News and Announcements
Actinogen Medical Makes Significant Progress with FDA and MHRA Approval After HY Results
- Published February 27, 2017 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
Actinogen Medical (ASX: ACW) is pleased to provide a summary of the company’s progression over the half year ended 31 December 2016.
KEY TAKEAWAYS:
- Significant progress was made after the reporting period, the FDA and MHRA granting regulatory approval of the company’s Phase II trial, XanADu.
- Actinogen also expects regulatory approval from the Australian TGA over the coming weeks.
- Regulatory approvals provide strong endorsement of the development of Xanamem™ and underscore the depth and quality of Actinogens existing research data.
- Actinogen expects to commence XanADu trial recruitment early in Q2 2017.
- The Company is also planning to support a second Phase II trial of Xanamem™ for the treatment of Diabetes Cognitive Impairment.
Significant process has been achieved since the company’s last press release. With the U.S Federal Drug Administration (FDA) and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) both granting approval of the Company’s Phase II trial of XanADu.
In addition, Actinogen is expecting approval for the trial from the Australian Therapeutic Goods and Service (TGA) over the coming weeks.
With XanADu now approved by the FDA and the MHRA, and with the TGA approval expected very soon, the Company has reached a pivotal point in its journey where it has a clear clinical path and timeline ahead for XanADu.
Dr Bill Ketelbey, CEO of Actinogen Medical, said: “We have made solid progress over the first half of 2017 and expect to reach some significant milestones over the medium term as we commence recruitment and dosing of patients for the XanADu trial…”
“Alzheimer’s disease has become one of the biggest public health challenges for modern society. New treatment options are desperately needed and XanADu is designed to demonstrate that Xanamem™ is an effective treatment option for this devastating disease”.
XanADu is the largest global Alzheimer’s dementia study conducted by an Australian biotech company.
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