Clinical design as fundraiser strategy
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 or greater response than placebo as measured by American College of Rheumatology criteria 8 weeks after treatment...