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Trial Recruiting Previous HCV Non-Responders for New Liver Health Compound

April 5, 2010

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An innovative substance with an obvious similarity to a common liver support supplement begins a Phase II clinical trial to protect the livers of those with Hepatitis C.

by Nicole Cutler, L.Ac.

Novelos Therapeutics, a Massachusetts based biopharmaceutical company, develops and commercializes oxidized glutathione-based compounds for the treatment of cancer and hepatitis. One of their products, NOV-205, has just enrolled its first participant in a Phase II clinical trial for Hepatitis C previous treatment non-responders. Although there are several chemical differences, a popular supplement taken by people with Hepatitis C has a distinct resemblance to this experimental compound.

For the estimated four to five million Americans with Hepatitis C, the current standard treatment of pegylated interferon and ribavirin can help only about 50 percent of those infected. For those with the virus who did not have a successful outcome with pegylated interferon and ribavirin, preventing any further decline of their liver's condition is a medical priority.

Prevention of liver disease progression has historically fallen into the categories of lifestyle modifications, herbal supplementation and alternative medical practices. However, Novelos Therapeutics' NOV-205 is one of the first pharmaceutical agents to be categorized as a hepatoprotective compound - meaning its goal is to protect the liver from incurring any further damage. Described not just as a hepatoprotective agent, but also a substance containing immune modulating and anti-inflammatory properties, NOV-205 is a unique formulation of oxidized glutathione and inosine.

NOV-205:

· Demonstrated safety, reduced viral load and improved liver function in a Russian trial of 178 patients with Hepatitis B and C.

· Was approved in Russia by the Ministry of Health in 2001 as a monotherapy for the treatment of Hepatitis B and C.

· Successfully completed a Phase 1b trial in the US, proving itself as a safe compound.

As of March 2010, an ongoing U.S. Phase 2 trial to expand the safety database and assess NOV-205's efficacy commenced. Taking on a notoriously challenging to treat population, this trial is being conducted on patients with Hepatitis C who did not respond to pegylated interferon/ribavirin therapy. Treatment centers are currently recruiting participants for this study in the states of Florida, Massachusetts and North Carolina.

While a detailed explanation of NOV-205's formulation remain under wraps, the Novelos Therapeutics product line clearly revolves around oxidized glutathione-based compounds. Glutathione is a well-known antioxidant that can benefit individuals with Hepatitis C. It is an enzyme found in all of the body's tissues that protects against potential damage from wastes and toxins.

Glutathione is available as an over-the-counter pill. However, its absorption into cells has been repeatedly questioned. A better way of boosting this antioxidant in the body, many experts advocate supplementing with glutathione's building blocks - so that the body can convert them into glutathione.

Since a liver with Hepatitis C must continually defend itself against damage from the virus, many people with this illness supplement with N-acetyl cysteine (NAC) - a building block of glutathione. While NOV-205 clearly contains a different form of glutathione, the logic behind this experimental drug is along the same lines as NAC supplementation. For the previous non-responders to Hepatitis C treatment who are lucky to get into this trial, NOV-205 could help thwart their liver disease progression. For everyone else, supplementing with NAC is a wise move in the name of hepatoprotection.

For more information about the eligibility requirements and recruitment centers for the NOV-205 clinical trial currently underway, visit http://www.clinicaltrials.gov/ct2/show/NCT01058512?term=NCT01058512&rank=1.

References:

http://www.clinicaltrials.gov/ct2/show/NCT01058512?term=NCT01058512&rank=1, A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy, Retrieved April 4, 2010, ClinicalTrials.gov, 2010.

http://www.hepatitis-central.com/mt/archives/2007/07/hcv_and_the_bod.html, HCV and the Body's Most Important Antioxidant, Nicole Cutler, L.Ac., Retrieved April 4, 2010, Natural Wellness, 2010.

http://www.hivandhepatitis.com/hep_c/news/2010/040210_b.html, Novelos Starts Phase 2 Trial of NOV-205 to Reduce Liver Damage in Non-responders to Interferon Therapy for Hepatitis C, Retrieved April 4, 2010, hivandhepatitis.com, April 2010.

http://www.novelos.com/docs/Novelos%20PR%203-25-10%20205%20Ph2%20initiation.pdf, Novelos Therapeutics Enrolls 1st Patient in Phase 2 Hepatitis C Trial with NOV-205, Retrieved April 4, 2010, Novelos Therapeutics, Inc., 2010.

Posted by Editors at April 5, 2010 11:43 AM

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