Auritec Pharmaceuticals Announces Opening of Clinical Trial in Arthritis

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Auritec Pharmaceuticals, Inc., an emerging drug delivery biotech, is proud to confirm that EP-104IAR, a sustained release injectable formulation for treatment of pain associated with osteoarthritis (OA), has entered a registered Phase I clinical trial. The clinical trial, which has Health Canada CTA approval, will be conducted across two sites in London, Ontario, Canada.

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“We are very happy,” said Dr. Smith, “that Auritec's technology has been able to lead to the development of a product that can revolutionize the treatment of osteoarthritis

EP-104IAR is a sustained release formulation using Plexis™, a proprietary Auritec technology platform, to deliver the steroid fluticasone. “We are very excited to enter our first in-human trial using the Plexis™ platform,” said Auritec’s CEO Dr. Thomas Smith. “EP-104IAR represents a clinical proof-of-concept that will help our other pre-clinical programs currently in development."

Osteoarthritis is the most common chronic condition of the joints. It occurs when the cartilage or cushion between joints breaks down leading to pain, stiffness and swelling. Symptomatic knee OA occurs in 10% of men and 13% of women aged 60 years or older. Estimated costs due to hospital expenditures of total knee and hip joint replacements is over $40 billion annually.

Auritec Pharmaceuticals, Inc. is a privately held R&D company specializing in innovative, extended release drug delivery systems. Its technologies include sustained release implants and injectables as well as new APIs. The technology platform that forms the basis for EP-104IAR was invented and further developed by Dr. Smith, who founded Auritec in 2002. Plexis™ forms the basis for the depot delivery of a broad range of drugs, including tacrolimus for the prevention of transplant rejection, and these other programs may be advanced by the EP-104IAR clinical trial.

In 2012, Eupraxia Holdings, Inc., a newly formed Delaware corporation, and Auritec entered into an agreement creating Eupraxia Pharmaceuticals USA, LLC (Eupraxia USA LLC). Following its formation, Eupraxia USA LLC entered into a license agreement with Auritec under which Eupraxia USA LLC licensed the Plexis™ platform technology and certain related intellectual property rights from Auritec for the sustained delivery of corticosteroids. The rights to utilize Plexis™ with fluticasone and to commercialize EP104IAR reside in Eupraxia USA LLC, a Delaware limited liability company.
Auritec owns 35% of Eupraxia USA LLC, and the remaining 65% is owned by Eupraxia Holdings and affiliated persons. Auritec's stake in Eupraxia USA LLC is especially valuable because it is "non-dilutive." Eupraxia Holdings, Inc. agreed to loan Auritec the money necessary to preserve Auritec’s interest in Eupraxia USA LLC and prevent dilution. In other words, no matter how many rounds of financing that it takes to monetize our technology, we can maintain our 35% equity interest after repaying the loans to Eupraxia.

“We are very happy,” said Dr. Smith, “that Auritec's technology has been able to lead to the development of a product that can revolutionize the treatment of osteoarthritis."

For more information visit Auritec Pharmaceuticals, Plexis™, and Auritec's Offer

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Alessandro Varotto
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