ASX Health Stocks: Pharmaxis jumps 9pc on FDA approval
Health & Biotech
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The ASX 200 Health Index (XHJ) is up by 0.57% at the time of writing, compared to the broader index which is up by 0.03%.
The US FDA has cleared Pharmaxis (ASX:PXS)’s Investigational New Drug application (IND) for a trial of its lead drug, PXS‐5505.
PXS‐5505 is an oral drug that has shown significant reductions in fibrosis in in-vivo models.
The trial design approved by the FDA calls for PXS‐5505 to be added to current chemotherapy standard of care in newly diagnosed HCC (hepatocellular carcinoma) patients.
HCC is the most common type of primary liver cancer, and occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection.
These malignancies are now the fourth leading cause of cancer‐related mortality worldwide, with a 19.6% 5‐year relative survival rates.
The IND approved today was submitted by the University of Rochester Medical Centre in New York, following positive pre‐clinical results.
“PXS‐5505 has recently progressed to a phase 2 clinical trial looking for evidence of disease modifying effects in the bone cancer myelofibrosis as a monotherapy,” commented Pharmaxis CEO, Gary Phillips.
“So exploring its additional potential to address cancers where fibrosis is limiting the clinical benefit of current chemotherapy‐ such as liver and pancreatic cancer‐ would be significantly value adding,” he added.
The Pharmaxis share price is up 9% at the time of writing.
The company has given an update on its ISLA-101 Phase 2a dengue fever clinical trial, saying that it has executed a contract with the clinical trial site and appointed the lead investigator.
First patient screening is anticipated to commence in early H2 FY22.
ISLA-101 is Island’s lead asset, which is being repurposed for the treatment of dengue fever and other mosquito borne diseases.
In its former life, ISLA-101 was the subject of 48 Phase I and II human clinical trials – work which saw it verified as safe in humans by multiple regulators.
Race has initiated a collaboration with the University of Wollongong that aims to advance development of an oral formulation of Zantrene.
This collaboration is expected to provide significant value to Race by expanding the market potential of Zantrene for new and existing cancer indications. All IP generated will be owned by Race royalty free.
Zantrene is a small molecule inhibitor of the Fatso/Fat mass and obesity associated (FTO) protein. FTO excess has been shown to be an important factor in the progression of a wide range of cancers.
The regenerative medicine company reported a 39% increase in first quarter FY22 revenue to $7m. The company was also able to improve its gross margin, rising it by 3% to 85% during the quarter.
Avita’s main product is its RECELL System, which was approved by the FDA in 2018.
The RECELL is used to treat acute partial-thickness thermal burn wounds, or in combination with meshed autografting in pediatric and adult patients.