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

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.