Cumberland announces new Portaban Phase II trial

Cumberland Pharmaceuticals Inc. has announced that it has initiated a Phase II clinical program involving Portaban.

"We are very encouraged by the preclinical findings supporting the use of Portaban and its potential as a new therapy for liver cyrossis patients," Cumberland CEO A.J. Kazimi said. "We remain focused on developing products that address unmet medical needs."

Cumberland’s investigational new drug (IND) application has been approved by the U.S. Food and Drug Administration (FDA) for the trial to proceed.

"I am excited to investigate a drug candidate with the potential to induce a clinically meaningful reduction in severe portal hypertension over a relatively short time frame." Medical Center of South Carolina Lead Investigator Dr. Don Rockey said. "Portal hypertension is largely responsible for events of hepatic decompensation including variceal bleeding, ascites, and encephalopathy, which contribute substantially to morbidity and mortality in these patients. By lowering elevated portal pressures, Portaban has the potential to decrease the risk of hepatic decompensation in liver cirrhosis patients over the short term, and may improve both liver function and structure over the long term through anti-inflammatory and anti-fibrotic effects."

Portaban was developed for the treatment of patients with portal hypertension linked to liver disease.