Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Mee
05 Agosto 2008 - 3:10PM
PR Newswire (US)
Investor Conference Call to be held on Wednesday, August 6, 2008 at
8:00 a.m. EXTON, Pa., Aug. 5 /PRNewswire-FirstCall/ --
Isolagen(TM), Inc. (AMEX:ILE) announced today positive top-line
efficacy and safety results from two pivotal, Phase III clinical
studies (Studies IT-R-005 and IT-R-006) of the Isolagen Therapy(TM)
for the treatment of nasolabial folds, or wrinkles. Each study,
conducted under an FDA Special Protocol Assessment (SPA), met all
primary endpoints and was highly statistically significant, making
this a major clinical milestone for the Company. "This is a
significant achievement for Isolagen and an important step towards
bringing the first ever autologous cell therapy product to the
market for aesthetic use. As the future evolves and current
therapies continue to show their age, the need for novel skin
rejuvenation products becomes evident. With these statistically
significant results, we believe we are now in an excellent
strategic position," said Nicholas L. Teti, Jr., Chairman of
Isolagen. "These results further support the proof of principle for
autologous cell therapy and open the door for further research in
aesthetics, acne scars, burn scars and other clinical
applications." The pivotal, Phase III placebo-controlled studies
investigating the efficacy and safety of Isolagen Therapy for the
treatment of nasolabial folds, or wrinkles, evaluated a total of
421 people at 13 clinical sites across the United States. In Study
IT-R-005, both the Evaluator and Patient evaluations met the
co-primary endpoints and were statistically significant achieving p
values of
Isolagen (AMEX:ILE)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Isolagen (AMEX:ILE)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024
Real-Time news about Isolagen (American Stock Exchange): 0 recent articles
Más de Isolagen, Artículos de Noticias