A Phase IIb development program of Provir (SP-303) as a treatment for respiratory syncytial virus will be delayed until at least January 1996, according to Shaman Pharmaceuticals, which noted that the delay came about after data from an improved and more sensitive analytical method suggested that the stability of biological samples collected in the study was in question.
Shaman recently completed Phase IIa studies on tolerance and safety involving 30 children with RSV, and the results confirm earlier studies in healthy adults, said the company. However, analysis of plasma and urine samples obtained from the children and stored frozen for three to 14 months is inconclusive at this time.
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