Cumberland Pharmaceuticals (CPIX) Commences Portaban Phase 2 in Portal Hypertension

September 14, 2016 4:07 PM EDT

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Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced the initiation of a new Phase II clinical program of Portaban for patients with portal hypertension associated with liver disease. The U.S. Food and Drug Administration (FDA) has cleared Cumberland's investigational new drug application (IND) for a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study.

Portaban is an oral formulation of ifetroban and the fourth development candidate in Cumberland's pipeline. Preclinical studies have shown ifetroban can reduce portal pressure, necrosis, inflammation, and fibrosis in multiple models of liver injury.

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

"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." said Dr. Don Rockey, lead investigator at the Medical Center of South Carolina. "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."

Cumberland previously completed an initial Phase II study for Boxaban® (ifetroban) for patients with aspirin-exacerbated respiratory disease (AERD), a disease involving chronic asthma that is worsened by aspirin. The Company has also completed an initial Phase II study for Hepatoren® (ifetroban) in patients with Hepatorenal Syndrome (HRS), a life-threatening condition involving progressive kidney failure.

Earlier this year, Cumberland announced the start of another Phase II clinical program with Vasculan (ifetroban) for the treatment of systemic sclerosis, a rare and life-threatening autoimmune disorder that affects the skin and internal organs.

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