LIPID-BASED THERAPIES
FOR BLADDER SYNDROMES

Our drug candidates are locally applied treatments for common bladder disorders. Our most advanced product, LP-08, targets interstitial cystitis—a painful, chronic inflammation of the bladder that afflicts an estimated 3.3M to 7.9M Americans.

Lipella Pharmaceutic...

31 May 2017

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.


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Lipella Pharmaceutic...

12 June 2015

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.


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Lipella Pharmaceutic...

27 August 2015

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.


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Lipella Pharmaceutic...

03 September 2013

Lipella Pharmaceuticals Inc. today announced the appointment of David L. Lucchino, co-founder and former Chief Executive Officer of Semprus BioSciences, to the company’s Board of Directors. Semprus BioSciences was acquired in May 2012 for $80M.

Mr. Lucchino co-founded Semprus BioSciences with Massachusetts Institute of Technology’s Institute Professor, Robert S. Langer, Sc.D., while earning his MBA as an Alfred P. Sloan Fellow. There, he successfully secured $28.5 million in venture financing and $5.4 million federal funding, led his team to obtain FDA approval and CE Mark to market the company’s flagship technology and grew the organization from two to 40 employees.

Prior to co-founding Semprus, Mr. Lucchino was a Senior Associate at Polaris Venture Partners, a $3 billion venture capital fund based in Boston. Additionally, Mr. Lucchino co-founded and served as Managing Director of LaunchCyte, an investment firm that specializes in developing biomedical intellectual property. LaunchCyte successfully co-founded six portfolio companies.

“David’s industry expertise and insight add a unique dimension to Lipella as we prepare to enter a new phase of growth,” said Jonathan Kaufman, President and Chief Executive Officer of Lipella. “We are delighted to welcome him to our board, and look forward to his many contributions."

Mr. Lucchino currently serves on the board of the Massachusetts Biotechnology Council and Multiple Myeloma Research Foundation. He is a Trustee of Mt. Auburn Hospital, a Harvard Medical School facility, where he serves on the hospital's Audit/Compliance and Nomination committees. He also serves on the Audit Committee for CareGroup, the parent organization of Mt. Auburn, Beth Israel Deaconess Medical Center and The New England Baptist Hospital. He most recently completed a 3-year directorship on the board of AdvaMed, the Advanced Medical Technology Association, the national trade association representing the U.S. medical device industry.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals Inc. is a privately held pharmaceutical company dedicated to the development of experimental therapeutic products that are designed to be delivered directly to the bladder via a urinary catheter. This local delivery option limits the risk of systemic side effects. Lipella’s R&D assets include experimental products for interstitial cystitis, overactive bladder and hemorrhagic cystitis. For further company details, visit www.lipella.com


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Positive Clinical Tr...

08 April 2015

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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Lipella Pharmaceutic...

13 May 2014

PITTSBURGH--(BUSINESS WIRE)--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 pre-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 recently received orphan designation from the FDA for the use of tacrolimus for 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,” according to George Harriston, President of the Radiation Cystitis Foundation.

“This funding provides financial support for our remaining requirements to obtain investigational new drug approval from the FDA, which is the primary regulatory requirement for starting clinical trials,” 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.


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By limiting drug distribution to the bladder, our products minimize the risk of the adverse effects that accompany traditional therapies.
Working with well-known active agents, they significantly boost the potential for therapeutic efficacy.

LP-08

A clinical-stage product for interstitial cystitis (IC). An “empty” liposome product, LP-08 has proven effective in clinical trials of patients with IC, showing significant efficacy with minimal side-effects.

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LP-09

A clinical-stage product for overactive bladder (OAB) that has shown marked reduction in urinary frequency and urinary urgency for patients with OAB, without the common side-effects associated with orally administered drugs.

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LP-10

A liposomal formulation of tacrolimus, a potent immunosuppressant that also has strong anti-inflammatory effects. Lipella received orphan designation from the US FDA for the use of tacrolimus for the treatment of hemorrhagic cystitis.

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