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IRVINE, Calif., July 16, 2024 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) announced today that its MAA submission to the Danish Medicines Agency (DKMA) has run out of time and in order to continue will be required to extend the MAA application to DKMA by re-submission with a new fee required. As it currently stands the application “does not meet the conditions of the Medicines Act for issuing a marketing authorization.” Although a great number of questions were resolved by the Company, there remain further responses required that will require additional cycle time. The Company is busy analyzing the approaches that are possible. Nymox cannot guarantee that all questions can be resolved. The Company believes that it has the data required to formulate the required re-submission.
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DKMA required Nymox to develop an assay and method to ensure impurities of Nymozarfex™ are below 0.1%, which was slightly lower than the submission percentage of 0.2%. Nymox collaborators have subsequently succeeded to develop the requisite method, but it took more time than DKMA permitted. DKMA stated: “Once the updated. . .method for ID, assay and related substances with acceptable LOQ of at least 0.1% is available it is expected that all related information in the dossier will be updated as confirmed. . .”;
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DKMA required Nymox to provide evidence that the long term follow up (LTFU) studies were double blinded, and Nymox provided a solid report from an independent audit confirming all LTFU studies were double blinded. DKMA then required additional information to augment the audit certificates already issued by the independent arm’s length audit which confirmed the double blind. Nymox has this information but there was insufficient time left to provide the submission required;
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The Nymozarfex data analysis was found to be robust, but DKMA had remaining major unresolved questions. The Company believes that it has solid answers to all remaining questions, but additional submission cycles are required; and
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There were no significant human clinical trial major safety issues for Nymozarfex.
The Company's MAA to MHRA in the U.K. is in the active process of responses to questions received from MHRA. Nymox will update later in the cycle when appropriate.
About NYMOX
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, the discomforts of surgery, and BPH surgery has side effects such as permanent retrograde ejaculation for many patients.