Lund, Sweden-based BioInvent International AB says that its therapeutic antibody product candidate BI-204 (anti-oxLDL) has reached the primary endpoint in a Phase I trial, and was safe and well tolerated. The firm is currently deciding whether to progress to Phase II.
In the trial, pharmacokinetic results showed that the half life was in the expected range for fully-human antibodies. The study, conducted in Denmark, involved a total of 80 healthy patients with elevated low-density lipoprotein cholesterol. The drug is being co-developed with Genentech, a wholly-owned unit of Swiss drug major Roche, under an agreement signed in January 2007.
Genentech owns commercialization rights for North America, while BioInvent has retained the rights for the rest of the world.
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