Nymox December 27 Message to Shareholders
Nymox December 27 Message to Shareholders
IRVINE, Calif., Dec. 27, 2023 (GLOBE NEWSWIRE) — Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) is pleased to provide this end-of-the year message to shareholders.
The Company has overall had a good year and we expect 2024 to be an even better year for our Shareholders.
2023 saw our 2nd and 3rd applications for Nymozarfex advance to the level of being accepted for review. While the outcomes from these 2 applications cannot be guaranteed, these are very solid advances for which we are justifiably extremely proud. There has not been a fundamentally new molecular class of BPH treatment approved in decades, so it should be understandable that it takes time and is not an easy task. The Company anticipates a busy year in 2024 that includes the many steps that daily go on in the real world of responding to all the scientific, clinical, administrative, and countless other obligations that need to be fulfilled in supporting these enormous projects.
CEO Dr. Paul Averback said, “We all agree that advancing the business of the Company requires our focus on obtaining approvals for Nymozarfex. We appreciate hearing from you, and we thank you for your enthusiastic and steadfast support.”
Our product has 2 clinical indications that are planned. One is for prostate enlargement (BPH) which is a problem for millions of middle aged or older men throughout the world, and for whom existing options need improvement. Any person with knowledge or experience with BPH will be familiar with the issues involved and the need for better options for these men whose lives have changed for the worse due to BPH. Our Nymozarfex drug is a great improvement and we are doing everything possible to seek its marketing approval. The drug is extremely safe and the effectiveness has been shown in a number of ways. We are hoping to have progress with the authorities and will keep our supporters up to date with all material news. At this point we have received the review questions after the submission initial review and we are involved in the response stage of the first new submission. We expect to receive initial feedback questions from the 2nd new submission early in 2024 but the date is thus far unknown.
The second major indication is for low grade prostate cancer. We have been very busy on this extraordinary advancement. and we hope to have more news for our supporters during Q1 or Q2 of 2024. There is an important potential place for Nymozarfex for low grade prostate cancer. Most men start out with a low grade cancer, and there is a need for a safe and effective initial treatment before the disease advances to where invasive interventions become necessary. Again, individuals with experience with this common clinical condition will be interested in this potentially major step forward.
Prostate cancer is the most common non-skin cancer in men. Approximately 1 in 8 men will develop prostate cancer.
Our clean-up of management in 2023 was a much-needed improvement, and we are delighted to have had the essentially unanimous support of shareholders in the termination of employees and agents who were involved in extreme and underhanded malfeasance, which we have already communicated. There is litigation involved and when there is material news as always, we will provide it in a timely manner.
The normal Annual General Meeting will occur in the near future after a temporary delay.
Nymox is in the process of submitting applications for the approval to market the Company’s first in class drug NYMOZARFEX (TM) 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, 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 (TM) for the treatment of low grade localized prostate cancer. The available long-term data newly assessed, confirmed that all available data shows that the NYMOZARFEX (TM) treatment had important and statistically significant benefit for reducing the long-term progression of these prostate cancers.
About NYMOZARFEX (TM) (Fexapotide)
NYMOZARFEX (TM) 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 1750 patients with over 1600 injections administered including over 1200 NYMOZARFEX (TM) administrations. NYMOZARFEX (TM) has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments.
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Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on Fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2022, and its Quarterly Reports.
For Further Information Contact:
Nymox Pharmaceutical Corporation 1-800-93NYMOX