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BioXell Announces Positive Phase II Results for BXL628 in Benign Prostatic Hyperplasia

Milan, Italy, 27th September 2004 – BioXell SpA, the Italian biopharmaceutical company, today announced successful results in its Phase IIa trial of BXL-628 in patients with Benign Prostatic Hyperplasia (BPH).
The primary endpoint of prostate volume reduction was met with a high degree of significance and the treatment was extremely well tolerated. In the 12-week double-blind, randomized placebo controlled study of 120 patients, BXL-628 showed a reduction of 7.2% in prostate volume versus patients on placebo (P0.0001). In a separate pre-defined responder analysis, 92% of patients on BXL-628 did not experience a clinically significant growth in prostatic volume, versus 48% of those on placebo (P0.0001).

Benign Prostatic Hyperplasia is a common disorder in elderly men, occurring in approximately 50% of men aged 60 years and in 90% of those aged 85 years. It is a progressive disease with a risk of urinary retention, bladder infections and renal failure. Treatment for BPH has so far consisted of orally administered 5 alpha reductase inhibitors and alpha 1 receptor antagonists, each associated with tolerability issues, specifically regarding sexual dysfunction. Because of its novel mechanism of action, BXL-628 does not affect testosterone levels and represents a new approach to the treatment of BPH, a market worth approximately €3 billion.

Professor Patrizio Rigatti, Study Coordinator at the San Raffaele Hospital, Milan, commented ”I believe that the results of this study can open a new avenue in the treatment of this common disease. With BXL-628 we may be able to block the natural progression of the condition without affecting androgen levels, and thus avoiding the negative sexual side effects seen with existing treatments. This would not only have a positive effect on quality of life but would also enhance patient compliance.“

Dr Enrico Colli, Chief Medical Officer of BioXell, said “We believe these results, along with some additional preclinical data on the effects of BXL-628 on the bladder, confirm that we have an exciting product to treat several different diseases with lower urinary tract symptoms.”

BioXell plans to begin a Phase IIb dose-ranging study in early 2005 and is beginning the search for a potential commercialization partner. The company is expecting to commence a Phase IIa study of BXL-628 in patients suffering from Overactive Bladder during the end of 2004, and in 2005 plans to begin two additional Phase IIa trials with BXL-628 in Interstitial Cystitis and another as yet undisclosed indication. The combined markets for these indications in the developed world are currently in excess of $5 billion.

Notes to the editor

About BioXell
BioXell is a private biopharmaceutical company focusing on the discovery and development of new treatments for urological and chronic inflammatory disorders. Through its proprietary technology platform based on Vitamin D3 analogues, BioXell has identified a number of promising lead development programmes. Its pipeline includes BXL 628 for benign prostatic hyperplasia as well as compounds to treat overactive bladder and other major urological indications. In order to further exploit its Vitamin D3 platform, BioXell is also collaborating with ProStrakan to develop drug candidates to cure osteoporosis and secondary hyperparathyroidism. Furthermore, based on its unique understanding of the inflammatory process and knowledge of GPCRs and TREM receptor biology, BioXell is also committed to a number of cutting-edge research projects to develop new drugs for chronic inflammatory diseases in collaboration with external partners. To date, BioXell has raised a total of over € 48 million through world-class specialised healthcare VC investors including MPM Capital, Index Ventures, AlpInvest Partners and Life Science Partners and government funding. BioXell currently employs 53 people and has sites in Milan, Italy and Nutley, NJ, USA.

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Publisher Contact Information:

Bioxell S.p.A.
+39 02-2104951

Company profile of Bioxell S.p.A.
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