New FDA Rules Expected to Expedite Testing of Samaritan's Drugs
13 Janeiro 2006 - 11:00AM
Business Wire
Samaritan Pharmaceuticals Inc. (AMEX:LIV), a developer of
innovative drugs, announced today, the new FDA guidelines for early
phases of drug development are expected to make it easier for
Samaritan to manufacture small quantities of compounds for Phase I
trials. The FDA's new guidance is intended to streamline drug
development by facilitating short-term human studies, using
sub-therapeutic doses to reveal mechanisms of action,
pharmacokinetic, and the pharmacodynamic properties of a drug that
will help Samaritan to select the most promising drugs to develop
out of a family of drugs. Dr. Greeson, CEO of Samaritan
Pharmaceuticals, stated, "We see these new less restrictive
guidelines as most beneficial to small baby Biotechs with limited
resources so we welcome these guidelines. The FDA estimates that
work done to prepare a request to allow human testing of an
experimental drug, currently costs $500,000 to $1 million, and
Biotechs can test thousands of drugs only to bring a few to human
trials." Dr. Greeson went on to say, "We believe Samaritan has an
incredibly hot pipeline, and although early stage, we have found
each of our indications has at least one promising drug that could
bring incredible rewards to our shareholders." Samaritan
Pharmaceuticals: "We LIV....to Save Lives." Samaritan
Pharmaceuticals is a drug development company driven to discover,
develop, and commercialize, innovative therapeutics' for AIDS,
Alzheimer's, Cancer and Heart disease. Samaritan, in collaboration
with Georgetown University, is advancing eight promising compounds,
out of its rich pipeline of 250 possible drug candidates, all of
which have the potential to create revenue-generating
opportunities. Additional information is at
www.samaritanpharma.com. 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
Web site. 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 15, 2005. The company
undertakes no duty to update forward-looking statements.
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