BioXell Reports Preliminary Phase IIa Results in Non-Bacterial Chronic Prostatitis
Effect on pain comparable to placebo, effect observed on inflammation and lower urinary tract symptoms
Milan, Italy, September 27, 2006 – BioXell S.p.A. (SWX: BXLN) today reported preliminary results from its proof of concept trial of Elocalcitol in patients with Non-bacterial Chronic Prostatitis. The effect of Elocalcitol was found to be no different from that of placebo on the primary endpoint, focused mainly on pelvic pain. In contrast, positive data for several secondary endpoints provide further support for the potential efficacy of the compound in both Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB), indications for which Elocalcitol is also currently in clinical development.
The primary endpoint analysis of the 3 month trial in 129 patients showed that both Elocalcitol and placebo reduced the total NIH/Chronic Pelvic Pain Syndrome (CPPS) symptom score by 15 points out of a possible score of 43. One of the secondary endpoints of the trial was the level of IL-8 in the semen, a marker for inflammation in which Elocalcitol showed a clinically relevant reduction. A positive signal was also detected in lower urinary tract symptoms (LUTS) - frequency, urgency, and nocturia - as recorded in micturition diaries. In particular, among patients who began the trial with a frequency of urination greater than 10 times per day, 55% of patients on Elocalcitol saw their frequency decrease to less than 10 (versus only 14% on placebo). The trial again confirmed the excellent safety profile of the compound which was no different from placebo.
Francesco Sinigaglia, CEO of BioXell, commented: “CP remains a disabling condition for which no approved treatment exists. While we are disappointed that Elocalcitol has no effect on chronic pelvic pain and will therefore not be developed further in indications where pain is a central component, we are very pleased to see clinical evidence that the compound reduces IL-8 levels, a marker for inflammation, as these correlate with BPH progression. This finding also opens up additional development opportunities for the compound, and the new data on LUTS are also very encouraging for both OAB and BPH, since they confirm the effect of Elocalcitol on the bladder.”
BioXell is currently conducting a 500+ patient Phase IIb trial in BPH which is on track to complete enrolment by the end of this year. Early next year, the Company will begin a large, pan-European Phase IIb trial in OAB which could potentially be used as one of the pivotal trials for registration.
The data analysis is still ongoing and will be finalized (including sub-group analysis) in the following weeks.
A conference call is scheduled today at 10:00 a.m. Central European Time to comment on these preliminary results. To participate in the conference call, please dial +41 91 610 56 00 (Europe & ROW), +39 02 3600 7818 (Italy), +44 (0) 207 107 0611 (UK), +1 (1) 866 291 4166 (USA). Digital playback will be available after the conference call starting at 12:00 p.m. for a period of 48 hours. Dial: +41 91 612 4330 (Europe & ROW), +44 (0) 207 108 6233 (UK), +1 (1) 866 416 2558 (USA); conference ID: 541 followed by #.
The conference call can also be listened to live at 10.00 CET at www.bioxell.com by clicking on the icon on the home page. A recording of the conference call will be archived in the Investors section of the website under Reports & Presentations.
As previously announced, BioXell will hold an R&D Day in Zurich on October 13, 2006, whose purpose will be to provide an in-depth overview of the Company’s clinical and pre-clinical R&D pipeline. Further details can be found on the BioXell’s web site.
BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat urological, inflammatory, and related disorders with significant unmet medical needs and representing large markets. The Company was founded in 2002 as a spin-out from Roche. BioXell’s strategic goal is to become a fully integrated pharmaceutical company by maximizing the commercial potential of its product portfolio and leveraging existing platforms into profitable partnerships. BioXell’s lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, is in Phase II clinical trials for Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB). In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. Since 2005 BioXell has a TREM-1 fusion protein in development for the treatment of septic shock in an exclusive partnership with Merck & Co., Inc. Furthermore, in 2006 BioXell in-licensed from Lay Line Genomics S.p.A. a novel anti-TrkA monoclonal antibody, MNAC13, which represents a potential new approach to the treatment of pain.
In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 58 people and has sites in Milan, Italy and Nutley, NJ, USA.
More information on BioXell can be found at: http://www.bioxell.com
This press release does not constitute or form part, or all, of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities, nor shall part, or all, of these materials or their distribution form the basis of, or be relied on in connection with, any contract or investment decision in relation to any securities. This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of BioXell, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of BioXell, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on these forward-looking statements. BioXell disclaims any obligation to update these forward-looking statements to reflect future events or developments.
- Contact Information
- Alvise Sagramoso
- BioXell S.p.A.
- Contact via E-mail
This news content was configured by WebWire editorial staff. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.