Unsuitable

Very limited published evidence of safety

Only negligible amounts in breast milk

Used in infants >1 month

Oct 19 · PDS is actively looking to license out EG-1962 and has had preliminary discussions with third parties who are looking at the data of EG-1962. Not listed in PDS pipeline and all development was ceased by Edge [7].

Mar 19 · PDS Biotechnology Corporation merges with Edge Therapeutics to form PDS Biotechnology Corporation [6].

Mar 18 · Edge has decided to discontinue the NEWTON 2 study. Development suspended whilst Edge carry out analyses of the cumulative unblinded data from the NEWTON 2 study to better understand the basis for the outcome.[5]

SAH affects 6-9 people per 100,000 of the population per year and constitutes about 6% of first strokes. Approximately 85% of patients bleed from intracranial arterial aneurysms, 10% from a non-aneurysmal peri-mesencephalic haemorrhage and 5% from other vascular abnormalities including arteriovenous malformation, vasculitis and abnormal blood vessels associated with tumour [1].

Mar 18 · Interim analysis performed on data from the day 90 visit of the first 210 pts with Aneurysmal SAH who were randomised and treated in the PIII NEWTON 2 study, suggests the study is unlikely to achieve its primary efficacy endpoint. Although there were no safety concerns attributed to EG-1962, the independent Data Monitoring Committee (DMC) recommended that the study be stopped because it has a low probability of achieving a statistically-significant difference compared to the standard of care in the study’s primary endpoint, if the study is fully enrolled.[5]