Titan Pharmaceuticals has completed preclinical study of its long-term,non-fluctuating dopamine agonist,as a treatment for Parkinson's disease.
The preclinical study included in-vitro characterization of implant formulations of two dopamine agonists created using the company's ProNeura drug delivery technology.
Ropinirole containing implants were selected for in-vivo testing in a subcutaneously administered dose escalating study in the standard MPTP(1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)induced preclinical primate model of PD.
The data reports that a sustained,non-fluctuating,subcutaneous dose of ropinirole delivered by the implant,safely decreased clinical symptoms of PD in the model over a period of several months,and the measured plasma levels of the drug were within the therapeutic window reported for treating PD in human subjects.
University of California Kinetics Foundation translational research and neurological surgery chair Krystof Bankiewicz said the results of the study are promising and support further investigation of the safety and efficacy of the implantable,continuous drug delivery product for treating Parkinson's disease.
"The goal of treatment with such a product would be to potentially alleviate'on/off'motor fluctuations and treatment-related dyskinesias that may be associated with current dopamine-replacement treatment regimens,"Bankiewicz added.
The company said$495,000 grant for the preclinical study was primarily funded by the National Institutes of Health under the Small Business Innovation Research(SBIR)program,and administered by the National Institute of Neurological Disorders and Stroke.
