Anavex Life Sciences Corp (AVXL)

[polarbear77]

My 2 cents on PD:

I respect your opinion Attila, and you may very well be right, but:

• first, after reading the various published findings and preclinical results from Dr Francardo’s years of research on our a2-73 compound with grants from the MJF Foundation, I have some difficulty believing that the FDA would’ve put the brakes on an IND request to move a US based phase 2 trial forward.

• perhaps with the multi-year Lund University & Dr Veronica Francardo connections and preclinical work being conducted in Sweden, it MAY have been the intention (and professional courtesy?) to conduct the ph2 in the EU all along. Dr M clearly is from Germany and Anavex has a business presence there, right?

• can’t a trial in the EU be designed to achieve US new CNS trial standards as well? Maybe a dumb question.

• and what with the “delay” and why hadn’t they already filed a CTA with the European regulators before now? Well the preclinical results from Lund University / Francardo were not released until 10/30/17.

• And as stated in the 10/30/17 p/r below “Further analyses are ongoing in order to better understand the underlying mechanisms that contribute to the neurorestorative properties of ANAVEX2-73.” Perhaps they did not yet have all of the information needed to file a complete CTA? Further analyses are ongoing... and supposedly you cannot submit CTA’s in December in the EU?

Maybe it was moved from a US trial to an EU trial unexpectedly, although he didn’t say that was the case.

And when we have results that concluded (among other things):

“new results indicate that ANAVEX2-73 has robust neurorestorative effects on the nigrostriatal dopaminergic pathway in all doses tested. The encouraging results we have gathered in this model, coupled with the favorable profile of this compound in the Alzheimer’s disease trial, support the notion that ANAVEX2-73 is a promising clinical candidate drug for Parkinson’s disease.”

Then I’m not sure there’s much KNOWN grounds to compel the FDA to brush an IND aside.... are they not interested ”robust neurorestorative effects....in all doses tested...” for PD patients?

There’s a significant unmet need there. Cruel disease, patients deserve better options; I can’t envision the FDA standing in the way, but anything’s possible obviously.

GLTY


Excerpted from 10/30/17 p/r:

ANAVEX®2-73 Shown to have Neurorestorative Effects in a Model for Experimental Parkinsonism

“The study’s principle investigators, Veronica Francardo, PhD and Angela Cenci, MD, PhD, Professor of Experimental Medical Research at Lund University, Sweden, stated, “These new results indicate that ANAVEX2-73 has robust neurorestorative effects on the nigrostriatal dopaminergic pathway in all doses tested. The encouraging results we have gathered in this model, coupled with the favorable profile of this compound in the Alzheimer’s disease trial, support the notion that ANAVEX2-73 is a promising clinical candidate drug for Parkinson’s disease.”
It was previously shown that ANAVEX2-73 significantly promotes recovery of motor functions (p<0.05), induces higher levels of striatal dopamine fibers (p<0.05) and reduces microglial activation (p<0.05) in a mouse model of nigrostriatal dopaminergic degeneration relevant to Parkinson’s disease.
A consistent abnormality in Parkinson’s disease is degeneration of dopaminergic neurons in the substantia nigra, leading to a reduction of dopamine axon fibers and dopamine levels in the striatum. As tyrosine hydroxylase (TH) catalyzes the formation of L-DOPA, the rate-limiting step in the biosynthesis of dopamine, tyrosine hydroxylase-deficiency levels are correlated with the severity of parkinson-like motor deficits.
The additional data reveals that ANAVEX2-73 not only seems to have a wide dose-response profile but also activates neuroplasticity mechanisms and exerts noticeable neurorestorative effects on striatal dopamine axon fibers. This was confirmed by expression of a marker of axonal regeneration in the striatum, Growth Associated Protein 43 (GAP43), being co-localized with TH, which was only found in the ANAVEX2-73-treated animal cohorts but not in the control cohort.
Further analyses are ongoing in order to better understand the underlying mechanisms that contribute to the neurorestorative properties of ANAVEX2-73.
The study is supported by The Michael J. Fox Foundation for Parkinson’s Research.
“These findings are very encouraging and support our strategy to initiate a randomized and placebo controlled phase 2 study in Parkinson’s disease with ANAVEX2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.”


http://www.anavex.com/anavex-life-sciences-drug-shows-efficacy-to-support-potential-disease-modification-in-parkinsons-disease/