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Actinogen Medical Limited (ACW)
is a publicly listed company on the Australian Securities Exchange (ASX).


{{businessSummary}}

General Overview

About Actinogen Medical Limited

Actinogen Medical is an ASX-listed biotechnology company developing innovative treatments for Alzheimer’s disease and the cognitive decline associated with neurodegenerative diseases and metabolic diseases, like Type 2 diabetes.

Their management team and scientific advisory board includes world-renowned Alzheimer’s disease and dementia researchers, and industry specialists in drug design and clinical trial management.

Actinogen Medical’s drug candidate Xanamem has been specifically designed to block the production of cortisol in the brain. Drugs that reduce cortisol in the brain offer a promising new approach to slowing, or even preventing, the cognitive decline associated with Alzheimer’s disease.

Actinogen Medical is currently conducting XanADu, an international multi-site Phase II efficacy and safety trial of Xanamem in patients with mild Alzheimer’s disease. Recruitment and treatment of patients started in 2017, with results expected in early 2019.


Products

Xanamem™

Xanamem has been developed in response to evidence that there is a strong association between chronically raised cortisol levels in the blood and in the brain, and the development of Alzheimer’s disease.

Cortisol is more commonly known as the “stress hormone” and is produced in times of physical and mental stress. While this response is quite normal, if cortisol remains elevated for long periods of time, it can become toxic to the neurons (nerve cells) in the brain. Patients with raised cortisol include those with diabetes, with depression, schizophrenia and PTSD, and many patients with Alzheimer’s disease. Interestingly, blood cortisol levels tend to also rise with normal ageing.

Data from several major studies have consistently shown an association between increased cortisol and cognitive decline, together with development of abnormal ß-amyloid protein plaques and neurotoxicity in the brain – the hallmarks of Alzheimer’s disease.

Some of the most compelling evidence supporting the cortisol hypothesis was provided by the Australian Imaging, Biomarker & Lifestyle Study of Ageing (AIBL) study published in early 2017. This study, funded by the CSIRO and several universities and medical research institutes demonstrated that healthy, elderly individuals with high cortisol levels were significantly more likely to develop Alzheimer’s disease than those with low cortisol levels. The study authors concluded that therapies aimed at lowering plasma cortisol levels should be considered as a way to prevent the development of Alzheimer’s disease.

Xanamem blocks the activity of 11ß-HSD1, an enzyme that converts inactive cortisone into its active form, cortisol in the brain. Blocking the activity of the enzyme therefore reduces the amount of cortisol in the brain. The enzyme is present in high concentrations in the hippocampus and the frontal cortex, the parts of the brain most associated with recent memory and behaviour, and the regions of the brain most affected by Alzheimer’s disease.

Xanamem was discovered by researchers at the University of Edinburgh in Scotland, and has been under development for over a decade. In late 2014, Actinogen Medical acquired the global rights to Xanamem, with the commitment to actively progress the clinical development of this very promising compound.

Alzheimer’s Disease

Alzheimer’s disease is a chronic neurodegenerative condition leading to rapid cognitive decline. ‘Cognition’ relates to how a person understands and acts in the world around them. Cognitive functions include memory, reasoning, awareness and decision-making, and to a large extent, influences their personality.

A gradual decline in cognitive function with age is normal, but in certain diseases, like Alzheimer’s, the decline begins earlier, and at a faster pace. The rapid cognitive decline can have a dramatic effect on a person’s ability to function in normal daily life, also affecting their family and the community around them.

Alzheimer’s disease is characterised by the presence of abnormal protein build-up in the brain, called amyloid plaques, with associated nerve cell degeneration and death, and loss of brain volume. It is not clear why these changes occur and what causes the rapid degeneration and death of the nerve cells. Unfortunately, the few drugs that are available to treat Alzheimer’s disease provide only a limited symptomatic benefit and do not slow down neurodegeneration.As the leading cause of death in the UK, and second only to heart disease in Australia, Alzheimer’s disease is poised to become thenext global public health crisis. There are almost 50 million Alzheimer’s disease sufferers world-wide and the number is set to double every 20 years. In the US alone, the cost of managing Alzheimer’s disease in 2013 was estimated at US$250bn, reaching US$1 trillion by 2050.

Of the top ten fatal illnesses, Alzheimer’s disease remains the only one that cannot be prevented, treated or cured. None of the current treatment options provide much more than short-term relief of dementia symptoms, and significantly, none can slow the progression of the disease.  Alzheimer’s disease sufferers desperately need new alternative treatment options, and ideally, drugs with the potential to reverse the decline in brain function or to slow disease progression.

Alzheimer’s disease develops years before the symptoms of dementia appear. It is likely that brain pathology begins up to 15 years before the appearance of mild cognitive impairment or clinical dementia. Earlier diagnosis and treatment is therefore a vital hurdle to overcome before they see a significant reduction in the burden of this disease.

ALZHEIMER'S DISEASE IS EMERGING AS THE MOST SIGNIFICANT HEALTH CHALLENGE OF OUR TIME

Research

PHASE 1 – SINGLE ASCENDING DOSE (SAD)

A Phase I, single ascending dose (SAD), randomised, double-blind, placebo-controlled study was successfully completed in 2013 with 48 healthy human volunteers. Xanamem was well tolerated with no serious adverse events, and demonstrated potent effects on pharmacodynamics biomarkers, consistent with substantial inhibition of 11B-HSD1 for at least 24 hours after a single dose.

More information on this completed Phase I study of Xanamem in healthy subjects can be found at Clinicaltrials.gov (Identifier: NCT02616445) and in Webster et al 2017.

PHASE 1 – MULTIPLE ASCENDING DOSE (MAD)

A second Phase I study, a multiple ascending dose (MAD), randomised, double-blind, placebo-controlled study in 40 healthy volunteers was successfully completed in 2015. Participants were given doses of 10mg, 20mg and 35mg Xanamem twice daily for nine days, and once on the morning of the tenth day (19 doses in total). The primary endpoint of the study confirmed the safety and tolerability of Xanamem. Additionally, the trial demonstrated how the body absorbs and metabolises Xanamem and helped define the optimal dose for the drug for future studies.

Two additional sub-studies included a fed-fasted study to confirm the effect of food on the absorption of Xanamem, and a CNS pharmacokinetic study. This key CNS sub-study confirmed Xanamem efficiently crosses the blood-brain barrier in concentrations that would adequately inhibit the excess production of cortisol in the hippocampus and frontal cortex of the brain, Xanamem’s primary site of action.

This Multiple Ascending Dose (MAD) study was conducted by Linear Clinical Research, a world-class clinical trial facility that is part of the QEII Medical Centre in Perth, Australia.

 



Contact Info

Actinogen Medical Limited

Level 9, Suite 1
68 Pitt Street
Sydney, NSW
AU Australia, 2000

Phone: +61 2 8964 7401
Email: info@actinogen.com.au
Website: http://actinogen.com.au/

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Actinogen Medical Limited Google Map
Actinogen Medical Limited Google Map

Share Registry

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Phone: +61 8 9324 2099
Fax: +61 8 9321 2337
Email: info@automic.com.au
Website: http://www.automic.com.au/

Suite 1A, Level 1
7 Ventnor Avenue
West Perth, WA
AU Australia, 6005


Important Information

The General Overview, Services, Products and Projects information for this profile was last edited on 24 Oct 2017.

All Financial Data is provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Share Prices nor any independent data provider is liable for any informational errors, omissions or other defects, incompleteness, or delays, or for any actions taken in reliance on Financial Data.

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