Charleston Laboratories, Inc. Phase I Clinical Trial

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Mon Jan 12, 2009 8:30am EST

Charleston begins Bioequivalence Study to Evaluate the Safety, Tolerability,
and Pharmacokinetics of CL-108

CHARLESTON, S.C., Jan. 12 /PRNewswire/ -- Charleston Laboratories, Inc, an
emerging specialty pharmaceutical company dedicated to reducing opioid induced
nausea and vomiting (OINV) in opioid pharmaceuticals, announced today the
initiation of a pharmacokinetic study on its first drug candidate, CL-108. 
"After many months' development in the lab, resulting in the optimal
formulation of this drug, it is ready for testing in man," said Dr. Bernard
Schachtel, Chief Medical Officer at Charleston Laboratories.  "This Phase I
study is being conducted to identify and characterize the release
characteristics of CL-108, showing its differences (and similarities) to
comparator drugs.  We expect that the in-vivo results from this study will
confirm the in-vitro results on CL-108, which can be advanced to the Phase III
efficacy and safety trial we discussed with the FDA at our Pre-IND Meeting."

In fact, Dr. Schachtel added, "When the results of the Phase I study are
available (in early 2009), Charleston Labs will be ready to test the efficacy
and safety of CL-108 in patients with acute pain.  Charleston Labs' Phase III
study on CL-108 is already in the planning stages," he said.  "Clinical
investigators have been selected at major U.S. universities to conduct this
large study beginning in 2009."  

"We are looking forward to achieving the expected results of our fast
dissolving low dose anti-emetic," said Paul Bosse, Chief Executive Officer at
Charleston Laboratories.  "CL-108 is the first of many planned therapeutic
products Charleston is advancing into clinical studies."  Reaching this
exciting milestone is a testament of perseverance and dedication by the entire
Charleston team."

All clinical studies for Charleston Laboratories are being overseen by SRC,
Inc., a contract research organization based in Jupiter, Florida that is
renowned for its clinical trials on patients' symptoms (such as nausea and
vomiting) and its record of drug approvals by regulatory authorities in the
U.S. and worldwide. 

About Charleston Laboratories, Inc.
Charleston Laboratories Inc, headquartered in Charleston, SC, is a privately
funded specialty pharmaceutical company developing and commercializing opioid
drugs with minimal or no opioid-induced nausea and vomiting (OINV).  
Charleston Laboratories intends to enter into discovery and commercialization
alliances with partners motivated to introduce novel pain therapies that
eliminate or significantly reduce nausea and vomiting. 

SOURCE  Charleston Laboratories, Inc.

Paul Bosse, CEO of Charleston Laboratories, Inc., +1-843-577-2626,
pbosse@charlestonlabs.com
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