Biota starts phase I trial of common cold drug

Melbourne-based Biota Holdings (ASX:BTA) has commenced a phase I clinical trial of its human rhinovirus (HRV) drug, BTA-798, for the prevention and treatment of one of the major causes of the common cold.

"This is the first time that we have taken one of our own original drugs into human clinical trials in our own right, and without a partner," said Biota CEO Peter Cook. "We now have the confidence, we have the ability, we have the financial strength to be able to contemplate at least early stage human clinical trials in our own right without partnering."

The double blinded study will be conducted in the UK and is expected to be completed by December 2006. Up to 48 participants will be orally administered with BTA-798 produced to GMP standards.

"This is a value adding move for our shareholders," said Cook. "Instead of trying to sell the products of your research at the preclinical level, when you are prepared to sell them somewhere between phase I or ideally phase II clinical trials you significantly add a lot of value. You take away an element of risk from a potential partner."

Cook said that Biota will seek to partner the company's HRV program after the successful completion of phase I trials.

"Ideally at some grand stage in the future we'd like to think that we take them all the way through, including phase III and market them in our in right, but we've got a little way to go before we get there," he said.

While there is currently no effective preventative or therapeutic treatment for HRV, it is the predominant cause of the common cold in children and is frequently the cause of the common cold in adults. HRV is also a major cause of hospitalisation for infants, asthma sufferers and patients with chronic obstructive pulmonary disease.

BTA-798 is a small orally active molecule that was discovered and developed by Biota scientists, with the initial support of an AusIndustry Start Grant in 1998.

Biota's shares were trading at $1.52 at press time, up $0.02.