Anavex 2-73 Editor’s Choice for Top Alzheimer’s Drug Trial
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Disclosure: The staff of Alzheimer’s Weekly LLC have no financial or personal relationships with Anavex Corporation. (Disclaimer)
HOBOKEN, NJ – Around the start of 2011, Anavex Life Sciences Corp. filed for Phase I clinical trials of Anavex 2-73 for Alzheimer’s.
Our staff voted it Editor's Choice as the #1 most promising trial drug. It was picked from a field of over 100 trials that treat dementias such as Alzheimer's. We plowed through more than 10,000 articles in the past three years, and Anavex stood out from the pack for its across-the-board satisfaction of our trial criteria.
What sets any one drug apart?
To understand what sets Anavex apart, let’s take a quick survey of dementia research today.
What We Learned from Recent Failures
When speaking of Alzheimer’s, which makes up over half the cases of dementia, the two treatment targets receiving the most attention are:
- Beta amyloid
- Tau
Recently, a lion-sized trial of Semagacestat by Ely Lilly failed. Its target was the beta-amyloid that many believe to be the cause of Alzheimer’s. (See the following video:)
It was a true crash-and-burn, over a decade in the making and ending in a spectacular anti-climax. According to leading researcher, Dr. Paul Aisen of the University of California, (Click here for the complete transcript),
“…this was a large treatment study, with thousands of participants. And, in such a program, you follow the data. You have an independent group monitoring the trial and monitoring the data, both for safety and for impact of drug on memory. And this monitoring led to the conclusion that the drug was carrying a risk, a risk of skin cancer, and wasn't improving memory.”
When one looks beyond this statement, beta amyloid and tau are still the most serious long-term targets.
As for their viability as near-term targets, there is industry-wide corporate silence. We need to look elsewhere for near-term treatments.
What Treatments Have Near-Term Potential?
When we research and review drug trials today at Dementia & Alzheimer’s Weekly, here are the top criteria worthy of attention:
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Small molecule drugs. These offer:
- Ease of production
- Low cost
- Access to intracellular targets, common to dementias such as Alzheimer’s
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Oral bioavailability
- Drugs in the form of a pill
- Easy to swallow
- OK to take at home
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Disease-modifying agent
- There are four available drugs for dementias such as Alzheimer’s. All four treat the symptoms but are not “disease-modifying.” They compensate for what is missing due to dementia without actually fixing anything. The famous maxim says, “Feed a man a fish, you have fed him for a day. Teach a man to fish, you have fed him for life.” So to, feed the brain what’s missing, you have fed it for a few hours. Fix the brain’s dementia, you have fed it for life. We need to fix this.
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Multiple pathways
- The biochemical cascade that results in dementias such as Alzheimer’s results from a lot of little things going wrong over the course of many years. In other words, it is caused by multiple pathways. Therefore, a good treatment should treat multiple pathways.
- There is a general consensus that to really beat dementias such as Alzheimer’s, we must find something that attacks the culprits on multiple fronts.
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Near-term availability
- New, untested treatment pathways hold near-term potential.
- Older, tested treatment pathways, such as Amyloid and tau, appear to have exhausted any near-term potential.
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Human trials
- A drug not in human trials is at least five years away from availability. Our readers are interested in what can be done for people living with dementia now. A drug trial needs to be at the stage where people are using the drug for it to be relevant.
Which Trials Are Most Promising?
There are a number of trials that satisfy many of these criteria and we are hopeful that great breakthroughs will come from them.
There are even drugs that satisfy ALL these criteria. Two that rise to the top are:
- Prana’s PBT2
- Anavex’ 2-73.
PBT2 holds the potential to be a true breakthrough, taking its own approach to combating dementias such as Alzheimer's.
A possible cloud in the forecast is PBT2's basis on the science of chelation. Scientists know a lot about chelation because people with atherosclerosis (plaque buildup in arteries) have been using it for 30 years. Notwithstanding, The American Cancer Society associates chelation with a long list of potentially dangerous complications.. Even with this concern, the PBT2 forecast looks sunny and bright, notwithstanding our awareness of the chance for unexpected thundershowers.
Anavex 2-73
That leaves us with Anavex vying for the number one spot. Here’s what we know about Anavex:
- It improves memory in animals
- It exceeded Aricept®’s efficacy in animals
- It offers some protection to the brain’s neuronal system
- It hits multiple non-amyloid, non-tau pathways
- Disease-modification has been demonstrated in some cases
- It’s an oral pill based on a small molecule
Most importantly, this week it filed for entry into human clinical trials. Phase-I work with human volunteers is scheduled to begin shortly. A Phase-IIa study in patients with Alzheimer’s and Mild Cognitive Impairment is currently scheduled to begin in mid 2011.
“The Phase-I study will be comprised of a total of 24 healthy human volunteers to allow us to test the maximally tolerated dose, pharmacokinetics, pharmacodynamics, safety and bioavailability of ANAVEX 2-73,” said Dr. Angelos Stergiou. As President of Genesis BioPharma Group, he is the Clinical Research Physician leading the Anavex trial. The trial is in collaboration with ABX-CRO and The University of Dresden.
Dr. Cameron Durrant, Chairman of Anavex, said, “This regulatory filing marks an important milestone in the clinical development path for ANAVEX 2-73 and our strategy to aggressively complete a Phase-I-and-IIa study in healthy human volunteers and patients, respectively.”
This means that Anavex is finally out of the gate and running. It is out of the lab and in the clinic, undergoing trials on real people to help their Alzheimer’s.
All that’s left is to add our prayers.
Related Videos & Articles
More Information
About Prana Biotechnology and PBT2
Aging often results in disease and illness from pathological interactions between certain metals and target proteins. Prana developed a library of chemical compounds to fight against such interactions, by preventing aggregation and corruption of proteins.
Prana Biotechnology's mission is to develop disease modifying therapeutics for the treatment of common neurological disorders. Prana's fpcus is on Huntington's, Alzheimer's, and Parkinson's.
Anavex 2-73 and Sigma-1 Receptors
Sigma receptors are a unique family of proteins, mainly in the CNS (Central Nervous System - that is, the brain and spinal chord). Receptors are classified as two subtypes: the sigma-1 and sigma-2. They can be told apart pharmacologically, functionally and by molecular size. Sigma-1 receptors have been cloned and are distinct from any known receptor class.
Sigma receptors in the CNS are involved in the modulation of neurotransmitter receptor function as well as neurotransmitter release and response. They are also involved in memory and learning processes, where they demonstrate potential neuroprotective and anti-amnesic properties. Modulatory action as well as the implication of many biochemical & cellular signaling pathways suggest sigma receptor s may be involved in many neuronal processes.
Anavex 2-73 is a novel sigma 1 receptor agonist. It targets Alzheimer’s.
Anavex 2-73 mode of action: In Alzheimer's, ANAVEX 2-73 has a best-in-class profile. Anavex is our staff’s #1 pick for most promising drug in a clinical trial. The choice was made from a field of over 100 active trials seeking to treat dementias such as Alzheimer's. Validated animal models have demonstrated its potency. To date, it has exhibited no toxicity in animal testing. It has been shown to blunt and oxidative stress, endoplasmic reticulum (ER) stress and mitochondrial stress. It treats via a novel mode of action
Preclinical Trial Results: Anavex 2-73 in vitro and in vivo mice-based studies have demonstrated behavioral, histological and pharmacological benefits. These include neuroprotection with nerve cell preservation as well as antiamnesic activity.
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In response to the comments below from Bishop and Prodiver, let's take a closer look Curaxis versus Anavex.
Alzheimer's Weekly obviously holds Curaxis' novel approach in the highest regard, as can be seen in the following video and article:
Can Regulating "LH" Halt Alzheimer's?
Both Anavex and Curaxis are conducting outstanding trials that hold great promise for a long list of reasons.
Notwithstanding, the decisive advantage in the Anavex trial is in the category of bioavailability. In plain English, the Curaxis medication requires the patient to get an implant, whereas the Anavex medication requires the patient to merely pop a pill.
There are millions and millions of people who could use a better way to treat Alzheimer's. Given that, there is no minimizing the importance of the ease and cost-effectiveness in making a potential medication available on a mass scale.
Curaxis has a lot of winning attributes, addressing Alzheimer's via multiple pathways.
Anavex shines in its simplicity.
May they both prove to be fantastic breakthroughs.
I agree with the last comment, this article didn't go very far on the competitive landscape...
One company is already having very good results, is far more advance on the clinical side (human, phase I and phase IIa done) and just secure a financing for its phase IIb: Curaxis Pharmaceutical (ex-Voyager).
Lots of hype on this one right now! Do your homework better next time.
Very surprised you didn't dig deeper. Dr. Mark Smith, who recently was killed, was on the scientific advisory board for Anavex. What you undoubtedly did not find, was that Dr. Smith helped Curaxis (formerly Voyager Pharmaceutical), put 2 and 2 together with Dr. Bowen to find that LH is the culprit. Dr. Smith was the lead scientific advisor from 2001 to about 2008, when Voyager ran out of money. They had statistically significant data. Dr. Smith was going to resume his activities with Curaxis, as they restart phase 2.
If you want the front runner, it's clearly www.curaxispharma.com
I am sure that Prana and Anavex are both very good companies. I do however, find it sickening that Curaxis is not the top candidate. My Grandmother was in the last trial that ended due to monetary issues. Her improvement was outstanding. How can people sit back and not acknowledge the results that came from Curaxis which is already much higher up in the clinical trial stages. I believe that they have the money now to start more clinical trials and that they are about to, but emphasis and GOOD P.R. need to be applied to the company. There is no Public relations to keep people informed of what could possibly be the cure that everyonhe is looking for. Big Pharma companies make Billions off of their drugs and you are telling me that they could not find the small amount of money "small to them" that it would have taken to sustain the trials.
LOOK THE DATA IS THERE IN WOMEN!!!! PLEASE HELP GET CURAXIS BACK UP AND GOING AGAIN AND HOPEFULLY WE WILL FIND A CURE SOONER RATHER THAN LATER. THERE IS NO WAY TO COMPARE A COMPANY "ANAVEX" TO CURAXIS DUE TO THE FACT THAT ANAVEX HAS FROM WHAT I UNDERSTAND ONLY STARTED A PHASE 1 TRIAL. WHOEVER RATED THIS NEEDS TO GO BACK AND LOOK AT HOW MANY DRUGS NEVER EVEN MAKE IT PAST PHASE 1 MUCH LESS SHOW POSITIVE RESULTS IN PHASE 2.
ALSO WE ARE TREATING A DISEASE THAT CAUSES PEOPLE TO FORGET THINGS, SUCH AS TAKING A PILL EVERYDAY AT A CERTAIN TIME. THE ANAVEX PILL IS JUST ANOTHER THING A PATIENT WITH DIMENTIA HAS TO REMEMBER. WITH CURAXIS AN IMPLANT WOULD OFFER FAMILY AND FRIENDS COMFORT AND EASE KNOWING THAT THERE PATIENT IS GETTING THE DOSE OF MEDICINNE THAT THEY NEED EVERYDAY WITH NO CHANCE OF FORGETTING TO TAKE A PILL.