On September 8, 2020 LIPAC Oncology LLC reported 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) (Press release, Lipac Oncology, SEP 8, 2020, View Source [SID1234564781]). LiPax, a proliposomal paclitaxel formulation in development for intravesical installation in the treatment of NMIBC, demonstrated a 56 percent responder rate in patients treated with LiPax alone.
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"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 a patient’s 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 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.