Monday, August 4, 1997
Smaller biotech companies in the midst of important clinical trials
face the dilemma of maintaining a study's blind while needing positive data to convince
investors that the company is deserving of their dollars. Fortunately, clinical trial
design can serve both compound development and financing needs. Cypress Bioscience Inc.
hopes that the pivotal trial of its Prosorba apheresis column in rheumatoid arthritis (RA)
patients will be an example of trial design with financial foresight.
CYPB (San Diego, Calif.) last week announced that an independent Data
Safety and Monitoring Board (DSMB) recommended continuation of the company's pivotal RA
trial after an interim analysis of 63 patients (see Clinical Status, B10). Patients
with severe refractory RA were given 12 weekly apheresis treatments with either a mock
treatment or the Prosorba column, which uses a Protein A-conjugated matrix to bind plasma
immunoglobulins and modulate the immune response. The trial, which began in June 1996, was
set to continue if Prosorba produced a 20 percent