Isolagen sees Ph III efficacy for wrinkle treatment

Isolagen has reported positive top-line efficacy and safety results from two pivotal, Phase III studies of its flagship autologous cellular repair therapy for the treatment of nasolabial folds, or wrinkles. The US firm noted that each study, conducted under a Food and Drug Administration Special Protocol Assessment, met all primary endpoints and was highly statistically significant.

In Study IT-R-005, both the Evaluator and Patient evaluations met the co-primary endpoints and were statistically significant (p<0.0001 and 0.0001, respectively). In IT-R-006, statistical significance was also achieved for both primary efficacy endpoints (p<0.0075 and p<0.0001 for the Evaluator and Patient evaluations, respectively.

"This is a significant achievement for Isolagen and an important step towards bringing the first ever autologous cell therapy product to the market for esthetic 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 Teti, chairman of Isolagen.