Nymox Pharmaceutical Corporation has announced positive results regarding the positive safety profile of NX-1207, phase 3 testing for benign prostate hyperplasia (BPH)). BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and
quality of life and can lead to acute urinary retention, incontinence, and other serious consequences. It is estimated that "50% of men in their fifites have pathological signs of prostatic hyperplasia and from 26%-46% of men between the ages of 40-79 suffer from moderate to severe urinary problems and symptoms associated with the condition."
Recent pharmacokinetic studies using a newly developed highly sensitive blood test for NX-1207 have shown that the drug is undetectable in the blood post-injection, providing strong evidence that the drug, once injected into the prostate, remains confined to the prostate and thus unable to affect other organs such as the liver, kidneys, heart, or testes. These results are consistent with the pharmacological profile of the drug and
with the extensive body of safety data from the more than 1,000 men treated with the drug to date demonstrating the absence of any significant drug-related side effects.
In addition, men treated with NX-1207 have not displayed any signs of an allergic or other immune reaction to the drug either on first injection or repeat injection. Extensive clinical immunogenicity testing of men in the Company's pivotal Phase 3 trials (NX02-0017 and NX02-0018) and Phase 3 repeat injection safety studies (NX02-0020 and NX02-0022) have found no evidence of anti-drug antibody formation after exposure to the drug. The Company will present more detailed scientific data from these studies at upcoming medical conferences.
Up until now, side effects from FDA approved drugs for BPH have been known to cause serious side effects including as impotence, decreased libido, ejaculation disorders, and male breast enlargement. However, Nymox reports that none of these have occurred in clinical trials (to date) involving NX-1207. Nor has it shown any increased risk of high-grade prostate cancer often associated with some approved BPH drugs. In fact the company states that “the area of the prostate targeted with NX-1207 treatment showed less prostate cancer progression with less radiation and surgery due to cancer progression as compared to controls in the recent NX03-0040 Phase 2 localized prostate cancer trial.