Spheramine Implants for Parkinson's: Clinical Study Continues

Spheramine brain implants improve mobility in moderate-to-advanced Parkinson's disease, according to a phase 1/2 open-label pilot study in 6 patients. A 4-year follow-up report* of the study was presented April 29 at the annual meeting of the American Association of Neurological Surgeons in Chicago and through a press release from Titan Pharmaceuticals, codeveloper of the therapy.

According to Titan, Spheramine improved mobility (per UPDRS motor scores) by an average of 44% and patient-reported quality-of-life scores by 23% at 48 months. Titan also claims that there were no Spheramine-related serious adverse events. One-year data from the open-label study justified the initiation of a double-blind, randomized, sham-surgery-controlled trial of Spheramine (STEPS). Information regarding the design of this study was also presented at the AANS meeting, and Titan CEO Mark Rubin, MD, expects results in the third quarter of this year.

Enrollment in STEPS (N = 71) was completed last year and included retired teacher Suzanne Davenport, who experienced a precipitous decline in her clinical status after Spheramine implantation in January 2005. Ms. Davenport's family is currently seeking compensation from Titan and Spheramine codeveloper Bayer Healthcare for her study-related injury.