LIPAC’s Lead candidate successfully completes phase 1-2a study
Phase 1-2a
LiPax is a proprietary neoliposomal intracavitary drug delivery platform designed to enhance the therapeutic index of paclitaxel. The delivery platform results in enhanced paclitaxel drug loading, while minimizing systemic exposure resulting in significantly lower toxicity and chemo-related side effects
LIPAC announced the successful completion of a Phase 1-2a clinical trial designed to predict long-term recurrence free survival rates (RFS) in patients with low-grade, highly recurrent NMIBC treated with LiPax.
LiPax demonstrated excellent safety with no systemic exposure of paclitaxel and no grade 3 or 4 toxicity and impressive clinical efficacy.
Study results demonstrate a 2-year recurrence free survival rate (RFS) of 83% compared to 49% for current standard of care (SOC) therapies. LiPax also demonstrated a 63 percent marker lesion responder rate (MLRR) in patients treated with LiPax alone, compared to 35% for current SOC therapies.
Persistence of paclitaxel (the active ingredient of LiPax) above therapeutic levels was demonstrated up to 48 hours following intravesical instillation.
In the clinical study, LiPax was well tolerated, with no significant adverse events and patients’ urinary health related quality of life was maintained before, during and after instillation of LiPax, as measured by patient reported outcomes.