Inovio Pharmaceuticals (NASDAQ:INO)
On Monday June 20, 2016 Inovio Pharmaceuticals along with one of its subsidiaries Gene One Life Sciences have received authorization from the FDA to begin a first ever trial in humans targeting the Zika Virus. This is a monumental event, because it will the first trial ever to begin treating humans with the Zika Virus. While it is good that Inovio is starting the trial, it has a long way to go before it can ever reach FDA approval.
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That is because the company is starting off with the typical phase 1 clinical trial targeting patients with the Zika Virus. This trial will use the company’s vaccine GLS-5700, which showed remarkable pre-clinical results. In pre-clinical trials the vaccine was sufficient enough to illicit T-cell responses in both small and large animals. Although, the company achieved positive results in animals it doesn’t mean that it will translate to positive results in humans.
In addition, the first phase 1 trial will primary assess the safety of the vaccine. While the phase 1 trial will test some efficacy based on T-cell response, it won’t translate into actual results against the Zika Virus itself. Therefore investors will probably have to wait until a phase 2 trial is completed to fully understand how well the vaccine combats the virus. On top of it all, the first study will enroll approximately 40 healthy patients to test out the vaccine response.
It will also be a dose finding study, meaning that the company will try to determine what the best dosage would be to achieve clinical efficacy in a larger phase 2 trial. The Zika Virus has swept the nation by surprise, and has been gaining ground since. It is estimated that the virus has spread to over 58 countries worldwide and is responsible for a host of many symptoms in patients. The good news is that investors won’t have to wait long to see the results for the first trial. Results from the phase 1 clinical trial is expected before the end of the year.
Nymox Pharmaceutical Corporation (NASDAQ:NYMX)
On June 23, 2016 shares of Nymox Pharmaceuticals soared by 32% after the company announced positive 7-year results for its lead drug candidate fexapotide or NX-1207. The 7 year trial tested 995 men with prostate enlargement — BPH. Before patients were entered into the trial they had to be tested for prostate cancer. Those who tested positive for prostate cancer, were not allowed to enter the study. That’s because the study was testing the men to see if the drug, NX-1207 could reduce the incidence of prostate cancer in these men.
The data was nothing short of amazing, because the drug was able to reduce the incidents of men with prostate cancer, compared to those who only took placebo. The data was statistically significant, and showed that the rate of men getting prostate cancer with BPH was only 1.3%. On top of having the drug being used for phase 3 BPH patients, Nymox also is using the drug for a phase 2 clinical trial in patients with prostate cancer. Earlier in the year, the company posted positive results using NX-1207 in patients with prostate cancer, meeting on the endpoints of the study.
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Investors who get in early on this may have a big opportunity to capitalize on some nice gains. The company’s market cap currently is at $161 million, but with the two positive results it has seen to date it should be much higher. While the phase 2 trial in prostate cancer needs to branch off into a phase 3 trial, the BPH trial has already met the primary endpoints in phase 3. That means that investor risk is reduced here, and it may not be a bad idea to take a look at this name.
[Image Courtesy of Wikimedia]