ASX Health Stocks: Paradigm rockets 21pc after getting FDA nod, Memphasys up 31pc on imminent launch
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is up by 1.27% at the time of writing, compared to the broader index which is higher by 1.15%.
Paradigm Biopharmaceuticals (ASX:PAR) rocketed by 21% this morning, following the US FDA clearance of its IND (investigational new drug) application.
The clearance has now allowed PAR to proceed with a Phase 3 trial for PPS/Zilosu.
The PPS/Zilosu (pentosan polysulfate sodium) is an injectable drug that treats pain associated with knee osteoarthritis.
The FDA initially had one outstanding question regarding the original submission, but has advised that the company’s responses have sufficiently addressed the question.
The trial will measure the change in pain and function after injections of PPS, compared with injections of placebo in participants with knee osteoarthritis pain.
Recruitment of patients is expected to begin in both the US and Australia during Q4 2021, with ethics approval already obtained in Australia.
In addition to commencing in the US and Australia, Paradigm is also entitled to start clinical trials in EU member countries with 10 sites already indentified.
“As the company progresses with the trial, we expect there will be increasing interest from the pharmaceutical industry in the commercial value of this potential blockbuster therapeutic,” commented Paul Rennie, Paradigm CEO and interim chair.
The reproductive biotech company announced the verification and validation assessments for its Felix device are now complete for early-access markets with low regulatory requirements.
It can extract viable sperm from poor-quality samples, giving couples who might not be able to otherwise conceive because of male infertility a chance at reproduction.
“We continue to believe that a maiden commercial sale can be made prior to the end of the calendar year,” says Memphasys executive chairman, Alison Coutts.
The brain tissue focused company has demonstrated positive efficacy results from a preclinical study of lead drug, ARG-007.
In an animal study, the results showed that ARG-007 very significantly reduced the volume of brain tissue death for HIE (hypoxic-ischaemic encephalopathy) compared to the control group which received a saline injection instead of ARG-007.
The medicinal cannabis company has signed a licensing deal worth an upfront US$1m for its distillate capture and dissolution matrix (EDCDM) technology.
The EDCDM technology enables the formulation and development of free flow solid oral dosage forms based on cannabinoid distillate, a result that until now had proven difficult to achieve.
The company has been awarded a $100k voucher to support the manufacture of clinical diagnostic tests in WA.
The funding targets future local production of Proteomics International’s PromarkerD blood test, the world’s first predictive diagnostic test for diabetic kidney disease.
The Europe-based biotech is set to ramp up its manufacturing and global distribution of liquid dose medicine, after completing the new production facility in Malta.
The opening of the new facility will create a European manufacturing hub for MXC’s lead drug CimetrA, as well as for other liquid form dose medicines.
The breast cancer screening company said it has completed the processing of 301 samples as part of its Cohort 4 testing that demonstrates the value of the BCAL test.
The BCAL test is the company’s proprietary non-invasive blood test for the detection of breast cancer, with results to date demonstrating 91% specificity and 87% accuracy.
This result signals achievement of the first milestone set out by the company at its IPO, and paves the way for progressing work on Cohort 5, the next stage in clinical validation of the BCAL test.
The company was awarded an “Advanced and Overseas Finding” R&D status for its NanaBis development by AusIndustry, a division of the Australian Government’s Department of Industry, Science, Energy and Resources.
NanaBis is a drug that was developed for cancer bone pain as a viable alternative to opioid use.
Expenses for developing NanaBis totalled around $27m, with this amount expected to be given a significant tax rebate by the R&D program.
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