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.