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The site will be located at Sportsmed Biologic in Melbourne, and directed by specialist sports physician Dr Phillip Bloom, who has more than two decades of clinical experience in osteoarthritis management.

This will be the first of 11 Australian sites earmarked for participation in the PARA_OA_012 study. Paradigm has also received informed consent from its first Australian patient, who will take part in the trial.

Alongside the Oz component, there will also be 48 sites in the States that are currently in advanced preparations for activation under the centralised ethics approval.

Managing director Paul Rennie said these were significant milestones for the Paradigm.

“The activation of our first site in Australia and the consenting of our first patients in Australia, with the US soon to follow, mark a significant operational achievement for the company,” Mr Rennie said.

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He continued: “I am particularly pleased to see the high level of engagement from leading clinical investigators and trial sites.

“I am also pleased that the company is progressing in line with our intended schedule.”

PAR has been trading at 30.5 cents.

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The trial’s Safety Review Committee (SRC) has looked at cumulative safety and pharmacokinetic data – including from the second dosed cohort of participants – and concluded that there are no issues.

This means Nyrada can proceed to the third cohort, for which it is already recruiting participants. It is expecting final readouts for the Phase 1 trial to be completed by the third quarter of the 2025 calendar year.

The company’s expectations for NYR-BI03 have been bolstered by positive newsflow throughout much of last year and into 2025, starting with an announcement in February 2024 that preclinical stroke study results had shown the candidate had achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.

This was followed by a preclinical study into coronary heart disease in October which revealed NYR-BI03 providing an 86% cardioprotective effect following myocardialischemic-reperfusion injury, a leading cause of tissue damage when blood flow is restored to the heart after injury.

Finally, last month Nyrada told investors about the results of a preclinical traumatic brain injury study which indicated a statistically significant (p = 0.043) neuroprotective effect provoked by NYR-BI03 following a penetrating traumatic brain injury.

The study in question was undertaken in collaboration with the Walter Reed Army Institute of Research and UNSW Sydney.

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The inclusion of these participants – enabled through Human Ethics Approval – comes on the back of positive results from this open-label trial, which showed a successful clinical response among 86% of patients after seven days of treatment; the same for more than 90% of patients after 14 days.

Crucially, the former is the main endpoint used by the U.S. FDA.

Data from the Phase II trial has led investigators to surmise R327G a safe and efficacious treatment for DFI, particularly given that, through the use of a gel, patients can avoid having to use oral or IV antibiotics for the condition.

“This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs,” Recce CEO James Grahama said today.

Mr Graham continued: “We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase Three programs in both Australia and Indonesia.”

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Alongside this new study will be Recce’s Indonesian Phase Three trial on the gel, which will also provide data for future regulatory submissions.

RCE shares have been trading at 28.7 cents.

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This follows the Oz biotech company securing $38.5 million in funding from Clendon Biotech Capital for clinical development of several drug candidates, including IRX-616a, through to Phase Three readiness.

The Phase One trial looks to ascertain the tolerability, safety, and efficacy of IRX-616a (a cannabidiol inhaler) among healthy participants, and will take the form of a randomised, double-blind, placebo-controlled, single-ascending dose.

“This execution allows for trial drug manufacturing timelines to be secured, and for the progression of our planning for the commencement of Phase Two trial dosing of healthy subjects later in the year,” CEO Darryl Davie said.

“The board and management are excited to advance IRX-616a into first-in-human trials.”

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He continued: “There are currently no FDA-approved, rapid-onset, inhaled therapies available to PD patients with IRX-616a, presenting as an exciting opportunity to address this very important unmet need.”

IRX moved north on the news to sell at 2.2 cents after a 22.2% spike.

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The headlining news is the HEALEY treatment period for the trial is being extended from 24 to 36 weeks to enable a longer evaluation of treatment effects.

The study will also be enriched for fast progressors, the company said, through a shift in the “show time for symptom onset,” from 36 to 24 months. On top of that, peripheral blood mononuclear cell collection has been added to aid future research and therapy development.

Neurizon also shared data showing its lead product, NUZ-001, has been slowing the decline in slow vital capacity; a key respiratory function and survival metric for ALS.

The analysis for this was undertaken by Berry Consultants, with their findings indicating SVC could be a secondary endpoint for NUZ-001.

Specifically, they found that treatment with NUZ-001 resulted in a 48% slowing in the loss of respiratory function for all 12 patients in the Phase 1 MEND Study – compared to untreated matched controls.

“Following a comprehensive review of the data from the first five completed regimens, HEALEY has implemented improvements to the HEALEY Master Protocol to maximise the potential for a positive outcome,” Neurizon’s managing director and CEO Dr Michael Thurn said after sharing the news.

“We were excited to learn about the strong correlation between reducing the respiratory function decline rate in patients treated with NUZ-001 and overall functional decline as measured by ALSFRS-R.

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“Having supporting positive secondary endpoints greatly increases the likelihoodof receiving accelerated approval.

“Over the coming months, the company will continue to work towards finalising participation in the HEALEY trial, with entry expected during H2 CY2025, which will include completing the two short-term pharmacokinetic studies required to lift the FDA’s clinical hold.”

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The approval – granted by the Bellberry Human Research Ethics Committee (HREC) – allows Race to push ahead with a trial to test the tolerability, safety, and pharmacokinetics of RC220 bisantrene on its own and together with doxorubicin.

Race is collaborating with Cancer Care Foundation on this trial. The approval means the Foundation’s main site, which is based at the Southside Cancer Care Centre in New South Wales, will soon be able to begin enrolling patients under the guidance of Principal Investigator Dr Mahmoud Alam.

This trial – which is open-label and multi-centre – will run across two phases, with 33 patients in the first phase receiving RC220 through intravenous infusion alone, followed by a combination treatment of IV RC220 and IV doxorubicin on a 21-day cycle.

In the Phase Two expansion stage, patients with solid tumours will be enrolled, receiving the optimal dosage of RC220 in combination with doxorubicin to check the safety of these two combined, as well as looking at several exploratory endpoints.

Bisantrene – Race’s focal asset – is a “small molecule chemotherapeutic” which has been showing therapeutic benefits for both adult and child patients, and data supporting its anticancer effects as well as indicating its lower cardiotoxicity in comparison to anthracyclines such as doxorubicin.

RC220 is being developed as a reformulated bisantrene (RC220).

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Race chief executive officer and managing director Dr Daniel Tillett said the approval was an important step.

“Receiving human ethics approval for the first RC220 trial is a significant milestone for Race, in line with our vision to improve cancer patient treatment by developing new cardioprotective therapies with anticancer benefits,” he said.

“I wish to thank the Bellberry HREC and the entire Race and George Clinical teams for all their efforts, which enabled us to reach this critical milestone.”

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The company said it had completed the placement, with shares priced at 14 cents each – a 2.5% premium to the 30-day volume-weighted average price. This was chiefly managed by Blue Ocean Equities and has already attracted strong demand – reflected in the fact the initial goal was $1.5 million.

The funds will go towards recruiting from a second site for the company’s Phase I/II skin cancer trial, and commencement of a Phase I/II anogenital trial in collaboration with the Peter MacCallum Cancer Centre in Melbourne.

Crucially, a successful outcome in the latter could enable orphan drug designation in the U.S. to fast-track trials in the rare disease indications.

Executive chair and CEO Thian Chew said the enthusiastic support during this placement reflected Invion’s growing profile.

“We are delighted to welcome new shareholders to Invion via the Placement, many of whom are sophisticated investors in the biotech space that are supporting thecompany after reviewing our achievements and the multiple milestones in our horizon,” he said.

“In addition to the skin and anogenital cancer trials, these milestones also includeupdates on the glioblastoma, oesophageal cancer and human papilloma virus studiesthat are fully funded by our partners.”

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The FDA has granted Neuren a Type C meeting – set for early April 2025 – to explore the efficacy endpoints of the trial program for candidate NNZ-2591.

This comes after a Type B End of Phase 2 meeting with the government agency, in which key features of the trial were discussed and agreed to.

NNZ-2591 is the company’s second drug candidate, which is in development with a focus on treating some neurodevelopmental disorders. During the Phase 2 clinical trial, it revealed positive results regarding Phelan-McDermid syndrome, Pitt-Hopkins syndrome, and Angelman syndrome.

CEO Jon Pilcher said Neuren was looking forward to a positive discussion with the FDA.

“Having a confirmed Type C meeting now establishes a clear timetable and in parallel we are continuing all our preparations, planning for mid-year commencement of the first ever Phase 3 trial for children with Phelan-McDermid syndrome,” he aid.

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Activities to support the study – particularly completion of the first prototype to collect images from the GI tract – have been completed at the research site, the University Medical Centre of the Johannes Gutenberg University in Mainz.

Optiscan CEO and managing director Dr Camile Farah visited Germany in January in preparation for this research, which will focus on using images of the GI tract to analyse the company’s Gen2 technology – particularly its imaging capability when it comes to diagnosing and treating GI diseases, including cancer.

Dr Farah was also on-site to lock in planning for the clinical phase of the trial, which will follow over coming months.

It is hoped this staged process of gathering pre-clinical and then clinical data with this Gen2 prototype will be helpful to engineers working with Optiscan in developing the company’s Gen3 flexible endomicroscope, which will be used in future clinical trials.

Collection of imaging datasets of various disease processes – taken from the current study – is also expected to aid with initiation of AI algorithm development by Optiscan’s CRC-P partner, Monash University.

“We are thrilled to be undertaking this study with the prestigious University Medical Center of Mainz,” Dr Farah said.

“It will be under the leadership of renowned world-leading gastroenterologist Professor Ralph Kiesslich, and represents a major step forward in helping to better understand and manage one of the world’s biggest health issues.

“GI diseases represent a significant global health challenge, affecting millions of lives each year. Early detection and precise intervention are critical, yet traditional diagnostic tools often fall short in providing timely and accurate insights.”

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The trial – whose full set of clinical results will be published in 2025’s first quarter – is evaluating the safety, effectiveness, and plasma pharmacokinetics of RECCE 327 Topical Gel as a topic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

Accordingly, participants have had the gel applied once daily to an area affected by ABSSSI for seven to 14 days, with interim data showing no “Serious Adverse Events,” and patients dosed achieving positive outcomes.

Recce will next roll out a Phase III trial of the gel in Australia in the first half of 2025, with this to serve as a registrational trial for the U.S. Food and Drug Administration and Australian Therapeutic Goods Administration.

The company has also been approved for Registrational Phase III trials on the same gel, this time targeting diabetic foot infections (DFI) in Indonesia; this would be one of the largest DFI studies in the world.

Recce CEO James Graham said interim information from the Phase III trial was promising.

“R327G has made significant progress over the last year, confirming its safety profile and demonstrating impressive efficacy as a topical gel formulation, especially considering the high degree of bacterial resistance present in many of the patients being treated in this Phase II trial,” he said.

“We look forward to the full dataset, which we expect will further support R327G’s progress toward regulatory evaluation.”

Recce shares last traded at 47.5 cents, a rise of 1.06% since market open.

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Results from a Phase 2a trial – reported in November – had shown ISLA-101 to be both safe and demonstrating ‘anti-dengue activity,’ leading the Safety Review Committee (SRC) to recommend trialling move on to the next phase.

While Phase 2a has concentrated on ISLA-101’s preventative arm, with a clinical trial involving four subjects randomised as 3:1 (active: placebo), Phase 2b will focus more on the therapeutic features of the drug, with 10 subjects randomised 8:2 (active: placebo).

To date, four of these subjects have been enrolled, and the second group of six is now expected within the next two weeks.

During the trial, they will be exposed to an attenuated strain of the virus and then administered either the placebo or ISLA-101 seven days later.

Island will primarily be looking for evidence of viremia (virus load in the bloodstream) reduction in subjects, although other endpoints will include confirming the safety of ISLA-101, and a reduction in the symptoms associated with dengue infection.

CEO and managing director Dr David Foster said the assessment of the drug was moving along promptly.

“We are excited to start the Phase 2b cohort right on schedule, following the strong datafrom our Phase 2a cohort and the subsequent recommendation by the SRC to move forward,” Mr Foster said.

“The SRC’s determination that there was evidence of antiviral activity in ISLA-101 treated subjects in the prophylactic setting was a landmark conclusion and we look forward to seeing if ISLA-101 may also be effective as a treatment in dengue-infected subjects.

“After an incredibly fruitful 12 months for the ISLA-101 clinical program, we look forward tocontinuing the momentum and exploring our lead drug candidate as a dengue therapeutic through the Phase 2b study.”

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The approval was received from the Belberry Human Research Ethics Committee (HREC) and will open the door to Radiopharm beginning its First In-Human (FIH) Phase 1 therapeutic clinical study of 177Lu-labelled RAD 202.

The latter is being developed to treat solid tumours that express human epidermal growth factor receptor 2 (or HER2), a transmembrane tyrosine kinase receptor that stimulates cell proliferation, differentiation, and survival.

It is often overexpressed in a range of tumours, including gastric, breast, bladder, pancreatic, and gynecological ones.

RAD202 is a single-domain monoclonal antibody (sdAb) that targets HER2, and this open-label trial is also a dose escalation trial of Lu-RAD202, with recruitment for it to be run across Australia.

CEO and managing director Riccardo Canevari said he was pleased the approval process had been successful, and the trial could now progress as planned.

“RAD 202 has the potential to address an unmet treatment gap in HER2-positive metastatic patients that are refractory to or unable to tolerate current standard of care treatments,” he explained today.

“With RAD 202, we hope to provide an alternative strategy that can improve clinical outcomes for patients with HER2-positive advanced cancers, while potentially preserving their quality of life.”

Radiopharm shares have risen following the news. At 10:53 AEDT, they traded at 2.5 cents – a rise of 19.05% since market open.

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The data – to be presented at the 66th American Society of Hematology annual meeting (ASH) – was from Syntara’s Phase 2 clinical trial for the drug, which was tested in combination with ruxolitinib (RUX).

It showed a 50% improvement in Total Symptom Score (TSS50) among 46% of evaluable patients following 12 weeks of treatment, with this rising to an 80% improvement at 38 weeks of treatment.

TSS50 is a standard efficacy endpoint used as the primary endpoint in clinical trials related to MF.

Spleen reduction volume (SRV) was another factor of importance, with 30% of evaluable patients achieving an SVR of 25%, while 20% reported an SVR of 35%.

Notably, both this variable and patient symptoms continued to improve over the period under assessment: Differentiating SNT-5505 from MF currently on the market and in later stages of development.

Professor of myeloproliferative neoplasms at Guy’s and St Thomas’ NHS Foundation Trust Claire Harrison said the drug candidate was showing positive signs of effectiveness and safety under this trial.

“This interim data confirms the excellent safety profile of SNT-5505 and also suggeststhat the mechanism of SNT-5505 may exert a long-term effect on the disease, with bothsymptoms and spleen volume continuing to improve as we now see patients on drug for9 months,” she said.

“This hasn’t been seen before with this class of drug and holds potential for real long-term benefits for MF patients.

“I look forward to seeing the data mature in the coming months to confirm these important early findings.”

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Two achievements have made this possible: The first being Recce’s gaining of approval from the Indonesian Drug and Food Regulatory Authority – Badan POM – for the Registrational Phase 3 clinical trial.

Alongside this, Recce’s human ethics committee has approved commencement of patient dosing, and the alignment of both means the trial is on-track to begin this quarter.

While extending its global therapeutic footprint is an important priority for any pharmaceutical company, one might ask why Recce has decided to launch a trial in Indonesia in particular.

In fact, the upward trend of diabetes in the country has been acknowledged as a serious health issue since the 1980s, and today it has one of the world’s largest patient populations for the condition.

Data from the International Diabetes Federation (IDF) has shown that, in 2021, 10.6% (or around 19 and a half million people) were affected by diabetes mellitus – the group of conditions associated with high blood glucose – in Indonesia. By 2030, this was predicted to grow to 11.3% of the population (accounting for more than 23 million people).

Crucially, the same data set indicated that in 2021, 73.7% of people with diabetes were undiagnosed.

People living with diabetes are faced with a number of associated health problems, including foot infections, urinary tract infections, and surgical site infections.

The former in particular can have serious consequences when left untreated: Diabetic foot infections (DFIs) remain the most common cause of nontraumatic foot amputations among people living with diabetes – 15% of patients experience this.

The infections are mostly found at the bottom of the foot, within its soft tissue, and they are often caused by more than one pathogen – with between 50% and 80% of these wounds being polymicrobial. The pathogens often responsible for DFI infections include S. aureus, Enterococcus, P. aeruginosa, and E. coli.

Taken together, the seriousness of diabetes growth within Indonesia – plus the large percentage of people who experience foot amputations as a result of DFIs – makes Recce’s Registrational Phase 3 trial for its topical gel to treat the latter a timely study.

In fact, it is one of the largest DFI studies in the world, and the first of its kind within Indonesia.

This was acknowledged by the chairman of Indonesia’s Drug and Food Regulatory Authority – also known as Badan POM – who said:

“The approval of Recce Pharmaceuticals’ Phase 3 clinical trial is an important step in advancing treatment options for DFIs in Indonesia. Badan POM is committed to supporting the timely development of innovative therapies to address this critical health challenge. This collaboration aligns with Indonesia’s mission to advance healthcare solutions for our population, and we look forward to seeing the impact of this trial for patients in need of new, effective anti-infective treatments.”

While contributing to Indonesia’s healthcare landscape through the introduction of a novel treatment for infectious diseases is a key goal of this trial, it also aligns with Recce’s goal of pushing its topic gel through to commercialisation.

Recce’s chief executive officer James Graham said being able to move forward with the Phase 3 trial was an important milestone for the company.

“The approval from the Indonesian National Drug and Food Authority to initiate this pivotal Phase 3 trial in Recce’s clinical development is a significant achievement, bringing Recce closer to commercialisation and profitability,” he said.

“We also acknowledge the support of Investment NSW, Austrade, and the Australian Embassy team in Jakarta who played an important role in helping with the approval process.

“We look forward to evaluating R327G in our first Phase 3 trial.”

As an anti-infective, the company’s R327 candidate is being assessed in various forms to check its efficacy in treating various bacterial wounds, burns, and skin infections.

During a preclinical study on rats, it revealed notable antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA), difficult-to-treat bacteria that causes staph infections.

In the form of a topical spray, R327 is also the subject of an ongoing Phase I/II study in patients with infected burn wounds, and has demonstrated impressive data so far, including the return of healthy skin growth, reduced swelling and infection, and signs of tissue penetration to the underlying infection.

Building on the success of this trial, Recce commenced a Phase I/II proof-of-concept study at the South West Sydney Limb Preservation and Wound Research Unit to evaluate the safety and efficacy of R327 in patients with mild skin and soft tissue diabetic foot infections (DFIs).

Thus, Recce’s new trial initiative in Indonesia aims to build on a solid history of assessment for this treatment.

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Associate Professor Chen, who works as a consultant ophthalmologist at the Institute as well as Royal Perth Hospital and Perth Children’s Hospital, will be speaking at the Asia Pacific Vitreo-Retina Society (APVRS) on November 23.

The focus of his presentation will be PYC’s ongoing phase 1/2 studies of drug candidate VP-001 in patients with RP11, with a particular focus on improved vision observed in the eye treated with VP-001 when compared to the untreated eye and baseline assessments.

This comes at an important stage for PYC’s development of the candidate, as it prepares to negotiate with the US Food and Drug Administration (FDA) in relation to a registrationaltrial for VP-001, anticipated to begin in mid-2025.

Leading up to this, the company will dedicate much of 1H of 2025 to engagement with the FDA around the design of this trial.

PYC shares moved up on this news, and at 13:08 AEDT, they were trading at $1.83 – a rise of 0.55% since the market opened.

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The main function of RAD204 – a single domain monoclonal antibody – is its targeting of PD-L1, a protein which helps control the immune system and is overexpressed in many solid cancers.

Radiopharm has been progressing a Phase 1 clinical trial to assess how Lu-labelled RAD204 is tolerated for the treatment of PD-L1 expressing cancers, and as per the approval notice, this will now include participants with Programmed Death-Ligand 1 (PD-L1) positive Small Cell Lung Cancer (SCLC), Triple Negative Breast Cancer (TNBC), Melanoma, Head and Neck Cancer (HNSCC), and Endometrial Cancer.

The original focus of the trial was on participants with Non Small Cell Lung Cancer (NSCLC).

Recruitment is ongoing at four locations in New South Wales, South Australia, and Western Australia, with this being supported by oncology care provider GenesisCare CRO.

Positive indications have already been yielded from Phase I imaging data of 16 patients with NSCLC, showing that RAD204 is safe and is associated with acceptable dosimetry.

Radiopharm CEO and managing director Riccardo Canevari said being able to extend the trial to other cancers was significant.

“The implications of including additional PD-L1 expressing tumor types beyond NSCLC in this study is far-reaching,” he said.

“Patients with five additional PD-L1 expressing tumor types are now eligible for this basket trial, supporting the potential of 177Lu-RAD204 for a tumor-agnostic indication and as an effective radioimmunotherapy based on a pan-tumor predictive biomarker.

“With RAD204, we hope to provide an alternative strategy that can improve clinical outcomes for patients with PD-L1 positive advanced cancers, while potentially preserving their quality of life.”

At 14:46 AEDT, Radiopharm was trading at 2.7 cents – a rise of 3.85% since the market opened.

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The approval – which was granted by the Belberry Ltd Human Research Ethics Committee (HREC) – represents an important milestone in development of this therapy to meet the needs of cancer patients, by allowing for effective and fast pain relief without the use of opioids.

IRX is particularly concerned with providing a safer alternative to current treatments, which often use opioids, especially fentanyl. This is crucial to meet the needs of patients suffering from BTcP, with the Total Addressable Market currently estimated at over US$1 billion.

IRX CEO Darryl Davies said this approval marked an important stage in progressing this treatment solution.

“Securing HREC approval to initiate this Phase 2 clinical trial of IRX-211 is a significantadvancement in our mission to bring safer, effective break-through pain relief solutions tocancer patients,” he said.

“IRX-211 has the potential to redefine how breakthrough cancer pain is managed, addressing a critical gap in the market currently for safe, fast-acting, non-opioidtreatments.

“We are committed to delivering a therapeutic solution that provides reliable reliefto cancer patients without the severe side effects and dependency risks associated with current opioid-based therapies like fentanyl.

“This trial represents a major step in our journey toward realizing that vision, and we are grateful to our dedicated team for their hard work in reaching this milestone.”

IRX shares have moved up on the news, and at 11:06 AEDT, they were trading at 3.5 cents – a rise of 16.67% since the market opened.

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Data taken from the trial indicates the gel – also known as R327G – has yielded a strong effective response from participants, all of whom have reported positive outcomes after treatment, including total cure or notable improvement.

At the same time, no Serious Adverse Events (SAEs) have been reported for the gel.

Chief Medical Advisor Dr Alan W Dunton said all indicators boded well from the trial, and underpinned Recce’s success with development and assessment of R327G.

“These interim results reflect a remarkable advancement in our journey to address critical unmet medical needs in anti-infective therapies,” he said.

“The robust response we are seeing with R327G is encouraging, especially as we near completion of the Phase II trial.

“Achieving a response of complete cure or notable improvement in all patients treated so far highlights the potential impact of R327G in treating complex bacterial infections, including diabetic foot infections.”

Recce shares moved up on the news, and at 12:51 AEDT, they were trading at 45 cents – a rise of 1.12% since the market opened.

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The clinical trialling project – entitled ‘CT:VQ – A Better Pulmonary Perfusion Test’ – focuses on technology which allows data related to airflow (ventilation, or V) and blood flow (perfusion, represented by Q) to be extracted from a CT scan.

Being able to do so would sidestep the use of any radioactive tracer or contrast, and facilitating the quantifying of data about V and Q – and differentiating between them – is an important diagnostic tool.

The trials for 4DMedical’s CT:VQ technology are specifically attempting to provide the evidence necessary to empower physicians to substitute 4DMedical’s CT:VQ for nuclear medicine VQ scans.

The U.S. market size for nuclear medicine VQ scans is over US$1 billion, with approximatelyone million tests run each year at an average cost of over US$1,000 per scan.

Managing director, CEO, and founder Andreas Fouras said the funding would help propel the testing further and help 4DMedical wok towards commercialisation of the technology.

“CT:VQ is set to disrupt a billion dollar segment of respiratory diagnostics by replacing nuclear VQ imaging with a technology that is faster, safer, cheaper, more convenient and more accessible,” he said.

“As a win, win, win change in healthcare practice, CT:VQ represents a once in a generation opportunity.”

4DMedical shares rose on the news, and at 10:52 AEDT, they were trading at 53.5 cents – a rise of 3.88% since the market opened.

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This follows news last month – on July 25 – of three patients showing confirmed responses to the drug, meaning that only two more are required in this first of two patient cohorts for the Phase 2a clinical trial (also known as the ACCENT trial).

More specifically, ‘confirmed partial response’ refers to one in which the patient shows at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained over a two-month period. A ‘confirmed complete response’ refers to a total absence of tumour lesions over a two-month period.

A total of 26 patients have been enrolled in the first cohort of ACCENT, and trial protocol demands that six of these achieve this (confirmed) response level in order for the trial to move forward, with the enrolment of 24 more patients.

Amplia CEO and MD Dr Chris Burns said these latest results mean that Amplia is reaching the goals set out for the ACCENT trial.

“The activity of narmafotinib in the ACCENT trial continues to be very positive, consistent with our previous clinical and preclinical data,” he said.

“We remain on track to complete the interim analysis by the end of this quarter.”

The news boosted Amplia’s share price, which at 12:12 AEST, was sitting at 10.5 cents, a rise of 16.66% since the market opened.