Paradigm Biopharmaceuticals Ltd (ASX:PAR) has commenced treatment of all 10 patients with its Zilosul® injectable pentosan polysulphate sodium (iPPS) drug in the US under the Federal Drug Administration (FDA) approved expanded access program (EAP).
Paradigm chief executive officer Paul Rennie said: “Paradigm is pleased that the treatment of the ten patients has been unaffected by the current COVID-19 pandemic and we thank all participants in the EAP for their commitment to the treatment regime.
“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.”
The first patient dosed is due to complete full treatment course as of Monday 23rd March.
Extended Access Program on track
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 6 weeks after completion of treatment.
The ten 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®.
Rennie said: “I would like to thank all the medical staff involved in the treatment of the 10 participants and of course thank the participants and Paradigm staff who have worked hard to achieve this milestone.
“I look forward to our ongoing dialogue with the NFL and the NFL Past Players Association.”
Paradigm expects to report the results of this data in quarter three 2020.
The company is observing all recommendations issued by the Australian Federal Government, States and Territories and has implemented strict protocols across its team both in Australia and the US to keep staff safe, productive and to minimize any interruptions to the business and FDA submission timelines in wake of COVID-19.
All Paradigm staff are working from home and have been for the past 3 weeks, so no shutdowns are expected to adversely affect the business.
Paradigm will continue to monitor and adhere to government notices but does not believe the impact from COVID-19 is material to the overall business operations at this time due to the fact no clinical trials are being undertaken and the majority of Paradigms staff already work remotely.
The company continues to work on the data and submissions to the FDA and regulators post the recent meetings and will use the opportunity to focus on these submissions in the months ahead.
Paradigm has a strong balance sheet with more than A$70 million cash and, while the COVID-19 pandemic is likely to cause some minor delays, the company is well-positioned and believes overall it is unlikely to have a material long term impact on the business.
Rennie will be presenting more information about the company's plans for 2020 at the NWR Small Cap Virtual Conference on Thursday 26 and Friday 27 March at 11:30am AEDT.