• Paradigm Biopharma set to submit application to TGA
  • EMVision uses artificial intelligence simulation


Paradigm to submit TGA application after successful trial

Paradigm Biopharmaceuticals (ASX:PAR) jumped 13% this morning after reporting a successful Day 365 clinical trial outcome in its Phase 2 study of knee osteoarthritis (OA).

Data showed that lead drug PARA_OA_008 (iPPs) demonstrated significant osteoarthritis pain reduction at 12 months. Functional improvements were also observed in patients.

A summary of the results include:

  • Significant pain reduction (p=0.054)
  • Significant functional improvement (p=0.048)
  • Durable improvements in stiffness
  • Significant improvement in overall WOMAC scores (p=0.054).

Paradigm previously reported attaining the primary endpoint at Day 56, significant improvement in pain and function at Day 56, and structural improvements in bone marrow lesions, cartilage, and osteophytes (bone spurs) by MRI at Day 168.

Based on these data, Paradigm now intends to proceed with a Provisional Approval application to the TGA.

The results of this clinical trial are also currently being compiled into a manuscript for peer review and publication.

“The 12-month durability of effect on OA pain and function following one 6-week course of treatment is truly an outstandingly positive trial outcome and separates iPPS from all currently available therapies for knee OA,” said Paradigm CEO, Paul Rennie.

“… it provides clarity for the appropriate dosing regimen for iPPS in treating knee osteoarthritis, and also support for the company’s global partnering prospects moving forward.”


EMVision successfully uses AI simulation

EMvision Medical Devices (ASX:EMV) has announced encouraging interim analysis from Stage 2 of its clinical trial.

A haemorrhagic stroke detection algorithm (‘blood or not’) has been developed based on simulated scan data and augmented real scan data.

A first interim analysis has indicated the accuracy of the haemorrhagic stroke detection algorithm prior to any fine-tuning with real haemorrhagic patient datasets.

These preliminary test dataset included 15 patients (5 haemorrhagic, 2 ischaemic and 8 without stroke) that were external to and not included in prior algorithm training.

The algorithm correctly identified all five haemorrhagic stroke patients and the other patients as being without haemorrhage.

EMV says these results serve as an encouraging indicator of the robustness of the model, and the ability of simulation data to accurately represent real-world clinical scenarios.

Following this interim analysis, complete clinical data from Stage 2 of the clinical trial will be used to train/test the full suite of AI algorithms.

Recruitment into Stage 2 of EMVision’s clinical trial continues to progress well across all three sites (Liverpool Hospital, Royal Melbourne Hospital and Princess Alexandra Hospital).

“Using simulation data is an effective way to accelerate our AI algorithm development alongside the patient data we are capturing from Stage 2 of our clinical trial,” said EMV CEO, Scott Kirkland.

“This will support our algorithm training and testing, dialogue with prospective partners, and our planned engagement with the FDA.”


Paradigm Biopharma and EMVision share prices today: