MENLO PARK, Calif., May 18, 2020 /PRNewswire/ -- LIPAC Oncology LLC today announced the presentation of positive interim data from the TD-001 trial evaluating the safety and efficacy of investigational agent LiPax (paclitaxel) for intravesical instillation in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC). The study was accepted for presentation at the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here.
Trial results showed 100% (6/6) of patients treated with Transurethral Resection of Bladder Tumor (TURBT) and LiPax achieved a complete response three, six and nine months after the start of therapy. The 12-month recurrence free survival rate was 85% (5/6) and 100% (3/3) for all patients that reached the 18-month mark. Follow-up will continue until all patients have reached the 24-month mark.
"By pairing a simple outpatient procedure (TURBT) with LiPax, we have an opportunity to substantially improve both clinical outcomes and quality of life for people living with highly recurrent NMIBC," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "This positive data validates that our proliposomal technology platform increases penetration and persistence of treatment and significantly improves the effectiveness of intravesical therapy."
Based on the biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, The AUA NMIBC guidelines recommend various durations of intravesical therapy after TURBT. The low to intermediate risk category is estimated to comprise 90,000 Americans, yet no intravesical agent is approved by the U.S. Food and Drug Administration for this disease.
In the study, 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 the active product ingredient (paclitaxel).
About The Phase 1/2a TD-001 Trial TD-001 is an open-label, single-arm, multi-center Phase 1/2a clinical trial of TSD-001 (paclitaxel) for intravesical instillation to evaluate its safety and efficacy in patients with low to intermediate risk NMIBC.
About LiPax LiPax (paclitaxel) for intravesical instillation is an investigational drug formulation of paclitaxel in Phase 2 development for the treatment of NMIBC. Utilizing the proliposomal technology platform, LIPAC Oncology's proprietary formulation to enhance persistence and penetration of bladder tissue to paclitaxel, is designed to enhance the standard of care of outpatient endoscopic tumor removal, histological risk assessment followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed enrollment in TD-001 in May 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition.
About LIPAC Oncology LLC LIPAC Oncology is a pharmaceutical company utilizing the proprietary proliposomal delivery system to enhance and reformulate proven cancer drugs into more effective treatments. The company was created in 2016 as a subsidiary of TesoRx Pharma LLC, a pharmaceutical company which has leveraged the platform technology to create therapeutic candidates for other indications. For more information, visit lipaconcology.com.
About TesoRx Pharma LLC TesoRx Pharma LLC is focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet needs. Its growing pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx's proprietary proliposomal delivery technology. The company was founded in 2010 through a collaboration with Western University of Health Sciences that includes joint R&D efforts at the TesoRx Centre of Excellence in Pomona, California. For more information, visit tesorx.com.