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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.”
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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.
Positive Phase 2a Fibromyalgia Results Deliver Pain Reduction in 100% of Patients, Strengthening IP Position and Clinical Trial Strategy
Tryptamine Therapeutics Limited (‘Tryp’ or the ‘Company’) (ASX: TYP), a clinical-stage biotechnology company is pleased to advise it has received highly encouraging, positive results from its recently completed Phase 2a clinical trial conducted in collaboration with the University of Michigan (‘UOM’) (refer ASX announcement: 10 July 2024). The results are both significant and clinically meaningful, and were presented by UOM researchers at the International Association for the Study of Pain (‘IASP’) 2024 World Congress in the Netherlands on 9 August 2024.
- Phase 2a fibromyalgia trial undertaken with University of Michigan (“UOM’) with results presented at the IASP 2024 World Congress on Pain 9 August 2024 in the Netherlands
- All patients dosed with TRP-8802 (TYP’s oral psilocybin formulation), and administered psychotherapy reported an improvement in fibromyalgia pain severity, sleep, pain interference and at least 3 other endpoints measured one month after dosing
- Fibromyalgia is a condition associated with widespread pain – 1m people in Australiai and ~10m people in the USii suffer from it and there are currently limited treatment options
- Results highlighted that there was a clinically meaningful reduction in pain, pain interference and fatigue
- Patients also reported a number of other improvements including clinically meaningful improvements in quality-of-life measures such as sleep, physical activity, and the ability to participate in daily social activities
- Clinically meaningful reduction in anxiety and improved cognitive abilities were also reported in 4 out of 5 patients dosed
- In addition, one patient reported during follow-up that their sense of smell had returned following a COVID- 19 diagnosis in 2021
- Results highlight the significant potential for psychedelic-assisted therapy as a compelling treatment pathway for fibromyalgia when compared to the inadequacies of incumbent treatments
- Results considerably strengthen Tryp’s IP position and lay a strong foundation for a future trial using TRP- 8803 (IV-infused psilocin) – Phase 2 trial planning now underway and expected to commence H1 2025
- Additional clinical trials progressing well at MGH for patients with IBS, and the beginning of Cohort 3 in the TRP-8803 Healthy Volunteer Study expected to begin soon – updates to be provided in due course
The trial was designed to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia, a condition associated with widespread pain and comorbidities that significantly impact daily living and patient well-being. The trial was undertaken by the UOM, a top-ranked public university in the US in collaboration with Tryp.
Results highlighted that 100% of patients experienced reductions in fibromyalgia pain, sleep disturbance and pain interference (refer figures one and two below).
Whilst appreciating the limitations of the small number of patients and the open label nature of the ‘signal’ style study, the results are highly encouraging and considerably strengthen TYP’s intellectual property position. Further, the results validate Tryp’s clinical trial approach targeting nociplastic pain with an initial focus on fibromyalgia and will inform an additional clinical study utilising TRP-8803 (IV-infused psilocin), which is expected to commence H1 2025.
Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)
Trial background:
The study was an open-label clinical trial with psychotherapy, seeking to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia. A total of five patients were recruited and were administered two doses of TRP-8802 in 15mg initial dose and 25mg second dose formats, two weeks apart. Patients were administered psychotherapy in concert with TRP-8802 and results were compared to baseline values one month following the completion of the second dose.
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This article includes content from Tryptamine Therapeutics 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.
LTP Secures Global Co-Development Agreement with Aptar Pharma
LTR Pharma Limited (ASX:LTR) (“LTR Pharma”, “the Company”) is pleased to announce that it has entered into a Co-Development Agreement (“the Agreement”) for SPONTAN for global markets.
Highlights:
- LTR Pharma (ASX:LTP) and Aptar Pharma have entered into a Co-Development Agreement for SPONTAN® for global markets.
- The primary goal is commercialisation of SPONTAN in the USA and other key markets.
- The Agreement will combine LTP’s pharmaceutical development capabilities with Aptar Pharma’s expertise in nasal spray technology, supporting a streamlined regulatory pathway and market access for SPONTAN.
The Agreement will encompass joint development and expertise, combining LTR Pharma's pharmaceutical development capabilities with Aptar Pharma's expertise in nasal spray technology – including Aptar’s VP7 model nasal spray components. The application for SPONTAN Nasal Spray will be filed in the US via the FDA’s 505(b)(2) expedited regulatory pathway, which governs a change in route of administration of an already approved drug, here Levitra® (Vardenafil) tablets.
The Agreement grants LTR Pharma access to Aptar Pharma’s comprehensive range of regulatory, analytical testing, and human factor services, which will considerably strengthen the FDA application process for SPONTAN.
A shared goal will be to focus on imminent market establishment and expansion, targeting commercialisation in the USA, and other key global markets – together with a long-term strategic alliance for ongoing innovation for healthcare solutions.
LTR Pharma Chairman, Lee Rodne, said:
“We are delighted to enter into a Co-Development Agreement with Aptar Pharma – a respected and experienced partner in our imminent goal to obtain regulatory approval for SPONTAN and to expand its global market reach and impact. As part of this, we will gain access to Aptar’s expertise in the VP7 nasal spray system and related specialised services to support our FDA application process. This vastly de-risks the FDA application process and elevates the profile of LTR Pharma as a long-term partner of a global market innovator, which we anticipate may create opportunities for other products with alternative indications in future.”
Guillaume Brouet, Vice President Analytical Regulatory and Scientific Affairs Aptar Pharma, said:
“We look forward to working closely alongside the LTR Pharma team to support its SPONTAN Nasal Spray application. We have purpose-designed facilities and experienced personnel to ensure a successful partnership throughout this Co- Development– within an efficient timeframe.”
LTP recently completed its clinical trial to compare the pharmacokinetics, safety, and tolerability of Vardenafil following administration of SPONTAN nasal spray and Levitra® tablets in healthy male adults. The trial showed that SPONTAN achieved a rapid absorption and faster onset of action compared to oral PDE5 inhibitors (i.e., vardenafil, sildenafil, tadalafil) and delivered a similar amount of drug (Cmax) at half the dose of the oral PDE5 tablet. Following the success of this clinical trial, medical providers have started prescribing SPONTAN in Australia under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).
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This article includes content from LTR Pharma 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.
First Patient Enrolled in CHM CDH17 Phase 1/2 Clinical Trial
Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), an Australian leader in cell therapy, is pleased to announce that the first participant has been enrolled in the Phase 1/2 multi-centre clinical trial for CHM CDH17 cell therapy.
The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours.
“This is great progress for this first-in-human study for bowel cancer patients with significant unmet need; congratulations to the CHM team and our investigational sites on this milestone.” said Dr Rebecca McQualter, Chief Operating Officer of Chimeric Therapeutics.
“It is exciting to see the advancement from the development of the CDH17 CAR T technology in our laboratory to the enrollment of the first patient in this Phase 1/2 study,” said Xianxin Hua, MD, PhD, Professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator.
Additional clinical trial sites are anticipated to open in the second half of 2024.
ABOUT CHIMERIC THERAPEUTICS
Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer, not just delay disease progression.
To bring that promise to life for more patients, Chimeric’s world class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies.
Chimeric currently has a diversified portfolio that includes first in class autologous CAR T cell therapies and best in class allogeneic NK cell therapies. Chimeric assets are being developed across multiple different disease areas in oncology with 3 current clinical programs and plans to open additional clinical programs in 2024.
Click here for the full ASX Release
This article includes content from Chimeric Therapeutics 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.
Successful Maiden Dosing of TRP-8803 (IV-Infused Psilocin) Completed in Global First
Tryptamine Therapeutics Limited (‘Tryp’ or the ‘Company’) (ASX: TYP), a clinical-stage biotechnology company focused on the development of an innovative and scalable intravenous-infused psilocin formulation which may be used in conjunction with psychotherapy to address significant unmet medical needs, is pleased to advise that it has successfully and safely completed the world’s first participant dosing using TRP-8803 (IV-infused psilocin) in a patient in Adelaide, South Australia.
- Completion of first participant dosing for TRP-8803 (IV-infused psilocin) Healthy Human Volunteer Study – Trial being undertaken alongside CMAX Clinical Research in Adelaide and marks a world-first in psychedelic treatment
- Study aims to refine and optimise dosing and infusion rates of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetics profile in up to 12 participants to determine TRP-8803’s safety in humans – results will inform TYP’s Phase 2a patient study pipeline
- Participant successfully underwent psilocin infusion over 140 minutes, progressed well through treatment and was discharged on completion
- TRP-8803’s potential advantages include a significant reduction in onset of the psychedelic state, more precise control of the depth and duration of the experience and a reduction in the duration of the intervention to a commercially feasible timeframe
- Successful first participant dosing reinforces management confidence in TRP-8803 and its potential
- Trial expected to completed during Q3 2024 with results to be reported thereafter – Positive results will provide Tryp with the potential to advance its clinical trial pipeline across multiple conditions
Tryp advises that the participant was provided with TRP-8803, the Company’s innovative IV-infused psilocin solution on Friday, 28 June for approximately 140 minutes and progressed through the treatment safely. The participant was discharged after dosing follow-up was completed.
TRP-8803, Tryp’s lead program alleviates a number of significant shortcomings of oral psilocybin therapy. Potential advantages of the Company’s IV-infused psilocin solution include a significant reduction in the time to onset of the psychedelic state, more precise control of the depth and duration of the psychedelic experience and a reduction in the overall duration of the intervention to a commercially feasible timeframe.
The Company will continue to work alongside CMAX Clinical Research to deliver the solution to the additional participants over the coming weeks. Tryp anticipates to receive interim results from the trial during Q3 2024, which will provide a greater understanding of the solution’s potential in humans.
Management commentary:
Tryp Chief Executive Officer, Mr. Jason Carroll said: “We are very pleased to have completed the world’s first TRP- 8803 treatment in a patient in Adelaide. Pleasingly, the maiden participant was delivered the infusion safely and was discharged on treatment conclusion, which provides management with confidence of TRP-8803 and the completion of this Healthy Human Volunteer Study.
“The trial, which being undertaken alongside CMAX is an incredibly important initiative for Tryp, as it will provide us with data highlighting TRP-8803’s safety in humans at escalating doses. This will form the basis of the Company’s clinical trial pipeline into other indications and ultimately our regulatory engagement.
“The Company expects that up to 12 participants to undertake infusion over the coming weeks and we look forward to provide further updates as the trial advances.”
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This article includes content from Tryptamine Therapeutics 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.
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