Nymox Pharmaceutical (NASDAQ:NYMX)
On July 27, 2015 Nymox surged as high as 100% after the company reported positive phase 3 results for its BPH study. BPH stands for benign prostatic hyperplasia, and is characterized by an enlarged prostate gland. This enlarged prostate gland causes problems such as problems of urinating or the need to urinate often.
Both phase 3 trials used Nymox’s drug known as NX-1207 — also known as fexapotide triflutate. Both of these phase 3 trials are extension studies and both were able to produce positive efficacy results for these patients. Both studies met the primary endpoint of being statistically significant over the placebo compound in each trial.
The NX-1207 drug and placebo compound were compared using a measurement score known as the AUA BPH symptom score. About 64% of the patients achieved a statistically significant higher score than those of the placebo patients. What makes these results even more impressive is that these patients only received one injection in a two year period and were able to achieve efficacious results.
With these results on hand Nymox can now talk with both the FDA and EMA — two regulatory authorities — and seek approval from each respective territory. Why on earth did the share price for Nyxom surge 100% in one day? Not only did NX-1207 achieve high efficacy but it did so with limited treatment necessary as compared to standard of care. Current treatments for BPH require a patient to have to take a pill everyday for the rest of their lives.
On the other hand NX-1207 only requires one injection that can last for a few years. Think about what option a patient would like to choose for their treatment? Pay for pills every month from a local pharmacy or go once to a doctors office for single injection. Most likely than not most patients would choose to receive a single injection that would work in the body for several years. There are about 3 million people in the U.S. diagnosed with BPH each year. Therefore the market is huge and Nymox has the ability to capitalize on a pretty big market for this indication.
Galena Biopharma (NASDAQ:GALE)
On July 29, 2015 Galena ended the day up around 5% after it had announced the launch of its new anti-nausea drug known as Zuplenz. Zuplenz is an oral soluble film that helps reduce nausea and vomiting in patients that receive toxic chemotherapy cancer treatment. Although this drug product helps with other toxic cancer treatments as well. As we all know current chemotherapy drugs may or may not clear the cancer but they definitely kill every white blood cell in the body.
This killing of good and bad white blood cells leads to nausea, vomiting, and other complications. More specifically Zuplenz helps with three types of toxic treatments: Chemotherapy-induced nausea and vomiting, Radiotherapy-induced nausea and vomiting, and post-operative nausea and vomiting.
Zuplenz is a type of formulation that is similar to a current anti-nausea drug known as ondanestron. Galena states that it will make available two different doses in which patients can take. The company will be able to supply 4 mg and 8 mg of Zuplenz to patients.
What makes this Zuplenz product superior to current therapies? Well for starters Zuplenz is taken as a film that a patient puts in their mouth and then dissolves in 10 seconds or less. No more having to swallow pills for that Nausea. In addition Zuplenz has some additional advantages over other medications as well such as:
- No drowsiness seen after taking it
- Is created with a fresh peppermint flavor to avoid nasty sour taste
- Drug can be taken without the need for water
- No nasty aftertaste like other drugs have
It is too early to see how patients and doctors respond to this type of treatment but with the clear advantages Zuplenz provides over current therapy ondanestron it will take a huge chunk of the market. Galena has this marketed drug along with other therapeutic pipeline drug candidates like its breast cancer vaccine Neuvax currently in a phase 3 clinical trial.
Synergy Pharmaceuticals (NASDAQ:SGYP)
On July 30, 2015 Synergy shares closed the day up 5% after the company announced positive results for its phase 3 trial in patients with Chronic Idiopathic Constipation — CIC. This was the second phase 3 study the company had initiated to provide efficacy of its drug compound Plecantide against a placebo. This phase 3 trial recruited 1,337 patients with CIC and were split into different dosing groups.
One group of CIC patients were provided with a lower dose of 3 mg of Plecantide, and the other group of patients were given a higher dose of 6 mg of Plecantide. What made the results of Plecantide so great? Well for starters both the 3 mg and 6 mg of Plecantide were superior to the placebo compound. Matter in fact patients on the drug obtained a 20% durable response rate compared to placebo patients who only obtained an 8% durable response rate.
The only serious adverse event observed in the Synergy drug Plecantide was diarrhea, which was slightly higher than placebo. Despite Plecantide having a slightly higher rate of diarrhea over placebo patients shouldn’t be a huge burden for the company. Synergy’s drug managed to achieve a higher efficacy over its placebo counterpart and a higher rate of diarrhea is not a huge cause for concern from the FDA. Now Synergy will have to meet with the FDA to determine an NDA filing date to attempt to gain regulatory approval for Plecantide in the CIC indication.