HASBROUCK HEIGHTS, N.J.—Clinical trials demonstrating the effectiveness of Nymox Pharmaceutical Corp.’s NX-1207 are offering hope for men with two common problems: localized low-risk prostate cancer and benign prostatic hyperplasia (BPH), known more commonly as an enlarged prostate.
According to Nymox’s CEO, Dr. Paul Averback, “Reduced tumor progression in this study suggests that if there is further validation, NX-1207 can potentially become a safe treatment option for men with low-grade localized prostate cancer.”
NX-1207 is in Phase 3 development in the United States and Europe for BPH, a common affliction of middle-aged and elderly men, affecting up to half of men over the age of 50 with symptoms that generally include trouble urinating, frequent urination or pain during urination. The company’s European partner for BPH is Recordati S.p.A.
A recent Phase 2 study for localized low-risk prostate cancer did not affect testosterone levels in treated men. Analysis of testosterone levels post-treatment for men treated with 2.5 or 15 mg of NX-1207 showed no statistically significant change as compared to control active surveillance patients. In more than 1,000 men who have been treated with NX-1207, there has been a favorable sexual profile.
One of the major problems with current prostate treatments for localized prostate cancer, such as radical prostatectomy, external beam radiation and brachytherapy, is the relatively high incidence of reported sexual dysfunction post-treatment. In eight completed studies, NX-1207 treatment has demonstrated that it has no significant adverse effect post-treatment on sexual function or testosterone levels. Previously reported study results showed that patients with NX-1207 treatment had significantly less Gleason grade progression, lower average prostate-specific anitgen (PSA) levels, lower numbers of biopsy cores showing greater malignancy and lower total volume of more malignant cancer compared to controls.
Thus far, NX-1207 has demonstrated a good safety profile as both a treatment for BPH and localized low-risk prostate cancer. In the current trial, a new high dose of the drug (15 mg) was safely used without drug-related adverse effects. NX-1207 has shown safety in repeat injection studies. It reportedly does not lead to immune responses such as antibody formation, which can cause significant drug toxicity and/or limit usage to single treatments because of drug neutralizing effects.
NX-1207 is a “proprietary protein that leads to apoptosis [cell death],” Averback explained. It induces apoptosis in a number of ways. It is administered via what is known medically as a “transrectal injection.” A doctor inserts a probe into the man’s anus to access the prostate. A needle is then threaded through the probe, through which the drug is injected directly into the prostate tissue.
The procedure is performed without anesthesia in a doctor’s office and takes only a few minutes. A major benefit of using the drug is that patients can be relieved of BPH symptoms for a year or more with a single transrectal injection versus having to take a pill every day, which comes with side effects. Surgery is an option but also carries risks and side effects, Averback said.
Current BPH drugs include Alpha-1 blockers (such as Flomax and Cardura), which relax the muscles in the prostate and make it easier to urinate, or 5-alpha reductase inhibitors (such as Proscar and Avodart), which work against male hormones to reduce the size of the prostate. For more severe cases of BPH, prostate surgery is an option.
BPH, one of the most commonly diagnosed diseases in older men, can have a significant negative impact on a man’s health. It is estimated that 50 percent of men in their 50s have pathological signs of prostatic hyperplasia, and 26 to 46 percent of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.
Averback thinks that the Nymox drug will be more effective and less bothersome in terms of side effects than current BPH pills and surgery. The company also believes that doctors and patients will be attracted to the convenience of treating BPH via injection once a year.
The BPH drug treatment market topped $5 billion in 2009, according to Nymox. Flomax sales alone in 2009 totaled $1.5 billion for Boehringer Ingelheim, although less expensive generic BPH drugs are now available.
The American Cancer Society estimates that more than 240,000 men in the United States will be newly diagnosed with prostate cancer annually and more than 28,000 men will die from the disease. Most cases are detected via PSA screening and are usually found to have localized tumors. Surgical removal of the prostate (radical prostatectomy) and radiation therapy with or without androgen deprivation therapy are the most common active treatment options for localized prostate cancer but have significant short and long-term adverse effects, including impotence, urinary dysfunction and other complications.