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Hep-C Drug TARVACIN Enters Ph1 at Bach

Anyone interested the fight against HEP-C should be aware of the phase1 study of TARVACIN initiated 8-8-2005 at Bach & Godofsky Infectious Diseases in Bradenton, FL., with Dr. Eliot W. Godofsky as principle investigator.  
[ news: http://tinyurl.com/cltum ]

Trial Title:
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Avatar universal
"...Using existing knowledge that viruses causing chronic infections are able to turn off the body's immune system and spread throughout the body, they will seek to develop a therapy that switches the immune system's natural defense against hepatitis C back on. If successful, this approach could be applied to the treatment of several other chronic viral infections..."
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Newswise — Researchers at the Columbus Children's Research Institute (CCRI) on the campus of Columbus Children’s Hospital have learned that through a recently awarded grant from the Grand Challenges in Global Health Initiative—founded by the Gates Foundation in partnership with the National Institutes of Health—they will collaborate with researchers at Emory University to investigate immunological strategies for curing chronic hepatitis C virus infections, The work will address and important public health problem as an estimated 200 million people are infected with the hepatitis C virus globally and are at increased risk for liver failure and cancer. The funding commitment for the work totals $12.5 million over five years.

Forty-three projects were selected for funding by the Gates Foundation, each tackling one of 14 major scientific challenges that, if solved, could lead to important advances in preventing, treating and curing diseases of the developing world. CCRI and colleagues plan to develop a new therapy for hepatitis C that is more effective and affordable than current treatment options. Using existing knowledge that viruses causing chronic infections are able to turn off the body's immune system and spread throughout the body, they will seek to develop a therapy that switches the immune system's natural defense against hepatitis C back on. If successful, this approach could be applied to the treatment of several other chronic viral infections.

“As one of 43 award recipients chosen from a pool of more than 1,500, we are thrilled to have the opportunity to contribute to the progress of global health,” said Christopher Walker, Ph.D., director of the Center for Vaccines and Immunity at CCRI and professor of pediatrics at The Ohio State University College of Medicine and Public Health. “We’re confident that through this collaboration, we have the expertise in place to be able to answer the challenge of ‘creating immunological methods that can cure latent infections.’”

Initial research will be conducted by the project’s principal investigator Rafi Ahmed, Ph.D., professor of microbiology and immunology at Emory University School of Medicine and director of the Emory Vaccine Center. The most promising candidates will be sent to CCRI for further testing.

Walker said work on the project will begin in September 2005.

About Columbus Children's Hospital
Columbus Children’s ranks among the top 10 in National Institutes of Health research awards and grants to freestanding children’s hospitals in the country and houses the Department of Pediatrics of The Ohio State University College of Medicine and Public Health. With nearly 600,000 patient visits each year, Children’s Hospital is a 112-year-old pediatric healthcare network treating newborns through age 21. In 2004, the Columbus Children’s Research Institute conducted more than 300 research projects and is the home of Centers of Emphasis encompassing gene therapy; molecular and human genetics; vaccines and immunity; childhood cancer; cell and vascular biology; developmental pharmacology and toxicology; injury research and policy; microbial pathogenesis; cardiovascular medicine; and biobehavioral health. Pediatric Clinical Trials International (PCTI), a site management organization affiliated with the hospital, also coordinated more than 50 clinical trials. In addition to having one of the largest ambulatory programs in the country, Children’s offers specialty programs and services. More than 75,000 consumers receive health and wellness education each year and affiliation agreements with nearly 100 institutions allow more than 1,700 students and 500 residents to receive training at Children’s annually. More information on Children’s Hospital of Columbus is available by calling (614) 722-KIDS (5437) or through the hospital’s Web site at http://www.columbuschildrens.com.

About Grand Challenges in Global Health
The Grand Challenges initiative was launched by the Gates Foundation in 2003, in partnership with the National Institutes of Health, with a $200 million grant to the Foundation for the National Institutes for Health (FNIH) to help apply innovation in science and technology to the greatest health problems of the developing world. Of the billions spent each year on research into life-saving medicines, only a small fraction is focused on discovering and developing new tools to fight the diseases that cause millions of deaths each year in developing countries.

About the Bill & Melinda Gates Foundation
The Bill & Melinda Gates Foundation works to promote greater equity in four areas: global health, education, public libraries, and support for at-risk families in Washington state and Oregon in the U.S. The Seattle-based foundation joins local, national, and international partners to ensure that advances in these areas reach those who need them most. The foundation is led by Bill Gates’ father, William H. Gates Sr., and Patty Stonesifer, and has an endowment of approximately $28 billion.

http://www.newswise.com/articles/view/513945/?sc=rsmn

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Avatar universal
no more ranting, the riba is boiling!!!!
Avatar universal
cjgaddy,

From my research, it looks like this tarvacin is about the only thing on the horizon with the potential as a monotherapy. (So far it is still "potential", but we should hear something relatively soon from this trial in Florida).
And talk about broad applicability! - Wow.  The lassa fever and CMV animal studies were unprecedented.  All in vitro work has also been incredible.  I refer to the data about effectiveness against six different enveloped virus families- including HIV 1 & 2, influenza A & B, smallpox, etc.

As impressive as the VX-950 study was, (compared to other studies on HCV-1), it is still looking as if VX-950 will need to be paired with interferon, whereas, if tarvacin works as it has in every mammal so far, it should actually get rid of the virus.

fingers crossed,

AB


80575 tn?1207132364
Hey Scott, what's your status?  Last I read you went backward to a Stage 2 (congrats) and was considering maintenance....are you on it now and if so what's it doing for you?  I wish you well.

Snook, thanks for your fishing comments.  My son and I live for tight lines...we were in the Keys this summer and caught barracuda to shark to yellow tail snapper.  Right now we are stalking Midwest catfish, bass and carp.  Keep up the fight with this disease.

Mike
Avatar universal
Actually, Alban, I have been following VX-950 for years now, and the company's stance hasn't changed-they are still looking at 950 as a possible monotherapy. The next phase 1B in Europe will be interferon and 950, as in vitro, inter. added an additional 1-2 logs in the already-impressive vl drop.
One of the Phase 2 studies will be a 3 month monotherapy and should start early next year. So far, no data has come out that suggests they need to pull the plug on it as a monotherapy.
Avatar universal
you're right.  I just went back and re-read the results of the phase 1B study, and it's basically 'up in the air' at this point.  

-- rapdity of viral load decline, undetectable HCV RNA & slow return of HCV RNA post-dosing suggest that VX950 should be explored as a monotherapy

-- combination therapy wih other antiviral agents or IFN may be required to obtain optimal responses

-- treatment duration with HCV PI therapy may be shorter than the current standard of care


AB
Avatar universal
one of the other possible combos they will be exploring is with merimepodib which is currently in late phase 2. So far, it has an additive effect to the current therapy, but I think they would prefer it to be used with 950.

Also, by the time 950 would be approved, I think Human Genome might have Albuferon out which is dosed once very 2-4 weeks. So, I think that interferon as we know it is on its way out in due time. I, like you, and probably many others would like to get away from interferon if possible. It would also be nice to eliminate riba with all of its nasty side effects. No matter which one is out first, or is best, it looks like the treatment landscape could change quite a bit in the next few years. If only it were tomorrow.
Avatar universal
I am already on a study with Dr Godofski and will check into this new study for you. My study is the nm283 and I received an email from Colonel J Gaddy to look into this new study.
I have dropped my viral levels from 1,222,000 to 4000 since I started in March of this year. I will know at the end of the week the results from my last blood tests that I had taken on Monday.
Keep smilind as I can see a little light at the end of the trail and hopefully it will get bigger.
Michael
80575 tn?1207132364
Scott,

Virus broke through at week 36 so I stopped.  Bx said almost no damage or inflammation and doc recommended watch-n-wait and come back in a year.  I asked him about clinical trials and he is pushing SCH-6 which make me wonder because VX-950 and NM283 are further along....maybe he's being paid by Schering to recommend SCH-6...any ideas?

Four weeks off tx and I began running again.  I feel very, very good but just wish I could kill this bug.
Avatar universal
Hi there,

Just a quick clarification, Albuferon is interferon.  It is interferon alpha-2b fused with an Albumin protein molocule just like peg interferon is interferon fused with a glycol molocule.  The Albumin molocule has a longer half life in the body so it only requires 2 week dosing.  I was on Albuferon for 24 weeks.  I did not clear.  My understanding is that the efficacy is about the same as the peg interferons, just easier to take.  I found this to be the case.

Best to you,
Steve
Avatar universal
There are several aspects about TARVACIN
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