Isolagen, Inc. Reports Positive Results from Open Label, Phase II Study of Isolagen Therapy(TM)
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. Results from these independent evaluations noted improvement in the appearance of wrinkles in more than 75 percent of study subjects using an evaluator-assessed, four-point scale developed for this study, ranging from "no improvement" to "marked improvement." Improvements were assessed using photographs of subjects taken at baseline and at the six-month time point.
Study IT-R-007 also included an assessment of skin quality of the study subjects, comparing results from baseline to the final six-month visit. Using a Skin Quality Assessment Tool developed for this study, 93 percent of subjects said their skin quality improved. Additionally, more than 95 percent of subjects showed improvements in skin quality based on the Treating Investigator Assessment. Subjects and treating investigators each assessed eight skin characteristics commonly seen as the face ages and solar damage increases. Skin quality characteristics assessed at baseline and the final six-month visit were: softness, suppleness, smoothness, firmness, thickness, moistness, evenness in appearance and refreshed appearance. While the Skin Quality Assessment tool is not validated, Isolagen is evaluating this scale for future use.
"As the principal investigator in the Isolagen IT-R-007 trial, I am optimistic about the study results which show improvement in patients' facial appearance," said Dr. Girish Munavalli, Assistant Professor of Dermatology at Johns Hopkins School of Medicine. "The results suggest that improvements in both skin texture and contour may be achieved following Isolagen treatment. I believe this outcome is a unique finding in the cosmetic injectable treatment market, utilizing the subject's own living cells to provide the basis for improvement."
Conducted at five US sites, the primary objectives of Study IT-R-007 were to assess the safety and efficacy of the Isolagen Therapy. In this open label study, all subjects received the Isolagen Therapy and there was no placebo control.
The Isolagen Process(TM) is a proprietary cellular processing system that creates a natural, living cell therapy. By multiplying a person's own collagen-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 the Isolagen Therapy, is designed to improve skin damage caused by the normal effects of aging, sun damage, acne and burns.
About Isolagen, Inc.
Isolagen(TM), Inc. (Amex: ILE - News) is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies. The company's technology platform includes the Isolagen Process(TM), a cell processing system for skin and tissue rejuvenation which is currently in clinical development for a broad range of aesthetic and therapeutic applications including wrinkles, acne scars, burns and periodontal disease. Isolagen also commercializes a scientifically-advanced line of skincare systems through its majority-owned subsidiary, Agera® 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 fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions 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 necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual 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. We operate in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the 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(TM), Inc.