Lipella Pharmaceuticals to Present at the AUA 2015 Annual Meeting

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.

Pittsburgh,  PA  –  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  intermicturition  intervals  and  histology  on  Sprague­‐Dawley  rats  exposed  to  targeted  bladder  radiation.  The  LP-10  formulation  was  adminitered intravesically; saline installations were used as controls.

“LP­‐10 has already demonstrated preclinical efficacy in chemo-cystitis,” said Dr. Jonathan H. Kaufman, Chief Executive Officer of Lipella Pharmaceuticals Inc. “We are pleased to see its preclinical 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 antiinflammatory 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 www.lipella.com.

Citations

Levanovich et al. Intravesical liposomal tacrolimus protects against radiation cystitis induced 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.