- Paradigm Biopharma submits response to the FDA
- INOVIQ says its blood test on cancer is highly accurate
Paradigm sends response to the US FDA
Paradigm Biopharmaceuticals (ASX:PAR) announced that it has submitted important documents to the US FDA for reviewing and agreeing upon the next steps for its Phase 3 clinical program targeting osteoarthritis treatment.
The submission includes responses to discussions from a Type D meeting held on January 1, presenting findings from five nonclinical studies, as well as data from a successful Phase 2 clinical trial, as well as clinical data from 600 participants.
These additional data have not previously been reviewed by the FDA.
Paradigm also submitted a draft of the Phase 3 clinical trial protocol for FDA review and comment.
Along with justifications on the minimal effective dose, the draft also presented the clinical trial protocol for Phase 3, updating the trial’s safety monitoring plans.
The FDA’s feedback is expected within three months.
Pending that clearance, Paradigm aims to start enrolling subjects for the Phase 3 trial (PARA_OA_012) in the second half of 2024. Preparation for clinical trial sites in Australia and the US are scheduled to begin in this quarter.
TGA marketing approval
Concurrently, Paradigm is also working on finalising its application for provisional approval from the Therapeutic Goods Administration (TGA) in Australia.
This application will include data from a manuscript detailing the results of the PARA_OA_008 Phase 2 clinical trial on its lead drug iPPS, and another manuscript comparing clinical data with other treatments for osteoarthritis.
If the TGA approves the application, Paradigm will then submit a full dossier for provisional approval marketing authorisation.
A provisional marketing approval from the TGA benefits both patients and manufacturers. Patients can access potentially life-saving treatments sooner, while manufacturers can bring innovative therapies to market faster and gather more data for full approval.
Getting provisional marketing approval from the TGA for iPPS in Australia would also speed up the process to generate revenues for Paradigm.
The manuscripts are currently being prepared and will be submitted to different journals for peer review and publication.
INOVIQ says its ovarian cancer blood test is highly accurate
Meanwhile, INOVIQ (ASX:IIQ) has announced the successful completion of a study validating its blood test for ovarian cancer.
The results showed that the test accurately identified 85% of all samples tested, including 76% of cancer samples and 94% of cancer-free samples.
This blood test combines a CA125 monoclonal antibody with INOVIQ’s SubB2M detection reagent.
A CA125 test measures the amount of the protein CA 125 (cancer antigen 125) in the blood.
INOVIQ says the study results have excellent reproducibility, a low limit of quantitation, and high overall accuracy, matching a leading CA125 test for ovarian cancer detection.
INOVIQ is essentially seeking to demonstrate if its SubB2M technology can be a superior detection reagent to improve the performance of multiple cancer biomarker tests.
The study aims to showcase the commercial potential of SubB2M for multiple cancers.
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