BioXell announces positive Phase IIb results for Elocalcitol in Benign Prostatic Hyperplasia
¨ Primary endpoint met - Elocalcitol highly effective in arresting prostate growth ¨ Clinically relevant effect observed on key symptomatic parameters ¨ Excellent safety profile confirmed
MILAN, Italy, October 12, 2007 - BioXell S.p.A. (SWX: BXLN) today announced top-line results of its Phase IIb trial of Elocalcitol in Benign Prostatic Hyperplasia (BPH), a common condition among the aging male population. The primary endpoint was met with a high degree of statistical significance, with Elocalcitol effectively arresting prostate growth. Elocalcitol also showed relevant effects on the symptomatic parameters urgency, frequency and nocturia, as well as on the urodynamic parameter maximum urinary flow rate (Qmax).
The analysis of the data is still ongoing, and more detailed results will be presented at BioXell's R&D Day in Zurich on October 17, 2007.
Enrico Colli, Chief Medical Officer and Head of R&D at BioXell, commented, "We are very pleased that the study has demonstrated the effectiveness of Elocalcitol in the treatment of BPH by arresting prostate growth and improving symptoms. Elocalcitol continues to show excellent safety and tolerability, avoiding the side effects associated with the currently available treatment options. These data will enable us to move Elocalcitol into the next phase of development."
"Elocalcitol acts on key factors in BPH progression and may represent a valid monotherapy alternative to the combination currently recommended by the American and European urology associations," commented Professor Walter Artibani, Director of the School of Urology at the University Hospital of Padua, Italy.
The double-blind, randomised, placebo-controlled, parallel group design trial, carried out on a total of 514 patients with BPH at 46 centres in Italy and Germany, was intended to determine the effect of Elocalcitol monotherapy (75 or 150 mcg), as well as a combination of Elocalcitol (150 mcg) with tamsulosin (0.4 mg), on prostate volume, measured with high precision magnetic resonance imaging (MRI), as well as on symptoms.
Preliminary data analysis
The primary endpoint of the study was met with high statistical significance. Among the total intention-to-treat (ITT) population, mean change in prostate volume after 24 weeks was +0.41% in patients receiving 150 mcg of Elocalcitol, compared with +2.55% in patients receiving placebo (p<0.0002), confirming the effectiveness of Elocalcitol in arresting prostate growth. Comparable results were found in the per protocol (PP) population.
The effectiveness of Elocalcitol in arresting prostate growth was further supported by the following results: ¨ In subgroups with larger prostates (60-80 cc), the mean change in prostate volume in patients treated with 150 mcg Elocalcitol was reduced by an even greater 4.5% compared with placebo. ¨ Among patients showing a decrease in prostate volume, a significantly higher percentage was found in the group treated with 150 mcg Elocalcitol compared to placebo (32.77% vs. 12.61%, p<0.0008).
In addition to its efficacy in arresting prostate growth, Elocalcitol showed clinically relevant effectiveness on several symptomatic and urodynamic parameters: ¨ A numerical difference was observed in the International Prostate Symptom Score (IPSS) for both Elocalcitol 150 mcg and a combination of 150 mcg Elocalcitol and tamsulosin, the "gold standard" symptomatic treatment for BPH, compared to placebo. ¨ A clear positive effect of Elocalcitol was also observed on the lower urinary tract symptoms (LUTS) urgency, frequency and nocturia, measured using micturition diaries, which are considered an accurate method of assessing the symptomatic efficacy of this kind of drug. In particular, with regard to urgency, which is recognized as the most disruptive symptom to BPH sufferers, a very strong, statistically significant effect was observed on the number of episodes per day in both the 150 mcg Elocalcitol (-3.12, p<0.0108) and combination (-2.83, p<0.0386) groups, compared to placebo (-1.82), in subgroups of patients with 3 or more urgency episodes per day at baseline. ¨ Both 150 mcg Elocalcitol and the combination led to a mean increase in maximum urinary flow rate (Qmax) of 2 ml/sec compared with only 1 ml/sec with placebo. This difference is at least as large as that observed in pivotal clinical trials with alpha-blockers.
The trial also confirmed the excellent safety and tolerability profile of Elocalcitol observed in previous clinical trials, with no safety concerns. The incidence of sexual side effects was lower with 150 mcg Elocalcitol than with placebo. As an indirect confirmation of the positive effect on Qmax, no cases of urinary retention were reported with 150 mcg Elocalcitol, whereas two cases were observed in the placebo group. Finally, Elocalcitol 150 mcg has also confirmed the lack of clinically relevant effects on calcium homeostasis parameters.
About Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hyperplasia (BPH) is a benign enlargement of the prostate which can cause troublesome lower urinary tract symptoms including both storage symptoms (frequency, urgency, and nocturia or night-time urination) and obstructive symptoms (hesitancy and decreased urine flow). BPH is a common disorder, affecting approximately 35 million men, and is progressive: according to the National Institute of Health, more than 50% of men over the age of 60 and approximately 90% of men over the age of 70 have some symptoms of BPH.
If untreated, BPH can lead to acute urinary retention and can often require surgery, with a potentially profound negative impact on quality of life. Current pharmacological options are unsatisfactory, as they are either ineffective in arresting prostate growth, or associated with unpleasant sexual side effects that negatively affect patient compliance. Despite these issues, sales of the existing drugs are currently $3.2 billion.
BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat important urological, inflammatory, and related disorders with significant unmet medical needs. 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, has successfully completed a Phase IIb clinical trial for Benign Prostatic Hyperplasia (BPH) and is currently in a Phase IIb clinical trial for Overactive Bladder (OAB), with a Phase IIa trial for Male Infertility scheduled for the fourth quarter of 2007. In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. These include BXL746, to enter Phase IIa trials for Post-Surgical Adhesions in 2008; MNAC13, an innovative new approach to the treatment of pain; and the TREM platform, with TREM-1 in development for the treatment of inflammatory conditions.
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: www.bioxell.com
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Posted: October 2007