Dr. Paul Averbac reports
NYMOX ANNOUNCES SUBMISSION OF NEW MARKETING AUTHORIZATION
APPLICATION SUBMISSION FOR NYMOZARFEX FOR BPH
Nymox Pharmaceutical Corp. has made a new formal submission in the United Kingdom for
Nymozarfex for the treatment of benign prostatic hyperplasia (BPH). The marketing authorization application
(MAA) was submitted to the United Kingdom Medicines & Healthcare products Regulatory Agency (MHRA). The new
submission includes England, Wales, Scotland and Northern Ireland.
The company will provide further information, including with respect to other submissions for Nymozarfex,
when the information becomes available.
Dr. Paul Averback, MD, chief executive officer of Nymox, said: "We thank our team members and many very important expert collaborators
for their efforts and perseverance involved in the ongoing process. This product is a major innovation and there is a
great need for men throughout the world to have access to this technology, which is unique. We will continue to
provide updates and all relevant communications whenever appropriate. The company is very grateful for the solid
support of our valued stakeholders."
About Nymox Pharmaceutical Corp.
Nymox is in the process of submitting applications for the approval to market the company's first-in-class drug
Nymozarfex to treat the symptoms of benign prostatic hyperplasia (BPH). BPH is one of the most common
conditions affecting middle-aged and elderly men throughout the world. BPH can be devastating to men who suffer
from the condition. Current treatments are associated with numerous intolerable side effects, including sexual
problems, such as impotence and retrograde ejaculation. Medications for BPH have been associated with prostate
cancer, depression, gynecomastia and other adverse effects. The majority of men stop taking the available
medications due to these and other problems. Surgery is often needed for advanced BPH. Surgery is usually
effective, but it is not without risks and the discomforts of surgery, and BPH surgery has side effects such as permanent
retrograde ejaculation for many patients.
Nymox recently reported 10-year follow-up new data on all available patients from its U.S. clinical trial of
Nymozarfex for the treatment of low-grade localized prostate cancer. The available long-term data newly
assessed confirmed that all available data show that the Nymozarfex treatment had important and
statistically significant benefit for reducing the long-term progression of these prostate cancers.
About Nymozarfex (fexapotide)
Nymozarfex is given in an in-office procedure that is administered in a few minutes without need of
anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1,750 patients with
over 1,600 injections administered, including over 1,200 Nymozarfex administrations. Nymozarfex has led to significant long-term improvements and has shown an excellent safety profile without the side effects
normally associated with existing BPH treatments.
We seek Safe Harbor.
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