Topic: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Raptor Pharmaceuticals Corp has a product called Convivia, which "will treat symptoms associated with alcohol intolerance due to ALDH2 Deficiency, an inherited metabolic disorder."

Product website:
http://www.raptorpharma.com/programs_convivia.html

Here's what the website says about the product, as of May 7, 2008:

Bennu's Convivia product will treat symptoms associated with alcohol intolerance due to ALDH2 Deficiency, an inherited metabolic disorder.  These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol.  Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.

Convivia is a proprietary formulation of a small molecule compound which has been previously approved for sale in the U.S. and Europe for unrelated indications.  Bennu plans to submit an investigational new drug ("IND") application to the Food and Drug Administration ("FDA") for the initiation of clinical trials anticipated for 2008.

ALDH2 Deficiency

ALDH2 Deficiency is an inherited metabolic disorder that is especially prevalent among east Asian populations.  In affected individuals, a gene polymorphism results in diminished activity of the ALDH2 enzyme, a component of the primary metabolic pathway for ethanol and other alcohols.  This leads to an accumulation of acetaldehyde, a known carcinogen, in blood, saliva, liver and other tissues after ingestion of ethanol.

ALDH2-deficient individuals experience a range of unpleasant physical reactions to consumption of even small amounts of alcohol, including facial flushing, nausea, headache, shortness of breath and dizziness.  Additionally, the ALDH2 polymorphism has been associated with dramatically increased risk of esophageal and other digestive tract cancers in numerous studies.  The prevalence of this enzyme disorder in Asian populations has been widely reported, and is generally estimated at between 30-50% of the populations of China, Japan, Taiwan, Korea and other Asian countries.

ALDH2 Deficiency has been recognized as a serious public health risk by some of the world's leading experts in alcohol- and acetaldehyde-related pathology:

     "ALDH2 deficiency is quantitatively the most important gene mutation potentially exposing humans to an increased risk of cancer."

        * Dr. Mikko Salaspuro, Helsinki University Central Hospital, "Can heavy alcohol use lead to some kinds of cancer?", Alcoholism: Clinical and experimental research, June, 2000, 24(6) 873-877

    "Many epidemiological studies have uniformly shown that the risk of alcohol related GIT cancers is markedly increased in Asians with the low-activity ALDH2 enzyme."

        * Helmut Seitz, Department of Medicine, University of Heidelberg and Nils Homann, Medical University of Schleswig-Holstein, "The role of acetaldehyde in alcohol-associated cancer of the gastrointestinal tract" Acetaldehyde-related Pathology: Bridging the Trans-disciplinary Divide, John Wiley & Sons, 2007

Clinical Development Plan

Bennu plans to initiate a phase 2a dose-ranging study in the spring of 2008, followed by a phase 2b study with final reformulated product in the second half of 2008.

It doesn't look like the product is out, yet, and it looks like studies will continue through 2008. No mention of an estimated release date.

2 (edited by jasko 2008-06-07 15:41:12)

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

I'm glad to hear this! I hope they progress with it!

Edit: I wonder what "followed by a phase 2b study with final reformulated product in the second half of 2008." means...

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Is there a status update on this product?

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

cant find any status updates after the phase IIa study, which started in April and ended in July.  ive read articles though that say that they are trying to push the product through the developement chain because 4-methylpyrazole, the compound used in convivia, is already approved by the FDA.  the only difference is in usage, since it is currently used for methanol poisoning.  i wonder how it is going too-

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

would the company divulge that kind of information on the phone to a random caller?

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Here is an article about Raptor Pharmaceutical's plan to develop the product-

http://www.devicespace.com/news_print.a … tyId=74114

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

another one-

http://starbulletin.com/2008/05/18/news/story03.html

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Anyone know of any news with Convivia?

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

http://www.news-medical.net/?id=42792

answered my own question. updated today , 11 Nov.

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Ahh fair play to them

Wonder how long it will take to hit the market in Asia...

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Any new news.  Im desperate to find something other than pepid ac.  Even when taking three pills I still get nauseous and red in the face.  This treatment would be a god send.

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

I really really hope this comes soon.  Im desperate for a better treatment than pepcid ac.

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

'Published retrospective studies have observed a significant correlation between recurrent drinkers with ALDH2 deficiency and an increase in risk for digestive tract cancers, liver diseases, late-onset Alzheimer's disease and other serious health disorders.' from the article at http://www.news-medical.net/?id=42792.

omg im freaking out at the moment, coz i drank A LOT in the last 4 years!! at least 3 times a week, getting completely wasted!! and the article suggests recurrent drinkers have a high chance for cancers and liver disease etc. I have toned down a lot this year, but after reading that article i am really worry the damage that i have done to my body!! im 23 yr old female, been taking zantac in the past year and a half.

does anyone think i already have made a massive damage to my body?? and if i go see a doctor and explain about my situation, would he be able to run some tests to see how my liver is and the risk of getting digestive tract cancers??

THANKS!

(I might have some occasional social drinks every now and then, but im really cutting out the big nites! )

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Guys, I'd like to take a moment of your attention for what I have to say:

It is extremely important that we do not run from the fact that acetaldehyde (the toxin resulted from alcohol breakdown in the liver) is one of the most potent carcinogenic agents that could be found in a person's body. We all know this, for the side effects of drinking to all of us is so undeniably powerful. The excruciating headache, the bizarre redness, the abnormally pounding heart, the sudden feeling that you're under the sun of a desert at noon, the almost unbearable hangover that sometimes lasts for days to come. We must understand that drinking is extremelly harmful (it is already harmful to "normal" individuals) for us under these conditions.

That is why I am urging you guys to take interest in the new drug that is being developed by Raptor Pharma (Convivia). It is already in phase II of development with (so far) very positive results on tested Asians that have the ALDH2 defect. Nothing has ever come closer to free us from this awful condition. Only we know what it feels like being restrained from fun. And when trying to engage in it, to be ridicularized by the visible and awful side effects shown.

If you can, send a message of support to the developers of this drug; tell them your story, and how this miraculous drug would boost your self-esteem. I am afraid of this possibility of this drug not being approved. We should show our support.

http://www.raptorpharma.com/convivia.html

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Will do, I really hope that this gets approved.

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

I would like to ditto Elephant's post above. I didn't know about the damaging effects of "asian flush" until recently and am quite disturbed by what I've read. That our bodies are exposed acetaldehyde for prolonged periods, especially in the mouth and GI. Also suprised about just how carcinogenic it is.
Now I've been drinking weekly for around 8 yrs, sometimes heavily. What I'm really concerned about is whether I've done irreparable damage to my body already. I am going to try to give up alcohol completely due to its carcinogenic effect on asian flush sufferers but i'm concerned that damage has already been done. Is there anyway to check etc?
I hope this forum realises how bad alcohol is for Alcohol flush sufferers. Zantac etc will help the visible effects but the carcinogenic effects are ever present. Cutting alcohol out is the only current solution. I really hope the Convivia drug comes out soon!

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

This is an email i recieved regarding Convivia from Ted Daley - Raptorpharma

Thank you for your inquiry.  Convivia is a clinical-stage product candidate, not yet approved for marketing in any country.  In 2008, Raptor conducted a clinical study in Hawaii in subjects of Japanese descent.  Additional clinical studies will be required, and we plan to focus our further clinical development and eventual commercialization efforts in Asian countries.  We have no specific timelines for marketing in any country at this time.

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Saw this today, looks like things are moving along!

http://www.marketwatch.com/story/raptor … dist=msr_2

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Does anyone know of any estimated date of release? Maybe just an educated guess? haha

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

I have also emailed Raptor Pharmaceutical and I am on their news mailing list.
They seem to be pretty poor at responding to inquiries. I have no heard any recent news about Convivia.

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

That link goes to nothing??

After 3 emails i got a reply, Ted Daley(president) told me that they are currently looking to further studies in Asia, but it's proving hard as people see Convivia as the reason why alcoholism is so much smaller in Asian countries than the rest of the world. I find this stupid not everyone wants to go out and get smashed we just want a cure so we can go out and enjoy ourselves without worrying.

22 (edited by redhead 2009-11-01 19:52:34)

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Convivia sounds good, but I think that the real cure is Alda-1, which is a compound that was developed pretty recently to prevent damage to the heart during a heart attack.   I think it's better because it increases acetaldehyde metabolism, rather than slowing down alcohol metabolism.  If you think about it, using 4-MP, the active ingredient of Convivia, will make you much drunker than you usually would get- probably dangerously drunk after even a small amount.  So, I emailed Raptor to see if they'd considered Alda-1, and here was the reply:


"Yours is an excellent suggestion, which I, at least, had missed.  We appreciate your interest in the program.  One aspect of Alda-1 that gives very small companies pause is the expected time it would take before one could test it in humans.  One advantage of 4-MP is that it is already approved for use in humans for certain applications.  While that provides no comfort as to whether it would work in the Asian flush application, it does mean that a lot of toxicological work has already been done and risks reduced.  Alda-1, for its part, has compelling proof-of-principle that involves the actual mutated enzyme.  But from a chemist's perspective, Alda-1 looks to have some potential toxicological issues, especially for a long-term, repetitive-dosing application like Asian flush.  For example, a primary hydrolysis product of Alda-1 is 2,6-dichlorobenzoic acid, a known breakdown product of herbicides and a compound with some level of known toxicity.  As you probably already know, there are those who consider treatments for Asian flush to be enabling of alcoholism or, at a minimum, unworthy of biotechnology efforts.  The fairness of those assessments aside, they tend to increase the regulatory hurdles likely to be thrown up by the FDA, particularly with regard to long-term safety.

That said, we will keep Alda-1 in mind and thank you again for bringing it to our attention."

hope this is of some use-

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Also, here is the URL for the Wikipedia entry for ALDH2, which is the enzyme that is mutated in asian flushers.  There's an image and brief description of Alda-1:

http://en.wikipedia.org/wiki/ALDH2

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

This is just ridiculous nothing seems to be happening with the Convivia program this whole year, the dissapointments continue

25 (edited by excellency 2010-06-30 12:41:38)

Re: Convivia by Bennu / Raptor Pharmaceuticals Corp.

Hey guys I'm new to this forum but it's great that there is a place where blush-sufferers like me can come together and discuss a topic that all affects us in different ways... anyways...I was doing so market research at my internship today and came across this...hot off the stove...looks like their's hope:

http://www.marketwatch.com/story/raptor … _news_stmp

Hope this develops quickly