The OLE study offers patients an opportunity to receive repeat injections of Ampion after they have completed the pivotal clinical trial.
This OLE study will address the regulatory requirements to allow an expanded commercial label for repeat administration of Ampion.
Ampion is the low molecular weight fraction of pharmaceutical 5% human serum albumin (HSA). HSA is the sole starting material used to manufacture Ampion and has been given to patients for more than 60 years with a demonstrated safety profile.
Ampio leverages the safety profile of HSA to develop a product for patients that has the potential to address the signs and symptoms for the unmet medical need of severe osteoarthritis of the knee.
Ampio is focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options.
The company develops compounds that decrease inflammation by inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and decreasing vascular permeability.
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