MENLO PARK, California., June 9, 2021 /PRNewswire/ — LIPAC Oncology LLC., a pharmaceutical company using its next-generation precision liposomal technology to locally deliver taxanes to target tissues, today announced positive results from its two-year follow-up to TD-001, the phase 1/2a trial of LiPax in patients with non-muscle invasive bladder cancer (NMIBC) who have undergone transurethral resection of bladder tumor (TURBT). The results show a recurrence-free survival (RFS) of 83% compared to 49% for current standard treatments.
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 adverse reactions), and no evidence of systemic exposure to paclitaxel, the active product ingredient. Patients treated with LiPax reported no adverse events such as burning pain, discomfort, and urinary frequency associated with current standard treatments for NMIBC.
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“These two-year follow-up data confirm the results of the first readout of this study that the target tissue penetration achieved by LiPax’s precision liposomal technology has the potential to improve patient outcomes without the tolerability issues of current standard treatments.” said Michael Oefelein, MD, Chief Medical Officer of LIPAC Oncology. “We look forward to bringing LiPax into phase 2b trials this year, bringing us one step closer to bringing this innovative new treatment option to patients in need.”
“There are currently limited treatment options for low-intermediate risk NMIBC patients, and up to half of these patients will return within two years.”1,” said Neal Shore, MD director of the Carolina Urologic Research Center and principal investigator for TD-001. “Current drug treatment regimens after TURBT have shortcomings for both patients and providers, including toxicities and stock shortages, highlighting the critical need for a treatment option that can improve patient outcomes without unpleasant side effects.”
The US Food and Drug Administration (FDA) has reached agreement on Phase 2b and Phase 3 pilot designs for LiPax, with the Phase 2b trial is expected to start in the fourth quarter of 2021.
LiPax is a precisely targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). The liposome-linked nanotechnology platform achieves targeted tissue penetration without systemic exposure, toxicity or chemo-related side effects. NMIBC is the leading program of additional orphan indications for upper duct urothelial cancer (UTUC), thoracic cancers (mesothelioma and malignant pleural effusion), and peritoneal and ovarian cancers. LiPax is designed to improve the standard of care for ambulatory endoscopic tumor removal followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a phase 2a clinical trial in studie August 2020 and intends to start 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 novel investigational therapies for the treatment of intracavitary cancers. The precision liposome-linked nanotechnology platform targets local liposomal delivery of taxanes for the treatment of multiple tumor types. LiPax, Leading Research Candidate for Treatment of Non-Muscle-Invasive Bladder Cancer, Enters Phase 2b development. The company’s pipeline includes multiple orphan indications based on its 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 2,596 patients from seven EORTC studies. Euro Urol. March 2006;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 January 17. PMID: 16442208.
SOURCE LIPAC Oncology LLC
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