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.

Positive Clinical Trial Results of Topical Botulinum Toxin for Overactive Bladder

PITTSBURGH--(BUSINESS WIRE)--A physician-initiated, double-blind, randomized, placebo-controlled clinical trial comparing the intravesical instillation of a topical botulinum toxin type A formulation (LP-09) to placebo in 24 subjects diagnosed with overactive bladder (OAB) showed significant reductions in both urinary urgency and urinary frequency. This result, published in European Urology, indicates the potential for reducing the need for cystoscopic needle injections when using botulinum toxin for treating OAB patients that are refractory to anti-muscarinic therapy. The clinical trial was conducted at Tzu Chi University, Hualien, Taiwan.

“The possibility of urinary retention and urinary tract infection are the primary drawbacks of the currently available botulinum toxins when treating OAB”

 

 

 

This elimination of the need for cystoscopic injections, if proven effective in larger clinical studies, could significantly impact the market adoption of botulinum toxin for the treatment of OAB. It is important to note that this study showed no treatment-associated urinary retention or increase in the patients’ post-void residual volume, which is a common adverse effect when using cystoscopic needle injection. “The possibility of urinary retention and urinary tract infection are the primary drawbacks of the currently available botulinum toxins when treating OAB,” according to Michael Chancellor MD, Chief Medical Officer of Lipella Pharmaceuticals. In an accompanying editorial, Professor Martin Michel from Johannes Gutenberg University, Mainz, Germany, who was not part of the study, noted that the possibility that botulinum toxin exerts its beneficial effects, at least in part, at the levels of the urothelium and/or afferent nerves raises the possibility that more direct targeting of these sites may maintain efficacy but have improved tolerability.

Lipella Pharmaceuticals Inc., the developer of LP-09, is a specialty biopharmaceutical company focused on the development of topical liposomal formulations for multiple therapeutic applications, including Interstitial Cystitis, Hemorrhagic Cystitis, and Overactive Bladder. Lipella’s initial pre-clinical development of LP-09 in the United States received funding from the National Institutes of Health Small Business Innovation and Research program. Further company details are available at www.lipella.com.

Caution: LP-09 is not currently approved for commercial use in any indication in the United States.

Citations

Kuo H-C, et al. Pilot Study of Liposome-encapsulated OnabotulinumtoxinA for Patients with Overactive Bladder: A Single-center Study.European Urology (2014), http://dx.doi.org/10.1016/j.eururo.2014.01.036

Michel MC. OnabotulinumtoxinA: How Deep Will It Go? European Urology (2014), http://dx.doi.org/10.1016/j.eururo.2014.02.046

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