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Invion Doses First Patient in Phase I/II Non-Melanoma Skin Cancer Trial
Invion Limited (ASX: IVX) (“Invion” or the “Company”) is pleased to announce the dosing of the first patient in its Phase I/II non- melanoma skin cancer (NMSC) trial conducted at Veracity Clinical Research (Veracity) in Brisbane.
Highlights:
- First patient has been dosed in Invion’s open label Phase I/II non-melanoma skin cancer (NMSC) trial using topical INV043.
- The study is being conducted at Veracity Clinical Research’s facilities, based in Queensland Australia.
- Skin cancer is one of the world’s most common cancers and NMSC constitutes >98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322.
- Preclinical studies indicate INV043 may have distinct advantages over current NMSC treatments, such as efficacy without scarring and with minimal pain.
- The NMSC trial follows the release of promising Phase II prostate cancer trial results using INV043, and Invion plans to leverage the NMSC data into a planned Phase II anogenital cancer trial
The trial marks a significant milestone for Invion and is designed to evaluate the safety and efficacy of its lead drug candidate INV043, a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT) for the treatment of multiple cancers.
Trial Design and Objectives
This open-label, adaptive trial provides flexibility to go beyond the testing and collection of human safety data of the topical formulation of INV043.
The initial part of the study aims to assess the safety profile of the topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (cSCC). Subsequent parts aim to address dose optimisation (dose-light interval and light intensity) and the identification of efficacy signals. Part 3 will expand testing to include superficial Basal Cell Carcinoma (sBCC)
The adaptive design allows for modifications to the trial procedures based on interim results, enhancing the efficiency and effectiveness of the study. As such, the trial will enrol a minimum of 18 patients, which can be increased depending on the results.
Veracity will select male and female patients over the age of 18 with non-metastatic cSCC and sBCC, although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
Significance of NMSC
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322. The prevalence of the disease highlights the urgent need for effective and affordable treatments with minimal side effects.
Currently, the mainstream treatment for SCC and BCC is surgery, which can lead to permanent scarring. Preclinical studies undertaken at the Hudson Institute of Medical Research showed the potential for INV043 to regress cancers without scarring and with minimal pain.
Next Steps
The NMSC trial follows the release of promising results from a Phase II prostate cancer trial using the same active pharmaceutical ingredient, INV043. Once the trial results have been analysed, in addition to progressing the NMSC program, Invion plans to leverage this data into a planned Phase II anogenital cancer trial using topical INV043, and potentially including the use of immune checkpoint inhibitors (ICIs) on the back of solid in vivo data from the Peter MacCallum Cancer Centre.
This study showed 80% complete pathological control of anal squamous skin cancers versus a 12% response rate on ICI treatments on a standalone basis.
The Executive Chair and Chief Executive Officer of Invion, Thian Chew, said:
“Having the first patient dosed in our NMSC trial is a significant milestone for Invion in demonstrating the potential for the Photosoft technology to address limitations and undesirable side effects of current standard of care for NMSCs, including scarring and pain.”
“On the back of the recently announced prostate cancer results, this trial can also provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers. This can then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”
The NMSC trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
Click here for the full ASX Release
This article includes content from Invion Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Resonance Contracted by Major Global Pharma Company for Clinical Drug Trial Worth $13.775 Million over 24 Months
Resonance Health Ltd (ASX: RHT) (Resonance or the Company) advises that it has been contracted by Sun Pharmaceutical Industries Limited, an international, publicly listed pharmaceutical company with global operations (Customer) to be the local Australian sponsor, and to provide clinical research organisation (CRO) services, trial site services, and imaging analysis services (collectively, Services), for their clinical trial in Australia of a new drug compound (Clinical Trial).
New Clinical Trial
The newly executed clinical trial agreement (Agreement) is worth an estimated AUD $13.775 million in revenue to the Resonance group over the next ~24 months, with the first payment of AUD $2.066 million due within 30 days of Agreement execution. Resonance, through its wholly owned subsidiary, CRO Services Pty Ltd (CRO Services), will serve as CRO and Local (Australian) Sponsor for the Customer and will engage and make payment to the institutions, trial sites, and the vendors needed to conduct the Clinical Trial.
Whilst the Company will receive the first payment within 30 days of Agreement execution, provision of the Services under the Agreement (and the remaining payments) are subject to (among other things) receipt of regulatory approvals to commence the Clinical Trial including human research ethics committee approval (Regulatory Approvals).
Resonance will provide its imaging analysis services at various timepoints throughout the Clinical Trial along with clinical trial site services through its recently acquired TrialsWest business. It is notable that trial sites are among the largest vendors for clinical trials of this nature, so a benefit of the TrialsWest acquisition is that a significant portion of the revenues payable to trial sites will now stay within the Resonance group.
The Company expects patient recruitment for the Clinical Trial could commence in early 2025, subject to receipt of Regulatory Approvals, with both TrialsWest sites expected to play a key role in the recruitment of subjects and the conduct of the Clinical Trial.
This contract win highlights Resonance’s strategy of providing its technology and services to the burgeoning and highly technical global pharma and clinical trials markets.
The material commercial terms of the Agreement are set out at Annex A.
Resonance Health CEO, Mr Andrew Harrison commented:
“The Agreement is a direct result of the incredible work the team have done in executing the existing clinical trial with the customer and more broadly the Company’s focus on winning more work in the global clinical trials ecosystem. This illustrates our ability to win repeat work from customers, and our capacity to scale the size of contract wins.”
This announcement has been authorised for release in accordance with the delegated authority of the Board of Directors of Resonance Health Ltd.
Click here for the full ASX Release
This article includes content from Resonance Health Ltd, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
ISLA-101 Phase 2a/b PROTECT Clinical Trial Progress Update
Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to announce progress on its ISLA-101 Phase 2a/b clinical trial in dengue fever.
- All key data samples have been collected following dosing of all subjects in the Phase 2a (prophylactic) trial as part of Island’s ISLA-101 Phase 2a/b PROTECT clinical trial in dengue fever
- Data currently being consolidated for review by the Safety Review Committee (SRC) in the coming weeks
- On track to release SRC recommendation on advancing the trial to Phase 2b by end of this calendar year
Following the announcement (ASX: 3 October 2024) that all subjects in the Phase 2a cohort of the trial had been dosed, Island confirms it has now collected the required samples to analyse how the viremia (viral load) levels in the blood of trial subjects have changed through the study. Other samples are being analysed for pharmacokinetic data as well as other blood analyses.
This data is currently being consolidated for review by the Safety Review Committee (SRC), who will meet in the coming weeks. The SRC will evaluate the safety of ISLA-101 in dengue infected individuals and consider if there is evidence of anti-dengue activity. They will then make a recommendation regarding advancing the trial to the Phase 2b cohort before the end of the calendar year.
Island’s CEO and Managing Director, Dr David Foster commented, “We are very pleased to be able to report that 46 days into the trial, we’ve collected the key data required for evaluation by the Safety Review Committee. From here, while we will continue to check in with patients up to 90 days post dosing, we look forward to providing all the data to the SRC for evaluation in the coming weeks. Importantly, this means we remain on track to report data before the end of the year from our Phase 2a component, and next steps for the Phase 2b cohort before the end of the year.”
Phase 2b will include 10 subjects randomised 8:2 (active: placebo) and will examine if ISLA-101 has activity as a treatment against dengue infection. This is the first time a potential countermeasure to combat the dengue virus, which afflicts more than 400 million individuals a year and for which there is no therapeutic option, is being investigated as both a preventative and therapeutic measure.
To subscribe to Island’s monthly newsletter, IslandWatch, and other forms of email communications, please visit this page of our website.
Click here for the full ASX Release
This article includes content from Island Pharmaceuticals, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Interim Data from Accent Pancreatic Cancer Trial Supports Continuation of Trial
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim analysis is 27 September 2024.
HIGHLIGHTS
- Data analysis up to 27 September 2024 from the ongoing ACCENT trial of narmafotinib in combination with chemotherapy has been undertaken
- Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed PRs having been recorded along with four (4) unconfirmed PRs and five (5) SDs
- The median duration on trial is longer than for comparative trials of chemotherapy alone
- The ACCENT trial has resumed recruitment for the final cohort of 24 patients and as of 24 October 2024, 3 patients have been recruited
As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.
Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:
- 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have subsequently recorded progressive disease (PD)
- 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
- 3 patients recorded PD as best response, while 3 other participants were considered ineligible or withdrew from the trial
- Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at any scan
- Median duration on trial at data cut-off is 136 days, which compares favourably with historical data for chemotherapy alone of 117 days
- Preliminary analysis indicates patients have a faster response to therapy in terms of tumour reduction, compared to historical data for chemotherapy alone
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.
Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course."
Click here for the full ASX Release
This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
InhaleRx Secures $38,500,000 Funding to Fully Fund Clinical Development Plans
InhaleRx Ltd (ASX: IRX) (‘InhaleRx’ ‘IRX’ or ‘the Company’), an Australian healthcare company developing unique drug-device products to address unmet medical needs in pain management and mental health sectors, is pleased to announce that it has entered into a significant funding agreement with Clendon Biotech Capital Pty Ltd (‘Clendon Biotech Capital’). This strategic partnership will provide the funding to cover all direct costs associated with the Phase 1 & 2 clinical development of the Company's key projects - IRX-211 and IRX-616a.
Highlights:
- Secured Funding: InhaleRx has secured a funding facility of up to $38.5 million from Clendon Biotech Capital to fully cover the clinical trial costs, including the associated non-clinical work and trial drug manufacturing costs for the IRX-211 and IRX-616a drug development plans through to the completion of Phase 2 clinical trials.
- Clinical Progress: This funding will enable InhaleRx to move forward with its clinical development plans for IRX211 and IRX616a, including non-clinical data. It will also enable IRX to address the requirements of the US Food & Drug Administration (‘FDA’) relevant to its recent IRX-616a Investigational New Drug (‘IND’) application.
- Focus on Transformational Therapeutics: With this strategic support, InhaleRx is well positioned to accelerate the development of breakthrough inhaled therapies for patients with unmet medical needs.
The funding agreement provides InhaleRx access to up to $38.5 million in funding, which is expected to allow the Company to reach the Phase 3 pivotal stage for both IRX-211 and IRX-616a within the next 2-3 years. The facility allows for the drawdown of funding as eligible expenditure is incurred.
Further details of the Clendon Biotech facility and options included within the proposed funding structure are included in Appendices 1 and 2.
Once approved, the Clendon Biotech Capital facility will allow the Company to immediately activate the specification adjustment and batch manufacturing work required in the manufacture of the requisite trial drugs for the proposed IRX616a (Phase 1), and IRX-211 (Phase 2) trials.
This partnership ensures that InhaleRx can move forward with the next stages of its clinical trials and non- clinical work, including addressing the further requirements outlined in FDA feedback related to its recent IND submission for IRX-616a.
While it is expected that this funding arrangement will cover all necessary clinical trial costs, InhaleRx will remain responsible for covering its operational and corporate overheads as these costs are specifically outside the scope of the funding arrangement. The Company remains confident in its ability to secure the necessary additional funding to meet these working capital costs and ensure continued operational sustainability.
About Clendon Biotech Capital
Clendon Biotech Capital is a Melbourne based venture capital investor which is keenly focused on small to mid-size bio-technology companies in its target therapeutic areas - neuroscience, gastroenterology, oncology and anti-aging.
The Board of InhaleRx views the partnership with Clendon Biotech Capital as a transformative step in securing the Company’s ability to execute its clinical development strategy, which will further position it as a leader in the inhaled therapeutics sector.
IRX’s CEO, Mr. Darryl Davies, said: "We are very excited to have Clendon Biotech Capital as a committed funding partner. This agreement enables InhaleRx to focus on advancing our key clinical programs, including addressing the requirements outlined in FDA feedback on our recent IRX616a IND application. While this partnership provides vital support for our clinical development program, we will continue to explore opportunities to fund our broader operational needs and ensure the long-term success of the Company."
The Drug Development Pathway for IRX-211
IRX-211 is a drug-device medication, specifically designed to target breakthrough cancer pain (‘BTcP’), a condition characterised by sudden, intense episodes of pain that occur despite otherwise controlled cancer related chronic pain.
IRX-211 delivers a precise dose of the medication designed to provide rapid onset relief, ensuring quick absorption and action when needed most.
BTcP can be particularly debilitating for cancer patients, and conventional treatments often fall short due to delayed onset of action or suboptimal dosing. IRX-211 aims to address this gap by providing fast, effective relief, leading to an improvement in the quality of life of individuals suffering with cancer-related pain. By offering a more targeted and efficient solution, IRX-211 expects to become a cornerstone in the pain management toolkit for cancer patients, enhancing their overall comfort and care.
With the Phase 1 clinical trial complete, the next stage for IRX-211 is to commence the planned Phase 2 Double-blind, Placebo-controlled, Multicenter, Cross-over Study with Titration Period to Evaluate the Efficacy and Safety of IRX211a for the Treatment of Breakthrough Cancer Pain (‘BTcP’) in opioid tolerant patients in order to assess safety and efficacy of IRX-211.
The trial has been strategically designed to mirror the registration trials used for the fentanyl products, which are the only FDA approved drugs for treating BTcP.
Click here for the full ASX Release
This article includes content from InhaleRX, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Positive results from Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) Study
TrivarX Limited (‘the Company’) (ASX: TRI) is pleased to announce positive top-line results from the Company’s recently completed Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study utilising its proprietary AI-backed algorithm, MEB-001. MEB-001 uses EEG and ECG signals recorded during sleep to identify current Major Depressive Episode (cMDE).
Highlights:
- Analysis of 400 patients in Phase 2 SAMDE study for current Major Depressive Episode (cMDE) study utilising MEB-001
- MEB-001 is TrivarX’s proprietary AI-driven algorithm which can assist with the effective screening of a cMDE
- MEB-001 performance results from Phase 2 SAMDE study reported high performance, marking a significant achievement in the Company:
- Sensitivity: 87% (95% CI 73-95%)
- Specificity: 72% (95% CI 66-77%)
- Positive Predictive Value: 35% (95% CI 27-45%)
- Negative Predictive Value: 97% (95% CI 93-99%)
- Results provide strong validation of MEB-001’s ability to assist in the screening and diagnosis of a cMDE – a condition which is commonly misdiagnosed
- There is currently no screening undertaken for cMDE in sleep centres in the US or globally, representing a major commercial opportunity for TrivarX
- Results advance TRI’s aim to become the first depression screening tool used in clinical practice in sleep centres
There is a well-established connection between mental health conditions, such as depression, and sleep disturbances. People with insomnia may have a tenfold higher risk of developing cMDE and among people with depression, 75% of sufferers have trouble falling or staying asleepi. Furthermore, misdiagnosis of major depressive disorder is estimated at upwards of 65% in the USii. Despite this, depression screening is not routinely included in sleep studies, even though up to 21% of people undergoing a sleep study have depressioniii.
Positive results from SAMDE study highlight MEB-001’s significant potential:
The objective of the study (ClinicalTrials.gov ID NCT05708222) was to use MEB-001 to detect the likelihood of a cMDE using Clinician Reporting Outcomes (CRO) assessment in individuals referred to a sleep clinic. A total of 400 patients were recruited across 15 sleep centres in the US. Out of these, 73 patients were excluded due to incomplete data or a split night/titration sleep study. MEB-001 also automatically identified 32 patients with significant anomalies in their sleep data. Notably, the MEB-001 algorithm was locked prior to the analysis ensuring no data from Phase 2 was used in its training.
Analysis of the results showed that MEB-001 reported promising performance across key parameters including sensitivity of 87% (95% CI 73-96%), specificity of 72% (95% CI 66-77%), positive predictive value (PPV) of 35% (95% CI 27-45%) and negative predictive value (NPV) of 97% (95% CI 93-99%) (refer table below).
These results provide considerable validation of MEB-001 and its ability in the screening and diagnosis of a current Major Depressive Episode (cMDE) in test subjects.
Management commentary:
Non-executive Chairman, David Trimboli said: “We are very excited to share the results from our Phase2 study, which highlight the effectiveness of MEB-001 in screening for cMDE. This is underscored by the significant increase in sensitivity coming from recent improvements to the underlying algorithm, which was increased from 71% in Phase 1, to 87% in Phase 2 – demonstrating that the algorithm can successfully identify more people with cMDE. Our very high NPV validates MEB-001’s potential as a screening test, with the likelihood of having depression when testing negative to be less than 3%.
“There is currently no screening undertaken for cMDE in sleep centres in the US or globally. Our most recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centres and marks a significant achievement in the Company’s history.”
Click here for the full ASX Release
This article includes content from TrivarX, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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