MILAN, Italy, Nov. 28, 2003 (PRIMEZONE) -- Milan, Italy, November 28, 2003 - BioXell SpA, today announced that it has completed patient enrolment in the Phase IIa trial of its novel lead compound, BXL-628, in Benign Prostatic Hyperplasia (BPH).The double-blind, randomised, placebo-controlled trial is being coordinated by the Division of Urology of the San Raffaele Hospital in Milan and involves 12 centres across Italy. The primary end-point of this 3 month study is prostate size reduction as measured by MRI scans, with secondary end-points being reduced symptom severity and urinary flow rate. Results are expected in the first half of 2004.
BPH, a benign enlargement of the prostate, is a common disorder occurring in approximately 50% of men over age 60. BPH can often cause chronic lower urinary tract symptoms that affect the social, psychological and sexual lives of patients leading to a profound and negative impact on their quality of life. The management of the disease involves high costs (both direct and indirect) that are expected to continue increasing over time due to the ageing of the general population and the increased awareness of the condition by both physician and patient.
The mechanism of action of this new compound provides a novel and unprecedented approach to the treatment of BPH, since BXL-628 appears to inhibit the growth of prostate cells by impairing the activity of several growth factors that are involved in prostate growth as well as in the pathogenesis of BPH. Importantly, this inhibition is achieved without direct anti-androgen activity, thus avoiding sexual dysfunctions and other side effects associated with current therapies.
"The timely completion of the enrolment of more than 160 patients in less than six months is a remarkable success for both BioXell and all the urology centres involved in this Phase IIa trial, also considering its complexity both from an organisational and technical point of view." said Enrico Colli, Chief Medical Officer of BioXell.
About BioXell
BioXell is a private biopharmaceutical company focused in the areas of urology and inflammatory disease with offices in Milan, Italy, and Nutley, NJ, USA. Through its two proprietary technology platforms based on Vitamin D3 analogues and TREM receptor biology, BioXell has identified a number of promising lead development programmes. Its pipeline includes a compound, BXL-628 for benign prostatic hyperplasia (currently in Ph II trials) as well as research projects in transplantation, diabetes, sepsis and other urological indications. BioXell has a collaboration with TaiGen Biotechnology (Taiwan) for the research and development of small molecules active against GPCRs in the area of inflammatory diseases. To date, BioXell has raised over Euro 39 million through the participation of world-class VC investors including MPM Capital, Index Ventures, Life Sciences Partners, and NIB Capital Private Equity. BioXell currently employs 50 people. More information on BioXell can be found on: www.bioxell.com
For further information, please contact:
BioXell SpA Noonan Russo Enrico Colli Veronica Cefis Sellar Chief Medical Officer Tel. +44.20.7726 4452 Tel. +39.02.2104951 Email. Email. Enrico.Colli@bioxell.com veronica.sellar@eurorscg.com
Alvise Sagramoso Chief Administrative Officer Tel. +39.02.21049550 Mobile +39.348 0172982 Email. Alvise.Sagramoso@bioxell.com
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