifically regarding sexual dysfunction. By contrast, due to its novel mechanism of action, BXL628 has the potential to overcome the limitations of currently prescribed therapies and if successful, could represent a new approach to the treatment of BPH, a market worth approximately EUR3 billion.

In addition to an ongoing Phase IIa trial in overactive bladder, BioXell also plans to evaluate BXL628 in non-bacterial chronic prostatitis. The company expects to initiate an additional proof of concept study in this indication by the end of 2005.

https://www.bionity.com/en/news/47540/bioxell-initiates-phase-iib-trial-of-bxl628-in-benign-prostatic-hyperplasia.html