Investigational NMIBC treatment TBC-1002 : LIPAC Oncology said that it has wrapped up a phase 1 clinical trial of TBC-1002 for the treatment of non-muscle invasive bladder cancer (NMIBC) and has now initiated a phase 2 A clinical trial.
The US pharma company, which is a subsidiary of California-based TesoRx Pharma, said that the phase 1 clinical results showed escalating doses of its investigational NMIBC treatment to be well tolerated without dose-limiting toxicity and irritative voiding (cystitis) symptoms. Furthermore, no systemic exposure or toxicity was noted, even with high concentrations of TBC-1002 being topically delivered to the bladder wall.
Results of the phase 1 clinical trial in non-muscle invasive bladder cancer also showed preliminary efficacy with no evidence of recurrences of bladder cancer observed up to 18 months following dosing. LIPAC Oncology said that all the adverse events during the early-stage clinical trial were minor.
TBC-1002, which is a proliposomal intravesical paclitaxel formulation (PLIP), is being developed for intravesical administration in the treatment of non-muscle invasive bladder cancer. Considered to be a common and highly recurrent disease, non-muscle invasive bladder cancer can often be difficult to treat.
According to LIPAC Oncology, TBC-1002, if approved, will become the first chemotherapeutic agent to be given the nod by the US Food and Drug Administration for the treatment of non-muscle invasive bladder cancer in more than 20 years.
Michael Oefelein – Chief Medical Officer of LIPAC Oncology, commenting on the company’s investigational NMIBC treatment, said: “We are excited about the potential of TBC-1002 to target bladder cancer directly.
“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 2019, the US pharma company started a phase 2A marker lesion clinical study to establish efficacy responder rates within 16 weeks, which predict two-year recurrence-free survival rates. Efficacy data recorded from the open-label study is likely to be released as early as November 2019 with the study results available in Q1 2020, said LIPAC Oncology.
TR Thirucote – Chairman and CEO of LIPAC Oncology said: “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.”
LIPAC Oncology revealed that more results on the clinical development program for its investigational NMIBC treatment will be disclosed at the China Biomedical Industry Cooperation Forum in Shenzhen this month and at the Society of Urologic Oncology in Washington, D.C. in December 2019.
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