• Paradigm successfully meets primary endpoint of Phase 2 trial
  • Immutep granted Fast Track designation by the FDA
  • ImpediMed signs strategic partnership with GenesisCare

Paradigm Biopharma (ASX:PAR) surged 19% this morning after announcing that the primary endpoint of its Phase 2 Clinical Trial has been met.

The PARA_OA_008 Synovial Fluid Biomarker Phase 2 Trial evaluated the treatment effects of iPPS on synovial fluid biomarkers associated with OA (osteoarthritis)-related pain, inflammation, and disease progression in humans.

Paradigm said it achieved positive top-line results in the trial, with patients demonstrating statistically significant improvement in WOMAC pain, function, and stiffness scores at day 56 for the twice-weekly group compared to placebo.

Of the 61 patients, 48 (78%) had KL grades 3-4, indicating moderate to severe OA.

In a separate canine study, positive interim observations on the effects of iPPS treatment on dogs with naturally occurring OA are also reported.

Seven of nine dogs treated with iPPS had a clinically meaningful functional improvement in the affected limb as measured by the total pressure index percentage (TPI%) at week 8 compared to baseline.

Osteoarthritis is the most prevalent form of arthritis and the risk of developing degenerate OA rises with increasing age.

This debilitating disorder severely impacts upon quality of life due to primarily affecting the hands, lower back, neck, and weight-bearing joints such as knees, hips, and feet

“These are meaningful signals that we will evaluate together with clinical and imaging outcomes in order to demonstrate disease modifying effects and to pursue regulatory authority guidance on a disease modifying pathway,” said Paradigm Chief Medical Officer, Dr Donna Skerrett.

Only last week PAR jumped some 27% off the back of positive FDA feedback on its Investigation New Drug (IND) submission.



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Immutep granted Fast Track by FDA

Immutep (ASX:IMM) has been granted Fast Track designation by the US FDA for efti in combination with pembrolizumab in 1st line non-small cell lung cancer.

Efti is the company’s first-in-class soluble LAG-3 clinical stage candidate which activates antigen presenting cells (APC) to engage both the innate and adaptive soluble LAG-3.

The latest approval marks the second Fast Track designation issued by the FDA for eftilagimod alpha, offering the potential for expedited development and review.

The FDA’s Fast Track designation process is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.

“This important designation that efti has now received across two indications, 1st line NSCLC and 1st line HNSCC, enables us to work more closely with the FDA to bring this novel treatment option to cancer patients in the most timely and efficient manner possible,” said Marc Voigt, CEO of Immutep.


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ImpediMed signs strategic partnership

ImpediMed (ASX:IPD) announced the signing of a Global Strategic Commercial Partnership and pilot program with GenesisCare.

The pilot program will consist of an initial roll out of 5 SOZO units to establish lymphoedema screening services for breast cancer patients in centres across the United States

Upon successful completion of the pilot program, GenesisCare will evaluate a staged expansion to additional sites in the US and globally.

GenesisCare is a global care leader with more than 6,000 highly trained healthcare professionals employed at more than 300 locations across four countries.

They are the one of largest providers of cancer care in US, Australia, Spain, and the UK.

“Our team will work closely with the five pilot sites to ensure successful implementation of SOZO within their existing workflows,” said David Anderson, Interim CEO of ImpediMed.

“These initial programs will create the template to bring lymphoedema prevention services to more cancer patients across the globe.”



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