In the past two weeks, we’ve received two very important developments in the fight against Alzheimer’s disease — one good, one bad.
I’ll begin with the bad.
On Tuesday, drug giant Eli Lilly announced it was halting development of its late-stage Alzheimer’s drug, Semagacestat.
According to Lilly's press release: “Patients taking Semagacestat saw their cognition, or memory and reasoning skills, and their ability to complete daily living activities like getting dressed worsen ‘to a statistically significantly greater degree’ than patients taking a placebo.”
A Forbes report published yesterday — The Man Who Predicted Eli Lilly’s Alzheimer Failure — explains what may have went wrong:
Eli Lilly is one of numerous drug companies, including Pfizer, Elan, Bristol-Myers Squibb and others, who are betting that stopping production of amyloid clumps in the brains of Alzheimer’s patients will slow the disease. All along, a handful of researchers have predicted that amyloid-blocking drugs could actually make the disease worse. One critic is Mark Smith at Case-Western-Reserve University in Cleveland. He is on vacation abroad now, but here is what he said in 2008:
Others say the Alzheimer’s field has it backwards. Far from being harmful, amyloid is “actually a response to injury that the brain secretes to protect itself, like a scar,” argues Mark Smith, a neuroscientist at Case Western Reserve University. By removing it, “you will make the disease worse.” Amyloid deposits are often found near cerebral blood vessels, hinting that amyloid may act as a sealant for damaged blood vessels.
If you recognize the name Mark Smith, that’s because Dr. Smith joined Anavex’s scientific advisory board in February 2009.
And that brings us to the good news regarding a biotech stock we’ve covered in these very pages for the last couple years...
Last week, Anavex Life Sciences (AVXL-OTCBB) announced details of its upcoming Phase I/IIa clinical tests.
This development is a huge achievement for the company, and for its sigma receptor approach for treating and preventing Alzheimer’s.
The trial will take place in Germany, using human volunteers. Most of the data will be oriented toward safety, but some information about the effectiveness of the drug will also be generated via the IIa tests.
Anavex Chairman Dr. Cameron Durrant, who I spoke to, expects results to be available next year.
The companies involved are, specifically, Genesis BioPharma Group and ABX-CRO. Both companies are experienced in this field of research, and their methods are in compliance with FDA standards.
According to the Anavex announcement:
"Selecting Genesis and ABX-CRO to advance ANAVEX 2-73 to the clinical research phase is a major milestone for us," states Dr. Cameron Durrant, Executive Chairman of Anavex. "Both partner organizations have a strong track record of conducting and managing, successful pre-clinical and clinical studies in Alzheimer's disease, including regulatory approaches. Genesis' competence in constructing and managing a strong and well thought out study plan makes them an ideal partner for ANAVEX 2-73. Furthermore, we have been impressed with the expertise ABX-CRO has demonstrated in the conduct of Phase I/IIa studies and their excellent relationships with leading academic centers."
Phase I dosing of healthy human volunteers with ANAVEX 2-73 is scheduled to begin this year, followed by Phase IIa work in early 2011 which is expected to provide some initial patient efficacy data.
There are many reasons why I’m confident in Anavex's prospects.
One is that prior animal tests (on rats, mice, and dogs) of ANAVEX 2-73 showed real benefits at very low doses.
Obviously, a drug that works in extremely low doses provides far more dosing and testing options. With lower doses, safety issues are more easily addressed. Moreover, it means that costs are lower and margins are greater when a drug comes to market.
We have seen several Alzheimer’s clinical trial failures this year, with Medivation being the most visible.
This has increased the media and investor exposure to Anavex’s sigma receptor research, which is emerging as a revolutionary platform to treat Alzheimer’s, as well as other diseases like cancer.
This may be one reason why Avanex’s stock has not only been stable during this year’s market volatility, but is up dramatically for 2010.
Take a look:
I’ve recently spent a couple days talking and meeting with the scientific team of Anavex.
I will have a more thorough report for you in September.
In the meantime, Anavex is strong buy at current levels under $4 a share.