EXTON, Pa., Aug. 5 Isolagen(TM), Inc.(Amex: ILE) announced today positive top-line efficacy and safety results fromtwo pivotal, Phase III clinical studies (Studies IT-R-005 and IT-R-006) of theIsolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles. Eachstudy, conducted under an FDA Special Protocol Assessment (SPA), met allprimary endpoints and was highly statistically significant, making this amajor clinical milestone for the Company.
"This is a significant achievement for Isolagen and an important steptowards bringing the first ever autologous cell therapy product to the marketfor aesthetic use. As the future evolves and current therapies continue toshow their age, the need for novel skin rejuvenation products becomes evident.With these statistically significant results, we believe we are now in anexcellent strategic position," said Nicholas L. Teti, Jr., Chairman ofIsolagen. "These results further support the proof of principle forautologous 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 theefficacy and safety of Isolagen Therapy for the treatment of nasolabial folds,or wrinkles, evaluated a total of 421 people at 13 clinical sites across theUnited States. In Study IT-R-005, both the Evaluator and Patient evaluationsmet the co-primary endpoints and were statistically significant achieving pvalues of <0.0001 and 0.0001, respectively. In Study IT-R-006, statisticalsignificance was also achieved for both primary efficacy endpoints, achievingp values of 0.0075 and <0.0001 for the Evaluator and Patient evaluations,respectively.
Top-line statistical results showed that p values at Month 6 followingthird injection were comparable to p values at Month 2, with both observationperiods achieving statistical significance.
*p values greater than or equal to 0.05 are considered statisticallysignificant.
Preliminary safety analyses showed the Isolagen Therapy was well toleratedwith safety results comparable to placebo in the clinical studies. No seriousadverse events related to Isolagen Therapy were observed in the studies.
"I am excited by these positive study results suggesting a clinicalbenefit from the Isolagen Therapy, a novel therapy using a person's own cellsfor the treatment of wrinkles," said Stacy R. Smith, M.D., study investigatorand Assistant Clinical Professor, Division of Dermatology, University ofCalifornia San Diego. "I believe the aesthetics community would welcome a new,first in class, regenerative therapy. The results of these pivotal studieswill generate even greater interest in the outcome of the ongoing Phase II/IIIclinical study of Isolagen Therapy for the treatment of acne scars, wherethere is a significant unmet need."
The Isolagen Process(TM) is a proprietary cellular processing system thatcreates a natural, living cell therapy. By multiplying a person's owncollagen-producing cells, or fibroblasts, into tens of millions of new cells,a personalized treatment is created that is then returned to the person'sskin. This first of its kind aesthetic treatment, known as the IsolagenTherapy, is designed to improve skin damage caused by the normal effects ofaging, sun damage, acne and burns.
"We are thrilled with the positive results from our pivotal Phase IIIclinical studies of the Isolagen Therapy," said Declan Daly, President andChief Executive Officer of Isolagen. "We intend to file our Biologics LicenseApplication (BLA) with the FDA in early 2009 and continue to progress ourongoing Acne trial. I want to thank the clinical investigators andcongratulate the Isolagen team for their exceptional performance and clinicalachievement in this groundbreaking pivotal study confirming our belief in thisinnovative approach to aesthetic skin