Actinogen Medical (ASX:ACW) has announced the enrolment of the first two US-based patients into XanADu this week. XanADu is its Phase II clinical trial of Xanamem in Alzheimer’s disease.
- Another major milestone for Actinogen Medical with first two US patients enrolled into Alzheimer’s trial, XanADu.
- XanADu is Actinogen Medical’s Phase II clinical trial of Xanamem™ in Alzheimer’s disease.
- These US patients highlight global reach of XanADu: the study will enrol 174 patients at 20 research sites in the USA, the UK and Australia.
- Momentum is building behind XanADu following the recent recruitment of the firstpatient into the trial, in Australia.
- Recruitment of US patients reflects success in taking Australian biotech research capability to the US market.
The study will enrol 174 patients at 20 research sites in the USA, the UK and Australia with the last patient expected to be recruited in Q4 2018 and top-line results expected by Q1 2019. The first US patients were enrolled at the Atlanta Centre for Medical Research in Atlanta, Georgia. Additional sites in the US are now open for active recruitment and more patients are expected to be recruited into XanADu over the next few weeks.
Professor Jeffrey Cummings, M.D., Director of the Cleveland Clinic Lou Ruvo Center for Brain Health in the United States said Xanamem could represent a major advancement in the treatment of Alzheimer’s, at a time when new treatments for the devastating disease are badly needed.
“This [XanADu] is one of the most significant studies that I have been involved in as it could provide the turning point needed in finding a new effective treatment for Alzheimer’s disease. Given the compelling evidence linking raised cortisol and the development of Alzheimer’s disease, the global medical community will be closely following this clinical trial,” he said.
Robert A. Riesenberg, MD, founder, president and CEO at the Atlanta Center for Medical Research, and principal investigator on the XanADu study commented “Alzheimer’s disease is ranked as the sixth leading cause of death in the United States. Being able to contribute to the search for a new, safe and quality medicine for this disease is integral to everything that the ACMR represents.”
The commencement of patient enrolment into XanADu follows regulatory approval to conduct the study from the Food and Drug Administration (FDA) in the USA, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and from the Therapeutic Goods Administration (TGA) in Australia.
“We are very pleased to have successfully recruited our first US patient into XanADu and to have such strong momentum building behind this landmark study,” said Dr Bill Ketelbey, CEO of Actinogen Medical.