Processa Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, recently disclosed the successful end of the safety tolerability review in its phase 1b trial of Next Generation Capecitabine. The company's stocks saw an increase of over 140% as a result.
In the phase 1b trial, two dosage schedules were established as suitable for the phase 2 trial. This next trial will focus on patients with advanced or metastatic breast cancer as the FDA has agreed that the data from the phase 1b trial supports the structure of the phase 2 trial, focusing on breast cancer treatments.
NGC-Cap is the term given to PCS6422 when administered with capecitabine, an antecedent of the 5-FU cancer drug. PCS6422 is given as a singular dosage 12-24 hours before a seven-day course of capecitabine followed by a drug-free week.
David Young, PharmD, Ph.D., President of Research and Development at Processa, expressed gratitude towards the patients and their doctors who took part in the trial. The findings were significant to the company. They noted that NGC-Cap in the phase 1b trial had better or similar tolerance compared to the already FDA-approved capecitabine, even though the contact with NGC-Cap's 5-FU cancer-treating metabolite was considerably higher, ranging from 2-10 times that of capecitabine. Consequently, this increased exposure suggests that NGC-Cap may be effective in delivering more 5-FU to cancer cells, potentially creating more cancer-destroying metabolites which, based on their small patient sample, has proven to boost the cancer-eliminating effect of NGC-Cap over capecitabine.
