On June 9, 2021 LIPAC Oncology LLC., a pharmaceutical company utilizing its next generation precision liposomal technology to locally deliver taxanes to target tissues, reported 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) (Press release, Lipac Oncology, JUN 9, 2021, View Source [SID1234583788]). Results demonstrate a recurrence free survival (RFS) rate of 83% compared to 49% for current standard of care therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.