Starting May 15th, patients in the trial will be given doses in an escalating fashion to provide pharmacokinetics data.
This study is being conducted at The Diabetes & Glandular Disease Research Center in San Antonio, under the supervision of Dr Sherwyn Schwartz. The FDA has reviewed the protocol, as well as the Institutional Review Board assigned to the protocol under the QR-333 IND program.
“We are excited to start the clinical trials for QR-333 in San Antonio,” said Dr Richard Rosenbloom, COO and executive vice president of Quigley Pharma. “We couldn’t be more pleased to be working with such a distinguished investigator as Dr Schwartz throughout the beginning stages of these trials.”
The original proof of concept study, completed in France, showed that study subjects improved quality of life measures as well as improved key symptoms associated with this complication of diabetes. The subjects tested had 67% of their symptoms improve, suggesting efficacy.