Aa
Alinia
Romark Laboratories, a privately-owned biotechnology company, today announced results of a randomized phase II clinical trial showing that 79% of interferon-naïve patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained virologic response (SVR), or undetectable level of virus, 12 weeks following treatment, compared to 43% of patients receiving the standard of care without nitazoxanide. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Interim results from this Phase II clinical trial will be presented on Tuesday November 6 in an oral presentation at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
"Patients treated with nitazoxanide responded earlier and maintained their responses without relapse after receiving only 36 weeks of treatment with peginterferon and ribavirin," said Dr. Emmet B. Keeffe, Chief of Hepatology at Stanford University School of Medicine. "These data suggest the emergence of a new therapeutic approach for treating hepatitis C. While more study is needed to confirm these results in a broader population of patients, nitazoxanide appears to increase the potency of interferon without increasing toxicity or inducing resistance."
Study Details
This Phase II randomized, controlled trial was conducted at two centers in Egypt and is part of the company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, which is designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with peginterferon or peginterferon and ribavirin (standard of care) in patients with chronic hepatitis C.
In the trial, 96 treatment-naive patients with chronic hepatitis C genotype 4 were randomized into three groups to receive either 48 weeks of standard of care treatment (n=40), 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon (a dual regimen, n=28), or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus standard of care treatment (a triple regimen, n=28). An additional 24 interferon-experienced patients were randomized to receive 12 weeks of nitazoxanide followed by either the dual regimen (n=12) or the triple regimen (n=12) for 36 weeks. Patients received 180 microgram injections of pegylated interferon (Pegasys®) once per week; nitazoxanide was administered as one 500 mg tablet twice daily; and ribavirin was administered as 1,000 or 1,200 mg daily according to weight.
Results
At 12 weeks following the end of treatment, naïve patients who received a triple regimen that included standard of care and nitazoxanide showed a significantly higher SVR (HCV RNA < 10 IU/mL, Abbott m2000) than the group receiving the standard of care regimen (79% vs. 43%, respectively) (p=0.006). The data also suggest a potential for eliminating or reducing the role of ribavirin in treating hepatitis C. Patients treated with a dual regimen of nitazoxanide and peginterferon showed an SVR at week 12 following the end of treatment that was not inferior to standard of care (68% vs. 43%, respectively) (+25%; 95% CI: -1%, +47%). Of 24 treatment-experienced patients, the triple regimen (n=12) resulted in an SVR of 25% at week 12 post- treatment, and the dual regimen group (n=12) had an SVR of 8%.
"Results from this trial validate a new approach to treating HCV that focuses on the interaction between the virus and the cell," said Jean-François Rossignol, M.D., Director of the Romark Institute for Medical Research. "With confirmation provided by this data we are aggressively pursuing development of nitazoxanide and related drugs to treat chronic hepatitis C and other viral diseases."
Nitazoxanide is the first of a new class of small molecule drugs called thiazolides that inhibit replication of a broad range of viruses. The drug was discovered by Dr. Rossignol and was initially developed by Romark and approved for marketing in the United States as the first treatment of cryptosporidiosis. Serendipitously, the development of nitazoxanide for treating cryptosporidiosis led to the discovery of its antiviral properties and ultimately to the discovery of a promising new class of antiviral drugs.
Romark is currently conducting a U.S. Phase II trial with nitazoxanide plus standard of care in patients with hepatitis C genotype 1 who were previously treated with interferon. The Company also plans to initiate a Phase II trial in treatment naïve patients early in 2008.
"Patients treated with nitazoxanide responded earlier and maintained their responses without relapse after receiving only 36 weeks of treatment with peginterferon and ribavirin," said Dr. Emmet B. Keeffe, Chief of Hepatology at Stanford University School of Medicine. "These data suggest the emergence of a new therapeutic approach for treating hepatitis C. While more study is needed to confirm these results in a broader population of patients, nitazoxanide appears to increase the potency of interferon without increasing toxicity or inducing resistance."
Study Details
This Phase II randomized, controlled trial was conducted at two centers in Egypt and is part of the company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, which is designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with peginterferon or peginterferon and ribavirin (standard of care) in patients with chronic hepatitis C.
In the trial, 96 treatment-naive patients with chronic hepatitis C genotype 4 were randomized into three groups to receive either 48 weeks of standard of care treatment (n=40), 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon (a dual regimen, n=28), or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus standard of care treatment (a triple regimen, n=28). An additional 24 interferon-experienced patients were randomized to receive 12 weeks of nitazoxanide followed by either the dual regimen (n=12) or the triple regimen (n=12) for 36 weeks. Patients received 180 microgram injections of pegylated interferon (Pegasys®) once per week; nitazoxanide was administered as one 500 mg tablet twice daily; and ribavirin was administered as 1,000 or 1,200 mg daily according to weight.
Results
At 12 weeks following the end of treatment, naïve patients who received a triple regimen that included standard of care and nitazoxanide showed a significantly higher SVR (HCV RNA < 10 IU/mL, Abbott m2000) than the group receiving the standard of care regimen (79% vs. 43%, respectively) (p=0.006). The data also suggest a potential for eliminating or reducing the role of ribavirin in treating hepatitis C. Patients treated with a dual regimen of nitazoxanide and peginterferon showed an SVR at week 12 following the end of treatment that was not inferior to standard of care (68% vs. 43%, respectively) (+25%; 95% CI: -1%, +47%). Of 24 treatment-experienced patients, the triple regimen (n=12) resulted in an SVR of 25% at week 12 post- treatment, and the dual regimen group (n=12) had an SVR of 8%.
"Results from this trial validate a new approach to treating HCV that focuses on the interaction between the virus and the cell," said Jean-François Rossignol, M.D., Director of the Romark Institute for Medical Research. "With confirmation provided by this data we are aggressively pursuing development of nitazoxanide and related drugs to treat chronic hepatitis C and other viral diseases."
Nitazoxanide is the first of a new class of small molecule drugs called thiazolides that inhibit replication of a broad range of viruses. The drug was discovered by Dr. Rossignol and was initially developed by Romark and approved for marketing in the United States as the first treatment of cryptosporidiosis. Serendipitously, the development of nitazoxanide for treating cryptosporidiosis led to the discovery of its antiviral properties and ultimately to the discovery of a promising new class of antiviral drugs.
Romark is currently conducting a U.S. Phase II trial with nitazoxanide plus standard of care in patients with hepatitis C genotype 1 who were previously treated with interferon. The Company also plans to initiate a Phase II trial in treatment naïve patients early in 2008.
68% 12 week SVR w/ NO RIBA! Ya reckon a Dr would prescribe this stuff off label? Seems like you could start with all 3 drugs and if things started going "ribasouth" you could reduce or just drop the riba. Isn't Procrit "off label" as far as HCV treatment is concerned. Wish I could find someone 'round here in a trailor to cook me up a batch, ahh, life in Alabama!! :) jerry
same with my doc, not impressed, he's waiting for the conference....genos aside, there's also the gastro effects, which if you are already expanded liver/spleen wise don't make this an appealing addition as any gas with no room left means writhing in pain.......
although I'm gonna bring it up with him when he gets back from the conference and see if anybody changed his mind.
personally, after reading up on 12 new drugs and trials this year and hopefuls with serious sides I'm starting to get a little less eager about phase 1 and 2 for anything.....take a hundred people...what likelihood is there of seeing the breach births so to speak. I'm beginning to see why phase 3 is the real proving ground for most of these molecules. (considering probably dozens have come and gone because they failed in one way or the other)
plus, and same here, no prejudice, but what can pass the bar in Egypt where everyone isn't Sue HAppy....well, you just can't throw things out there in this country without the legals crying foul for every and anything...besides the FDA regulates studies, monitors bank accounts of researchers for payoffs etc........do they even have an FDA there???????
although I'm gonna bring it up with him when he gets back from the conference and see if anybody changed his mind.
personally, after reading up on 12 new drugs and trials this year and hopefuls with serious sides I'm starting to get a little less eager about phase 1 and 2 for anything.....take a hundred people...what likelihood is there of seeing the breach births so to speak. I'm beginning to see why phase 3 is the real proving ground for most of these molecules. (considering probably dozens have come and gone because they failed in one way or the other)
plus, and same here, no prejudice, but what can pass the bar in Egypt where everyone isn't Sue HAppy....well, you just can't throw things out there in this country without the legals crying foul for every and anything...besides the FDA regulates studies, monitors bank accounts of researchers for payoffs etc........do they even have an FDA there???????
I asked my doc a while ago about Alinia, he was less than enthusiastic because I am not geno 4. Seems Egypt has a HUGE population of geno 4 and that genotype has some specifics about it that may not apply to the other genos. This was just a brief conversation he and I had, so there is still much I do not know.
I do know that NOW that Vertex is about 18 months away from FDA approval, we have new drugs coming out of the woodwork. And I am very very glad about it. I am SO going to have a much better chance next time I tx than last time, the whole paradigm of SOC has changed like a m$$%$%# in only three years. And what a great change it is.
I'm ready, bring it on. Telaprevir, with a small side of Alinia and the new interferon that only needs to be injected bi-weekly. Now if only we could get past the riba, I would not be dreading the tx again as much. But I keep remembering how much it has all changed, we are finally catchin a break here!!
Willow
I do know that NOW that Vertex is about 18 months away from FDA approval, we have new drugs coming out of the woodwork. And I am very very glad about it. I am SO going to have a much better chance next time I tx than last time, the whole paradigm of SOC has changed like a m$$%$%# in only three years. And what a great change it is.
I'm ready, bring it on. Telaprevir, with a small side of Alinia and the new interferon that only needs to be injected bi-weekly. Now if only we could get past the riba, I would not be dreading the tx again as much. But I keep remembering how much it has all changed, we are finally catchin a break here!!
Willow
Scratch the post before.
I have no bias towards or against Egypt, Arabs or Islam, but I have to raise a caution about drawing a lot of conclusions from an early phase study in Egypt.
I don't think the health system there is generally in a place to carry out rigorous trials, with strict attention to selection, blinding, maintenance of the blind, etc.
I doubt the FDA will put a lot of stock in it.
Alinia could have value, but this info should to be discounted somewhat.
I have no bias towards or against Egypt, Arabs or Islam, but I have to raise a caution about drawing a lot of conclusions from an early phase study in Egypt.
I don't think the health system there is generally in a place to carry out rigorous trials, with strict attention to selection, blinding, maintenance of the blind, etc.
I doubt the FDA will put a lot of stock in it.
Alinia could have value, but this info should to be discounted somewhat.
Considering all the attention telapervir gets it sure seems like this post would be making a bigger splash than it is. Wasn't HR somehow involved or interested in Alina. I mean, 79% 12 week SVR w/ few if any additional sx seems like a HCV ROCK OUR WORLD kind of thing. Is this a "too good to be true " thing? I've been looking hard at the 950 phase 3 trial but MAN, this news kinda shakes that plan up. WHY was this thing done in Egypt and on g4s of all genos? I'm confused. jerry
I knew it! I knew it! I knew it! SWEEEEEEEEEETTTT!!!!
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
