Paradigm Reports Significant Reductions In BML In Various Body Sites

  • May 08, 2019 AEST
  • Team Kalkine
Paradigm Reports Significant Reductions In BML In Various Body Sites

Paradigm Biopharmaceuticals Ltd (ASX: PAR) is an ASX listed healthcare company, focusing on repurposing pentosan polysulphate sodium (PPS) for the treatment of medical conditions that have an active role in inflammation. The important properties of the activity of PPS are its tissue regenerative and anti-inflammatory properties.

On 8th May 2019, the company released an update regarding clinical programs and commercial progress.

Material reductions in bone marrow lesions

Bone marrow lesions (BML) are identified through excessive water signals in the marrow space. They are a significant source of pain and linked to increased disease activity in many musculoskeletal conditions.

Bone marrow lesions in subchondral bone of people with knee osteoarthritis are linked to pain and progression of cartilage loss over time. Previous results of Paradigm’s phase 2b clinical trial demonstrated a clinically meaningful reduction in BML Grade among the group of patients who received injectable Pentosan Polysulfate (iPPS).

The company has now reported significant reductions in BML in sites of the body other than the knee using iPPS under the TGA special access scheme. The other sites included hip, knee cap and ankle. Further, the company is observing the whole-body effect of iPPS. The company is focused on the treatment of OA of the knee for its upcoming phase 3 trial, which also demonstrates the potential of iPPS for treatment on all sites affected by bone marrow lesions.

The manufacturing phase of iPPS has been completed, which will support the upcoming requirements under its phase 3 OA and MPS trials and its requirements under TGA special access and FDA compassionate use.

Paradigm’s upcoming IND filings with the FDA would require the batch records of manufacturing completion and ownership.

The application for compassionate use of iPPS to the FDA is expected to be submitted in the coming weeks. Upon its successful approval, the company will be able to the treat up to 50 past NFL football players in the US. The first 10 NFL players have agreed for receiving the treatment and sites have been identified as well. The result for the treatment is expected to be visible in late 3Q19 period.

Paradigm’s main OA competitor

One of the main competitors of the company for the treatment of Osteoarthritis (OA) was Tanezumab, nerve growth factor antibody. Recently, it had conducted phase 3 trial results which showed neither of the two dosage levels met all co-primary efficacy goals and both doses fared worse than placebo on safety.

Conclusion of $77.9 million capital raising and further catalysts

PAR has successfully completed the capital raising of $77.9 million via placement and institutional entitlement offer. It is now focusing on delivering on its pipeline of catalysts for 2019, some of which are as follows:

  • Appointment of highly regarded US-based CMO – in Q2 CY2019.
  • Ross River Phase 2a (safety study) trial results release – during Q2/Q3 CY2019.
  • Possibility of being acknowledged with “fast track status” for phase 3 OA trial.
  • File IND and meet with FDA re phase 3 trial in OA - Q3 CY2019.
  • File IND for pivotal Phase 2/3 for Mucopolysaccharidosis (MPS) – in Q2 CY2019.

On 13th March 2019, the company published its investor presentation stating all the operational updates and future catalysts for 2019.

Technical Outlook

The stock of the company last traded at A$1.510, down by 1.307% (as on 8 May 2019) from its previous close. The market capitalisation of the company is A$277.24 million. The 52-week high and low of the stock is A$2.149 and A$0.381 respectively. In the last one year, the stock has delivered a good return of 291.6%, and the YTD return stands at 54.35%.


This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. Kalkine Media does not in any way endorse or recommend individuals, products or services that may be discussed on this site. Our publications are NOT a solicitation or recommendation to buy, sell or hold. We are neither licensed nor qualified to provide investment advice.


All pictures are copyright to their respective owner(s) does not claim ownership of any of the pictures displayed on this website unless stated otherwise. Some of the images used on this website are taken from the web and are believed to be in public domain. We have used reasonable efforts to accredit the source (public domain/CC0 status) to where it was found and indicated it below the image.


There is no investor left unperturbed with the ongoing trade conflicts between US-China and the devastating bushfire in Australia.

Are you wondering if the year 2020 might not have taken the right start? Dividend stocks could be the answer to that question.

As interest rates in Australia are already at record low levels, find out which dividend stocks are viewed as the most attractive investment opportunity in the current scenario in our report.

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK