Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to provide a current January 2020 update on several important corporate activities and achievements since the last update in October 2019.
The Company recently received the necessary information regarding the formatting and content of its upcoming regulatory filings for its Fexapotide Triflutate (FT) first in class injectable drug to treat the symptoms of prostate enlargement (BPH) in men. The Company is proceeding to integrate safety data from its four Phase I and Phase II BPH clinical trials as well as the safety data from Prostate Cancer Study NX03-0040 into the final dataset (that also includes 4 Phase 3 trials) that will be part of the New Drug Application (NDA) submission. The filings seeking approvals in the US and in Europe are now targeted for the first half of 2020 in both jurisdictions. At this point, the Company does not have any barriers to report and does not expect any delays.
Nymox is further pleased to report that another peer review publication (as anticipated in the Company’s October 21, 2019 Press Release) was recently accepted and published in Research and Reports in Urology. This publication discusses the selective cellular ablation capabilities of Fexapotide Triflutate to induce apoptosis (natural cell death) in prostate glandular cells which are a major part of the prostate enlargement which defines benign prostatic hyperplasia. Selective pharmaco-ablation is achieved while leaving the nerve cells and urethra and other nearby tissues (all crucial for normal sexual function) unaffected. In fact, the Company has previously reported a statistically significant improvement in sexual function reported by men treated with FT for BPH in its U.S. Phase III long-term follow up studies.
A fourth new and important peer review article is expected to appear in the near term. Further information will be provided when the new article appears.
Dr Paul Averback, CEO commented, "We are very pleased to provide these positive substantiated updates to shareholders today. Now, after many months of intensive work with our regulatory advisors and experts, we are confident that we have the needed clarity concerning the optimal formatting and content protocols being undertaken. The Company is currently highly focused on expeditiously completing the final legs of its regulatory pre-filing responsibilities.”
The new peer review article reported in January 2020 and published in Research and Reports in Urology provided detailed documentation of the selective pharmco-ablation mechanism of action of FT, demonstrating the highly selective reduction of prostate cells which comprises one of the most important underlying reasons for the highly superior safety and efficacy of Fexapotide.
According to the new paper, "a traditional major challenge for treatment has been to promote or to directly produce tissue destruction that is structurally selective at the microscopic (histological) level, in order to avoid undesirable toxicities and irreparable damage to key adjacent structures. For example, transurethral resection, high energy laser extirpations and other methods may damage prostatic nerves and peri-urethral musculature, with the consequent occurrences of ejaculatory disorders, sexual dysfunction and /or incontinence."
The article further states, “this is the first demonstration of a molecular treatment that can produce structurally significant and focally targeted destruction of prostate epithelial gland growth combined with complete or near complete preservation of key nerves and structural elements in intimate structural proximity to the foci of ablation.”
A review article on the progress in the development of Fexapotide entitled "Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia" authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); and Claus G. Roehrborn, MD (University of Texas Southwestern Medical Center, Dallas, TX) was published in Therapeutic Advances in Urology. 2019;11:1-16.
The clinical trial results for Fexapotide treatment of BPH are published in the World Journal of Urology May 2018, Volume 36, pages 801–809 (https://doi.org/10.1007/s00345-018-2185-y) in a peer review report entitled "Fexapotide Triflutate: Results of Long- Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY); Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA); Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA); Susan Kalota, MD (Urological Associates of Southern Arizona, Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY); Richard Levin, MD, FACS (Chesapeake Urology Research Associates, Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York, NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants, Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS (Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS (Brooklyn Urology, Brooklyn, NY).
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