ILE Isolagen

Isolagen Announces Positive Phase II Dental Study Results EXTON, Pa., June 30 /PRNewswire-FirstCall/ -- Isolagen, Inc. (AMEX:ILE) today announced positive results of its Phase II dental study conducted by Dr. Michael McGuire to determine the safety and efficacy of the Isolagen Process for the treatment of interdental papillary insufficiency commonly referred to as "black triangles." The analysis of the Investigator and Subject Visual Analog Scale assessment demonstrated that the Isolagen Process was statistically superior to placebo at 4 months after treatment. In May 2004 Isolagen initiated the Phase II randomized, double-blind, placebo-controlled clinical study to determine the safety and efficacy of the Isolagen Process for the treatment of interdental papillary insufficiency. Dr. McGuire, Past President of the American Academy of Periodontology and a clinical researcher in tissue engineering stated, "The results are very encouraging. The Isolagen Process appears to offer the potential to grow gum tissue which is something that no other product or treatment has ever been shown to do before." "Based on these positive results, the company and its clinical experts expect to prepare protocols for Phase III Pivotal trials to assess the efficacy and safety of our dental product candidate for the treatment of interdental papillary insufficiency. These clinical trials will be traditional double blind, internal and placebo controlled studies and will be designed to assess the therapeutic efficacy and safety of our dental product candidate as an aesthetic product for improving the appearance of gum tissue," stated Dr. Lindner, Senior Vice President of Medical and Business Affairs. Although results of the Investigator and Subject assessment demonstrate that the Isolagen Process was statistically superior to placebo, an analysis of objective linear measurements did not yield statistically significant results despite a positive change observed as a result of treatment with the Isolagen Process. The Company's clinical experts believe that current measurement techniques are not precise enough to accurately record the positive change. The Company is investigating alternative measurement techniques to assess change in future trials. "We are very pleased with the results of the Phase II study and the potential of the Isolagen Process to improve the appearance of patients with periodontal disease," stated Frank DeLape, Chairman and Interim CEO of Isolagen. About Isolagen, Inc. Isolagen specializes in the development and commercialization of autologous cellular therapies for soft and hard tissue regeneration. The Company's product candidates are based on its proprietary Isolagen Process. Based on the accumulated experience of the Company through its retrospective study, clinical trials and treatment of patients in the United Kingdom, the Company believes that the Isolagen Process utilizes the patient's own cells to create safe and effective therapies to treat the underlying cause of the patient's condition. Autologous cellular therapy is the process whereby a patient's own cells are extracted, allowed to multiply and then injected into the patient. Isolagen's product candidates are designed to be minimally invasive and nonsurgical. Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. Information contained in forward-looking statements is based on current expectations and is subject to change, and actual results may differ materially from the forward-looking statements. Isolagen, Inc. does not undertake to update any such forward- looking statements or to publicly announce developments or events relating to the matters described herein. For additional information, please visit: http://www.isolagen.com/ . DATASOURCE: Isolagen, Inc. CONTACT: Martin Schmieg, Chief Financial Officer of Isolagen, Inc., +1-484-713-6000; or investor relations, Kate McNeil or John Nesbett, +1-212-825-3210, both for Isolagen, Inc. Web site: http://www.isolagen.com/

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