Re: all alone

[Guest guest]

Which new treatment ?? There are several new ones coming .Albuferon, Infergen ,

thymosin , gamma interferon , and the list goes on . Haha , dont worry which

ever it is it is more effective than the current interferon and ribavirin drugs

.. I have lots of information on each of these new medications so if you can help

narrow the list I can get information to you .

all alone

Hello group.

I need to talk to others with the same health problem as me. My doctors don't

want to treat me with the standard treatment. They say I will be a good candiate

for the new treatment coming out soon. Has anyone any information on the new

treatment?

It's a pleasure having you join in our conversations. We hope you have found

the support you need with us.

If you are using email for your posts, for easy access to our group, just

click the link-- http://groups.yahoo.com/group/Hepatitis_C_Central/

Happy Posting

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[Guest guest]

I would like some information on them and how far do

you think they are away from entering the market. I

would also like information on the upcoming studies.

DO you also know anythign about that Vertex drug?

--- elizabethnv1 wrote:

> Which new treatment ?? There are several new ones

> coming .Albuferon, Infergen , thymosin , gamma

> interferon , and the list goes on . Haha , dont

> worry which ever it is it is more effective than the

> current interferon and ribavirin drugs . I have lots

> of information on each of these new medications so

> if you can help narrow the list I can get

> information to you .

> all alone

>

>

> Hello group.

> I need to talk to others with the same health

> problem as me. My doctors don't want to treat me

> with the standard treatment. They say I will be a

> good candiate for the new treatment coming out soon.

> Has anyone any information on the new treatment?

>

>

>

>

>

> It's a pleasure having you join in our

> conversations. We hope you have found the support

> you need with us.

>

> If you are using email for your posts, for easy

> access to our group, just click the link--

> http://groups.yahoo.com/group/Hepatitis_C_Central/

>

> Happy Posting

>

>

>

>

------------------------------------------------------------------------------

>

[Guest guest]

Here is some info to get you started , and if you are interested in a clinical

trial and have not treated yet there are some clinicals enrolling right now for

you . If you need any more info just lemme know , hope this helps

Hepatitis C Treatments in Current Clinical Development

Alan Franciscus

Editor-in-Chief

PDF (download)

There are many potential targets being pursued by drugs treating HCV. A number

of compounds for these targets are in early " test-tube " development or

pre-clinical " animal " development phases. Most of these compounds, however, will

never make it to trials in humans (clinical studies). In fact, only one in 1,000

compounds makes it to human testing. Of those drugs that make it to human

testing only 1 in 5 will receive FDA marketing approval. Therefore, every effort

has been made to focus this list only on treatments that are known to be in

current active clinical development.

There are many new drugs in development to treat hepatitis C. When new drugs are

tested they will be compared to the current standard of care-the combination of

pegylated interferon and ribavirin. In addition, most experts believe that when

new drugs are approved to treat hepatitis C that they will be used in

combination with pegylated interferon and ribavirin.

When a company is ready to proceed to clinical trials, it files an

Investigational New Drug Application (IND) with the Food and Drug Administration

(FDA). Most clinical trials are designated as phases I, II, or III, and

sometimes IV based on the type of questions that the study is seeking to answer.

Study Phases

a.. In Phase I clinical trials, researchers test a new drug or treatment in a

small group of people (20-80) for the first time to evaluate its safety,

determine a safe dosage range, and identify side effects.

b.. In Phase II clinical trials, the study drug or treatment is given to a

larger group of people (100-300) to see if it is effective and to further

evaluate its safety.

c.. In Phase III studies, the study drug or treatment is given to large groups

of people (1,000-3,000) to confirm its effectiveness, monitor side effects,

compare it to commonly used treatments, and collect information that will allow

the drug or treatment to be used safely.

d.. In Phase IV studies, the drug is already on the market for a particular

indication, but is now being tested for a different indication, use, or disease.

The testing of new drugs is a long process that typically takes about 12 years

from pre-clinical testing to FDA approval and marketing to the general public.

To see a chart showing the timeline for new drug development, click here.

The following table will be updated as clinical developments move forward:

Quick Reference Chart

Click on the name of the drug to view the history of the drug development.

Phase I Phase II Phase III Phase IV

ANA971 ANA245 REBIF Infergen/Consensus

Oral Interferon alpha HepXT-C IP-501 Amantadine

VX 950 Rituximab (Rituxam) Viramidine

JTK 003 NM283 Zadaxin

EMZ702 ISIS 14803

HCV/MF59 E-1

SCH-6 Civacir

HCV-796 Merimebodib- VX-497

Interferon gamma-1b

Omega Interferon

Multiferon

BILN 2061

IDN-6556

Ceplene

Albuferon

Medusa Interferon

MX-3253

IC41

Table of Hepatitis C Drugs in Current Clinical Development

Click on the name of the drug to view the history of the drug development.

Drug Name Drug Category Pharmaceutical Company

Oral Interferon alpha Oral Interferon Amarillo Biosciences Phase I

Comments: Testing low dose oral administration of alpha interferon

absorbed through mucosal membranes.

HCV-796 Polymerase Inhibitor ViroPharma

/Wyeth Phase IB

Comments: To date, HCV-796 has demonstrated potent efficacy in inhibiting

viral replication in cell-based assay systems and in an animal model for

hepatitis C. In these studies, HCV-796 antiviral activity was highly selective

and significantly reduced HCV RNA levels in an in vitro replicon assay.

JTK 003 Polymerase Inhibitor AKROS Pharma Phase I

Comments: Inhibits HCV genotype 1 polymerase

HCV/MF59 Vaccine Chiron Phase I

Comments: In collaboration with CSL Ltd. and St. Louis University.

SCH-6 Serine Protease Schering Phase I

Comments: In tests it was found the SCH-6 could protect the cell's

defenses and actually may prevent the HCV virus from blocking the immune

response and help restore the body's natural antiviral response.

ANA971 Isatoribine ANADYS Phase I

Comments: A prodrug of isatoribine. A recent clinical study of 48

subjects, including 28 patients infected with hepatitis C reported that the

intravenous administration of ANA971 was well tolerated and safe at all doses

tested. It has shown biological activity against hepatitis C as well significant

reductions in HCV RNA (viral load).

ANA245 Isatoribine ANADYS Phase I/II

Comments: Interim results of the Phase 1B clinical trial show that

isatoribine is biologically active in adults with chronic HCV infection and

results from dosing a cohort of six HCV infected patients with 800mg of

isatoribine showed a statistically significant reduction of viral load (p=0.03)

at the end of one week, with a median change in viral load from baseline of

-0.94 log10 units.

CPG 10101 (Actilon) Immunomodulator Coley Phase I/II

Comments: In a study of 45 HCV positive patients receiving 20 mg dose

twice weekly a 90% reduction in HCV viral load was achieved. The drug was found

to be safe and well tolerated. Studies on Actilon monotherapy as well as in

combination with pegylated interferon plus ribavirin are being planned.

Rituximab (Rituxam) Anti-CD20 Monoclonal Antibody Genetech/IDEC Phase

I/II

Comments: Under investigation for treatment of cryoglobulinemia. Currently

approved for non-Hodgkin's lymphoma.

NM283 (Valopicitabine) Polymerase Inhibitor Idenix Pharmaceuticals Phase

I/II

Comments: HCV polymerase inhibitor was found to be effective in reducing

HCV RNA viral loads in 99.0% of 9 patients in an on-going phase II clinical

trial and no serious side effects were observed. Larger studies are planned.

HepXT-C Monclonal Antibody XTL Phase I/II

Comments: Phase I studies on 35 chronic HCV patients indicated good safety

and bioactivity. Phase II study of HCV prophylaxis on post liver transplant

patients underway.

IC41 Therapeutic Vaccine Intercell Phase II

Comments: a combination synthetic therapeutic vaccine (medicines to

increase the T-cell response plus peptides identified through studies of people

with natural immunity to HCV or successful response to HCV therapy). IC41 has

completed phase I & phase II studies and has been shown to have a good safety

profile in healthy adults and previously treated HCV patients who failed to

achieve a successful treatment outcome. In the HCV patients there was an

increase in T-cell response and a temporary reduction of HCV RNA (viral load).

Larger trials are being planned for 2006 and 2008.

Medusa Interferon Longer acting interferon Flamel Technologies Phase II

Comments: Enrollment of patients in phase I/II clinical study to

demonstrate the safety profile and define the maximum tolerable dose of this

long acting interferon. The study will also compare the pharmacokinetic profile

of the long-acting interferon, compared with interferon.

VX-950 Protease Inhibitor Vertex Phase II

Comments: In a study of 34 HCV positive patients it was found that VX-950

produced substantial reductions (1,000 fold) in HCV RNA (viral load) in all

doses. The 750 mg dose produced a 25,000 fold decrease in viral load in 4 out of

8 patients. VX-950 was found to be safe and well tolerated. Additional studies

are being planned using VX-950 monotherapy, as well as in combination with

pegylated interferon.

Albuferon Longer Acting Interferon Human Genome Sciences Phase II

Comments: A form of time-released interferon that is produced by fusing

human serum albumin to interferon. In phase II clinical trials Albuferon was

found to be safe and well tolerated and produced a 99.9% decrease in HCV RNA

(viral load). Larger studies are planned.

IDN-6556 Caspase Inhibitor Idun Pharmaceuticals Phase II

Comments: Caspase inhibitors do not have any direct antiviral properties,

but are believed to preserve the cell structure and protect the liver from

damage caused by HCV. Phase I study completed in May 2002 which included

patients with stable hepatitis C infection. Data from a Phase 2a clinical trial

of an oral formulation of IDN-6556 in patients infected with HCV reported

positive safety and tolerability of the drug as well as its ability to reduce

elevated aminotransferase (ALT and AST) levels.

ISIS 14803 Antisense Isis Pharmaceutical / Elan Phase II

Comments: Genetically inhibits translation (production) of disease-causing

proteins. This compound appears to be well-tolerated, with minimal adverse

effects. A larger trial combining ISIS 14803 with pegylated/ribavirin is

currently underway.

E-1 Therapeutic Vaccine Innogenetics Phase II

Comments: Phase III expected 2004-2005. Study results indicated that 38%

of patients showed improvement in liver fibrosis score

Civacir Polyclonal Antibody NABI Phase II

Comments: Prevention of post-transplant recurrence of HCV. Preliminary

results show positive safety and pharmacokinetics results.

VX-497 (Merimebodib) IMPDH inhibitor Vertex Phase II

Comments: The preliminary results of a phase II study showed the

combination of VX-497, pegylated interferon and ribavirin was safe and

well-tolerated, and VX-497 exhibited an antiviral effect against HCV.

Omega Interferon Interferon BioMedicine Phase II

Comments: New formulation intended to target the liver specifically in

order to reduce the side effects in other tissues.

Multiferon Long Acting Interferon Viragen Phase II

Comments: Company is making long-acting pegylated version of product in

cooperation with Valantis.

Ceplene Histamine Maxim Phase II

Comments: Completed phase II studies. Currently in clinical trials with

pegylated interferon.

BILN 2061 Serine Protease Boehringer - Ingelheim Phase II

Comments: Intended to block viral replication. Shows dramatic decrease in

HCV viral load with only 48 hours of therapy. One of the most promising

potential new HCV therapies. However, phase II trials were put on hold until

potential toxicities seen in monkeys taking high doses are resolved.

Interferon beta-1a (REBIF) Interferon Ares-Serono Phase III

IP-501 Anti-fibrotic Indevus Phase III

Comments: Anti-fibrotic agent to treat/prevent cirrhosis. Seems to

stimulate collagenase to breakdown collagen - a component of scar tissue.

Viramidine Nucleoside Analogue Valeant Pharmaceuticals Int'l Phase III

Comments: A prodrug of ribavirin that specially targets liver cells. In

phase II studies of viramidine and pegylated interferon treatment response rates

were similar between the ribavirin and viramidine arms, but the incidence of

hemolytic anemia observed in the viramidine arm was 4% compared to 27% in the

ribavirin arm. Larger studies are underway.

Thymosin alfa-1 (Zadaxin) Immunomodulator SciClone Phase III

Comments: Boosts the immune system. Used in combination with interferons

and ribavirin. Phase III clinical trials in the U.S. are fully enrolled with

over 1,000 patients receiving Zadaxin in combination with pegylated interferon.

SVR data is expected in early 2006.

Consensus interferon (Infergen) Interferon InterMune Phase IV

Comments: Data from on-going phase IV clinical trials of high daily dosing

of Infergen in combination with ribavirin looks promising

Amantadine Broad Antiviral Endo Labs Solvay Phase IV

Comments: Anti-flu agent on the market. Has shown mixed results of

efficacy in combination with interferons.

Recently cancelled clinical trials:

Drug Name Drug Category Pharmaceutical

Company

Clinical Phase

Heptazyme RNA inhibitor RPI Studies Cancelled

Levovirin Nucleoside Analogue Valeant Pharma-ceuticals Int'l Studies

Cancelled

Interleukin-10 Anti-fibrotic Schering-Plough Studies Cancelled

R803 Non-nucleoside HCV Polymerase Inhibitor Rigel Pharmaceuticals

Studies Cancelled

HCV-086 ViroPharma/Wyeth Studies Cancelled

all alone

>

>

> Hello group.

> I need to talk to others with the same health

> problem as me. My doctors don't want to treat me

> with the standard treatment. They say I will be a

> good candiate for the new treatment coming out soon.

> Has anyone any information on the new treatment?

>

>

>

>

>

> It's a pleasure having you join in our

> conversations. We hope you have found the support

> you need with us.

>

> If you are using email for your posts, for easy

> access to our group, just click the link--

> http://groups.yahoo.com/group/Hepatitis_C_Central/

>

> Happy Posting

>

>

>

>

------------------------------------------------------------------------------

>

[Guest guest]

Thanks for posting all that info.

I do wonder why so many of the studies have been cancelled.

It's important to note that a lot of folks do not tolerate

interferon in any form so really none of these combinations

would work for them. some studies are using monotherapy of the

new drugs alone and getting good results although not

spectacular. I have been watching NM283 and it's in Phase II

trials and looking pretty good. The manufacturer says it's

scheduled to enter the drug approval pipeline in 2006 but God

knows how long that takes. ric

If you'll be my dixie chicken, I'll be your tennessee lamb

And we can walk together, down in dixieland.

Lil' Feat

[Guest guest]

this just came into another list:

Doctors Fight Liver Disease

With Body's Own Stem Cells

By Martyn Halle

The Telegraph - UK

5-28-5

British doctors have made a " significant "

breakthrough using patients' own stem cells to

regrow their livers, raising the possibility of it

replacing organ transplants in future.

Last year The Sunday Telegraph revealed

that specialists had perfected a technique that

could cure people with liver disease. Importantly

it used the patients' own stem cells, rather than

the controversial practice of cells harvested

from aborted embryos.

Six weeks ago stem cells were extracted

from the blood of the first five human volunteers,

and injected into their livers. Early results

show that inside the patients' livers, the cells

have already started to grow.

Nagy Habib, the professor of liver

services at Hammersmith Hospital, who is overseeing the

project, said: " The treatment is still

experimental, but we hope that we have made a significant

breakthrough. "

The initial experiment was to prove the

technique worked using just a few stem cells, but

already, there are signs of some liver function

being restored.

The new treatment involves injecting the

cells into the hepatic artery in the liver under

local anaesthetic. Karl Hodgson, a 42-year-old

reformed alcoholic and drug taker from Bournemouth,

was one of the five patients treated by Prof

Habib. He was given a place on the trial after his

mother saw this newspaper's original article on the

internet.

Stem cells retain the potential to turn

into many different types of tissue. They can be

obtained from blood, bone marrow, or more

controversially from aborted embryos. But Prof Habib has

proved that stem cell treatments can work without

having to resort to foetal stem cells.

He is now planning a second phase of the

trial this summer, which is designed to test the

treatment's ability actually to reverse the

disease.

Alison , the chief executive of the

British Liver Trust, said: " Like many new

technologies they take time, but stem cell technology

represents a huge leap forward in treating many

diseases. "

© Copyright of Telegraph Group Limited

2005.

http://www.telegraph.co.uk/news/main.j

If you'll be my dixie chicken, I'll be your tennessee lamb

And we can walk together, down in dixieland.

Lil' Feat

[Guest guest]

Have you seen this study ?

oVALOPICITABINE (NM283) ALONE & IN COMBINATION WITH PEG-INTERFERON IN PATIENTS

WITH GENOTYPE-1 CHRONIC HEPATITIS C:

Preliminary results from an ongoing phase II, multicenter studyâ?

Reported by Jules Levin

DDW, Chicago, May 2005

Several new drugs for HCV are in clinical trials in HCV+ patients and appear

promising including NM283, a polymerase inhibitor administered orally, and

VX-950, an HCV protease inhibitor. NM283 plus peg-IFN may provide a treatment

option for previous pegIFN+RBV partial responders. The protease inhibitor is

still in a preliminary liquid formulation, as the initial study in patients was

first just reported, and the company Vertex, is working on a tablet formulation.

In addition, for the first time data was publicly reported, at DDW, for a new

HCV drug called CPG 10101, or Actilon. Actilon is a member of a new class of

investigational medicines known as TLR Therapeutics being developed by Coley

Pharmacueticals for the treatment of major medical conditions including cancers,

infectious diseases, allergy and asthma. TLR Therapeutics target Toll-like

receptors (TLRs) which act as immune system sentinels that recognize the

distinct molecular patterns characteristic of foreign pathogens. Coley & the

presenter at DDW, Dr Bruce Bacon, believe that Actilon stimulates TLR9,

targeting dendritic cells and B cells, to induce both early and long term immune

responses. The short-term innate immune response is thought to drive rapid

reductions in viral load in the blood. Longer term, Actilon is thought to

promote virus-specific adaptive immunity, including strong T cell responses, to

provide sustained anti-viral effects. In a phase Ib study in 42 adult patients

with chronic HCV who previously failed IFN/RBV & most had genotype 1, 20mg of

Actilon administered twice weekly by subcutaneous injection HCV viral load

achieved a maximum log decrease of 1.4 within 5 weeks. Actilon appeared safe &

tolerable. I will report more extensive data from this study. These drugs are in

relatively early stages of clinical development although NM283 development is

ahead of these other two drugs. But, it will be several years before NM283 or

these others may reach availability to patients. And of course, that is if

development runs smoothly without safety & activity problems.

NM283 Study

At DDW on May 17, 2005 in Chicago, l reported an update with

new data on ALT from the study of NM283.

AUTHOR SUMMARY:

NM283 showed marked antiviral activity:

--8/16 patients receiving NM283+PegIFN were PCR-negative at week 24. 3/16

patients are still pending between weeks 2 & 24.

--Mean HCV RNA (viral load) declined -4.5 log IU/mL (range: -2.33 to -6.2 log by

week 24.

--all 9 patients completing week 24 had >=2 log reductions in viral load

--8/9 patients were below the LLOQ for Amplicor PCR (<600 IU/mL)

--6/9 patients were below LLOD for Taqman PCR (<10 IU/mL)

--4/5 patients had detectable PCR at week 12 but had multi-log reductions after

week 12.

-- said the kinetics of response to NM283+PegIFN may be different from

the kinetics of response to pegIFN+RBV, perhaps synergistic.

--no HCV RNA â?obreakthroughsâ? to date, with data to 24 weeks; viral

genotyping underway

--good tolerability: negligible hemotologic side effects-possible safety

advantage without ribavirin

--large phase III studies are planned for prior treatment failures &

treatment-naïve patients

Here is some background information provided by Dr . In phase I/II

study, NM283 reduced HCV RNA, viral load, by a mean 1.2 log in 2 weeks at

optimal dosing. 87% of patients had previously failed IFN therapies. In vitro,

NM283 & IFNa show synergistic antiviral effects in BVDV model. This data

supports early clinical investigation of NM283 plus peg-IFNa, to maximize

antiviral efficacy & minimize resistance.

This study was designed initially to take a short-term look at safety, antiviral

activity & pharmacokinetics for 28 days. Due to encouraging early data,

treatment was extended to 12, then 24, and finally to 48 weeks via protocol

ammedments, with FDA & investigator agreement. The study extension provides

exploratory longer-term efficacy & safety data for the combination of NM283 plus

Peg-IFN, prior to controlled phase IIb-III trials. Treatment extension required

continued tolerance & virologic response:

>=2 log reduction from baseline at week 12

PCR negative at week 24.

The study is ongoing to one year, 12 & 24 week data were presented at DDW.

The trial is an open-label PK interaction & safety study enrolling 30

treatment-naïve adults with compensated chronic hepatitis C with HCV RNA >5 log

& ALT<5 times the upper limit of normal (ULN). Eligible patients received NM283

(n=12) vs NM283 plus peg-IFNa-2b (n=18). NM283 was administered initially at 400

mg/day and then increased to 600mg/day & then to 800mg/day to day 8, then

800mg/day to day 28.

The majority of patients were Latino because Dr enrolled many patients

in San . Baseline mean HCV RNA was 6 log & ALT was 63-70 IU/mL.

30 patients were enrolled; EVR was assessed at week 12. Only 1 patient on NM283

monotherapy achieved EVR. 9 of 18 patients receiving combination therapy

completed 24 weeks.

NM283 appears safe & tolerable in the study. There were no serious adverse

events or dose-limiting toxicities.

SAFETY & TOLERABILITY

Typical IFN side effects, no unexpected side effects.

Nausea, vomiting common in both NM283 & combination treatment arms, reported to

be transient, probably related to NM283 & IFN. Onkly 1 patient discontinued for

AE (decreased libido due to IFN). Only 1 grade _ lab abnormality observed during

treatment:

--grade 3 ANC (absolute neutrophil count) reduction (620/mm3) at day 11 in a

patient receiving combination therapy

--ANC returned to baseline levels at day 15, remained stable for the duration of

treatment

--no dose interruption or treatment modification required

WEEK 12 HCV RNA RESPONSE

Mean HCV RNA reduction was -3.01 log IU/mL in the combination arm (n=16) & -0.87

IU/mL in the NM283 monotherapy arm (n=12). 12 patients in the combination arm

had >1.7 log reduction; 4 were PCR negative.

WEEK 24 HCV RNA RESPONSE

Viral load was reduced by 1.9 log IU/mL from baseline in the patient receiving

monotherapy (n=1). In the combination arm the mean HCV RNA reduction was -4.5

log IU/mL.As you can see from the graph the mean viral load was below Amplicor

LLOD of 50 IU/mL.

As you can see from the graph below several patients had viral load reduced to

low levels within 12-16 weeks after beginning therapy but several patients

became responders between weeks 12 to 24. At week 24, 8/9 patients had <600

IU/mL, 7/9 had <50 IU/mL, and 6 of 9 patients had <10 IU/mL using the sensitive

TaqMan assay.

In the 5patients receiving combination treatment who were still PCR+ at week 12,

4 continued to have responses after week 12.

Median ALT was 65-70 at baseline & 43% of patients normalized ALT at week 12 &

63% were normal at week 24.

Re: all alone

Thanks for posting all that info.

I do wonder why so many of the studies have been cancelled.

It's important to note that a lot of folks do not tolerate

interferon in any form so really none of these combinations

would work for them. some studies are using monotherapy of the

new drugs alone and getting good results although not

spectacular. I have been watching NM283 and it's in Phase II

trials and looking pretty good. The manufacturer says it's

scheduled to enter the drug approval pipeline in 2006 but God

knows how long that takes. ric

If you'll be my dixie chicken, I'll be your tennessee lamb

And we can walk together, down in dixieland.

Lil' Feat

It's a pleasure having you join in our conversations. We hope you have found

the support you need with us.

If you are using email for your posts, for easy access to our group, just

click the link-- http://groups.yahoo.com/group/Hepatitis_C_Central/

Happy Posting

------------------------------------------------------------------------------