- Paradigm Biopharmaceuticals (PAR) has completed its osteoarthritis treatment for 10 ex-NFL patients under a U.S. Expanded Access Program
- The Expanded Access Program provides a way for doctors and patients to gain access to investigational new drugs to treat patients with conditions for which there are currently no options
- All patients were given Paradigm’s Zilosul knee osteoarthritis treatment product
- Zilosul contains a compound which is used to treat inflammation
- Paradigm expects to receive results from all 10 patients in the third quarter of the 2020 calendar year
- The U.S. Food and Drug Administration (FDA) has also granted Paradigm’s MPS-I treatment Orphan Drug Designation
- This milestone means Paradigm’s drug, which aims to treat pain and inflammation in MPS-sufferers, is eligible for tax credits
- Paradigm is up a slight 3.20 per cent on the market and shares are trading for $1.94 each
Paradigm Biopharmaceuticals (PAR) has completed its osteoarthritis treatment for 10 ex-NFL patients under a U.S. Expanded Access Program.
“Paradigm is excited to have achieved this milestone, especially during the current health conditions created by COVID-19 and would like to thank all those involved in the Expanded Access Program for their continued diligence to the treatment program,” CEO Paul Rennie said.
The Expanded Access Program (EAP) began on February 18 with the treatment focusing on ex-NFL players.
An EAP provides a way for doctors and patients to gain access to IND (investigational new drugs), biologics, and medical devices to diagnose, monitor, and treat patients with serious conditions or diseases for which there are currently no options.
The ex-NFL players were given Paradigm’s Zilosul knee osteoarthritis treatment product.
Under this program, the patients first had their knees scanned and gave a baseline pain score before any treatments began.
The patients were then given an injection of Zilosul, which was followed up by two more injections every six weeks.
Scans and pain scores were then given once the treatment was completed.
Paradigm expects to receive results from all 10 patients in the third quarter of the 2020 calendar year.
Zilosul is known as an injectable pentosan polysulfate sodium, or iPPS, treatment.
Traditionally, PPS’s have been used to treat inflammation but the application to date has been fairly minimal. Before Paradigm started using PPSs, they were primarily used for bladder inflammation and preventing deep vein thrombosis.
FDA Orphan Drug Designation
The FDA (Food and Drug Administration) has also informed Paradigm that its Orphan Drug Designation request for MPS-I has been granted.
The company has now received FDA Orphan Drug Designation for MPS-I and MPS-VI.
This means Paradigm can now receive tax credits for testing and waive New Drug Application and Biological Licensing Application user fees.
Paradigm can also receive eligibility for a seven-year marketing exclusivity.
MPS (mucopolysaccharidoses) are a family of orphan diseases (rare diseases that affect a small amount of the population) which has a rate of infecting 3.5 in every 100,000 live births.
Those with MPS often experience middle ear disease, deafness, upper airway obstruction, learning difficulties, behavioural issues, dementia, and severe bone dysplasia (a genetic disorder that affects bone growth and development).
Some people also experience the enlarging of organs and tissues which causes them to become inflamed and scarred.
Current treatment for those with MPS includes Enzyme Replacement Therapy which aims to reduce non-neurological symptoms and pain.
However, those who have used it claim they still experience ongoing stiffness, pain and inflammation throughout their body.
It is hoped that Paradigm’s iPPS treatment can be used to treat this as well.
Paradigm is up a slight 3.20 per cent on the market and shares are trading for $1.94 each at 11:35 am AEST.