NetScientific PLC (AIM:NSCI) noted that the temporary suspension by portfolio company PDS Biotechnology Corporation (NASDAQ:PDSB) of patient recruitment for one of their clinical studies is not expected to affect the overall timing of clinical data.
PDS issued a statement announcing that the Phase 2 clinical trial led by the National Cancer Institute (NCI), evaluating PDS0101 in combination with two investigational immune-modulating agents in advanced HPV cancers, had paused recruitment due to an issue that is not specific to the trial itself.
The issue is unrelated to any safety or efficacy concerns with the triple combination, NetScientific said, and it is anticipated that it will be determined in a timely manner with trial recruitment to then resume immediately.
PDS chief medical officer Dr Lauren Wood said: “We know from the interim data that this combination has the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-associated cancers who have limited treatment options.
“While the trial is experiencing a slight administrative delay, we are pleased to report that the PDS0101 trial recruitment has progressed well and it is anticipated that it will resume recruitment shortly.
“We believe, based on the previously reported results, that this treatment could significantly improve survival benefit for these patients, and we look forward to resumption of the trial in the near term.”
Ilian Iliev, CEO of NetScientific, added: “As indicated by PDS, it is anticipated that this temporary suspension in recruitment for this clinical trial will be resolved in a timely manner and is not expected to affect the overall timing of clinical data. The issue is not specific to the PDS0101 trial and is unrelated to any safety or efficacy concerns with the triple combination. We remain supportive of the PDS strategy and look forward to clinical data and the next milestones.”
The trial is evaluating the novel combination in both checkpoint inhibitor naïve and refractory patients with advanced HPV-associated cancers that have progressed or returned after treatment.