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Cellegy has trouble scaling up
Monday, March 9, 1998
Changes to clinical protocols between Phase II and Phase III always
leave companies open to disappointment, as untested variables are introduced into pivotal
studies. The latest victim is Cellegy Pharmaceuticals Inc., whose Phase III trial of
Glylorin monolaurin for congenital ichthyosiform erythroderma failed to show a difference
from placebo cream in the primary end point of scaling.
The skin condition is characterized by scaling. CLGY (Foster City,
Calif.) appears to have run into three problems: a change in protocol that led to problems
with patient compliance; unequal randomization; and a small patient population that
probably exacerbated the first two issues.
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