Processa Pharmaceuticals Innovative Cancer Treatment Demonstrates Higher Efficacy at Lower Doses Over Capecitabine

Processa Pharmaceuticals Inc PCSA provides an interim analysis from its Phase 1b Next Generation Capecitabine (NGC-Cap) study.

Thus far in the Phase 1b study, patients have received doses of NGC-Cap ranging from 75 mg once a day to 225 mg twice daily, significantly less than the 1,600 mg to 2,500 mg twice-a-day dose administered for FDA-approved capecitabine. 

These much lower doses for NGC-Cap result in 5-FU exposure up to 10 times greater than the higher FDA-approved capecitabine doses due to NGC-Cap's unique metabolic pathway. 

5-FU comprises 5-fluorouracil, the main metabolite of capecitabine that further metabolizes into desirable cancer-killing molecules called anabolites and undesirable molecules called catabolites that cause unwanted side effects.

In addition, the side effects associated with FBAL (fluoro-beta-alanine, the primary catabolite formed from the metabolism of 5-FU), such as hand-foot syndrome, that can lead to capecitabine intolerance, were almost non-existent, likely because FBAL exposure was approximately 1% of the exposure seen after FDA-approved capecitabine administration.

The interim analysis also shows that an improvement in the side effect profile was observed at a 5-FU NGC-Cap exposure of 5-6 times greater than FDA-approved capecitabine.

These data confirm that the metabolic pathways that regulate how NGC-Cap is processed in the body suggest NGC-Cap may offer higher efficacy at lower doses of the underlying capecitabine agent, while simultaneously offering a better safety profile from less production of the side-effect producing catabolite FBAL that causes many of the dose-limiting side effects from treatment with capecitabine alone. 

It is believed that NGC-Cap's ability to inhibit the production of catabolites like FBAL is key to the success of NGC-Cap. Further clinical studies are needed to confirm these interim observations.

Price Action: PCSA shares are down 19.7% at $0.53 on the last check Tuesday.