NetScientific PLC (AIM:NSCI), the investment group, has announced that its portfolio company, PDS Biotechnology Corporation (NASDAQ:PDSB), has submitted updated documentation and a phase III trial protocol to the US Food and Drug Administration (FDA).
This is for the evaluation of a combination treatment using PDS0101 and KEYTRUDA for HPV 16-positive head and neck cancer.
The study, named VERSATILE-003, will compare the safety and effectiveness of the combined treatment against using Merck checkpoint inhibitor alone.
The main goal of the trial is to measure overall survival rates. The study will be conducted at 90-100 global clinical sites, with the trial expected to begin in the last quarter of the year.
"Interim data from our ongoing VERSATILE-002 phase II clinical trial have been very encouraging, with impressive interim OS and PFS results," said Lauren Wood, chief medical officer of PDS.
"With VERSATILE-003, we have an opportunity to confirm the phase II results from VERSATILE-002 in a controlled, Phase 3 clinical trial comparing the combination of PDS0101 and KEYTRUDA to KEYTRUDA monotherapy."
The announcement was made alongside the release of second-quarter results from PDS, which revealed the US-listed biotech had made significant clinical progress.
Moreover, the business remains well funded with $60.6 million in the bank as at 30 June.