LAS VEGAS, Nov. 6, 2006 (PRIMEZONE) -- Samaritan Pharmaceuticals Inc. and Samaritan Pharma Ireland, Inc. (AMEX:LIV) developers of innovative drugs, announced today it has submitted an Investigational New Drug (IND) application to evaluate its lead compound Caprospinol (SP-233) as a potentially new and novel pharmaceutical treatment for Alzheimer's disease. This is an important first step, to test Caprospinol's future in humans, as a potential memory-saving Alzheimer's drug.
Unlike drugs currently used to treat Alzheimer's that just alleviate symptoms, Caprospinol might potentially be a viable treatment for the disease itself. Preclinical studies have shown that Caprospinol targets and binds to the beta-amyloid protein, washing out beta-amyloid plaque from the brain. Today, the beta-amyloid protein is what most researchers believe is the cause of Alzheimer's disease.
Scientists at Samaritan Laboratories, Georgetown University, led the preclinical studies for Caprospinol, while Samaritan's Drug Development executives amassed the seven thousand pages of data to formulate the IND submitted to the FDA. PharmaPlaz, Ireland, Samaritan's collaborative manufacturing partner, led the chemistry, manufacturing and controls (CMC) section of the submitted IND.
Dr. Greeson, CEO of Samaritan Pharmaceuticals, stated, "The long race to develop a cure, or even a viable treatment, for Alzheimer's disease is quickly turning into a sprint for Samaritan. We at Samaritan are extremely excited to apply to enter the sprint and will do everything possible to remain in the running to find a cure or viable treatment for this horrible disease."
Investigational New Drug Application (IND)
After preclinical testing to show the biological activity of a compound against a targeted disease is completed, a company then files an IND with the FDA to begin testing of the drug in people. These preclinical tests normally take about 3 1/2 to 4 years to complete. The FDA has 30 days to review and determine if the IND will become effective. The IND will show results of previous experiments, how, where and by whom the new studies will be conducted. The IND also looks at the chemical structure of the compound, how it works in the body, and any toxic effects found in the animal studies. The IND will also look at how the compound is manufactured.
Alzheimer's Disease
Alzheimer's is a degenerative brain disease that usually begins gradually, causing a person to forget recent events or familiar tasks. Communication becomes more difficult as the disease progresses, leaving those affected struggling to find words, finish thoughts or follow directions. Eventually, most people with Alzheimer's disease become unable to care for themselves. Analysts predict the Alzheimer's market could reach $4B annually by 2013.
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Disclaimer
The company disclaims any information that is created by an outside party and endorses only information that is communicated by its press releases, filings and Website. This news release contains forward-looking statements that reflect management's current beliefs about the potential for its drug candidates, science and technology. However, as with any biopharmaceutical under development, there are significant risks and uncertainties in the process of development and regulatory review. There are no guarantees that products will prove to be commercially successful. For additional information about the factors that affect the company's business, please read the company's latest Form 10-K/A filed November 2, 2006. The company undertakes no duty to update forward-looking statements.