Australian (ASX) Stock Market Forum

ACW - Actinogen Medical

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I've picked ACW for the October Monthly Comp ........ it came up in a Weekly scan.
This reversal trade has a Higher Low in place now and the trend looks to be trying to go up, so I'm looking for a breakout sometime this month and continue upwards.
The last few weeks have been stronger than the XAO :xyxthumbs.


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and back trading on positive clinical data.....

Dr Steven Gourlay, Actinogen’s CEO and MD, said:
“We are very pleased to see such positive clinical data for patients with biomarker-positive, mild Alzheimer’s Disease. The results extend findings of therapeutic effects on cognition in two prior trials of cognitively normal, older volunteers to patients with early Alzheimer’s Disease. The data also validate the dose range planned for our upcoming trials in Alzheimer’s Disease and Depression. “Xanamem has the potential to be a novel daily oral therapy for Alzheimer’s Disease and other conditions that could be safely used alone or in combination with other therapies. The results affirm our confidence in the upcoming clinical trials that will confirm if Xanamem can make a significant improvement in the lives of patients and their families living with serious neurological and psychiatric conditions.”
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Certainly time for an update. ACW is turning it around now and moving higher in price and volume. Someone is interested.


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now MC of $150M on news of 26 Jun

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..
Positive Xanamem® phase 2a biomarker trial published in the Journal of Alzheimer’s Disease demonstrating potential Xanamem efficacy in patients with elevated blood pTau

ACW is pleased to announce the peer-reviewed publication of its phase 2a biomarker trial entitled “Plasma pTau181 Predicts Clinical Progression In A Phase 2 Randomized Controlled Trial of the 11β-HSD1 Inhibitor Xanamem for Mild Alzheimer’s Disease” in the 100th edition of the Journal of Alzheimer’s Disease.

Highlights of the publication include:
• Participants comprised 72 patients from the previous XanADu phase 2a trial of mild Alzheimer’s disease who had available stored plasma (blood) samples and gave informed consent for the new trial
• Patients with elevated pTau181 had much more rapid progression than patients with lower levels in four key clinical endpoints: ADCOMS (p<0.001), CDR-SB (p<0.001), MMSE (p=0.12) and ADAS-Cog14 (p=0.19)
• In the 34 patients with elevated pTau181 a potentially large and clinically meaningful Xanamem treatment effect compared to placebo was seen in the CDR-SB (LS2 mean difference 0.6 units, p=0.09) and positive trends were observed in a Neuropsychological Test Battery of cognition (LS mean difference 1.8 units, p=NS).

Dr Dana Hilt, the Company's Chief Medical Officer said:
"To our knowledge Xanamem is the first drug of this class to have such compelling data. The previously published PET study highlighted just how effective Xanamem is at reaching its target enzyme in the brain at safe and well tolerated doses of 5 and 10 mg/day. No other inhibitor of 11β-HSD1 has ever demonstrated robust central nervous system target engagement in this direct way.
“This new peer-reviewed publication reports that Xanamem 10 mg potentially slows AD progression in patients with high plasma pTau181. The other trends toward benefit on cognition are consistent with our two, prior phase 1b studies in older healthy volunteers which showed improved attention and working memory.
“Further data on cognition are anticipated when the XanaCIDD trial of cognitive impairment and major depressive disorder reports results next quarter. The XanaMIA phase 2b trial in 220 patients with mild to moderate AD is on-going.”
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A bit of a jump yesterday on the update, but the earlier results from 12 Aug knocked the SP down and it has not yet recovered fully.
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On-going analysis of the XanaCIDD phase 2a depression trial data found a consistent benefit of Xanamem® treatment on symptoms of depression in a variety of different endpoints. The consistent benefits observed support the conclusion that a 10 mg Xanamem dose is clinically active in controlling brain cortisol and has clinically significant anti-depressant activity.

Highlights of the updated results are:
• MADRS depression score improvement confirmed (p < 0.05) and positive effects were observed in five of six pre-specified subgroups, indicating broad effect in the population studied
• Analysis of further data from a second, well-validated endpoint for clinical function in depression, called the Patient Global Impression of Severity, reveals consistent Xanamem benefits that corroborate MADRS observations
• New MADRS responder analyses underscore MADRS benefit at Week 10 with a 50% higher rate of remission of depression
• Maximal benefits on depression for all endpoints at Week 10, four weeks after the end of treatment, indicate a durable therapeutic effect resulting from controlling brain cortisol
• Xanamem’s durable therapeutic effect is consistent with the known pharmacology of cortisol to modify gene expression and consequent protein synthesis and thus Xanamem may be controlling underlying “stress” biological processes for an extended period
• The XanaCIDD data indicate that Xanamem’s novel mechanism has clinically significant activity for the treatment of Major Depressive Disorder and we are exploring the path forward in MDD with regulators, global thought leaders and potential strategic partners.
 
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