Replies to post #86962 on Biotech Values

[DewDiligence]

Two chimpanzees given a higher dose of the drug had a 350 percent drop in levels of the virus in their blood and liver.

A drop in viral load cannot exceed 100%, so obviously the Reuters newswire is in error. I presume the author meant to say that viral load fell to 1/350 of baseline (a drop of 2.54 logs).

Yet another example of the astonishing arithmetic illiteracy that is prevalent in today’s society.

Thanks for the post—I'll add this drug to the next update of the HCV compilation.

[iwfal]

Two chimpanzees given a higher dose of the drug had a 350 percent drop in levels of the virus in their blood and liver.

What the heck does that mean - did the chimps start producing anti-HCV? (Gotta love the lay press)

BTW - Chimps are generally pretty poor models for HCV. Best that might exist, but still pretty poor. E.g. they clear virus at a much higher rate than humans in acute infection, the chimps that end up with chronic infection typically seem to have a substantially lower viral load, they don't respond to interferon at all, ... .

[stockbettor]

Hepatitis C drug fights virus in new way: link to another article (Technology Review)

Hepatitis C Drug Targets RNA
A new drug suppresses the virus in chimps without generating resistance.

By Emily Singer
Friday, December 04, 2009


An experimental drug developed by Danish startup Santaris effectively controls the hepatitis C virus in chimpanzees without creating drug-resistant forms of the virus--a major advantage over other compounds in clinical development. The compound, a synthetic nucleic acid that binds to a microRNA molecule required for viral reproduction, is now in early-stage clinical trials. It is the first microRNA-targeting drug to be tested in humans.

Approximately 170 million people across the globe are infected with the hepatitis C virus, a chronic infection that can lead to cirrhosis, liver cancer, and the need for a liver transplant. While drugs exist to treat the virus, they carry serious side effects and work in fewer than half of all infected patients. "The treatment is very harsh and needs to be taken for 48 weeks," says Robert Lanford, the lead author on the new study, which was published online today in Science. "Most people can't tolerate it that long, especially if they have liver disease."

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http://www.technologyreview.com/biomedicine/24059/

[stockbettor]

>>Hepatitis C drug fights virus in new way << update on Santaris drug

Santaris Pharma A/S advances miravirsen, the first microRNA-targeted drug to enter clinical trials, into Phase 2 to treat patients infected with Hepatitis C virus

Hoersholm, Denmark/San Diego, California, September 22, 2010 — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naïve patients infected with the Hepatitis C virus (HCV).

Paving the way to conduct the first clinical trials of a microRNA-targeted drug in the United States, Santaris Pharma A/S also received acceptance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). In addition to the United States, the Phase 2a clinical trials will be conducted in the Netherlands, Germany, Poland, Romania, and Slovakia.

The World Health Organization estimates about 3% of the world’s population has been infected with HCV and that some 170 million are chronic carriers at risk of developing liver cirrhosis and/or liver cancer2. Approximately 3-4 million Americans are chronically infected with an estimated 40,000 new infections per year1. In Europe, there are about 4 million carriers2. The current standard of care, pegylated interferon in combination with ribavirin, is effective in only about 50% of those treated1.

Developed using Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform, miravirsen is a specific inhibitor of miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication. Miravirsen is designed to recognize and sequester miR-122, making it unavailable to the Hepatitis C virus. As a result, the replication of the virus is effectively inhibited and the level of Hepatitis C virus is reduced.

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http://www.santaris.com/Library/documents/miravirsenPhase2clinicaltrials.pdf