EXTON, Pa., Aug. 25 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc.
(Amex: ILE) announced today results from a prospective, open label, Phase II
study (IT-R-007) of Isolagen Therapy(TM) for the treatment of facial wrinkles
and creases in approximately 40 subjects. Study subjects received two
treatments of Isolagen Therapy in multiple facial regions ('full face')
approximately five weeks apart. The study results reported improvement in the
appearance of wrinkles as scored by a high percentage both of study subjects
as well as of independent panel evaluators. The study results also reported
improvement in skin quality as scored by a high percentage of both study
subjects and participating investigators.
Six months following their final treatment ('the six-month time point'),
83 percent of subjects reported an improvement in their self-assessed score of
the appearance of their wrinkles. This scale was the same as the one used in
the recently completed Isolagen Therapy pivotal efficacy studies
(IT-R-005 and -006). At the six-month time point, the results from the
independent panel evaluation of study photographs also showed improvement in
the appearance of wrinkles, with the independent panel scoring improvement in
over 75 percent of participants.
'We are very pleased with the outcome of this exploratory study,' said
Declan Daly, President and Chief Executive Officer of Isolagen. 'We are
particularly interested in the responses around skin quality, as this is the
first time we have assessed the Isolagen Therapy for these important skin
characteristics.'
Study IT-R-007 Study Results
As seen in all previous studies of Isolagen Therapy, treatment was very
well tolerated in Study IT-R-007. No serious adverse events related to the
Isolagen Therapy were observed.
Efficacy results from the trial showed that 83 percent of study subjects
reported improvement in the appearance of their wrinkles using a subject-
assessed, five-point response scale that ranged from 'very dissatisfied' to
'very satisfied.' Improvement was defined as a one point move on the scale.
The subject assessment scale is the same scale used in the recently completed
IT-R-005 and 006 pivotal Phase III studies of Isolagen Therapy.
The study results also included assessments from an independent panel of
three aesthetic dermatologists and plastic surgeons who were not involved with
the treatment of subjects in the study.
