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Health & Biotech
Paediatric neurological biopharmaceutical company Neurotech (ASX:NTI) has reported further clinical improvement at 20 Weeks for paediatric autism patients treated with its NTI164 drug.
The results showed improvement in the severity of illness, socialisation, adaptive behaviour, communication and reduction in anxiety.
“Based on the significance of the efficacy outcomes shown at 20 weeks, and attractive safety profile of NTI164, we have now filed a clinical trial protocol with the Human Research Ethics Committee (HREC) at Monash to commence a Phase II/III trial of NTI164 in approximately 55 children with ASD,” executive director Dr Thomas Duthy said.
“Subject to the receipt of HREC approval, the company is targeting commencement of patient recruitment in Q4 CY2022.
“We look forward to providing further details on our final trial protocol following HREC approval and including this important longer-term safety and efficacy data reported today into our pre-IND submission for the US Food and Drug Administration.”
AROVELLA THERAPEUTICS (ASX:ALA)
The company says it will close its Perth-based research and development facility to focus its resources on its invariant Natural Killer T (iNKT) cell platform and cease expenditure on the OroMist platform.
The company will focus entirely on the development of its iNKT cell therapy platform, which has potential to generate allogeneic cell therapies that target both blood cancers and solid tumours – also recently announcing it will be collaborating with Imugene (ASX:IMU) to combine its iNKT cell platform and Imugene’s onCARlytics platform.
The closure of the facility in Q1 FY23 will incur one-off restructuring costs not expected to exceed $300k in FY2023 but thereafter is estimated to save $1.5m per annum based on historical costs.
ARGENTICA THERAPEUTICS (ASX:AGN)
The company is developing novel therapeutics to reduce brain tissue death after stroke, and says healthy participants in the first cohort of its Phase 1 clinical trial of ARG-007 have been successfully dosed, indicating good safety and tolerability of the drug.
Follow up data will be presented to the Scientific Review Committee (SRC) in the coming days to seek approval to progress to the second cohort.
And should the SRC approve Argenica to progress to dosing the second cohort, a sentinel dosing will be initiated immediately – that’s when a single volunteer receives the investigational drug at least 24 hours prior to the remaining subjects in the dose cohort with the aim of identifying any unpredicted serious safety issues related to drug dosing in a single subject prior to exposing a larger group of subjects.
RADIOPHARM THERANOSTICS (ASX:RAD)
The company has entered into a clinical supply agreement that will see NorthStar supply Radiopharm with Actinium-225, which is key to the development of several radiopharmaceutical products within the company’s portfolio.
This is the second supply agreement it has secured for Actinium-225, and this supply will be utilised in drug trials involving targeted alpha therapy in multiple disease areas.
The initial order is expected to occur during the first half of 2024, with the agreement for an initial period of 10 years and may be extended unless agreed otherwise by either party.
The Independent Data Monitoring Committee (IDMC) for the company’s randomised, controlled Phase IIb TACTI-003 trial has reviewed initial safety data and recommended continuing the trial with no modifications.
TACTI-003 is evaluating eftilagimod alpha (or efti which is much easier to read and say) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as a first line therapy in approximately 154 patients with head and neck squamous cell carcinoma (HNSCC).
PARADIGM BIOPHARMACEUTICALS (ASX:PAR)
The first UK subject has now been randomised and has commenced dosing in the company’s global PARA_OA_002 phase 3 study for the treatment of pain associated with knee osteoarthritis (OA).
The trial will will evaluate the dose and treatment effect of injectable pentosan polysulfate sodium (iPPS).
The global trial has activated eight sites across Australia, 58 sites in the US, and Paradigm aims to activate a total of seven sites across the UK.
Health & Biotech
Health & Biotech
Health & Biotech
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