Nymox's (NASDAQ:NYMX) enlarged prostate drug (NX-1207) continues to make progress toward approval in Europe and the US. It can be administered in about 10 minutes by an urologist in his office setting, with little discomfort. It does not need to be taken daily. A single dose of NX-1207 showed improvement in Benign Prostate Hyperplasia (BPH) conditions receiving a symptom score of (8-10 points in 90 days). That is double the improvement shown in currently approved BPH drugs (3-5 points); furthermore, NX-1207 doesn't have the sexual, hypertensive, and other side effects of approved medications. A dose lasts for years and with some having no further enlargement for 8 years.
There are several trials of NX-1207 underway now: the first is a Phase III trial, which is for U.S. approval. A second trial underway is also a Phase III trial: it is for European approval.
The third trial is an altogether different matter: it is a Phase II trial to see if NX-1207 might be useful against prostate cancer. (GlobalNewswire updates)
The above mentioned Phase III for U.S. approval has thus far been satisfactory.
The Safety Monitoring Committee's review, dated February 14, 2012 BPH trials indicate no serious problems. But then, there have been no safety concerns in over 8 years these clinical trials. Recruitment for the US Phase 3, the "pivotal trials," of clinical patients are now over 80% complete, and it continues at 80 locations. The total number of patients in trials is now at 980, and, good progress was being made toward full enrollment in the pivotal stage 3 trials. This is encouraging since it seems, in my opinion, the US Stage 3 trials should be over in about 18 months.
In the above mentioned Phase 3 trial for European approval has just started.
On February 21, 2012 Recordati (OTC:RCDTF) and Nymox announced the start of the European Phase III Clinical Trial for NX-1207. The partnership between Recordati and Nymox was signed on 16, December 2010 and included the European Union, Russia, the CIS, the Middle East, South Africa, and the Magheeb area of North Africa. The partnership looks good because Recordati is a large pharmaceutical company with over 2,800 employees. This trial should lead to European approval of NX-1207 - European approvals tend to be much easier than U.S. approvals.
In the above mentioned Phase II trial: to see if NX-1207 is effective against prostate cancer.
On March 1, 2012, Nymox announced the start of a U.S. Phase II clinical trial to see if NX-1207 can treat low grade localized prostate cancer. This clinical trial will enroll 150 men in a 2 dose, 6 week study. This trial is happening because the drug has shown positive activity against prostate cancer cells at a higher dose then current trials. There is an unmet need for a safe and effective treatment of low risk localized prostate cancer without the potential side effects associated with current treatments. I am excited about the potential of this trial because the drug already works on BPH and should it work on prostate cancer- it could, in my opinion, result in blockbuster potential sales.
In order to finish the US trial of the drug NX-1207, Nymox needs to find some more patients for the pivotal Phase III U.S. study. Then it needs to wait a year to finish the Phase III trial and get the final results. Finally, they need to file for U.S. approval of the drug. All of this will probably take 2-3 years to reach final approval for the U.S. market. Sometime during this time frame, Nymox will need to find a U.S. partner to market and sell the drug. Recordati will market the drug in Europe and many other parts of the World. Perhaps Nymox will need an Asian partner as well. There are millions of men that need an improved treatment for enlarged prostates. In middle aged men and later, 50% of all men develop enlarged prostates- there needs to be another option besides prostate surgery or the current medication with all its side effects.
This chart shows the price range of Nymox over the last 4 months. It has traded over the $7.50 to $8.50 per share range. There has been no dominant trend to speak of. This price represents a value of $266 million on March 22, 2012 according to yahoo.finance. I feel this price represents a fair value of Nymox's current worth. This price should increase as we near the end of the pivotal Phase III trials in the U.S. and Europe. A cure for enlarged prostate should be worth well over a billion dollars in my opinion.
Disclosure: I am long NYMX.