Anavex could present the 12 week and other future results at any of these forums --
ICNE 2016: International Conference on Neurology and Epidemiology, 25-26 February 2016, London, UK
10th Annual Drug Discovery for Neurodegeneration Conference, 6–8 March 2016, Miami, FL, USA
14th International Athens/Springfield Symposium on Advances in Alzheimer Therapy, 9-12 March 2016, Athens, Greece
2016 Annual Meeting of the United States & Canadian Academy of Pathology, 12-18 March 2016, Seattle, WA, USA
5th European Conference on Clinical Neuroimaging (ECCN 2016), 14-15 March 2016, Roma, Italy
5th World Congress on Neurology and Therapeutics, 14-16 March 2016, London, UK
The 10th World Congress on Controversies in Neurology, 17-20 March 2016, Lisbon, Portugal
American Society for Neurochemistry 2016, 19–23 March 2016, Denver, CO, USA
Biomarker Summit 2016, 21-23 March 2016, San Diego, CA, USA
18th International Neuroscience Winter Conference, 2-6 April 2016, Sölden Austria
13th Annual Congress of the Society for Brain Mapping & Therapeutics, 8-10 April 2016, Miami, FL, USA
2016 Zilkha Symposium on Alzheimer Disease & Related Disorders, 10 April 2016, Los Angeles, CA, USA
68th American Academy of Neurology Annual Meeting, 15-21 April 2016, Vancouver, BC, Canada
9th International Symposium on Neuroprotection and Neurorepair (ISN&N), 19-22 April 2016, Leipzig, Germany
31st International Conference of Alzheimer's Disease International (ADI), 20-24 April 2016, Budapest, Hungary
Genomics of Brain Disorders, 25-27 April 2016, Cambridge, UK
Epigenetic and Metabolic Regulation of Aging and Aging-Related Diseases, 1-5 May 2016, Santa Fe, NM, USA
4th International Conference on Molecular Neurodegeneration, 9-11 May 2016, Seoul, Korea
6th Annual Traumatic Brain Injury Conference, 11-12 May 2016, Washington, DC, USA
2016 Annual Scientific Meeting of the American Geriatrics Society (AGS), 19-21 May 2016, Long Beach, CA, USA
European Academy of Neurology Co
From today's PR --
“The ongoing Phase 2a adaptive trial of ANAVEX 2-73 in mild-to-moderate Alzheimer’s patients continues to move ahead and we look forward to sharing additional results as the year progresses,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “In parallel to the ongoing Phase 2a trial, the Anavex team is also moving forward with plans for a Phase 2/3 trial of ANAVEX 2-73, which would include a larger group of Alzheimer’s patients and an additional control arm. Also this year, we are scheduling a Phase 2 human trial of ANAVEX 2-73 in a non-disclosed indication and other advancements with our pipeline compounds. We continue to be encouraged by the Company’s progress.”
They "look forward to sharing additional results as the year progresses" on the Phase 2A trial. If the results at 12 weeks are imminent, why not say "as the month progresses"? Hard to understand what the timing of the results is going to be.
"Anavex team is also moving forward with plans for a Phase 2/3 trial of ANAVEX 2-73, which would include a larger group of Alzheimer’s patients "
Moving forward? That' s good. But no mention of FDA discussions any more in this regard. Why not?
They are scheduling a Phase 2 human trial of ANAVEX 2-73 in a non-disclosed indication and other advancements with our pipeline compounds. Nothing new here! Why not mention which pipeline compound? Is it 3-71?
All in all, a disappointing update from my POV.
"I do intend to write a novel in the future - each chapter will be a story loosely based on an interesting epilepsy patient."
Take a look at the best selling books written by Dr Atul Gawande ... he has a similar theme.
Ok that's fair, MOA is less important than the clinical effect of course. But if 2-73 is combined with donepezil, it helps to know the MOA if you want to optmize the dosing, right?
Do you know if they have two arms in the Part B trial -- one with 2-73, the second with 2-73 + donepezil?
There were 32 patients in Part A, so they need to wait until all 32 patients have completed 12 weeks of dosing in Part B with 2-73 or 2-73 + donepezil before they can release the results. I doubt that will happen this week or next. But it will happen this month for sure. Stay tuned!
"If Anavex 2-73 or 3-71 acts at the start of this pathophysiological process, it may stop the decoupling of neural networking process that leads to Alzheimer’s"
Do you think that 2-73 acting as acetylcholinesterase inhibitors, Muscarinic M2, M2 or M3 receptor antagonists, NMDA receptor antagonists, or Sigma-1 receptor agonists could have the neural network decoupling effect that you mentioned?
The PR announcing the results of the Phase 2A Part A trial was issued on Nov 9. If we assume that all patients from Part A commenced Part B on that date, the 12 week mark would be reached on Feb 1. Hence I expect the earliest we can hope to see the 12 week results is this week. In all likelihood, it will take longer since all patients may not have started dosing on the same day.
There are two events planned for February – Feb 8 : Bio CEO & Investor Conference in NYC; Feb 26 : Epilepsy Pipeline Conference in San Francisco. They may release the results at either of the above in conjunction with a press release. if they will don't do it at the Feb 8th event, it will be at the Feb 26th event. I don't know which of the two they will pick for the results release. But it'll be soon in any case. Hold on to your shares, if the news doesn't come next week as many of us are hoping, the shorts may pile on again and take the stock down.
"I was once a fan of AVXL. Until they extended 2a part b"
What was your issue with the trial extension to part B?
The higher dose of 2-73 (30-50 mg) versus donepezil (5-15 mg) is required because 2-73 has a lower binding affinity to the S1 receptor. What causes the synergistic effect between the two drugs as has been reported? A lot more work is needed to understand. They also have A3-71 in pre-clinical phase now. Does any one know when they may advance it into clinical trials? Could they potentially use it in combo with 2-73 if a synergistic effect is seen there? Stay tuned!
"My guesses are they are dosing 2-73 based on tolerability, i.e. if the patient can tolerate 50, that's what they'll get."
Are you saying they are doing an escalating dose study on each of the 32 patients to ascertain the dose? That would add several weeks to the trial. It would be far easier and less costly to use the same fixed dose for each patient. This has ben established from the Phase 1 study as being 55 mg. So they used 30 mg and 50 mg in Part A of Phase 2A. What are they using Part B in combo with DZP?
You could be right on the DZP dose that they continue each patient of the the doctor-prescribed dose.
I believe all 32 patients from Part A opted to continue on to Part B, which is a great sign. Were they randomized to the two arms of part B as 16 per arm? Per the original protocol, the two arms were 30 mg and 50 mg 2-73 as oral capsules. But the fall presentation sugggests they changed that to 2-73 in one arm, and 2-73 + donepezil in the second arm.
From clintrials dot gov:
Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease
There are 4 arms in the trial –
Phase 2A Trial Part A: Anavex2-73 oral then the Anavex2-73 intravenous formulation
Participants first receive Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. After a washout period of 11 days they then receive the Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days.
Phase 2A Trial Part A: Anavex2-73 intravenous then the Anavex2-73 oral formulation
Participants first receive Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. After a washout period of 11 days then they receive the Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days.
Phase 2A Trial Part B: Anavex2-73 30 mg oral formulation
Participants will receive the 30 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks.
Phase 2A Trial Part B: Anavex2-73 50 mg oral formulation
Participants will receive the 50 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks.
The study design asks for 32 participants, 16 males and 16 female participants. All participants have the option to go on to the second part (PART B) of the study, the extended open-label study exploring the cognitive effect of the drug for another 52 weeks where the oral form will be exclusively administered.
On Slide 18 of the fall presentation at the website, they mention two arms: Anavex2-73, Anavex2-73 + Donepezil
It is not clear if they changed the study design given in clintrials.gov to include a 2-73 + donepezil arm in Part B of the Phase 2A trial. What dose of each drug are they using in Part B? They used 50 mg and 30 mg of 2-73 in Part A. Are they using the higher dose of 50 mg in Part B? What dose is being used for donepezil – the usual dose is 10 mg, but it can range from 5-15 mg.
We may see a 3 million share volume by EOD and up +15% ... that will bring in the momentum traders into this stock tomorrow and another big voume day and another big move up. But that will be NOTHING compared to what we will see on the good news to come with the 12 week results release. Hold on, do not sell!
Hey ctixers ... which premiere stocks are you talking about that may produce ten-baggers? I'm hanging on to AVXL and some other pharma now. Now looking into beaten-down oil stocks which I expect will be up by the end of 2016.
Here's the opinion of Piper Jaffray on the AXON situation --
Axovant Sciences (AXON) Sell-Off Creates Buying Opportunity - Piper Jaffray
February 2, 2016 11:07 AM EST
Piper Jaffray analyst Charles Duncan reiterated an Overweight rating and $23 price target on Axovant Sciences (NYSE: AXON) with shares under pressure after Pfizer (NYSE: PFE) announced discontinuation of its 5-HT6 antagonist (SAM-760) program in Alzheimer’s.
Duncan notes there are clear differences from RVT-101 on potency, clinical trial design, and patient enrollment criteria, as well as the availability of extensive data to inform dosing.
"First, the SAM-760 PhII program was in AD-associated psych disturbances, and may have experienced enrollment issues as well as challenges inherent to early trials on dosing and adequate PK," he commented. "We’d note that Axovant is pursuing RVT-101 in cognition and daily functioning: endpoints that we believe are better suited to this target and against which RVT-101 produced meaningful clinical improvement at the PhIIb (and now PhIII) dose."
They view clinical read-through between the two programs as minimal and do not believe the probability of RVT-101 success is compromised by this news.
In advance of enrollment updates from MINDSET to reduce execution
The Pfizer trial halt explains the tandem rise of AVXL and fall of AXON today ... good sign of things to come!
"Pfizer said it had halted a mid-stage trial of its drug, an antagonist of the serotonin 6 receptor, because data so far showed it was futile. Axovant has a similar drug in late-stage trials, acquired from GlaxoSmithKline, which had shelved the medicine after it performed poorly in clinical studies"
Will AVXL rise to where AXON's market cap used to be?? Stay tuned!!! We'll find out soon!
Mr. Skarpelos, a director of Anavex, is a self-employed investor with 17 years of experience working with private and public companies. For the past 10 years, he has been focused on biotechnology companies involved in drug discovery and drug development projects.Mr. Skarpelos was engaged as a consultant to Anavex Life Sciences for one year effective August 2, 2010. His experience has led to relationships with researchers at academic institutes in Europe and North America. Mr. Skarpelos is a founder of Anavex Life Sciences, and is its largest shareholder.