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AIKO Biotechnology, Inc. completes
first-in-man study of lead compound.
PORTLAND, ME, OCTOBER 19, 2009. AIKO Biotechnology, Inc. completed the first
Phase I human clinical trial of AIKO-150, the lead compound in its portfolio.
According to AIKO President, Bill Emhiser, “Using the FDA’s Exploratory IND
mechanism, AIKO was able to conduct this Phase I trial to confirm the prediction
that AIKO-150 will reverse opioid-induced constipation at dosages that do not
precipitate withdrawal in a highly sensitive population. This is in stark
contrast to conventional opioid antagonists such as naloxone that trigger
withdrawal at extremely low doses in opioid-dependent subjects. We believe this
trial validates the superiority of AIKO’s patented neutral antagonists to treat
a broad array of opioid-induced side effects. More specifically, this trial
substantiated high potential for co-formulation of AIKO-150 with an opioid to
create an abuse-resistant pain reliever without the GI side effects associated
with opioid use.”
This trial demonstrated the mechanism of action of AIKO-150, showing for the
first time in humans that neutral antagonists do not precipitate severe
withdrawal reactions in opioid-dependent subjects at dosage levels that relieve
the gastro-intestinal slowing associated with opioid use.
AIKO’s Exploratory Phase I trial was designed to demonstrate that AIKO-150 acts
as a neutral antagonist in humans, exhibiting high potency for relief of opioid-induced
gastro-intestinal slowing while being less potent for precipitating opioid
withdrawal. Four increasing doses of AIKO-150 were administered to
methadone-dependent subjects. Results showed:
• Extremely high potency for decreasing GI transit time.
• Significant abdominal distress at high doses, without significant scores for
objective or subjective withdrawal measures.
• Dose-proportional pharmacokinetics, similar to those expected from published
studies of AIKO-150 as a human metabolite of naltrexone.
“The results of this trial are very encouraging and we hope to complete a second
Exploratory Phase 1 trial in the near future,” according to Wolfgang Sadee,
Chief Scientific Officer.
AIKO-150 is AIKO’s lead compound in its portfolio of naltrexone/naloxone analogs,
such as naltrexol, naltrexamine, naloxol and their derivatives, shown to be
neutral at the mu opioid receptor (patent 6713488).
Support for this trial was provided, in part, by a Development Award from the
Maine Technology Institute.
About AIKO Biotechnology, Inc.: Contact - Janet Yancey-Wrona,
jyancey@aikobiotech.com ,
207.317.0960
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.
AIKO Biotechnology, Inc.
2 Union Street
Suite 501
Portland, ME 04101
Victor Otley, Chairman
votley@aikobiotech.com
Cell: 207-329-6093
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