• Recce Pharma surged after positive Phase I study
  • Impedimed shares jumped as Cigna Healthcare included its product in the payor system
  • Imugene receives clearance from the US Patent Office


Recce Pharma announces positive results from Phase 1

Anti-infection biotech Recce Pharmaceuticals (ASX:RCE) surged 14pc this morning after announcing positive results from its Phase I study of lead drug RECCE 327 (R327).

Independent examiners have confirmed that the study in 80 human subjects (eight cohorts) achieved all primary study end-points and showed R327 to be safe and well tolerated.

R327 is an intravenous and topical therapy being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria.

Results of the trial showed that R327 was well tolerated with a good safety profile across all dose groups from 50mg to 6,000mg when administrated intravenously over one hour infusion.

All treatment emergent adverse events (TEAEs) across the cohorts were classified as mild or moderate.

The results also showed a significant dose-dependent concentration of R327 in both the urine and the plasma, highlighting the potential of R327 as a potential treatment of sepsis and UTI (urinary tract infections).

These studies indicated that R327 could potentially replace the use of antibiotics. In hospital wards, antibiotics account for approximately 10% of episodes of acute renal failure and 60% of drug-related kidney damage.

These results have now paved the way for the next stage of R327’s clinical development in sepsis and UTI.

“We look forward to building off these results by initiating a Phase II study in patients with early-stage sepsis,” said Recce executive chairman Dr John Prendergast.



Impedimed’s BIS included by US top 5 insurer

Impedimed (ASX:IPD) jumped 16% after announcing the first medical policy from a top five national payor covering its bioimpedance spectroscopy (BIS) testing in the US.

The omnibus policy, published by Cigna Healthcare, covers testing using ImpediMed’s SOZO Digital Health Platform for individuals at risk for limb lymphoedema.

Cigna provides coverage for over 16 million members,health insurance coverage in all 50 states, and is top 5 payor in 38 states.

“Cigna’s policy provides access to coverage for all individuals at risk of developing limb lymphoedema without prior authorisation and impacts all 50 states,” said Impedimed CEO, Richard Valencia.

“Each new policy adds to the already growing momentum of our expanding commercial effort.”


Imugene gets US patent green light

Imugene (ASX:IMU) rose 7% after receiving clearance from the US Patent and Trademark Office for a patent that protects its oncolytic virotherapy CF33, including VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1).

The patent protects the method of composition and method of use of Imugene’s licensed oncolytic virotherapy to the year 2037.

Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.

“Imugene receiving this patent allowance for the CF33 family of oncolytic viruses from the US patent office is a crucial step forward,” said Imugene CEO, Leslie Chong.

“And with the US being the largest healthcare market in the world, this is a particularly important patent milestone.”


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