TesoRx Subsidiary LIPAC Oncology Announces Completion of Phase 2A Clinical Trial of LiPax in Patients with Non-Muscle Invasive Bladder Cancer
63% Response Rate in Patients with Highly Recurrent and Heavily Pretreated Low-Grade Non-Muscle Invasive Bladder Cancer
(Menlo Park, Calif.) September 8, 2020 - LIPAC Oncology LLC, a subsidiary of TesoRx Pharma, today announced the successful completion of a Phase 2A marker lesion clinical trial designed to predict long-term (two-year) recurrence free survival rates in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC) treated with LiPax (paclitaxel). LiPax, a proliposomal paclitaxel formulation in development for intravesical installation in the treatment of NMIBC, demonstrated a 63 percent responder rate in patients treated with LiPax alone.
“Non-Muscle Invasive Bladder Cancer is difficult to treat and highly recurrent. By pairing a simple outpatient procedure (Transurethral Resection of Bladder Tumor or TURBT) with LiPax, we have an opportunity to substantially improve both clinical outcomes and quality of life for patients,” said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. “This data adds to the positive evidence observed in our Phase 1 trial, with an 83 percent recurrence free survival rate following one year of treatment.”
Persistence of LiPax above therapeutic levels was demonstrated up to 72 hours following intravesical instillation. In the study, LiPax was well tolerated. No significant adverse events were observed, and patients’ urinary health related quality of life was maintained during and after installation of LiPax, as measured by patient reported outcomes.
“Together, the results of our Phase 1 and Phase 2A clinical trials support moving LiPax into Phase 2B development for Non-Muscle Invasive Bladder Cancer,” said TR Thirucote, Chairman and CEO of LIPAC. “LiPax’s ongoing promising results in bladder cancer provides further validation of our drug delivery technology that is being used in the development of LIPAC’s other pipeline assets. We look forward to advancing our orphan-designated programs for Upper Tract Urothelial Carcinoma, Ovarian Cancer, Mesothelioma, and malignant plural effusion into the clinic in 2021.”
Based on the biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, The American Urological Association NMIBC guidelines recommend various durations of intravesical therapy after TURBT. The low to intermediate risk category targeted by LiPax is estimated to comprise 90,000 Americans, yet no intravesical agent is approved by the U.S. Food and Drug Administration for this disease.
About LiPax
LiPax is a novel, investigational formulation of paclitaxel in phase 2 development for the treatment of NMIBC. LIPAC Oncology’s proprietary formulation utilizes their proliposomal technology platform to enhance the persistence and penetration of bladder tissue by paclitaxel. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal through a histological risk assessment followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a Phase 2A clinical trial in August 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition.
About LIPAC Oncology LLC
LIPAC Oncology is a pharmaceutical company utilizing the proprietary proliposomal delivery system to enhance and reformulate proven cancer drugs into more effective treatments that include many orphan indications. The company was created in 2016 as a subsidiary of TesoRx Pharma LLC, a pharmaceutical company which has leveraged the platform technology to create therapeutic candidates for other indications. For more information, visit lipaconcology.com.
About TesoRx Pharma LLC
TesoRx Pharma LLC is focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet needs. Its growing pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx’s proprietary proliposomal delivery technology. The company was founded in 2010 through a collaboration with Western University of Health Sciences that includes joint R&D efforts at the TesoRx Centre of Excellence in Pomona, California. For more information, visit tesorx.com.
###