PRISM Q&A CORNER
Dr. Michael Chancellor, Lipella PharmaceuticalsLipella Pharmaceuticals Advances Innovative Treatments and Support During Urology Awareness Month
September is Urology Awareness Month, dedicated to raising awareness about a wide range of urological diseases and conditions, including bladder, kidney, and prostate cancers, as well as non-malignant issues such as incontinence, urinary tract infections, erectile dysfunction, and kidney stones. This initiative brings together the urology community to highlight the importance of urological health.
Lipella Pharmaceuticals (Nasdaq: LIPO) is leading the way when it comes to new treatments and support during Urology Awareness Month and throughout the year, particularly for those who suffer from hemorrhagic cystitis.
Hemorrhagic cystitis (HC), a painful condition marked by lower urinary tract symptoms including hematuria (blood in the urine) and irritative voiding, is a critical health challenge in the field of urology. HC is caused by damage to the bladder’s epithelium and blood vessels due to factors like toxins, pathogens, radiation, chemotherapy, or disease. Patients undergoing chemotherapy or hematopoietic stem cell transplantation are particularly vulnerable, especially when exposed to total-body irradiation.
In light of Urology Awareness Month, we sat down with Dr. Michael Chancellor, Co-founder and Chief Medical Officer of Lipella Pharmaceuticals, to discuss the challenges of managing hemorrhagic cystitis. Dr. Chancellor is a renowned expert in urology, having authored over 550 peer-reviewed articles and 11 books, and is a professor at the Oakland University William Beaumont School of Medicine in Michigan. His pioneering research in stem cell therapies, tissue engineering, and drug discovery has earned him national and international recognition, making him a leading figure in the development of innovative treatments for urological conditions.
In this Q&A, Dr. Chancellor shares his insights into hemorrhagic cystitis, current treatment challenges, and promising developments in the field.
A:Hemorrhagic cystitis is a serious condition characterized by bleeding from the bladder wall, which can occur as a side effect of pelvic radiation therapy or bladder-toxic chemotherapy – it is one the most challenging conditions that I treat. These treatments are commonly used for pelvic malignancies like prostate and uterine cancer. Millions of patients are diagnosed with these cancers each year, and around 20% of them undergo pelvic radiation therapy. While these therapies are essential for cancer treatment, they can also cause long-term damage to the bladder, leading to HC.
HC is not only painful but also potentially life-threatening, with a mortality rate of around 4%. What makes it so challenging to treat is the poor blood flow to the damaged bladder tissue, which limits the effectiveness of existing therapies. Right now, the available treatments, such as steroids or vitamin E, are largely ineffective. Some efforts focus on adjusting radiation to minimize bladder damage, but this can compromise the overall effectiveness of cancer treatment.
As urologists, we’re left managing a condition that severely impacts patients’ quality of life, yet there are no FDA-approved treatments for HC. This creates an urgent need for more effective therapies that can provide both symptom relief and reduce the risk of further complications. In 2022, we launched our Radiation Cystitis Patient Registry to raise awareness of this serious issue in the medical community and to bring hope to more people who suffer from HC.
Q:A:Our product, LP-10, is an intravesical liposomal formulation of tacrolimus designed for the treatment of moderate to severe hemorrhagic cystitis. Tacrolimus has been safely and effectively used since the 1980s, primarily for its potent vasoconstrictive and anti-inflammatory properties. What makes LP-10 unique is its targeted delivery directly into the bladder via intravesical instillations. This allows us to achieve localized treatment with minimal systemic absorption, as demonstrated by our pharmacokinetic analysis, which showed a very short duration of systemic uptake.
In our Phase 2a study, we treated 13 patients with up to two courses of LP-10 bladder instillations. The results were encouraging, with patients showing improved urinary symptoms, including decreased blood in the urine, reduced cystoscopic bleeding, and fewer ulceration sites. Importantly, 58% of patients achieved complete or near-complete resolution of bleeding, a significant improvement for those suffering from HC.
A:The safety profile of LP-10 is strong—none of the patients experienced serious adverse events related to the treatment, and all tolerated the bladder instillations well. Based on these findings, we plan to initiate a larger Phase 2b trial in the first half of 2025, further exploring the dose-escalation and efficacy of LP-10 in a broader patient population. We believe LP-10 has the potential to address a critical unmet need in HC treatment, and our mission is to deliver the first FDA-approved treatment for this patient population.
In addition to our work on hemorrhagic cystitis, we are also expanding our pipeline to target other serious and rare diseases. We are currently recruiting patients for our Phase 2a clinical trial in Oral Lichen Planus (OLP), a condition that severely impacts patients’ quality of life. LP-310, a novel liposomal-tacrolimus oral rinse based on LP-10, is being investigated as a potential treatment for OLP, and we expect to report top-line data from this study by the end of 2024.
Lipella remains committed to addressing significant unmet medical needs, whether in the field of urology or in other critical areas, through innovative therapies designed to improve patients’ lives.
September is Urology Awareness Month, dedicated to raising awareness about a wide range of urological diseases and conditions, including bladder, kidney, and prostate cancers, as well as non-malignant issues such as incontinence, urinary tract infections, erectile dysfunction, and kidney stones. This initiative brings together the urology community to highlight the importance of urological health.
Lipella Pharmaceuticals (Nasdaq: LIPO) is leading the way when it comes to new treatments and support during Urology Awareness Month and throughout the year, particularly for those who suffer from hemorrhagic cystitis.
Hemorrhagic cystitis (HC), a painful condition marked by lower urinary tract symptoms including hematuria (blood in the urine) and irritative voiding, is a critical health challenge in the field of urology. HC is caused by damage to the bladder’s epithelium and blood vessels due to factors like toxins, pathogens, radiation, chemotherapy, or disease. Patients undergoing chemotherapy or hematopoietic stem cell transplantation are particularly vulnerable, especially when exposed to total-body irradiation.
In light of Urology Awareness Month, we sat down with Dr. Michael Chancellor, Co-founder and Chief Medical Officer of Lipella Pharmaceuticals, to discuss the challenges of managing hemorrhagic cystitis. Dr. Chancellor is a renowned expert in urology, having authored over 550 peer-reviewed articles and 11 books, and is a professor at the Oakland University William Beaumont School of Medicine in Michigan. His pioneering research in stem cell therapies, tissue engineering, and drug discovery has earned him national and international recognition, making him a leading figure in the development of innovative treatments for urological conditions.
In this Q&A, Dr. Chancellor shares his insights into hemorrhagic cystitis, current treatment challenges, and promising developments in the field.
Hemorrhagic cystitis is a serious condition characterized by bleeding from the bladder wall, which can occur as a side effect of pelvic radiation therapy or bladder-toxic chemotherapy – it is one the most challenging conditions that I treat. These treatments are commonly used for pelvic malignancies like prostate and uterine cancer. Millions of patients are diagnosed with these cancers each year, and around 20% of them undergo pelvic radiation therapy. While these therapies are essential for cancer treatment, they can also cause long-term damage to the bladder, leading to HC.
HC is not only painful but also potentially life-threatening, with a mortality rate of around 4%. What makes it so challenging to treat is the poor blood flow to the damaged bladder tissue, which limits the effectiveness of existing therapies. Right now, the available treatments, such as steroids or vitamin E, are largely ineffective. Some efforts focus on adjusting radiation to minimize bladder damage, but this can compromise the overall effectiveness of cancer treatment.
As urologists, we’re left managing a condition that severely impacts patients’ quality of life, yet there are no FDA-approved treatments for HC. This creates an urgent need for more effective therapies that can provide both symptom relief and reduce the risk of further complications. In 2022, we launched our Radiation Cystitis Patient Registry to raise awareness of this serious issue in the medical community and to bring hope to more people who suffer from HC.
Our product, LP-10, is an intravesical liposomal formulation of tacrolimus designed for the treatment of moderate to severe hemorrhagic cystitis. Tacrolimus has been safely and effectively used since the 1980s, primarily for its potent vasoconstrictive and anti-inflammatory properties. What makes LP-10 unique is its targeted delivery directly into the bladder via intravesical instillations. This allows us to achieve localized treatment with minimal systemic absorption, as demonstrated by our pharmacokinetic analysis, which showed a very short duration of systemic uptake.
In our Phase 2a study, we treated 13 patients with up to two courses of LP-10 bladder instillations. The results were encouraging, with patients showing improved urinary symptoms, including decreased blood in the urine, reduced cystoscopic bleeding, and fewer ulceration sites. Importantly, 58% of patients achieved complete or near-complete resolution of bleeding, a significant improvement for those suffering from HC.
The safety profile of LP-10 is strong—none of the patients experienced serious adverse events related to the treatment, and all tolerated the bladder instillations well. Based on these findings, we plan to initiate a larger Phase 2b trial in the first half of 2025, further exploring the dose-escalation and efficacy of LP-10 in a broader patient population. We believe LP-10 has the potential to address a critical unmet need in HC treatment, and our mission is to deliver the first FDA-approved treatment for this patient population.
In addition to our work on hemorrhagic cystitis, we are also expanding our pipeline to target other serious and rare diseases. We are currently recruiting patients for our Phase 2a clinical trial in Oral Lichen Planus (OLP), a condition that severely impacts patients’ quality of life. LP-310, a novel liposomal-tacrolimus oral rinse based on LP-10, is being investigated as a potential treatment for OLP, and we expect to report top-line data from this study by the end of 2024.
Lipella remains committed to addressing significant unmet medical needs, whether in the field of urology or in other critical areas, through innovative therapies designed to improve patients’ lives.
