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Biotech Tracker: Neuroimmunophilin Ligands Still Need to Demonstrate Therapeutic Effect
February 23rd 2004. The National Institutes of Health initiated a 195-patient, phase II clinical trial of Guilford’s (NASDAQ: GLFD) GPI 1485 for newly diagnosed, treatment-naïve, Parkinson disease. Study subjects will be randomized to receive GPI 1485, another agent, or placebo for 12 months. Results are expected “in the second half of 2005.” Other phase II GPI 1485 trials remain ongoing for both Parkinson disease and post-prostatectomy erectile dysfunction.

Although GPI 1485 has been well tolerated and has generated some evidence that it may retard dopamine transporter loss, the drug did not generate a significant therapeutic effect in terms of motor symptoms of Parkinson disease after six months of treatment in earlier investigation.

GPI 1485 is a small molecule neuroimmunophilin ligand. In September 2001, Amgen (NASDAQ: AMGN) terminated its agreement with Guilford, returning all rights to the neuroimmunophilin ligand (NIL) technology it had licensed from Guilford in 1997. NIL technology repairs degenerated nerve cells. It has succeeded in creating viable nerve cells in the lab, but has stalled in its translation to human clinical application. In July 2001, preliminary results of a phase II NIL-A study demonstrated the agent’s failure to meet its primary efficacy endpoint of motor symptom reduction in patients with Parkinson disease. Spectrum’s (NASDAQ: SPPI) Neotrofin has also had a rocky developmental road in several neurodegenerative diseases including Alzheimer disease, spinal cord injury, and Parkinson disease.

 

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