19:05:33 EDT Tue 14 May 2024
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Nymox's Nymozarfex MAA accepted for review in U.K.

2023-10-26 10:56 ET - News Release

Dr. Paul Averback reports

NYMOX REPORTS NEW NYMOZARFEX MARKETING APPLICATION IS ACCEPTED FOR REVIEW

Nymox Pharmaceutical Corp.'s recent submission of fexapotide triflutate for the treatment of symptoms of benign prostate enlargement (benign prostatic hyperplasia, referred to as BPH) has been validated by the United Kingdom authorities, at U.K. Medicines & Healthcare products Regulatory Agency (MHRA). The formal review process has now started. The trademarked name for the new product is Nymozarfex. The marketing authorization application (MAA) was submitted Sept. 25, 2023. The new submission includes England, Wales, Scotland and Northern Ireland. The company will continue to provide further information, including other expected submissions, when the information becomes available.

Dr. Paul Averback, MD, chief executive officer of Nymox, said: "We are extremely pleased that the Nymozarfex MAA submission was accepted for review by the U.K. authorities. We again thank our long-term supporters, and all team members and expert collaborators from many disciplines for their solid contributions and steady efforts involved in the ongoing process. There is a great need for men throughout the world to have access to this treatment technology, which is unique. We will continue to provide updates and communications to our valued supporters whenever appropriate."

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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