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BioXell Initiates Phase IIb Trial of BXL628 in Benign Prostatic Hyperplasia

Milan, Italy, 7th July 2005 – BioXell S.p.A., an Italian biopharmaceutical company that is discovering and developing new treatments for urological disorders, today announced initiation of a Phase IIb clinical trial evaluating the efficacy of its lead compound BXL628 in Benign Prostatic Hyperplasia (BPH).

Coordinated by the Division of Urology at the San Raffaele Hospital in Milan, the study will enroll more than 500 patients in 60 urology centres across Italy. Using a double-blind, randomised, placebo controlled, parallel group design, the trial’s primary objective is to confirm the ability of BXL628 monotherapy to reduce prostate volume after 24 weeks of treatment. Secondary endpoints are severity of symptoms, urinary flow rate, sexual function and Quality of Life. In addition, the study will evaluate the effectiveness of a fixed combination of BXL628 and tamsulosin, currently the “gold standard” alpha-blocker therapy for BPH.

"By evaluating these clinically relevant objectives, we expect important new information about the optimum medical treatment for BPH, as well as data that will be instrumental for the further development of the drug" said Enrico Colli MD, Chief Medical Officer at Bioxell.

"We are extremely pleased with the rapid progress of our clinical development programmes on BXL628, and we are highly committed to making our lead compound a standard of care in the treatment of a number of urological diseases" commented Francesco Sinigaglia MD, Bioxell’s Chief Executive Officer.

BioXell successfully completed a Phase IIa clinical trial in September 2004. Comprehensive data from that study, reported at the March 2005 annual meeting of the European Urology Association in Istanbul, demonstrated that the drug significantly reduced prostate volume without affecting the androgen levels, thus avoiding the negative sexual side effects associated with current therapies. In particular, the data showed that after only three months of treatment, 29% of patients treated with BXL628 experienced a clinically significant reduction of prostate volume, vs. none of the patients who had received placebo. The drug was also shown to be extremely well tolerated and accepted by patients.

BPH is a common disorder in elderly men, occurring in approximately 50% of men aged 60 years and in 90% of those aged 85 years. The disease can often cause chronic lower urinary tract symptoms such as urinary urgency, frequency and nocturia (night-time urination). This affects the psychological and sexual life of patients leading to a profoundly negative impact on their quality of life. Recent studies have shown that BPH is a progressive disease with a risk of acute urinary retention, urinary tract infections and need for surgery.

More than 54 million individuals suffer from BPH worldwide (2003), but only 5 million are currently treated with drug therapy. Due to aging populations, the prevalence of the disease is expected to increase. In the U.S. alone, social costs associated with BPH have grown from $4 billion in 1993 to $26 billion in 2003.

BPH is commonly treated by orally administered 5 alpha reductase inhibitors and alpha 1 receptor antagonists, both of which are associated with tolerability issues, specifically regarding sexual dysfunction. By contrast, due to its novel mechanism of action, BXL628 has the potential to overcome the limitations of currently prescribed therapies and if successful, could represent a new approach to the treatment of BPH, a market worth approximately €3 billion.

In addition to an ongoing Phase IIa trial in overactive bladder, BioXell also plans to evaluate BXL628 in non-bacterial chronic prostatitis. The company expects to initiate an additional proof of concept study in this indication by the end of 2005.

http://www.bioxell.com/index.html

About BioXell

Spun-out from Roche in January of 2002, BioXell is a private biopharmaceutical company focusing on the discovery and development of new treatments for urological disorders that represent large, currently underserved markets. With analogues based on its proprietary Vitamin D3 technology platform, BioXell is sponsoring three Phase II clinical programmes, specifically evaluating BXL628 for benign prostatic hyperplasia, overactive bladder, and non bacterial chronic prostatitis. In May 2005, BioXell announced a partnership with Merck to advance its TREM receptor biology programme into the clinic. BioXell is also collaborating with ProStrakan to develop Vitamin D3 drug candidates to treat osteoporosis and secondary hyperparathyroidism. To date, BioXell has raised a total of over €70m through world-class specialised healthcare VC investors including MPM Capital, Index Ventures, BB BIOTECH, AlpInvest Partners and Life Sciences Partners as well as government funding. BioXell currently employs 60 people and has sites in Milan, Italy and Nutley, NJ, USA.

Posted by J Strax, Aug 8 2005.