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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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