• EMV Medical Devices delivered its first portable brain scanner
  • Firebrick Pharma gets patent in Australia
  • Antisense to progress on clinical trial

EMVision delivers first brain scanner

EMVision Medical Devices (ASX:EMV) jumped 7% after announcing the delivery of a fully-commissioned 1st Gen portable brain scanner to the first clinical site, Liverpool Hospital, for a multi-centre trial.

Liverpool Hospital’s biomedical engineering department has now successfully completed essential testing to commence the trial.

EMV says it anticipates receiving an administrative “green light” for activation to commence the first participant scanning this month.

“This is a pivotal moment for our company,” said EMV CEO, Dr Ron Weinberger.

“This multisite trial across pre-validation and subsequent validation phase will provide crucial clinical evidence for the safety and efficacy of our product.”

EMV has developed and is seeking to commercialise a potentially cost effective, portable, medical imaging device using electromagnetic microwave imaging for diagnosis and monitoring of stroke and other medical applications.

The technology is the result of over 10 years of development by researchers at the University of Queensland.

Today’s development marks an important phase in the development and commercialisation of this breakthrough portable brain scanner.

“We look forward to updating in the near future on the advances of our product portfolio and the latest clinical data,” said Dr Weinberger.

Firebrick gets Aussie patent

Firebrick Pharma (ASX:FRE) said a patent covering the unique formulation of Nasodine Nasal Spray has been accepted in Australia.

The patent will expire in June 2041, and will also be filed in the US, Europe and a number of other key markets.

“This is a very important development for Firebrick because it gives us our first composition patent for Nasodine,” said executive chairman, Dr Peter Molloy.

The two pre-existing Nasodine patents, covering intranasal use of povidone-iodine (PVP-I) for the common cold and pandemic viral diseases respectively, are ‘method-of-use’ patents.

The latest patent covers the pharmaceutical composition of the Nasodine formulation, regardless of intended use or site of application.

“If ultimately granted in the US and Europe, this patent significantly extends the patent protection around Nasodine and should make it more valuable for partnering, in my view,” added Dr Molloy.

Island Pharma to go ahead with Phase 2

Island Pharma (ASX:ILA) announced that ISLA-101 capsules for use in the upcoming Phase 2a PEACH clinical trial in dengue fever have completed analytical testing, further demonstrating the viability of the material for use in the trial.

Following investigation of batch capsule samples, it has been confirmed these capsules have excellent content uniformity, which is a measure of the consistency of the level of active ingredient in each of the capsules.

“This is the final step required prior to submission of the ethics application for the study, which is expected to take place imminently,” said Island Pharma CEO, Dr David Foster.

“Having now passed this important checkpoint, we look forward to finalising the stability testing and moving forward with our PEACH study,” Dr Foster added.

The samples will now continue to undergo required stability studies, and the company expects to receive these results in early December.

This will allow Island to file an Investigational New Drug (IND) application submission with the US FDA in December. The PEACH trial is then expected to commence in January 2023.

Antisense advances ATL1102 program in the US

Antisense Therapeutics (ASX:ANP) has initiated the process with Contract Research Organisation (CRO) Pharmaron to conduct a nine-month chronic monkey toxicology study.

The study is intended to support the advancement of ANP’s ATL1102 program in the US for Duchenne muscular dystrophy (DMD) or any other clinical application of ATL1102.

Successful completion of the toxicology study is expected to be the final requisite step for the lifting of the partial clinical hold in the US that presently limits the dosing of ATL1102 to 25mg per week for six months.

This partial lifting will allow ANP to apply for expedited program status with the US FDA including Fast Track or potential Breakthrough Therapy designation.

“The company expects that this investment in the chronic toxicology study should remove a key hurdle to lifting the partial clinical hold and in initiating clinical DMD studies under an IND, and in turn provides more certainty on the path forward in the US,” said chair of Antisense Therapeutics, Dr Charmaine Gittleson.


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