Lipella Pharmaceuticals to Present at the AUA 2015 Annual Meeting

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Lipella Pharmaceuticals’ LP-10 asset, which has received FDA Orphan Drug designation, has now shown in-vivo efficacy in both chemo- and radiation cystitis models.

In-vivo efficacy results from non-clinical studies of LP-10, Lipella’s intravesical drug candidate for radiation cystitis (RC), will be presented Saturday, May 16 at the 2015 Annual Meeting of the American Urological Association (AUA) in New Orleans, LA.

The study, to be published in the August 2015 issue of the Journal of Urology, showed that LP-10 was able to reverse harmful consequences of radiation on a mammalian bladder in-vivo. Measures observed included inter-micturition intervals and histology on Sprague-Dawley rats exposed to targeted bladder radiation. The LP-10 formulation was administered intravesically; saline installations were used as controls.

“LP-10 has already demonstrated pre-clinical efficacy in chemo-cystitis,” said Dr. Jonathan H. Kaufman, Chief Executive Officer of Lipella Pharmaceuticals Inc. “We are pleased to see its pre-clinical efficacy confirmed in radiation-cystitis as well, and look forward to completing IND enabling studies in the near future.”

About Radiation Cystitis
Radiation cystitis is an inflammatory condition of the urinary bladder characterized by chronic radiation-induced bleeding. Pelvic radiation, both external beam and brachytherapy, represent the cornerstones of cancer therapy for a variety of pelvic area cancers including prostate, ovarian, cervical, and colorectal cancers. Radiation from these treatments can cause collateral bladder damage, which can appear after a latency period of months to years.

If not adequately managed, radiation cystitis can result in cystectomy (surgical removal of the bladder) and can be fatal. This places a significant burden on patients and the healthcare system, and can be devastating to patients who are already fighting a malignancy. Currently, there are no FDA-approved drugs indicated for the treatment of radiation cystitis.

About LP-10    
LP-10 is a proprietary liposomal formulation of tacrolimus, a potent immunosuppressant that also exhibits strong anti-inflammatory effects. In 2012, Lipella received Orphan Designation from the US FDA for the use of tacrolimus for the treatment of hemorrhagic cystitis. Hemorrhagic cystitis is characterized by gross bleeding in the bladder caused by chemo- or radiation cystitis.

About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a biopharmaceutical company focused on the development of new drugs to treat patients with urinary bladder diseases and disorders. More information is available at http://www.lipella.com.

Citations
Levanovich et al. Intravesical liposomal tacrolimus protects against radiation cystitis in-duced by 3-beam targeted bladder radiation. American Urological Association. Poster Presentation. New Orleans, LA. 16 May 2015.

Rajaganapathy et al. Intravesical liposomal tacrolimus protects against radiation cystitis induced by 3-beam targeted bladder radiation. Journal of Urology, In Press, 2015.

Chuang et al. Intravesical immune suppression by liposomal tacrolimus in cyclophospha-mide-induced inflammatory cystitis. Neurourology and Urodynamics 30: 421, 2011.

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