Next Investors logo grey

FDA feedback puts Actinogen’s phase II trial one step closer to US approval


Published 08-JUN-2016 18:02 P.M.


1 minute read

Hey! Looks like you have stumbled on the section of our website where we have archived articles from our old business model.

In 2019 the original founding team returned to run Next Investors, we changed our business model to only write about stocks we carefully research and are invested in for the long term.

The below articles were written under our previous business model. We have kept these articles online here for your reference.

Our new mission is to build a high performing ASX micro cap investment portfolio and share our research, analysis and investment strategy with our readers.

Click Here to View Latest Articles

Following FDA feedback, Actinogen Medical (ASX:ACW) is progressing well towards final FDA approval of its Phase II trial of XanamemTM, its Alzheimer’s disease drug.

Actinogen plans to run the trial in the US – the largest market for Alzheimer’s drugs in the world.

The ASX-listed biotech company told its investors in a note this morning that good progress had been made in securing final FDA regulatory approval under an Investigational New Drug (IND) for its Phase II trial.

After feedback from the FDA, Actinogen will develop a revised protocol around the Phase II trial which will be harmonised across the US, UK and Australian research sites.

Patients are expected to be enrolled in the Phase II trial in the second half of this year.

Actinogen told shareholders that the harmonisation of the protocol around the Phase II trial was important “in light of the changing competitive and regulatory landscape in Alzheimer’s drugs in development”.

Actinogen will also receive a significant visibility boost in the global medical research community when it presents its data on XanamemTM at major US Alzheimer’s congresses and publishes the results in peer-reviewed medical journals, in the second half of the year.

About ACW and XanamemTM

ACW is led by Dr Bill Ketelbey, a former Pfizer Vice President who played a leading role in developing the multi-billion dollar drug Aricept in Australia and New Zealand.

XanamemTM has been developed to specifically target the 11B-HSD1 enzyme which produces cortisol, the so-called ‘stress hormone’.

ACW is targeting cortisol as it says there is substantial evidence that excess cortisol in the body leads to changes affecting memory and the development of abnormal amyloid protein plaques and neural death, in the brain – the hallmarks of Alzheimer’s disease.

The cost of Alzheimer’s treatment in the US alone was estimated to have reached $250 billion back in 2013 – with this figure tipped to rise to $1 trillion by 2050.

General Information Only

S3 Consortium Pty Ltd (S3, ‘we’, ‘us’, ‘our’) (CAR No. 433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information and is for informational purposes only. Any advice is general advice only. Any advice contained in this article does not constitute personal advice and S3 has not taken into consideration your personal objectives, financial situation or needs. Please seek your own independent professional advice before making any financial investment decision. Those persons acting upon information contained in this article do so entirely at their own risk.

Conflicts of Interest Notice

S3 and its associated entities may hold investments in companies featured in its articles, including through being paid in the securities of the companies we provide commentary on. We disclose the securities held in relation to a particular company that we provide commentary on. Refer to our Disclosure Policy for information on our self-imposed trading blackouts, hold conditions and de-risking (sell conditions) which seek to mitigate against any potential conflicts of interest.

Publication Notice and Disclaimer

The information contained in this article is current as at the publication date. At the time of publishing, the information contained in this article is based on sources which are available in the public domain that we consider to be reliable, and our own analysis of those sources. The views of the author may not reflect the views of the AFSL holder. Any decision by you to purchase securities in the companies featured in this article should be done so after you have sought your own independent professional advice regarding this information and made your own inquiries as to the validity of any information in this article.

Any forward-looking statements contained in this article are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results or performance of companies featured to differ materially from those expressed in the statements contained in this article. S3 cannot and does not give any assurance that the results or performance expressed or implied by any forward-looking statements contained in this article will actually occur and readers are cautioned not to put undue reliance on forward-looking statements.

This article may include references to our past investing performance. Past performance is not a reliable indicator of our future investing performance.