Ho Wah Genting inks new agreement for Phase IV vaccine trials
KUALA LUMPUR: Ho Wah Genting Bhd (HWGB) today announced that its wholly owned subsidiary HWGB Biotech Sdn Bhd's (HWGB Biotech) joint venture partner, US-based E-MO Biology Inc (EBI), entered into a new clinical trial agreement (CTA) with US-based Roderick A. Comunale II MD Inc and America Diagnostics & GeneScan Diagnostics Inc (ADGD).
The new CTA is to appoint Roderick A. Comunale II MD Inc as the principal investigator to commence Phase IV clinical research study on the effectiveness of poliomyelitis virus vaccine (PVV) for prevention of COVID-19 using ADGD as the laboratory.
This new CTA is the latest inked deal following EBI obtaining a CTA approval from the US Food and Drug Administration (US FDA) to commence its Phase IV clinical research study on the PVV vaccine.
HWGB Biotech general manager, medical & pharmaceutical research Dr Yaman Walid Kassab said this agreement with Roderick A. Comunale II MD Inc and ADGD represents continued momentum toward the company's goal of advancing the clinical research of the potential indication of PVV vaccine for the prevention of Covid-19.
"We look forward to learning more about the potential of PVV vaccine in this trial with patients living with Covid-19," he said in a statement today.
The objective of Phase IV clinical trial is to collect additional information about the side effects or long term risks and potential benefits, on top of how well the vaccine works when used widely on several thousand people.
To recap, EBI on 18 September 2020 signed an agreement to engage the services of Roderick A. Comunale II MD Inc and ADGD to conduct a clinical research study entitled "Inactivated Polio Vaccine in prevention of COVID-19 in high risk population in a Phase IV study".
The study is focused on the effects of inactivate polio vaccine-IPV, conducted according to the United States Food and Drug Administration approved protocol and to be provided by EBI.
Currently for Stage 1 and Stage 2, there will be a total 300 volunteers to be enrolled for the clinical study in the US.