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Hepatitis C Vaccine Ready for Phase I Trial

October 17, 2007

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A potential Hepatitis C vaccine is beginning Phase I trials in Canada and France. Known as TG4040, this gene-based vaccine will be evaluated for safety and immune response in ribavirin/interferon non-responders and those who have yet to attempt Hepatitis C treatment.

New Therapeutic Vaccine May Offer Hope for Chronic Hepatitis C Patients

www.associatedcontent.com

According to a press release, everything is ready and set to test a new vaccine that may offer hope for people who suffer from Hepatitis C and have relapsed after standard treatment.

Standard treatment consists of treatment with Ribavirin and Pegylated-Interferon Alpha for about six months. Some patients may fail at this standard treatment and may have a relapse in the disease. Additionally, and according to the press release, standard treatment is effective in 50% of the patients completing therapy, is lengthy and often poorly tolerated.

Transgene therapeutic vaccine candidate TG4040 (MVA-HCV) is set to be tried (Phase I trial) on approximately 24 patients that are chronically infected with the Hepatitis C Virus (HCV) and who have relapsed after standard treatment. The trial will be done in Canada.

The protocol for this clinical trial class for one subcutaneous injection of TG4040 per week over a 3-week period together with a boost injection at Month 6. Safeety and immunity responses will be the hallmarks of this study.

The safety data, as well as preliminary viral and immunological data, is planned to be available for the public by end of 2008. Another Phase I study of TG4040 is currently being performed in France on 15 Hepatitis C patients who have never received any other therapy for their condition. Preliminary results are expected at the end of 2007.

Hepatitis C is a blood-borne, infectious, viral disease that is caused by a hepatotropic virus called Hepatitis C virus (HCV). An estimated 150-200 million people worldwide are infected with hepatitis C. In the U.S., those with a history of intravenous drug use, inhaled drug usage, tattoos, or who have been exposed to blood via unsafe sex or social practices are increased risk for this disease. Hepatitis C is the leading cause of liver transplant in the United States (Ryan and Ray 2004).

Sixty to Seventy per cent of people infected develop no symptoms during the acute phase (first 6 months). Some patients experience acute phase symptoms but they are usually mild and rarely lead to a specific diagnosis of hepatitis C. Symptoms of acute hepatitis C infection include decreased appetite, fatigue, abdominal pain, jaundice, itching, and flu-like symptoms.

What is TG4040?

TG 4040 is a recombinant MVA vaccine virus containing nucleotide sequences encoding non-structural immunogenic NS3, NS4 and NS5B proteins of the hepatitis C virus.

Who is Transgene?

Transgene is a biopharmaceutical company dedicated to the discovery and development of gene-based therapeutic vaccines and immunotherapy products for the treatment of cancer and infectious diseases. In addition to TG4040, Transgene has other products in the pip-line such as vaccines candidates for Non Small Cell Lung Cancer, Cervical Intraepithelial Neoplasia (CIN 2-3), and Cutaneous B-cell Lymphoma.

Sources:

Transgene extends therapeutic vaccine candidate TG4040 development program against chronic Hepatitis C. Transgene Press Release. URL: http://www.transgene.fr/us/pdf/communique_presse/communiques_divers_2007/PR-US_%20TG4040_01-10-07.pdf

Ryan KJ; Ray CG (editors) (2004). Sherris Medical Microbiology, 4th ed., McGraw Hill, pp. 551-2.

Transgene web site. URL: http://www.transgene.fr/fr/index.php

By Rafael B.
Published Oct 01, 2007

Posted by Editors at October 17, 2007 12:51 PM