By Terry Chrisomalis
Anavex Life Sciences Corp
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.
Sophiris Bio Inc
On November 10, 2015 shares of Sophiris Bio Inc (NASDAQ:SPHS) closed the day up 180% after the company announced positive phase 3 results for patients with BPH. First we must understand what BPH stands for to move further. BPH stands for benign prostatic hyperplasia — enlarged prostate gland. This is a fairly big market as there are about 3 million people in the U.S. each year who are diagnosed with this problem. The phase 3 trial that is treating these patients with BPH uses a drug known as PRX302.
The reason for the huge surge in share price is because the company met on the primary endpoint of the study. The drug demonstrated statistical significance in the International Prostate System Score — IPSS – which was measured by a total score from baseline. The primary endpoint of the study produced an IPSS score of 7.60 versus 6.58 on the placebo side. This means that the drug achieved statistical significance with a p-value of p = 0.043.
The company will now have to run another phase 3 trial with a similar clinical design. Only if the next phase 3 trial comes out positive can Sophiris file an NDA to the FDA for approval of its PRX302 drug. As mentioned above the market opportunity is huge, because this drug could potentially earn the company $2 billion in revenue annually. I think that these positive results should be reproduced again, and the share price should continue to trade up accordingly.
KaloBios Pharmaceuticals Inc
On November 14, 2015, KaloBios Pharmaceuticals Inc (NASDAQ:KBIO) announced that it would liquidate its assets as it could no longer continue operations with the current cash on hand. In addition, the company stated that they would not be able to obtain the proper funding in the amount of time allotted, to continue with other drugs in the pipeline. The whole downward spiral started with two different trials failed to produce meaningful results.
Back in 2014 Kalabios had announced that its Asthma drug, KB003, had failed a phase 2 study. That was a bad setback, but things got worse the next year when the company announced that its phase 2 drug in patients with Cystic Fibrosis had also failed. Both of these failures really hit the company hard but it seemed like it was going to recover until this new liquidation announcement. Beforehand the company announced that it wanted to target new oncology compounds.
The two oncology compounds that were going to be targeted were hematological malignancies — blood cancer of the bone marrow — and Chronic myelomonocytic leukemia — another blood cancer. The hematological malignancies drug was in a phase 2 clinical study, and the CMML study was in a phase 1 study. The lack of money really took this down, as the company chose to liquidate instead of attempt to find funding for the company. Did theytake the easy way out? That’s hard to say for sure, but one thing for sure is that investors have been left holding the bag. The company in charge of this liquidation effort is known as The Brenner Group.
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