MILAN, Italy, March 27, 2003 (PRIMEZONE) -- BioXell SpA, the Italian biopharmaceutical company, today announced that it has initiated recruitment for the Phase II trial of its novel lead compound, BXL-628, in Benign Prostatic Hyperplasia (BPH).The trial, a double-blind, randomised, placebo-controlled study involving 120 patients, will be coordinated by the Division of Urology, Universita Vita e Salute-San Raffaele, Milan and involve 12 centres across Italy.
BPH, a benign enlargement of the prostate, is a common disorder in elderly men 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, negative impact on their quality of life. The management of the disease involves high 'total costs' (direct and indirect costs) that are expected to continue increasing over time due to the ageing of the general population and the increased awareness of the condition.
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 Phase II trial is a result of many years of research in this field in Italy and is a significant achievement for a company as young as BioXell. We believe that this new drug will substantially contribute to the improvement in the quality of life of people affected by this condition," said Enrico Colli, Chief Medical Officer of BioXell.
BioXell is a private biopharmaceutical company with a competitive edge in immunology. Through its two strong technology platforms based on the TREM receptor system and Vitamin D3 analogues, BioXell has identified a number of molecules, including BXL-628 for benign prostatic hyperplasia currently in Ph II. In addition, the company has research programmes in inflammatory diseases including asthma, psoriasis and sepsis and has a collaboration with TaiGen Biotechnology (Taiwan) for the research and development of GPCRs in the area of inflammatory diseases. In March 2002, BioXell raised 22m Euro in a first-round financing from a consortium of three top-tier venture capital firms: MPM Capital, Index Ventures and Life Sciences Partners. BioXell has a network of key academic collaborations, including Washington University, St. Louis (USA) and the Universities of Arkansas (USA), Milan, Florence, Modena, Zurich (CH), Lund (S) and Kuopio (FIN). Based in Milan, Italy, BioXell employs 44 people. More information on BioXell can be found on: www.bioxell.com