Paradigm Biopharmaceuticals Secures Key U.S. Patent

• Patent to use PPS to treat bone marrow edema granted by US patent office

26 August 2015, Melbourne Australia: Paradigm Biopharmaceuticals Limited (ASX:PAR) has been granted a patent by the United States Patent and Trademark Office (USPTO) to use the drug Pentosan Polysulphate Sodium (PPS) for treatment of bone marrow (o)edema.

The granting of this patent in the US adds to Paradigm’s growing intellectual property portfolio. Paradigm’s bone marrow edema (BME) patent is already granted in Australia and New Zealand. In addition Paradigm’s PPS respiratory patent is already granted in Australia, New Zealand and China.

In addition to patents, Paradigm has registered trademarks and a 20 year exclusive supply agreement for the drug PPS from the Germany-based manufacturer bene pharmaChem.

BME lesions are also known as bone bruising and is a painful and debilitating injury with no approved pharmaceutical products to treat the condition. It usually affects sportspeople but also results from other injuries. BME lesions are caused by fluid build-up and micro-fractures inside the bone causing severe pain. Current treatment of BME includes using both steroidal and non-steroidal anti-inflammatory drugs, which can have serious side effects.

Paradigm will launch a Phase 2a clinical study of PPS in trial subjects with BME lesions at sites in Australia from late 2015.

Enquiries:
Paul Rennie
Managing Director and CEO
0437 778 300

Rudi Michelson
Monsoon Communications
03 9620 3333 or 0411 402 737

About Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals (ASX:PAR) is an Australian biopharmaceutical company focused on repurposing historic drug PPS (Pentosan Polysulphate Sodium) as a potential new treatment for Bone Marrow Edema (BME) lesions arising from sporting injuries as well as for respiratory diseases including Allergic Rhinitis (AR), or hay fever.

PPS is a well-established anti-clotting and anti-inflammatory agent that has been used for over 60 years to treat interstitial cystitis and preventing and treating deep vein thrombosis. It has a solid safety and efficacy profile.

BME is also known as bone bruising and is an extremely painful and debilitating injury. It typically affects sportspeople but can also result from a range of injuries including car accidents and falls. BME is caused by fluid build-up and micro-fractures inside the bone, causing severe pain. There is no approved pharmaceutical product to treat this condition. Current treatment of BME includes the use of steroidal and non-steroidal anti-inflammatory drugs, which can have serious side effects. Paradigm will launch a Phase 2a clinical study of PPS in BME trial subjects at sites in Australia from late 2015. Paradigm has also acquired patents over the use of PPS as a new treatment for respiratory diseases including Allergic Rhinitis (AR), Allergic Asthma (AA) and Chronic Obstructive Pulmonary Disease (COPD). Paradigm also acquired pre-clinical data, nasal formulation and other data from the previous developer Glycan BioSciences LLC, allowing Paradigm to fast-track its treatment for AR into clinical trials in early 2016.

Antihistamines and corticosteroid nasal sprays are standard existing treatments for AR. Long-term use of corticosteroids is associated with adverse side effects whereas Paradigm’s AR product is a non-steroidal pharmaceutical.

Repurposing an existing drug diminishes early developmental risks associated with traditional new drug development and usually means shorter development times, lower development costs and less safety risk.

Paradigm has also acquired intellectual property over exosomes; a new technology in stem-cells and regenerative medicine fields. This technology offers the company the potential to participate in the development of new generation regenerative medicine products.

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