Isolagen, Inc. specializes in the development and commercialization of autologous cellular therapies for soft and hard tissue regeneration. The Company's two product candidates, which are directed at the aesthetic and dental markets, utilize its own Isolagen Process, which can utilize 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. The product candidates are designed to be minimally invasive and non-surgical. Isolagen is also developing its lead product candidate for the correction and reduction of the normal effects of aging, such as wrinkles and nasolabial folds. In March 2004, the Company announced positive results of its first Phase III exploratory clinical trial for its lead product candidate. In July 2004, it announced the commencement of two pivotal Phase III trials, which are being conducted in two different geographic and demographic populations in the United States as two identical trials for the treatment of facial wrinkles. The injection phase of both Phase III studies was completed in December 2004 and the Company expects to file a biologics license application (BLA) for this product candidate during 2005. In 2003, the Company began limited commercialization for its dermal product in the United Kingdom. During the year ended December 31, 2004, Isolagen initiated a Phase II clinical trial for the cosmetic (or black triangle) application of this product candidate. The enrollment phase of this study is complete and the data from the acute (four-month) phase of the study is being analyzed. The Isolagen Process begins when the patient's physician obtains a three-millimeter elliptical punch biopsy from behind the patient's ear using a local anesthetic. This location is used because it has had limited exposure to the sun and so the procedure does not leave a visible scar. The sample is then packed in a special transport vial that is provided to the physician and is shipped overnight to the current Good Manufacturing Practices (cGMP) laboratory. After completion of a series of quality control tests, the cells are released and shipped to the physician's office overnight. Up to three injections are supplied and administered to the patient at approximately two-week intervals. Dermal Product Candidate On March 3, 2004, Isolagen announced positive results of its four-month clinical endpoint. Of the evaluable population, 77% of treatment group patients were responders, whereas 36% of the placebo group was responders (p<0.0001). In this statistically significant result, response was determined by a change of two or more points on a seven-point photoguide scale four months following the first injection. Although the primary endpoint for this study was four months, evaluations continued for six, nine and 12 months after first injection. The Isolagen treatment was offered to placebo patients after six months evaluation. On July 28, 2004, the Company announced a positive response in 82% of the Isolagen treated patients who were evaluated at six months. The therapeutic effect of the Isolagen Process compared with placebo was demonstrated at six months (82.2% vs. 38.2%, Fisher's exact, p-value<0.0001). Results of a 12-month follow-up assessment on only the Isolagen treated group demonstrated the therapeutic effect was maintained with a response rate of 82.4% in those patients who were evaluated at 12 months. A p-value is a statistical measure of the probability of drawing an erroneous conclusion from an experimental result. A p-value of less than or equal to 0.05 is generally considered to signify a statistically significant result, which means a result is unlikely to occur by chance. There were no serious adverse events related to the Isolagen Process. There was some mild edema and bruising observed at the injection site in both the placebo and treatment groups, which resolved spontaneously. T

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