The management of COA Research and Manufacturing Limited Company (COA-RMLC) has denied reports that its flagship product, COA-72, is currently undergoing clinical trials as an HIV treatment, following a media publication that appeared in the Daily Graphic last week.
In a statement issued Monday, the company said the report, which followed a visit by the Parliamentary Select Committee on Health to COA-RMLC’s facilities on July 14 inaccurately suggested that COA-72 was under official trial for HIV therapy.
“At no point during the meeting with the Parliamentary Select Committee did COARMLC claim that COA-72 was undergoing FDA-approved clinical trials,” the company said, clarifying that it had not received regulatory clearance from Ghana’s Food and Drugs Authority (FDA) to initiate trials.
The FDA has also issued a public disclaimer confirming that no such clinical trial has been approved, a position COA-RMLC said it supports.
COA-72 Still in Pre-Clinical Phase
COA-72 is the latest formulation from the plant-based medicine manufacturer and is believed, according to internal and collaborative studies, to exhibit properties with potential to combat viral infections and some cancers. However, the company stressed that these are preliminary findings and not substitutes for formal regulatory trials.
The company revealed that an application to conduct clinical trials was submitted to the FDA in 2019. While the regulator acknowledged the application and outlined the steps required to begin trials, COA-RMLC has not yet fulfilled those criteria, which include partnerships with accredited research institutions and adherence to international protocols.
No Claims of Cure, But Call for Investment
COA-RMLC emphasized that it has never claimed FDA approval for COA-72 and reiterated that none of its earlier products, including COA Mixture, COA Plus, COA-MT, and COA Capsules, are approved for HIV treatment.
“While these products are not intended or approved for HIV treatment, the research laid the foundation for the development of COA-72,” said the company’s founder and CEO, Mr. Samuel Ato Duncan, during the committee’s visit.
The company is calling for government and institutional support to enable formal clinical trials of COA-72, which it believes could contribute up to $76.8 billion annually to Ghana’s economy and generate thousands of jobs, if proven effective.
Regulatory Commitment
COA-RMLC reiterated its commitment to working within regulatory frameworks and global best practices, promising full compliance with FDA, WHO and other international health guidelines.
“We deeply regret any confusion caused by the miscommunication in the media and trust that this statement provides the necessary clarity, COARMLC remains focused on its mission to innovate responsibly in the field of plant-based medicine for the benefit of public health and national development.” the statement concluded.
