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Health & Biotech
Proteomics International Laboratories (ASX:PIQ) has given up recent gains after announcing a delayed US launch for its predictive test for kidney disease, which was originally planned for Q2 2024.
PIQ says the work required to launch a novel test has multiple components and “the complexities involved in bringing a new test into broad clinical use have meant the process is taking longer than expected”.
The company says it continues to engage with its US licensee Sonic Healthcare USA, a division of Sonic Healthcare (ASX:SHL), and will provide further updates to the market when information becomes available.
“Significantly, our experience with PromarkerD has provided the company with invaluable knowledge and experience to accelerate the commercialisation of other tests in development,” PIQ says in the ASX announcement.
“To this end, the necessary technical work has already commenced to prepare for the commercialisation of PromarkerEndo, the Company’s test for endometriosis, and PromarkerEso, the company’s test for oesophageal cancer.”
“The company remains focussed on executing further licensing and distribution deals in new jurisdictions for its PromarkerD test and is currently in discussions with a number of parties.”
PIQ in February announced its novel PromarkerEndo blood test for endometriosis has been clinically validated in an independent patient group.
RAC has announced the appointment of Brendan Brown as chief financial officer (CFO), effective from April 1, 2024.
The clinical-stage biopharmaceutical company, which is focused on reformulating and bringing to market the anti-cancer drug bisantrene , says Brown is a partner and director of Prime Accounting & Business Advisory Pty Ltd, which is part of Prime Financial Group (ASX:PFG) .
RAC says the chartered accountant and registered tax agent has significant practical experience having worked with numerous life science clients through the past 20 years and succeeds Christina Manfre of PKF Sydney Pty Ltd.
“We thank Christina for her time with Race and welcome Brendan to his new role as Race CFO,” CEO Dr Daniel Tillett says.
“Race has had a productive working relationship with Prime over the last two years being responsible for Race’s successful R&D Tax Incentive claims.
“We are pleased to be expanding our engagement with both Brendan and Prime as we advance our new formulation of bisantrene in the clinic in 2024.”
In what it claims as “Australian first” VIT says its JV Cortexa Pty Ltd has supplied GMP Psilocybin for therapeutic use by a patient outside of a clinical trial, under the authorised prescriber scheme.
Australia is currently the only market in the world to permit GMP Psilocybin for therapeutic use, outside of clinical trials, after the Therapeutic Goods Administration (TGA) approved psychedelic substances used in magic mushrooms and MDMA.
From July 1, 2023, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) could be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.
According to VIT Cortexa is now established as the first Australian company able to immediately manufacture, supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA’s authorised prescriber Scheme.
In May 2023, VIT announced the establishment of 50:50 joint venture Cortexa with Canadian-listed PharmAla Biotech Holdings Inc, a biotechnology company focused on the research, development, and manufacture of MDXX class molecules (including MDMA) to supply both MDMA and Psilocybin that meet an acceptable standard of good manufacturing practice for prescription use in Australia.
VIT says since the rescheduling, Cortexa has been building a national network of relationships with research institutes, key opinion leaders, emerging clinicians, and supported psychiatrists for obtaining their authorised prescriber status.
The company says supply arrangements have been secured for both clinical trials and authorised prescribers’ use for 2024 and beyond.
While Race Oncology is a Stockhead advertisers, they did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
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