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Tuesday 25th October 2016

Bioxell lead drug fails in trial

14th April 2009

Italian biopharmaceutical company BioXell has announced it will cut costs following disappointing results in trials of its Phase IIb trial of a drug for overactive bladder.


The company reported that in an urodynamic, multi-center, double-blind, placebo-controlled study on 257 patients, Elocalcitol showed no statistically significant effect, which was that participants were urinating less when they first did so involuntarily.

In the trial, the patients were randomized into three groups (placebo, 75mcg, 150mcg), and treated daily for four weeks.

An evaluation of the effect of Elocalcitol on bladder volume at the first involuntary detrusor contraction, following four weeks of treatment, showed a failure to meet targets of effectiveness.

Performed in 47 centres in the UK, the Netherlands, Italy and eastern Europe, the trial also aimed to measure additional urodynamic parameters, symptoms severity and patient's perception of bladder condition.

However, the drug showed a statistically significant improvement in 'bladder volume at first desire to void' in the target population. Numerical improvements in most other urodynamic parameters compared to placebo were observed but did not reach statistical significance, the company said.

The news caused the company's share price to dive.

Francesco Sinigaglia, CEO of BioXell, called the results "disappointing."

But he said: "Data on the secondary endpoints are encouraging and we will be discussing the full data set with our experts and investigators in the coming weeks."

Bioxell, which is listed on the Zurich stock exchange and does not yet have a drug on the market, said it would scrap some other drug studies as it cuts costs in the wake of the news.

It said its short-term objective was now to limit spending very carefully.

Around 26 million people in seven major pharmaceutical markets are affected by an urgent need to urinate frequently and often at night.

The company now has an estimated three years to redefine its strategy before its money runs out, analysts estimated.


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