Clinical trial planned for stem cell treatment for stress urinary incontinence

ITL Laboratories, L.L.C. ("ITL") is planning a clinical trial to determine the effectiveness of a stem cell treatment for stress urinary incontinence. A recent clinical trial by Austrian researchers has demonstrated the potential usefulness of expanded muscle stem cell injections in the treatment of urinary incontinence.

ITL plans to use its proprietary stem cell expansion technology to expand patients own muscle stem cells to treat stress urinary incontinence -- a condition that affects almost 15 million people (primarily women) worldwide. The condition occurs when the urethra narrows or otherwise becomes abnormal, or when the sphincter muscles that help open and close the urethra become weak or diminished, causing urine leakage when an individual exercises, coughs, sneezes, laughs or lifts heavy objects.

The cells used in the trial are not controversial because they are generated from the patient's own body. The treatment, which addresses the underlying problem of urinary incontinence, is believed to be one of the first stem cell therapies to enter clinical practice.

The trial is expected to begin in the summer of 2005 after the company establishes its offshore laboratory and medical clinic.

EpiPharma, Inc. announced on January 18, 2005 that it has entered into an agreement to purchase 25% of ITL, an entity engaged in the research, development and administration of adult stem cells, including human umbilical cord stem cells (USCs) for the treatment of neurological and degenerative diseases.