29 Aug, 2013

Good results achieved in tolerance studies for the new generation of SPAGO Pix

The new generation of the MRI contrast agent SPAGO Pix, with improved pharmacokinetic properties, which was developed earlier this year has now been shown to give good results in preclinical tolerance studies.

SPAGO Imaging has improved the pharmacokinetic profile of SPAGO Pix in order to increase the
in vivo stability and half-life (the time the contrast agent is in vascular circulation). The rationale for this is to lower development risk and further increase the MR image quality of cancer lesions. As outlined in a previous communication, we have achieved the expected results which have been verified in preclinical MR studies which showed excellent contrast enhancement and high quality tumor images. The positive tolerance results further strengthen the project. Consequently the next phase of dose-finding studies and toxicological GLP studies can be started on the finalization of the GLP quality material production.

– These results are important for us as they significantly reduce the risk level of the project. Before starting clinical studies with SPAGO Pix we will confirm that no unexpected toxicological findings are seen. Work is ongoing with toxicological pilot studies which will be followed by regulatory GLP toxicological studies. On completion of the preclinical toxicological studies, clinical studies will commence. Our aim is to outlicense the project to a partner, says Andreas Bunge, CEO, SPAGO Imaging AB.

The new SPAGO Pix material has a much improved pharmacokinetic profile, improved tolerance and generates higher quality MR images than previous material.

For further information contact Andreas Bunge, CEO, SPAGO Imaging AB, +46 708 242525.

SPAGO Imaging conducts research and development in the nanomedicine field with a focus on cancer diagnostics and treatment. The development is based on SPAGO’s two platform technologies, IonXgel and 3PEG.

IonXgel is a unique nanomaterial and the basis for SPAGO’s novel cancer selective MRI contrast agent, SPAGO Pix. SPAGO Pix has the potential to significantly improve cancer diagnosis with MRI (Magnetic Resonance Imaging). This novel contrast agent is designed to visualize smaller soft tissue tumors with an increased specificity, i.e. with fewer false positive results. This could make it possible to provide patients with earlier treatment and avoid unnecessary, stressful and costly diagnostic procedures and treatment. Contrary to the commercially available contrast agents, SPAGO Pix is free from gadolinium. Gadolinium is known to cause NSF, a serious and debilitating side effect, in certain patients with poor renal function.

The SPAGO Pix portfolio also includes opportunities within cancer selective drug delivery for improved cancer treatment, as well as additional MR imaging indications.

Further information can be found on www.spagoimaging.se.

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