Biotechnology company Argenica Therapeutics (ASX: AGN) reports that independent Data Safety Monitoring Board (DSMB) has recommended that the Phase 2 clinical trial of ARG-007 in acute ischemic stroke patients continues with no modifications to the study protocol.
Undertaking a review by an independent DSMB complies with Good Clinical Practice (GCP). The purpose of the DSMB is to monitor the rates of serious and non-serious adverse events, endpoints, and study performance in the Phase 2 clinical trial of ARG-007.
In addition, the DSMB can provide recommendations regarding the continuation, modification, or termination of the study to Argenica and will practice due diligence to ensure, given all available information, that subsequent subjects are not placed at any undue risk.
The DSMB is an independent multidisciplinary committee consisting of an independent Chairperson neurologist, two additional independent neurologists and a biostatistician with relevant clinical trial experience.
Importantly there were no serious adverse events in the 46 patients dosed to date. One patient suffered two non-serious adverse events that have been reported as possibly related to the administration of ARG-007.
This patient suffered bradycardia (slowed heartbeat) and hypotension (low blood pressure) more than eight hours after dosing in the trial, with the patient recovering from both adverse events quickly. As the trial is double blinded, it is not known if this patient received placebo or ARG-007 and accordingly under the study protocol, such events must be reported.
Of the 46 patients reviewed under the DSMB, the average age of participants is 71.3 years, with 17 men and 29 women dosed. The trial is stratifying patients into two groups, patients that receive tissue plasminogen activator (tPA), which dissolves blood clots, and those that don’t, to allow Argenica to determine whether there is any impact of ARG-007 on tPA, and vice versa, in a clinical setting. Therefore, the split between these two groups is stratified, with 18 participants receiving tPA and 28 participants not receiving tPA.
The next DSMB meeting to review safety data and make a recommendation as to whether the study may continue as per the study protocol will be held post dosing of the next 23 patients (i.e. total of 69 patients dosed in the trial).
All 10 hospital sites are now activated and able to recruit and dose patients in Argenica’s Phase 2 trial of ARG-007 in AIS patients. Of the 10 sites activated, seven sites have now dosed patients, with a total of 58 patients of 92 (63%) having been dosed.
Argenica notes that three sites have yet to dose patients, however given the enthusiasm of the sites to be included in the trial, the company is confident that the sites will be recruiting patients in the near term.
Argenica anticipates dosing of all 92 patients will be completed by the end of Q2 CY25. This timing accounts for periods of expected low recruitment over December and January. Further, Argencia’s CRO has confirmed topline data will be provided within weeks of the final 90 day follow up of last patient dosed.
“We are delighted to have passed the halfway milestone of dosing in our Phase 2 trial and achieved currently 63% recruitment. This is a significant milestone for the company and with a green light from the DSMB to continue the trial unchanged, demonstrates we are delivering on our stated objectives. We thank the investigators, and all personnel involved for their dedication and commitment to the study,” Managing Director, Dr Liz Dallimore, said.
