OctoPlus and Leiden University Medical Center to start patient trials with novel drug against chronic middle ear infection

19-Jan-2004

An innovative drug against chronic middle ear infection will go into patient trials shortly in Leiden, The Netherlands. drug delivery and development company OctoPlus and the Leiden University Medical Centre (LUMC) have joined forces in this clinical trial, with OctoPlus taking responsibility for further commercialisation. The product has a unique mechanism of action. It may offer benefits for patients with chronic middle ear infection and other chronic infections of the upper airways that can not be treated adequately with existing antibiotics. In pre-clinical studies, the drug was proven to neutralize toxic microbial degradation products and showed no side effects.

Middle ear infections and other infections of the upper airways often result in the presence of toxic microbial degradation products, so-called toxins, that remain at the site of infection. These toxins are unresponsive to traditional antibiotics and as a result chronic infections can occur. Often, surgical procedures are required to treat these infections. The new drug, developed by LUMC, has a novel mechanism of action; it neutralizes toxins at the site of infection and locally restores the body's natural clearance mechanism.

Middle ear infections are very common, affecting approximately 15% of all children. Given the mechanism of action of the drug, the potential exists to expand into other indications in the future, for example sinusitis and chronic bronchitis.

Clinical trials will be lead by prof. Dr. Grote, Department of Otorhinolaryngology and will take place in collaboration with Dr. Drijfhout, Department of Immunohematology and Blood Transfusion. "There is a clear need to develop novel therapies for infections of the upper airways to combat the increasing resistance against established antibiotics and to address chronic infections that do not respond well to current therapies", says prof. Dr. Grote .

Joost Holthuis, Chief Executive Officer of OctoPlus said: "We are very pleased to work with the LUMC as a strong clinical partner and look forward to first patient data on safety and efficacy of this novel compound."

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