The challenge of delivering drugs to neurological targets has been a major roadblock to many promising therapies for treating diseases and disorders of the brain. It is well understood that the blood brain barrier (BBB) blocks the vast majority of all small-molecules and virtually all large molecules from reaching therapeutic targets within the brain. Unwanted systemic side effects have been an issue, along with the need for higher dosages. And if a drug is successful in crossing the BBB, there can be challenges related to the drug’s selectivity, i.e., affecting areas in the brain other than just the desired neurological target.
Direct infusion of drugs into neurological targets was proposed years ago as a means of solving many of these challenges. Direct delivery has the potential to solve the BBB issue, reduce or eliminate unwanted systemic side effects, significantly lower dosage requirements, and enable higher selectivity to a desired target within the brain.
The obvious approach for implementing direct drug delivery in the brain is conventional stereotaxy, however several failed neurological drug trials suggest that the use of conventional stereotaxy does not result in consistent and accurate delivery of drugs. The reason conventional stereotaxy has been ineffective for direct drug delivery is simple: conventional stereotaxy is a blind procedure, relying on indirect targeting and offering no detailed intraprocedural visualization. The inherent inaccuracies from brain shift, co-registration errors, and system limitations cannot be overcome. A new approach is needed and the new approach is here: a visualized procedure.
The ClearPoint system is an interventional platform that enables real-time, minimally invasive, MRI-guided procedures in the brain. Using the ClearPoint system, a neurosurgeon sees and selects a neurological target location, aims the ClearPoint targeting device and watches via MR-imaging as a drug delivery cannula is advanced to the target location inside the patient’s brain. The surgeon then visually monitors the flow and administration of the drug to the point of delivery.
The ClearPoint system can be thought of as a high-resolution GPS for the brain, rather than an old paper Rand McNally atlas. With road maps, drivers essentially had to guess whether they were following the correct path en route to their destination. GPS allows us to keep tabs on our progress in real time. Likewise, ClearPoint gives surgeons real-time guidance for reaching their target, plus the ability to observe the delivery of the drug, as it is infused.
The ClearPoint system is poised to solve a decades-old problem that has hindered the success of many promising drugs for treating neurological diseases. With ClearPoint, the drug reaches the neurological target; the so-called “delivery effect” can be separated from drug effect. Unwanted systemic side effects can be reduced or eliminated and lower dosages can be utilized. And from a business perspective, the novel route of administration offers an opportunity to enhance or extend patent life of a drug therapy.
ClearPoint is currently involved in five investigational drug trials, three for treating brain tumors and two for treating Parkinson’s disease.
As the healthcare industry grows to meet the challenges posed by neurological diseases, the right therapy, coupled with an accurate, simple and effective delivery method, will usher in a new wave of critically needed treatments.
Filed Under: Drug Discovery