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Dendrimer-based MRI contrast agents to be characterised

By Kirsty Barnes , 14-Oct-2005

Dendritic Nanotechnologies (DNT) has signed a collaboration agreement with Nanotechnology Characterisation Laboratory (NCL), which is focused on the discovery and development of dendrimer technologies.

DNT's Starburst and Priostar dendrimers are spheroid nanoparticles that are precisely engineered to carry molecules encapsulated in the interior or attached to the surface.

They can be used to deliver precise quantities of a drug or contrast agent to a specific location within the human body.

The platform also serves as a targeted diagnostic and therapeutic delivery system for a wide variety of drugs to cancer cells and other diseases.

Improved efficacy, enhanced solubility, and lower toxicity have been demonstrated for many existing drugs.

This collaboration agreement may facilitate a new licencing opportunity for DNT's STARBURST dendrimers, as macromolecular dendrimer-based medical resonance imaging (MRI) contrast agents for non-invasive cardiovascular diagnostics.

The agreement with DNT is one of the first characterisation agreements entered into by the NCL and will be used to perform a preclinical assessment of DNT's intravascular dendrimer-based MRI contrast agents.

The preclinical assessments undertaken by NCL intend to generate enough data in support of an investigational new drug filing (IND) with the US Food and Drug Administration (FDA), and ultimately, entry into the FDA's Phase I clinical trials.

This will be the second dendrimer-based application submitted to the Food and Drug Administration (FDA).

Starpharma Holdings Ltd. (a DNT license holder and investor) is currently entering Phase II clinical trials with a dendrimer-based topical microbicide, VivaGel, aimed at the prevention of HIV.

The dendrimers will be subjected to an assay cascade consisting of physical characterisation, in vitro studies, and in vivo ADME/Tox protocols.

"Development of dendrimer-based MRI contrast agents for sensitive, non- invasive intravascular agents is highly desired in the medical world," said Robert Berry, DNT's chief executive officer.

"The Starburst dendrimers have demonstrated intravascular properties that increase sensitivity and image clarity with potentially lower dosage compared to currently available general- use contrast agents," he added.

The ability to control the properties of size, surface, and encapsulation are critical to any intravascular agent product.

Feasibility studies on dendrimer-based contrast agents have demonstrated excellent carrying capacity, superior image enhancement, and sufficient retention for imaging, with good routes of elimination.

The use of dendrimers as a platform for new therapies has already yielded promising results: DNT has been utilised in Magnevist, AG Schering's off-patent, low molecular weight, market-leading contrast agent, within its Starburst and Priostar dendrimers.

DNT's technology has allowed Magnevist molecules to be contained within the dendrimer interior, resulting in the creation of a macromolecular contrast agent with the surface available for further modification.

In 2005, the National Institute of Standards and Technology, the Food and Drug Administration, and the National Cancer Institute established the Nanotechnology Characterisation Laboratory to perform preclinical efficacy and toxicity testing of nanoscale materials.

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