MENLO PARK, Calif., June 9, 2021 /PRNewswire/ -- LIPAC Oncology LLC., a pharmaceutical company utilizing its next generation precision liposomal technology to locally deliver taxanes to target tissues, today announced the positive results from the two-year follow-up for TD-001, its Phase 1/2a study of LiPax in patients with non-muscle invasive bladder cancer (NMIBC) who have undergone transurethral resection of bladder tumor (TURBT). Results demonstrate a recurrence free survival (RFS) rate of 83% compared to 49% for current standard of care therapies.
At both 12 and 24 months, LiPax was well tolerated with no change in patient reported urinary health related quality of life, no dose limiting toxicity (grade 3 or greater severity adverse events), and no evidence of systemic exposure to paclitaxel, the active product ingredient. Patients treated with LiPax did not report adverse effects such as burning pain, discomfort, and urinary frequency associated with current standard of care treatments for NMIBC.
"This two-year follow-up data reaffirms the results of this study's initial readout, which is that the target tissue penetration achieved by LiPax's precision liposomal technology has the potential to improve patient outcomes without the tolerability concerns of current standard of care therapies," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "We look forward to advancing LiPax into Phase 2b trials this year, bringing us one step closer to providing patients in need with this innovative new treatment option."
"There are currently limited treatment options for low-intermediate risk NMIBC patients, and up to half of these patients will recur within two years1," said Neal Shore, M.D. Director of the Carolina Urologic Research Center and principal investigator for TD-001. "Current post-TURBT drug treatment regimens have shortcomings for both patients and providers, including toxicities and supply shortages, which highlights the critical need for a treatment option that can improve patient outcomes without bothersome adverse effects."
The U.S. Food and Drug Administration (FDA) has agreed on Phase 2b and Phase 3 trial designs for LiPax, with the Phase 2b trial expected to initiate in Q4 2021.
LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). Its liposome-bound nano-technology platform achieves targeted tissue penetration with no systemic exposure, toxicity or chemo-related side-effects. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), thoracic cancers (mesothelioma and malignant pleural effusion) and peritoneal and ovarian cancers. 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 initiate a Phase 2b study in the second half of 2021 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 intracavitary cancers. Its precision liposome-bound 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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1 Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17. PMID: 16442208.
SOURCE LIPAC Oncology LLC
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