Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
https://www.fox5vegas.com/news/us_world_news/reports-spain-locks-down-as-coronavirus-infections-spike/article_6a780a6f-772a-59a3-959b-7d361261bb60.html
14-week study in PD patients with dementia
January 27, 2020 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced that it has met its enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study in Parkinson’s Disease Dementia (PDD).
“Participants are either outpatients, or residents of an assisted-living facility. Participant has a designated study partner, who spends at least 10hrs per week with the participant,
in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.”
https://clinicaltrials.gov/ct2/show/NCT03790709?term=Anavex&draw=2&rank=6
“Former CDC director: It's time to restrict visits to nursing homes”
“Nursing homes are ground zero for Covid-19”
https://www.cnn.com/2020/03/08/health/coronavirus-nursing-homes-frieden-analysis/index.html
Perhaps they could use the following paper as justification to apply for funding to test A2-73 on CV.
“Sigma-1 Receptor Regulates Early Steps of Viral RNA Replication at the Onset of Hepatitis C Virus Infection”
“In this study, we describe the discovery of nonopioid sigma-1 receptor (S1R) as a cellular factor that mediates the early steps of viral RNA replication. “
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3648129/
At a minimum they could look for a university to use an MTA for testing purposes.
The FDA has already granted approval to the placebo. .
Placebo very likely = Standard of Care drug.
I am simply pointing out that when you do get results from this trial they need to be reviewed in the proper prospective.
Have a look at table 2. Do you see where 48.8% of patients taking a ChEi inhibitor should be expected to remain unchanged or actually improve their ADAS-cog scores at 12 months?
“Table 2 Changes in cognitive and functional abilities during three years of ChEI treatment in mild AD”
https://alzres.biomedcentral.com/articles/10.1186/alzrt210/tables/2
If A2-73 works it probably needs to make those numbers better that’s all I am saying.
I believe you should expect ~50% of the patients in the placebo arm of this trial to improve their ADAS-cog scores. If that’s the case you would need to see 70 to 75% of the active drug participants improve their scores. 50+(20-25)= (70-75), that’s what I’m pointing out.
What percentage of patients on the placebo (SOC) do you expect to improve their ADAS -cog scores in this trial?
So you expect ~ 70% of the patients taking an effective dose of A2-73 to improve their ADAS-cog scores in this trial?
“97% Consistency: MMSE, ADCS-ADL and EEG/ERPs: Identified relations show that high dose (concentration) is linked to improved response and low dose (concentration) to poor response”
I believe that’s from a trial with doses of 10,20,30, 40, and 50 mgs btw.
First you need to be able to administer an effective dose without toxicity issues, then you can start figuring out how rich investors will be based on length of dosing.
https://www.anavex.com/wp-content/uploads/2018/05/Anavex-ANAVEX2-73-CTAD-Phase-2a-November-2017.pdf
https://alzres.biomedcentral.com/articles/10.1186/alzrt210
“Results
After three years of ChEI therapy, 31% (MMSE) and 33% (ADAS-cog) of the patients showed improved/unchanged cognitive ability, 33% showed improved/unchanged global performance and 14% showed improved/unchanged IADL capacity. Higher mean dose of ChEI and lower educational level were both predictors of more positive longitudinal cognitive and functional outcomes. “
One could invest based on the probability of success or one could invest based on the belief that others believe the probability of success has increased... and therefore the stock price will increase.
If I recall correctly it was stockgumshoe who drove his followers to IPIX. Promotion tends to have a positive impact on stock prices and Tom Bishop sure sounds like he is all aboard AVXL and also the PI pretty much said A2-73 works, didn’t he?
Not sure why Claytrader isn’t looking at the longer term chart for the next resistance point. Looks like ~$6 to me.
Headed for $5.90 to $6.
I thinking the stock hits 5.90 to $6 pre-readout.
A quick skim didn’t seem to answer the question here either, but had some interesting stuff for “the FDA is the problem” crowd.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019
“Access: First Cycle Approval and Approvals Compared to Other Countries
First Cycle Approval
CDER approved 43 of the 48 novel drugs of 2019 (90%) on the “first cycle” of review, meaning without a “complete response” letter from FDA that requires re-submission with additional information, resulting in a delay to approval. From 2011 through 2018, CDER approved 309 novel drugs, of which 261 (84%) were approved on the first cycle. This high proportion of first-cycle approval reflects the extent to which CDER staff and drug developers work together to ensure that the studies supporting approval are well designed and that the application contains the information CDER needs to be able to fully review, and if appropriate, approve an application.
First cycle approval prevents delays in bringing valuable new therapies to market.
“
Thanks Doc already corrected my oversight. Good news today for Anavex, Anavex investors, and Rett patients and their families.
Yes you could be correct. I should have read more carefully.
Today’s news is good news!
Here were the details from that quote.
Both efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) and the Clinical Global Impression – Improvement (CGI-I) showed significant improvement with respect to baseline after 7 weeks of treatment. The RSBQ Total average scores improved from 50 to 34 points (2-tailed Wilcoxon signed rank test, p = 0.027) and the CGI-I scores were positively correlated with RSBQ Total scores at 7 weeks (2-tailed Spearman’s rho = 0.956, p = 0.003).
Supporting the clinical assessments, plasma levels of the biomarker Glutamate also decreased significantly (Week 0 vs. Week 7; 2-tailed Wilcoxon signed rank test, p = 0.046) and levels of Glutamate at Week 7 were directly correlated with CGI-I scores at Week 7 (2-tailed Spearman’s rho = 0.837, p = 0.038) with greater decreases in Glutamate associated with greater improvement in these efficacy scores.”
Interesting that they apparently have decided to titrate from only 1 mg daily in their trial. Looks like from one mg daily upwards for 7 weeks instead of starting at 5 mgs.
Preliminary Clinical Data is derived from the ANAVEX®2-73-RS-001 study on the first 6-patient cohort ranging in age from 18 to 36 years, who completed the pharmacokinetic (PK) part of the study and who received a low dose of approx. 5 mg daily oral liquid dose of ANAVEX®2-73 (blarcamesine) for 7 weeks. Patients are continuing participation in the ANAVEX®2-73-RS-001 open label extension study.”
Official Title:
A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients With Rett Syndrome
Arm Intervention/treatment
Experimental: Active arm
Week 0-7: Take 1 ml orally of the product daily (solution of ANAVEX2-73)
Drug: ANAVEX2-73
Liquid oral solution
Placebo Comparator: Placebo arm
Week 0-7: Take 1 ml orally of the product daily (placebo)
Drug: Placebo
Liquid oral solution
https://clinicaltrials.gov/ct2/show/NCT03758924?term=Anavex&draw=2&rank=4
Good news today. Very nice.
“Ages Eligible for Study:
18 Years to 45 Years (Adult)”
I don’t think he’s dead. Probably just roasted
“People living with very early and early stages of Alzheimer’s disease in Sydney and Melbourne and are up to the age of 85 interested in participating in the study can email alzheimerstrials@hammond.com.au”
Oh and by the way, if you elect to participate in the Anavex trial, Dr Macfarlane has been nice enough to tell participants and investigators how to potentially break the masking of the trial so both can tell if participants are taking A2-73 and not a placebo.
“Participants getting side effects, such as dizziness, suggest improvements from the drug, he said.”
Looks like a potential faux pas to me.
https://www.australianageingagenda.com.au/2020/01/31/early-findings-of-alzheimers-drug-trial-show-promise/?unapproved=10398&moderation-hash=3e16534a9c96875ff72e335e7d85f72d#comment-10398
“For example, trial particpant Rosie Craven had lost confidence and enjoyment in many areas of life before she joined phase three of the study.”
Could they have increased the doses from Phase 2b to phase 3?
“We’ve certainly seen individual patients, who both seem to be getting side effects from the drugs and who have shown significant improvements,” Professor Macfarlane told AAA.”
“Participants getting side effects, such as dizziness, suggest improvements from the drug, he said.
“The fact that they’re getting side effects and they were expected side effects based on what we know about the drug, does suggest that the people who are showing the improvements are on the active drug,” Professor Macfarlane said.”
“The trial is expected to open new sites in Europe and North America in the coming months, he said.”
It’s very likely coronavirus scare related stock trading.
If you don’t think so, just look at NNVC, who imho is a poster child for broken promises on product development timelines and also just sold more shares in a secondary.
Unfortunate timing on the trial status update by Anavex. It happens.
This is probably coronavirus related price action imho. Algorithms at work?
First off endpoints being hit or missed is far from occurring at this point. The last patient is enrolled, the last patient completes the trial, the data from all sites is collected by the CRO, the data is locked, the data is analyzed, the data is presented to the company (if the company was not the one completing the data compilation), management sits down and decides the most positive way to present the data to investors.
If evidence is obvious that endpoints were met it’s easy. We met our endpoints!!! Hurray.
If endpoints are missed then it’s best to offer an explanation of the possible reason for failure and explain how the company plans to proceed.
Here is an example...
“A significant imbalance (4.8 points) in the baseline Severe Impairment Battery ("SIB") scores occurred, by chance, between the Bryostatin-1 treatment group and placebo group," stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer. "After consulting with our Scientific Advisory Board and statistical experts, we were advised that, in a small study such as this, a baseline imbalance could prevent a definitive analysis of Bryostatin-1 treatment versus placebo in SIB scores at the primary (Week #13) and secondary endpoints as provided in the original Statistical Analysis Plan ("SAP")," stated Dr. Alkon.
"Due to the baseline imbalance observed in the study, and because a clear signal of benefit could be observed in the raw data from the pre-specified Moderate Stratum, we conducted a post-hoc analysis using paired data for individual patients, with each patient as his/her own control," stated Kazem Kazempour, Chief Executive Officer of Amarex, Inc., the biostatistician retained to analyze the data from the 203 study under the SAP. “
Then you raise cash by issuing shares with warrants. It can be painful to investors.
If Anavex were to miss endpoints (I said IF) then the easy explanation is to say the doses were below therapeutic doses, we are checking for that in the OLE. Seem reasonable?