Actinogen Medical Receives Approval from the TGA

Actinogen Medical (ASX: ACW) is pleased to announce that it has received approval from the Australian Therapeutic Goods Administration (TGA) to conduct XanADu, its Phase II clinical trial of its drug candidate, Xanamem™.

KEY TAKEAWAYS:

• Regulatory approval received from the TGA to commence patient recruitment into the Phase II clinical trial of Xanamem™ in Alzheimer’s disease- “XanADu”.
• TGA approval follows earlier FDA (USA) and MHRA (UK) approvals and is the final regulatory approval being sought for this clinical trial.
• XanADu remains on target to treat first patients with Xanamem™ in early Q2 2017.
• XanADu to enrol 174 patients at clinical sites across the USA, UK and Australia.
• XanADu is the largest global Alzheimer’s dementia study conducted by an Australian biotech company.

Xanamem™’s novel mechanism of action differentiates if from other Alzheimer rugs under development. It has been specifically designed to block excess production of cortisol, the stress hormone, in the areas of the brain most affected by Alzheimer’s disease. Raised cortisol levels have been strongly associated with Alzheimer’s disease and lowering cortisol in the brain is an important new target for treating the disease.

“We are delighted with these ongoing regulatory approvals for XanADu, as we are now finally able to start treating Alzheimer’s patients with Xanamem™. New treatment options are desperately needed and XanADu is designed to demonstrate that Xanamem™ is an effective treatment option for this devastating disease,” said Dr Bill Ketelbey, CEO of Actinogen Medical.

Prominent Australian Alzheimer’s expert, Associate Professor Michael Woodward AM, from the Medical and Cognitive Research Unit at Austin Health in Victoria, welcomed the XanADu trial and Actinogen’s work on Xanamem™.

“Novel treatment approaches are our best hope of effectively treating Alzheimer’s, so I am extremely pleased to participate in this landmark, global study of Xanamem™ in mild Alzheimer’s,’ he said.

“Too many drugs are failing to show efficacy. Xanamem™ is different as its novel mechanism of action of inhibiting cortisol production in the brain has the potential to make a truly meaningful difference to those with Alzheimer’s. It is especially gratifying that this study is an Australian initiative and that so much of the development of Xanamem™ will be carried out in Australia. It’s an impressive achievement that reaffirms our ability to punch well above our weight in medical research and should make Australians proud.”

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