Hope for Alcohol Damaged Liver Patients Print
By Marilyn Mullen   
Monday, 03 November 2014 20:07

  Hope for alcohol damaged liver patients.

If the liver is so severely damaged and can no longer function normally, it is called decompensated liver disease. Alcohol, sepsis (fatal whole-body inflammation caused by severe infection), hepatotoxic medications and renal impairment are some of the causes for liver decompensation. Medications that have negative effects on the liver are called hepatotoxic medications while renal impairment refers to the failure of kidney to filter wastes from the blood sufficiently.

There is a biotherapeutic company developing a treatment for alcohol-induced liver decompensation – Vital Therapies Inc. (NASDAQ: VTL).

Alcohol-induced liver decompensation, or AILD in short, refers to liver failure caused by binge drinking, and can occur with or without chronic underlying liver disease. AILD can be either acute alcoholic hepatitis (AAH), caused by alcohol alone or non-AAH AILD, caused by alcohol on top of existing liver disease.

The estimated addressable AILD population is said to be 30,000 per year in both the U.S. and EU.

The company's investigation AILD treatment in focus is ELAD, a bio-artificial liver support system that operates outside the body, or extracorporeal, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant.

ELAD has gotten orphan designation in the US and Europe for the treatment of patients with acute liver injury.

- The company initiated a randomized phase III trial evaluating the ELAD System in alcohol-induced liver decompensation last April. The trial, dubbed VTI-208, designed to enroll 200 subjects has so far enrolled 150. The preliminary results from this trial are expected in the first half of 2015.

- Another phase III randomized clinical trial of ELAD is in subjects with acute alcoholic hepatitis who have failed steroid therapy. The trial, designated VTI-210, is designed to enroll 150 subjects. The company expects to enroll the first patient in the trial later in 2014.

Steroids are hormones that form naturally in the body. Steroids are used to treat a variety of conditions in which the body's own defense system is damaged. For these people, steroid therapy may eliminate the need for kidney dialysis.

- A phase II/III clinical trial of ELAD in subjects with fulminant hepatic disappointment, or FHF, and surgery-incited intense liver malfunction, or SILF, named VTI-212, was started in the month of June 2014. Fulminant hepatic failure is a variety of acute liver failure with severe hepatic malfunctions and may result in serious complications such as excessive bleeding and increasing pressure in the brain.

The phase II part of the trial will select 40 subjects, which might later be trailed by a randomized, controlled stage III segment the scale of which has not yet been set, as indicated by the organization. The phase II data are expected in 2015 or 2016.

Vital Therapies have incurred losses since inception, and as of June 30, 2014, had an accumulated deficit of $124.1 million. The company has no approved products and yet to receive revenues from the sale of products to date. The fiscal year ends in December.

The company ended June 30, 2014 with cash equivalents of $90.8 million.

Incorporated in California in May 2003 as Vitagen Acquisition Corp., the company changed its name to Vital Therapies Inc. in June 2003. The company went public on the NASDAQ Global Market on April 17, 2014 under the ticker symbol “NASDAQ: VTL” and on 29 September, 2014 was offering its shares at a price of $20.08 each.

VTL has thus far hit a low of $10.66 and a high of $35.20.




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