PLIP Program (ProLiposomal Intravesical Paclitaxel)

LIPAC’s signature PLIP program is based on a neoliposomal reformulation of Paclitaxel that greatly increases its lethality against cancer cells and enhances persistence and permeation of active drug into tissue via localized administration. Indications being targeting with this program include:

• Non Muscle Invasive Bladder Cancer (NMIBC)

• Upper Tract Urothelial Carcinoma (UTUC)

• Stage III/IV Ovarian Cancer

• Peritoneal Cancer

Pre-clinical Studies

The effectiveness of the formulation was confirmed in early laboratory studies after the program’s lead formulation, TSD-001 (LiPax), exhibited 100 times more lethality against T24 human cancer cells compared to unformulated Paclitaxel.

In a subsequent animal model, TSD-001 demonstrated 50%+ response rates with no systemic toxicity in mice inoculated with human bladder cancer cells (see below).

Clinical Studies

A Phase 1-2a Pilot Study of TSD-001 for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer has been completed.

Part 1 of a Phase 1-2a study was to establish the maximum tolerable dose for TSD-001 in patients with low grade non-muscle invasive bladder cancer. Part 2 thereafter was completed to establish responder rates by administering the maximum tolerated dose established in Part 1 in a marker lesion study in similar patients.

Part 1 of the study enrolled up to 6 subjects with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder and received escalating doses of TSD-001 every 2 weeks for 6 treatments until dose limiting toxicity (or until the maximum deliverable dose) was observed.

Part 2 of the study enrolled an additional 9 subjects with low-grade, stage Ta (multifocal) TCC of the bladder who received weekly TSD-001 for 6 weeks at the highest nontoxic dose (360 mg) established in part 1 of the study.

Read more about the TSD-001 Trial.