On November 9, 2015 Anavex Life Sciences Corp. (NASDAQ:AVXL) reported positive phase 2a results for the trial treating patients with Alzheimer’s. This trial tested two clinical endpoints. The first clinical endpoint was testing for safety as it is customary with all phase 2a trials. The second endpoint was looking for preliminary clinical efficacy. In terms of safety, the company’s clinical compound Anavex 2-73 was safe and well tolerated in all patients.
In terms of efficacy the drug displayed that it worked in improving patient clinical outcome. The drug was able to score positively with 32 patients in all four preliminary tests measured: •Event-related Potentials •P300 Tests •mini-mental state examination — MMSE •Cogstate battery
All tests came out positive as an early look. One test in particular known as the “Event-Related Potentials” test was very good. That is because it showed that Anavex 2-73 achieved statistical significance. Meaning, that the trial obtained a p-value of p < 0.0007. Why is this p-value a good thing? All clinical trials, that attempt to muster through the FDA, must obtain a statistically significant p-value. While these results are preliminary in nature, it doesn’t dispute the fact that they are positive.
Why the huge drop the same day results were announced? The results weren’t bad but there were a lot of bearish articles that tanked the share price. I would say it is best to ignore those articles as they don’t jump into the science of the results. Instead, they only look at the promotions the company has done in the past. After all, if the results of the PART A portion of the trial were so bad patients wouldn’t have gone on to join the PART B portion.
Other big pharma companies like Biogen and Eli Lilly have been struggling with their Alzheimer’s research. Biogen saw a setback with its Alzheimer’s drug in the phase 1b trial, known as the PRIME trial. This is because the company saw good results using its 3 mg and 10 mg of its drug, but failed to produce similar results in the 6 mg dose cohort. The drug was shown to reduce amyloid plaques in the brain but had no effect on cognition like Anavex did. Eli Lily saw some good preliminary results, but they tested their trials by comparison. That means they took one of their phase 3 trials and compared it with the other. They looked at patients who took treatment early compared to those that took treatment afterwards. If you want to pick a winner in the Alzheimer’s space then Anavex is your best bet based off statistical results to date.
Replies: nice.holding Sophiris,cap is really a joke for a ash111 on 11/23/2015 3:27:39 PM "If you want to pick a winner in Cbdpotential on 11/23/2015 3:30:10 PM
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