EXTON, Pa., Oct. 22 Isolagen(TM), Inc.(Amex: ILE) presented today an analysis of results from the completed pivotalPhase III studies (Studies IT-R-005 and IT-R-006) of the Isolagen Therapy(TM)for the treatment of nasolabial folds, or wrinkles. Both studies, conductedunder a U.S. Food and Drug Administration (FDA) Special Protocol Assessment(SPA), reported statistically significant results meeting all primaryendpoints. The analysis was presented today in a company webcast. Pleasevisit www.isolagen.com for the complete audio and slide presentation.
"The full analysis of data from these pivotal safety and efficacy studiesis very exciting and further supports the potential of Isolagen Therapy as aninnovative treatment for wrinkles. In addition to improving the appearance ofwrinkles, the effects of Isolagen Therapy in the studies were observed tobuild over time, which may allow for gradual rejuvenation of the skin," saidStacy R. Smith, M.D., study investigator and Assistant Clinical Professor,Division of Dermatology, University of California San Diego. "There is agrowing demand for minimally invasive procedures that rejuvenate the skin."
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's skin.This first-of-its-kind aesthetic treatment, known as Isolagen Therapy, isdesigned to improve skin damage caused by the normal effects of aging, sundamage, acne and burns.
"We are very pleased with the analysis of our Phase III pivotal studies,which highlights the potential of Isolagen Therapy to provide a uniquetreatment paradigm in the field of medical aesthetics," said Declan Daly,President and Chief Executive Officer of Isolagen. "These significant resultsfrom our pivotal wrinkle trials confirm our belief that Isolagen Therapy hasthe potential to become the first ever autologous cell therapy product totreat wrinkles, and may one day be positioned similarly for additionalclinical applications including acne scars and burn scars."
Study 005 and 006 Data Analysis Highlights
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. Results from both studies were statistically significant forthe co-primary endpoints assessed at Visit 6.
In Study IT-R-005, both the Evaluator and Patient evaluations met the co-primary endpoints and were statistically significant, achieving p values of<0.0001 and 0.0001, respectively. In Study IT-R-006, statistical significancewas also achieved for both primary efficacy endpoints, achieving p values of0.0075 and <0.0001 for the Evaluator and Patient evaluations, respectively.
Studies IT-R-005 and IT-R-006 were identical Phase III, double-blind,randomized placebo-controlled studies that were conducted under a SPAagreement with the FDA. The primary efficacy endpoints were required to beco-primary endpoints comprised of a Subject Assessment Scale and an EvaluatorAssessment Scale (the Lemperle scale). Under the SPA, a two-point improvementon both scales was required to demonstrate efficacy of Isolagen Therapy ascompared to placebo.
The Subject assessed response rates for studies IT-R-005 and IT-R-006 were57 percent (Isolagen Therapy) versus 30.1 percent (placebo) and 45.5 percent(Isolagen Therapy) versus 17.6 percent (placebo) in the Intent to Treat (ITT)populations, respectively. The Subject response rates for the Modified Intentto Treat (MITT) population, those subjects who received at least one of threetreatments, were 68.7 percent (Isolagen Therapy) versus 33.7 percent (placebo)and 51.0 percent (Isolagen Therapy) versus 19.2 percent (placebo) in IT-R-005and IT-R-006, respectively.
Further, subject-assessed response rates scored as one-point improvements-- often the criteria for other aesthetic products -- were nearly 80 percent(Isolagen Therapy).
The occurrence of local adverse events was low in these studies, andevents reported were mostly mild in nature and of short duration. In thesestudies, adverse events seen with Isolagen Therapy were similar to those seenin the placebo group.
"The results from these studies further support the hypothesis thatIsolagen Therapy provides a well tolerated therapy for facial rejuvenation,"concluded Dr. Smith.
The Phase III wrinkle studies were conducted under the FDA SPA regulations.The SPA process results in an agreement with the FDA that successful clinicaltrial results can form the basis of an efficacy claim for a marketingapplication. Although significant, the SPA does not guarantee approval of aBLA.
"We remain on schedule to file our BLA in early 2009," continued DeclanDaly. "I am very proud of the Isolagen team as we continue to deliver onclinical milestones and work toward validating the promise of the IsolagenTherapy both in wrinkles and additional clinical applications, such as acnescars and burn scars."
About Isolagen, Inc.
Isolagen(TM), Inc. (Amex: ILE) is an aesthetic and therapeutic companycommitted to developing and commercializing scientific advances and innovativetechnologies. The company's technology platform includes the IsolagenProcess(TM), a cell processing system for skin and tissue rejuvenation whichis currently in clinical development for a broad range of aesthetic andtherapeutic applications including wrinkles, acne scars, burns and periodontaldisease. Isolagen also commercializes a scientifically-advanced line ofskincare systems through its majority-owned subsidiary, Agera(R) Laboratories,Inc. For additional information, please visit www.isolagen.com.
Isolagen Forward Looking Statements
All statements in this news release that are not based on historical factare "forward-looking statements" within the meaning of the Private SecuritiesLitigation Reform Act of 1995 and the provisions of Section 27A of theSecurities Act of 1933, as amended, and Section 21E of the Securities ExchangeAct of 1934, as amended. Forward-looking statements in this press release,include, without limitation, the ability of Isolagen Therapy to become thefirst ever autologous cell therapy product to treat wrinkles, and to bepositioned similarly for additional clinical applications including acne scarsand burn scars, and the ability of Isolagen to file its BLA in early 2009.While management has based any forward-looking statements contained herein onits current expectations, the information on which such expectations werebased may change. These forward-looking statements rely on a number ofassumptions concerning future events and are subject to a number of risks,uncertainties, and other factors, many of which are outside of our control,that could cause actual results to materially differ from such statements.Such risks, uncertainties, and other factors include, but are not necessarilylimited to, those set forth under Item 1A "Risk Factors" in the Company'sAnnual Report on Form 10-K for the year ended December 31, 2007, as updated in"Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filedsince the annual report. We operate in a highly competitive and rapidlychanging environment, thus new or unforeseen risks may arise. Accordingly,investors should not place any reliance on forward-looking statements as aprediction of actual results. We disclaim any intention to, and undertake noobligation to, update or revise any forward-looking statements. Readers arealso urged to carefully review and consider the other various disclosures inthe Company's Annual Report on Form 10-K for the year ended December 31, 2007,as well as other public filings with the SEC since such date.
SOURCE Isolagen, Inc.