AIKO Biotechnology, Inc. files exploratory Investigational New Drug Application for treatment of adverse effects related to prescription pain reliever use

PORTLAND, ME, August 22, 2008. AIKO Biotechnology, Inc. announced that it has filed its first Exploratory Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) today. AIKO's lead compound, AIKO-150, is targeted to the prevention and treatment of adverse effects resulting from the use of prescription pain relievers such as morphine, oxycodone and hydrocodone. These opioid drugs are the most prescribed medications in the US, and are considered the best treatment for acute and chronic pain. However, their use is often compromised by severe side effects such as bowel dysfunction and addiction liability. AIKO Biotechnology is developing a portfolio of compounds that counteract, prevent and treat the adverse effects of opioids, and, unlike other opioid antagonists on the market, AIKO's compounds are expected to be well-tolerated due to their unique pharmacologic properties that form the basis of AIKO's intellectual property.

AIKO President Bill Emhiser confirmed that AIKO's first IND filing represents a major milestone for AIKO Biotechnology, "AIKO-150 is the only compound we know of that has the potential to confer abuse resistance to existing opioid drugs while at the same time preventing the debilitating GI side effects that often accompany the prescribed use of these medications. Everyone agrees that our animal data is interesting, so creating human data is critical for maximizing the value of AIKO's technology. Pursuing a small-scale human trial using the Exploratory IND mechanism is a good, cost-effective means to prove the mechanism of action of our compound in humans at significantly lower expense than a traditional IND. Private investors and Maine Technology Institute Development Awards have provided the support needed to complete our proposed trials."

"This Exploratory IND represents a significant step along the drug development pipeline", explained Dr. Janet Yancey-Wrona, AIKO's Chief Operating Officer. "To complete the IND filing, we took information learned from a meeting with the FDA over a year ago, conducted animal studies to support our planned clinical trial, researched years of literature that document the human exposure to our lead compound as a metabolite of an existing drug and developed a protocol to confirm the mechanism of action in humans of this important drug candidate. Positive results will lead to full-scale development of AIKO-150 for the treatment of opioid-induced bowel dysfunction and other adverse effects of opioid use. We look forward to the comments and direction that will be provided by the FDA as they open our IND."

Dr. Brian Dallaire, AIKO's clinical studies consultant, explained that the "Exploratory IND is a relatively new mechanism that allows a company to investigate the safety and mechanism of a new drug candidate in a limited number of subjects. Since AIKO-150 is known from decades of human exposure to be safe, and animal studies suggest that very low doses are needed to treat the peripheral effects of opioids, we believe AIKO's compound is a good match for the Exploratory IND."

About AIKO
AIKO Biotechnology, Inc. ("AIKO") is a start-up biotechnology company located in Portland, ME focused on the discovery and validation of novel compounds for the treatment of pain and the side effects associated with prescription pain reliever (opioid) use, such as GI dysfunction, addiction and abuse.

Contact
Janet Yancey-Wrona
jyancey@aikobiotech.com
207.317.0960