Akela Pharma Repeats its Fentanyl TAIFUN® Preclinical Toxicology Studies
News Jul 09, 2008
Akela Pharma Inc. has announced that as previously requested by the FDA, it has started over again the required inhalation toxicology studies. The studies performed at US based CRO are expected to produce results allowing Akela to start the longer term safety arm of the Fentanyl TAIFUN® Phase III clinical trial in patients in the second quarter of 2009.
"We are still on track to deliver the required toxicology studies results in time to allow us to meet our previously disclosed regulatory submission timelines of Q1-2010 for the E.U. and Q3-2010 for the U.S." said Dr. Halvor Jaeger, CEO of Akela Pharma Inc.
In new studies a novel oxygen-delivery therapeutic restored the function of oxygen-starved heart tissue in an animal model of global hypoxia. Unlike its experimental predecessors, the new drug does not appear to cause systemic side effects or overcorrect with excessive blood oxygenation, which can itself be toxic. Instead, the new drug delivers its precious oxygen cargo only to the tissues that need it most.READ MORE
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