Friday, July 17, 2020 1:05:23 PM
Research institutions
The company is working with five study sites in the U.S. and has completed all site selection visits and is working to finalize all contract negotiations. The company has also received approval from a central institutional review board that applies to all sites. The states where the institutions are located include Florida, Illinois, Missouri and Ohio.
The company has also signed agreements with two research sites in Australia and one in Romania. Ethics approval for the study has been submitted in Australia and will be submitted for Romania and the Philippines shortly.
Investigator-led COVID-19 study in South Korea
One research site was initiated at the end of May, 2020, and two sites were initiated in early June for the investigator-led COVID-19 phase 2 trial in South Korea. Dr. Dong Sik Jung, professor, in the division of infectious disease of Dong-A University Hospital, has now begun the process of screening patients.
ifenprodil manufacturing
The company retained Cascade Chemistry, a U.S.-based contract research organization specializing in chemical synthesis, to scale up cGMP (current good manufacturing practice) manufacturing of ifenprodil.
The company requires the active pharmaceutical ingredient (API) of ifenprodil in order to develop new formulations of the drug including an injectable and a slow release tablet. Cascade is nearing completion of its first engineering run of API with the cGMP synthesis to begin shortly.
The company is also working with the U.S. FDA on its plans to have finished product of ifenprodil manufactured and available in as short a time frame period as possible, should the phase 2b/3 trial achieve positive results.
Cash position
The company currently has an approximate cash balance of $7.5-million. The company believes the funds on hand will be sufficient to cover the costs of the company's phase 2 IPF and chronic cough study, the cost of supporting the investigator-led phase 2 COVID-19 study in South Korea and the multinational phase 2b/3 COVID study, to their full conclusion, including all general operating expenses.!!!!!!!!!!!!!!!!!!!!!!!!!!
SKorea Ifenprodil manufacturing w/AGN?
https://adisinsight.springer.com/drugs/800055643
...GLTA...
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