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Re: New Drugs on the Way?
Jan. 24, 2004

Hi Lloyd,

My name is P.T. from Baltimore, MD. I just started your program about a week ago and what a word of difference, like opening a door and walking back 10 years in time. Thanks for the life saver just as this shit was starting to grab hold of me!

I agree with all of your opinions regarding Hep C and the money machine also known as our medical institutions. They are ever so concerned about our suffering and they treatments we need (lol). If that were the case, my 100% full coverage medical insurance should be covering the expense of your program! With 4 children, it's not in the budget but I was starting to slip away and it is worth every penny.

I was speaking with your secretary about an article I saw on the web which may interest you. I copied and pasted it below for you. Let me know if you have seen this, and what do you think about it.

Thanks a million for the reasonably affordable difference you have made in my life.

P. T.

Hepatitis C Drug Development at Boehringer Ingelheim

Ingelheim, Germany, 28 October 2003 - The journal Nature has published an article describing a novel, small molecule anti-hepatitis C virus (HCV) compound discovered by Boehringer Ingelheim at its virology research center in Laval, Québec, Canada. The compound, named BILN 2061, is an orally active inhibitor of the HCV NS3 protease and the first member of this new drug class to be tested in humans. The Nature paper describes the discovery and early clinical trial results with BILN 2061 and demonstrates the promise of this class of anti-HCV agents for the treatment of HCV disease.

Administration of BILN 2061 to a limited number of patients infected with HCV for two days resulted in a marked reduction of the hepatitis C virus plasma levels and established the first proof-of-concept in man for an inhibitor acting by this mechanism. Routine chronic safety testing of high, supra-therapeutic doses in animals did, however, show relevant side effects which need further analysis. Boehringer Ingelheim is currently studying the available pre-clinical data in order to decide on their impact on the clinical development of this substance. There are currently no trials ongoing with BILN 2061 and decisions about future trials will be made after thorough evaluation of toxicity findings in animal studies

Scientific results achieved so far are available to the medical community.

General Information About Hepatitis C
Hepatitis C virus infection is a serious cause of chronic liver disease with more than 170 million infected individuals worldwide. Current interferon (IFN)-based therapies are suboptimal especially in patients infected with HCV genotype 1 and are poorly tolerated, highlighting the unmet medical need for novel therapeutics. The HCV-encoded NS3 protease is an enzyme essential for viral replication and has been considered an attractive target for therapeutic intervention in infected patients.

Boehringer Ingelheim
The Boehringer Ingelheim Corporation is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 156 affiliates in 44 countries and a total of about 32,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2002, Boehringer Ingelheim posted net sales of 7.6 billion euro while spending about one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Sheila A. Burke
Associate Director, Communications & Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877

By Daniel DeNoon
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Thursday, April 17, 2003

April 17, 2003 -- The central mystery of hepatitis C now is solved. A new finding promises more effective, shorter, and easier hepatitis C treatments.

What Michael Gale Jr., PhD, and colleagues discovered is how hepatitis C virus establishes lifelong infection. They found that the virus makes a key that lets it turn off a cell's anti-virus machinery. And they found that a type of drug -- already in development by several companies -- robs the virus of this key. Without it, the anti-viral machinery comes to life. It churns out a chemical called interferon that rids the cell of the hepatitis C virus.

"The beauty of [this type of drug] is it can clear persistently infected cells," Gale tells WebMD. "The cells rid themselves of hepatitis C virus within an average time of four to five days."

Gale and colleagues at University of Texas Southwestern Medical Center, Dallas, wondered why hepatitis C virus is able to cause long-lasting infection. Most viruses can't do that. Gale guessed that hepatitis C virus must somehow disable a crucial immune response -- some part of the innate immune system that's part of almost every cell in the body.

A crucial clue came from the McGill University lab of John Hiscott, PhD, in Montreal. Hiscott was studying the molecular switches that trigger interferon release inside a cell. One of these triggers is called interferon regulatory factor 3 or IRF-3. He gave Gale some IRF-3 to work with.

Gale's lab then found that a protein made by hepatitis C virus blocks IRF-3.

"By blocking it completely, hepatitis C virus prevents the cell from mounting an immune response," Gale says. "That lets the virus get a foothold soon after infection. Once it has this foothold, it never lets go."

The IRF-3 blocking protein is an enzyme called protease. Like hepatitis C virus, the AIDS virus also makes a kind of protease. Drugs that disable protease -- protease inhibitors -- revolutionized AIDS treatment. Several inhibitors of hepatitis C protease are now in the drug pipeline. Schering-Plough Corp. gave Gale some of its experimental drug, which he calls SCH6.

"We found that SCH6 not only inhibits hepatitis C protease, but also allows restoration of this cellular immune response," Gale says. "We could restore the ability of infected cells to respond to the virus, and naturally clear the virus on its own."

There's more good news. Gale's lab worked with genotype 1. It's the most common type of hepatitis C in the U.S. -- and the hardest kind to treat. Yet the protease inhibitor knocked it out.

By attacking the virus and also turning on antiviral immunity, hepatitis C protease inhibitors would have a dual action. And there's likely a third kind of action. Protease inhibitors likely would make current interferon treatments work better, at lower and less toxic doses. That's an exciting idea to Leslye Johnson, PhD, chief of the enteric and hepatic diseases branch at the National Institute of Allergy and Infectious Diseases.

"If a compound like this goes forward into clinical trials, it has the potential for dual activities and may work better than what's out there now," Johnson tells WebMD. "It might also allow people to use decreased doses of interferon. This finding opens new possibilities that are important for drug development. What it says for patients is that a hepatitis C protease inhibitor, as long as it is safe and everything else, could have multiple ways of getting rid of the virus. That is really the bottom line."

At least three drug companies are working on hepatitis C protease inhibitors. Farthest along appears to be BILN 2061 from Boehringer Ingelheim Pharma. It's already being tested in humans. The Schering-Plough product is not yet ready for human tests, says Schering spokesman Robert Consalvo.

Gale's findings appear in the April 17 issue of the online journal Sciencexpress. Also appearing in the same issue is an article by Hiscott's lab, offering new insights into how viruses trigger a cells antiviral immune response. That finding may lead to drugs effective not only against hepatitis C, but all viruses.

SOURCES: Sciencexpress, April 17, 2003. Michael Gale Jr., PhD, University of Texas Southwestern Medical Center, Dallas. Leslye Johnson, PhD, chief, enteric and hepatic diseases branch, National Institute of Allergy and Infectious Diseases. Robert Consalvo, director of external communications, Schering-Plough Corp.

Hi PT:

This is not new.

I have read about a few different companies who tried it on humans. This initial story is wide spread, the results that surfaced a few moths later have not been so well spread.
The people schering tried this on died 2 to 4 months later from heart attacks.

The inhibitor causes some major damage.

This is 10 years off if it works according to the FDA.

I would not wait. My doctor told me in 1995 when interferon failed that the medical community may come up with something in 5 years, that 5 years has come and gone and nothing new. Even the new peg intron and Pegasus is the same interferon.

This is a complex virus and it is not going away with a magic bullet anytime soon.
I hope I am wrong.

In good health

Hey Lloyd,

Thanks for the quick response and the update on those articles. 10 years huh, I would be dead by then and I'm only 39. I will work 40 hrs. of overtime a month for the next 20 years and stay on your program if that is what I have to do to control or eliminate this thing.  Interferon is not an option and as you stated, I can't just sit and wait.  I have had the virus for 20 years.  My load 3 years ago was 800,000 and it is now 8,000,000.  I am not sure about the other levels as I am awaiting a copy of my tests.

Two days into the program and the exhaustion was greatly diminished.  5 days in now and the urine is a bright yellow green instead of tea color and the ache in my side has subsided a good bit.  I already feel a lot better than a 5 days ago.

If I have any questions do you prefer email, or should I call and ask one of your secretaries?  I know you have 30,000 plus clients and I don;t want to tie up a bunch of your time.  Is peanut butter and/or hot dogs ok to eat?

P. T.



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