Lipella Pharmaceuticals Receives National Institutes of Health Funding for Its Hemorrhagic Cystitis Phase-2 Clinical Trial

PITTSBURGH--Lipella Pharmaceuticals Inc., today announced the award of a grant by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support the clinical development of LP-10, a topical-formulation of liposomal tacrolimus for the treatment of hemorrhagic cystitis.

“If LP-10 proves successful in the clinic, that could have a significant improvement in the lives of those with complications resulting from pelvic radiation therapy, which is often employed for the treatment of prostate cancer”

Hemorrhagic cystitis is a rare and serious complication of either pelvic radiation therapy or certain types of chemotherapies commonly used for treating pelvic area cancers. Hemorrhagic cystitis causes significant urinary bleeding that can ultimately result in cystectomy (surgical removal of the urinary bladder) if not adequately managed. There are currently no approved drugs for hemorrhagic cystitis, and existing management strategies (such as hyperbaric therapy) are extremely costly with limited availability.

To date, pre-clinical studies using LP-10 have demonstrated in-vivo efficacy in an animal model. Tacrolimus (the active ingredient in LP-10) is a powerful immunosuppressant primarily indicated for suppressing transplant rejection. Lipella has also received orphan designation from the FDA for the use of tacrolimus for hemorrhagic cystitis. 

“This funding provides financial support for our pending Phase-2 clinical trial,” stated Jonathan Kaufman, Chief Executive Officer of Lipella.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals Inc. is a specialty biopharmaceutical company focused on the development and commercialization of novel liposome formulations for multiple therapeutic applications. Lipella’s research and development assets include experimental and clinical stage products for interstitial cystitis, overactive bladder, and hemorrhagic cystitis. Lipella is a privately held company based in Pittsburgh, PA. For further company details, visit www.lipella.com.

Caution

LP-10 is currently not approved for commercial use in any indication in the United States and is limited by U.S. Federal Law to investigational use only.

The project described is supported by Award Number R44DK102247 from the NIDDK. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIDDK or the National Institutes of Health.

Lipella Pharmaceuticals Announces Enrollment of First Patient in Phase-2 Trial in Interstitial Cystitis

Lipella has enrolled and treated the first patient in a 36-subject, Phase-2a, U.S. clinical trial designed to evaluate the safety and efficacy of LP-08 in patients with Interstitial Cystitis

Pittsburgh, PA (PRWEB) August 27, 2015

Lipella Pharmaceuticals Inc. today announced dose administration for the first patient in a Phase-2 clinical study testing its liposomal formulation (LP-08) in 36 subjects diagnosed with Interstitial Cystitis, an incurable, chronic, and debilitating disease of the urinary bladder that involves urinary urgency, frequency and chronic pelvic pain. The study will assess the safety and tolerability of two dose levels of LP-08 compared to placebo.

The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses compared to placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of an LP-08 80 mg dose. For further study details, refer to the following link to ClinicalTrials.gov: Link

The initiation of the Phase-2a study follows the successful conclusion of an open-label clinical trial evaluating LP-08 in 14 subjects. In this prior study, a course of four weekly intravesical instillations of LP-08 was associated with statistically significant improvements in pelvic pain and urgency scores four weeks beyond the completion of treatment. These benefits were not accompanied by treatment-associated adverse events. This positive outcome was published in the journal International Urology and Nephrology.

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.

Lipella Pharmaceuticals Inc.
David Chancellor
Office: 412-894-1853
david.chancellor(AT)lipella.com
Source: Lipella Pharmaceuticals Inc.

Citation
Peters KM, et al. Liposomal bladder instillations for IC/BPS: an open‐label clinical evaluation. International Urology and Nephrology 46(12):2291-2295, 2014.

Acknowledgment
The project described is supported by Award Number R44D0K85733 from the National Institute of Diabetes And Digestive And Kidney Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Diabetes And Digestive And Kidney Diseases or the National Institutes of Health.

Lipella Pharmaceuticals to Present at the BIO International Convention

Lipella Pharmaceuticals will present at the 2015 Bio International Meeting in Philadelphia, PA on Tuesday, June 16. 

Pittsburgh, PA (PRWEB) June 12, 2015

Lipella Pharmaceuticals Inc, today announced that Chief Medical Officer Michael Chancellor, MD will present at the 2015 BIO International Convention in Philadelphia, PA. The presentation will take place on Tuesday, June 16, at 10:45 a.m. (EST) in Theater 3 at the Pennsylvania Convention Center, 1101 Arch St.

Dr. Chancellor will provide an overview of Lipella’s current pipeline of drug candidates for indications in Interstitial Cystitis, Hemorrhagic Cystitis, and Overactive Bladder. For further company details visit http://www.lipella.com or Lipella’s exhibition space in the NIH Innovation Zone at the Bio International Convention, Booth 101.

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 infor-mation is available at http://www.lipella.com.

Lipella Pharmaceuticals Inc.
David Chancellor
Office: 412-894-1853
david.chancellor(at)lipella(dot)com

Source: Lipella Pharmaceuticals Inc.

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.

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