Samaritan Announces Positive Data in Nonclinical (IND) In-VitroStudies for Promising Alzheimer's DrugSamaritan Announces Positive Data in Nonclinical (IND) In- Vitro Studies for Promising Alzheimer's Drug
LAS VEGAS, May 3, 2007 (PRIME NEWSWIRE) -- Samaritan Pharmaceuticals Inc. (AMEX:LIV), a developer of innovative drugs, is pleased to announce positive results were attained with its late-stage preclinical/nonclinical testing of Caprospinol (SP-233), with well recognized in-vitro models.
Although nonclinical research results are imperfect predictors of clinical responses, laboratory animals remain the best experimental models for identifying and measuring a compound's biological activity and for predicting a drug's clinical effects. Because animal studies are performed before and during clinical studies, the term "nonclinical" is generally preferred to preclinical when discussing the full spectrum of in-vitro and non-human in-vivo tests associated with drug development. By studying a drug's dose-response characteristics, adverse and residual effects, Samaritan and the FDA gain valuable insights, as to a drug's probable action, and effect in humans.
Samaritan completed a series of in-vitro studies to determine SP-233's metabolic stability in liver microsomes. SP-233's results were positive since it was reported to be stable in all four species tested: human, dog, rat and mouse species. The metabolic stability of a drug candidate, e.g., drug substance in liver microsomes of different species, is determined in order to assess the potential of SP-233 to form undesired potentially toxicity or pharmacologically inactive metabolites.
In addition, positive results were reported where SP-233 was shown to have no CYP inhibition potential for CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 suggesting that SP-233, is unlikely to cause, or alter the metabolism of co-administered drugs, and thus cause, a drug-drug interaction, which could give rise to severe side effects.
Dr. Janet Greeson, CEO of Samaritan Pharmaceuticals stated, "We are extremely excited about the potential of SP-233 to not only restore memory impaired by beta-amyloid toxicity but also prevent future beta-amyloid memory impairment. We anticipate these results will strengthen SP-233's investigational new drug application (IND) filed with the FDA."
"Transforming Today's Science Into Tomorrow's Cures..."
Samaritan Pharmaceuticals, Inc. is an entrepreneurial biopharmaceutical company, focused on commercializing innovative therapeutic products to relieve the suffering of patients with Alzheimer's disease, Cancer, Cardiovascular disease, HIV, and Hepatitis-C. Samaritan, in collaboration with Pharmaplaz, Ireland, is advancing SP-01A, an "oral" HIV viral-entry inhibitor, to Phase III since it has completed Phase IIb clinical studies with positive results. Samaritan has three drug candidates in nonclinical studies to develop IND applications, it's building upon the IND application for Caprospinol, SP-233, to treat Alzheimer's disease patients; evaluating the use of SP-1000 for acute coronary disease patients; and the use of SP-10T1 as an "oral treatment" for Hepatitis-C patients. In addition, Samaritan has acquired the marketing and sales rights to sell nine revenue-generating products in Greece and/or various Eastern European countries.
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 filed April 13, 2007. The company undertakes no duty to update forward-looking statements.
Posted: May 2007