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Kosan out licenses motilin receptor agonist to Pfizer

Kosan Biosciences says that Pfizer has initiated a phase 1 clinical trial of its motilin receptor agonist PF-04548043 under development for the treatment of gastroesophageal reflux disease and other GI disorders

US biotech Kosan Biosciences has revealed that Pfizer initiated a phase 1 clinical trial of its motilin receptor agonist PF-04548043 under development for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) disorders.

The phase 1 clinical trial will test the safety, tolerability and pharmacokinetics of PF-04548043 in healthy subjects. Motilin is a hormone secreted by the small intestine and stimulates gastrointestinal movement. Motilin activity is mediated through the G-protein coupled motilin receptor found on smooth muscle cells of the GI tract and elements of the enteric nervous system.

In preclinical studies, PF-04548043 showed an improved safety profile relative to erythromycin and accelerated gastric emptying, suggesting that it may provide symptom relief in several GI diseases.

In December 2006, Kosan and Pfizer established a worldwide license agreement for Kosan's motilin agonist programme in a deal worth USD 250m for the successful development and commercialisation of PF-04548043 for one indication, as well as royalties on global sales.

Hsp990 inhibitor registration trials open
In other news, Kosan has opened the Tanespimycin in Myeloma Evaluation registration programme (TIME-2 trial) and has been enrolling patients for its lead Hsp90 inhibitor, tanespimycin (KOS-953).

The TIME programme includes two clinical trials: TIME-1 and TIME-2. TIME-1 is a pivotal phase III trial to be conducted in a first-relapse patient population. TIME-2, which is designed to be supportive of the TIME-1 trial, is a phase II/ III trial in patients with relapsed-refractory disease.

TIME-2 also has the potential to support registration in a relapsed-refractory setting. The TIME program will use Kosan's new, proprietary injectable suspension formulation of tanespimycin, which will be the first Hsp90 inhibitor to enter such a programme.

7th August 2007

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