On October 25, 2019 LIPAC Oncology LLC reported the successful completion of a Phase 1 clinical study and progress in a Phase 2A study to further investigate TBC-1002 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) (Press release, Lipac Oncology, OCT 25, 2019, View Source [SID1234542535]). Phase 1 study results showed escalating doses of TBC-1002 to be well tolerated with no dose limiting toxicity and no irritative voiding (cystitis) symptoms. No systemic exposure or toxicity was observed, even with high concentrations of TBC-1002 being delivered topically to the bladder wall. Phase 1 results also indicated preliminary efficacy with no evidence of bladder cancer recurrences observed up to 18 months after dosing. Adverse events were minor.
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TBC-1002 is a proliposomal intravesical paclitaxel formulation (PLIP), in development for intravesical administration in the treatment of non-muscle invasive bladder cancer (NMIBC). NMIBC is a common and highly recurrent disease that can often be difficult to treat. If approved, TBC-1002 would be the first chemotherapeutic agent approved by the U.S. Food and Drug Administration for this indication in more than two decades.
"We are excited about the potential of TBC-1002 to target bladder cancer directly," said Michael Oefelein, Chief Medical Officer of LIPAC. "Having treated bladder cancer for more than 23 years, it is very clear that new treatment options and more effective delivery systems could help improve both clinical outcomes and quality of life."
In August, LIPAC commenced a Phase 2A marker lesion clinical study to establish efficacy responder rates within 16 weeks, which predict long-term (two-year) recurrence free survival rates. Efficacy data from this open label study is expected as soon as November 2019 with the study results available in the first quarter of 2020.
"Having established the technology to deliver chemotherapeutic agents safely in human trials, we look forward to applying this technology in other investigational areas such as upper tract urothelial carcinoma (UTUC), ovarian cancer and peritoneal cancer," said TR Thirucote, Chairman and CEO of LIPAC.
Further results on the clinical development program for TBC-1002 will be presented at the China Biomedical Industry Cooperation Forum in Shenzhen in October and at the Society of Urologic Oncology in Washington, D.C. in December.