Intravesical Liposome Treatment for Interstitial Cystitis

DESCRIPTION (provided by applicant): Interstitial cystitis (IC) is a chronic, severely debilitating disease of the urinary bladder. It can be described as a chronic inflammatory condition of the bladder wall, characterized by urinary frequency and urgency, and severe suprapubic and/or pelvic pain. Presently, there is limited medical therapy for IC and new and effective treatment is a major unmet medical need. Lipella Pharmaceuticals Inc. intends to be the leading company specializing in the use of intravesi cal liposome technology to treat IC. We have developed a method of formulating highly specific liposomes for intravesical instillation. The technology is licensed from inventions and research by Drs. Leaf Huang and Michael Chancellor at the University of P ittsburgh. Based on their research that a liposome itself can provides a soothing effect to an irritated bladder (RO1 DK068556; Fraser et al. 2003), Lipella Pharmaceuticals expects that intravesical liposome formulations can present an improved activity in patients with IC. Prior to submitting this phase-II proposal, phase-I funding was used primarily to explore preclinical safety considerations of LP-08, a novel intravesical liposome therapy for IC, in a rat model. This phase-II proposal includes further s afety studies, specifically measuring consequences of expected repeat dosing, as well as developing manufacturing scale-up procedures necessary for subsequent human testing. The effort proposed here would, in part, contribute to pre-clinical data collectio n prior to filing an FDA Investigational New Drug (IND) application, a regulatory requirement prior to administering LPA-08 in humans. PUBLIC HEALTH RELEVANCE We propose key preclinical experiments in an animal model to validate follow-on inves tment for clinical development of a novel treatment for painful bladder syndrome, an incurable chronic illness involving pain, urinary urgency, loss of sleep, depression and anxiety in approximately 500,000 women domestically.