Pharmaceutical Business review

Innocoll given OK for phase II study

CollaRx Gentamicin is a Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary CollaRx technology. Upon application to a wound the product releases the antibiotic gentamicin.

According to Innocoll, studies suggest its effectiveness in the treatment and cure of infected chronic wounds, including diabetic foot ulcers. There are no topically applied antibiotics currently marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers.

Innocoll plans to study the treatment of diabetic foot infections of varying severities in a series of phase II trials. The lead indication is for the treatment of mild infection where CollaRx Gentamicin will be compared to an orally administered antibiotic, the current standard of care. In future trials, Innocoll plans to investigate the product as an adjunct to systemic therapy for treating infections of higher severity and also as a method to prevent ulcers from becoming clinically infected.

Innocoll believes the product will be a major investment for the company and has the potential to become a platform for expanding its direct sales and marketing from Europe into the US.

“We are currently in the process of securing the necessary finance to fund this and other near term clinical programs to progress our development pipeline,” stated Dr Michael Myers, president and CEO of Innocoll.