LIPAC Oncology Announces Successful Type B Meeting with the U.S. FDA for the Study of LiPax for Non-Muscle Invasive Bladder Cancer
MENLO PARK, Calif., April 29, 2021 /PRNewswire/ -- LIPAC Oncology LLC today announced the conclusion of a successful Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss Phase 2b/3 clinical trials of LiPax in patients with low-grade highly recurrent non-muscle invasive bladder cancer (NMIBC). The feedback from the FDA provides a clear path for LIPAC Oncology to initiate the Phase 2b trial for LiPax in the second half of 2021.
"We appreciate the thoughtful feedback and guidance from the FDA and acceptance of our proposed design for the Phase 2b/3 trial of LiPax," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "Non-muscle invasive bladder cancer is difficult to treat and highly recurrent. With the lack of existing treatment options for low to intermediate risk NMIBC, the unmet medical need is very high."
LIPAC Oncology recently 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 NMIBC treated with LiPax. In this study LiPax demonstrated a 63 percent marker lesion responder rate in highly recurrent and heavily pretreated patients. Based on these results, the FDA agreed that the Phase 2b trial will be a dose selection study with low dose (90 mg) and high dose (360 mg) arms and will enroll approximately 30 patients in each arm. The Phase 3 trial will be a randomized, double-blind, placebo-controlled trial in patients with low-grade recurrent NMIBC with a time to event primary endpoint after a one-year treatment phase.
"LIPAC Oncology is pleased to reach this important point in the development of LiPax, bringing us one step closer to providing this therapeutic option to the patients who could benefit from a novel approach to treatment," said Will Robberts, President of LIPAC Oncology. "We have made significant progress with the program, including executing a successful Phase 1/2a trial, securing a strategic partner in South Korea and expanding the global intellectual property protection with formulation patents being granted in Europe, Japan, China and other territories."
Non-muscle invasive bladder cancer (NMIBC) is a cancer found in the tissue that lines the inner surface of the bladder. Bladder cancer is the sixth most common cancer in the U.S., and 74% of all bladder cancer is non-muscle invasive. Approximately 90,000 patients are newly diagnosed with NMIBC per year in the U.S. alone with as many as 390,000 patients per year newly diagnosed with NMIBC worldwide. The disease is marked by a high recurrence with a five-year recurrence rate averaging 50%.
Treatment of NMIBC is based on risk stratification. Patients are initially treated with a simple outpatient procedure involving transurethral resection of bladder tumor (TURBT) followed by a single, immediate instillation of intravesical chemotherapy to eliminate any residual tumor cells. 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 induction and maintenance intravesical therapy after TURBT for intermediate risk patients. The low to intermediate risk category targeted by LiPax is estimated to comprise 95,000 Americans per year, yet no intravesical agent is approved by the FDA for this disease.
LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of NMIBC. Its liposome-bound technology achieves targeted tissue penetration with no systemic exposure and toxicity. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), peritoneal and ovarian cancers and thoracic cancers (mesothelioma and malignant pleural effusion). LIPAC Oncology's precision nano-technology platform provides targeted local liposomal delivery of taxanes (paclitaxel) to allow for deep tissue penetration in the bladder with no systemic exposure, dose-limiting toxicity or chemo-related side effects. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal 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 focused on advancing the development of new investigational therapies to treat intra-cavitary cancers. Its precision nano-technology platform targets local liposomal delivery of taxanes for the treatment of multiple tumor types. LiPax, its lead investigational candidate for the treatment of non-muscle invasive bladder cancer, is in Phase 2b development. The Company's pipeline includes multiple orphan indications based on the established LiPax formulation. For more information, visit lipaconcology.com.
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SOURCE LIPAC Oncology LLC