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Paradigm Biopharmaceuticals in halt pending response to Food & Drug Administration update

The halt will remain in place until Monday, April 6, or until an announcement is released to the market.

Paradigm Biopharmaceuticals Ltd - Paradigm Biopharmaceuticals in halt pending response to Food & Drug Administration update
The company’s regulatory consultants are reviewing the FDA update

Paradigm Biopharmaceuticals Ltd (ASX:PAR) (OTCMKTS:PBIGF) is in a trading halt pending an announcement in response to an update from the Food & Drug Administration (FDA).

In its application to the ASX for a trading halt, the company said its regulatory consultants were reviewing the FDA update.

“Accordingly, pursuant to ASX Listing Rule 17.1, the company requests the trading halt in order to finalise its review and update to the market,” PAR stated.

The halt will remain in place until the start of normal ASX trading on Monday, April 6, 2020, or when an announcement is released to the market, whichever occurs first.

Securities in the company, which has a market cap of approximately $334.3 million, last traded at $1.69, up from $1.17 at the close of trade on March 19.

Zilosul® treatment underway

PAR recently started treatment of all 10 patients with its Zilosul® injectable pentosan polysulphate sodium (iPPS) drug in the US under the Federal Drug Administration approved expanded access program (EAP).

Each patient in the program is first screened to measure their baseline pain scores under the WOMAC osteoarthritis index as well as MRI scans to determine the presence of Bone Marrow Edema Lesions (BMEL) within the knee joint.

Follow-up scans and pain measurements will then be recorded at six weeks after completion of treatment.

The 10 patients being treated under the EAP, including former NFL players Thomas Everett and Richard Van Druten, have all failed many of the other current standards of treatments for knee osteoarthritis and thus far have provided positive feedback about the early effects of treatment with Zilosul®.

“Encouraged by feedback”

Paradigm chief executive officer Paul Rennie said: “We continue to be encouraged by the anecdotal feedback from each patient as they progress through the treatment cycle and look forward to presenting the results to the market once available.

“The conclusion of the enrolment and commencement of treatment by all 10 participants is an example of how Paradigm continues to drive its business forward even in the face of the challenges of the COVID-19 pandemic.”

Quick facts: Paradigm Biopharmaceuticals Ltd

Price: 3.15 AUD

Market: ASX
Market Cap: $707.92 m

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