On April 21, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported the recent allowances of 4 new different US and international patents concerning the Company’s prostate enlargement and prostate cancer treatments (Press release, Nymox, APR 21, 2020, View Source [SID1234556462]). The new US and international patents that have been allowed are further expansions of Nymox’s intellectual property covering the Company’s prostate treatment technologies.
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Nymox CEO, Dr Paul Averback stated, "Intellectual property is one of the backbones of the biopharmaceutical industry. We are therefore very pleased to report that another 4 patents have recently been allowed. During the past year a total of 10 new patents have been allowed which adds to the Company’s very strong intellectual property position for the future. Nymox continues with intensive work to maximize our IP portfolio for the long-term value and strength of the Company’s proprietary foundations."
Dr. Averback added, "Operationally at the present time, our employees are doing very well and are following the prescribed guidelines in their area, including working remotely, where necessary. On a different note, we are also extremely pleased with the reactions and feedback we are receiving from multiple sources with regard to the recent (Feb 2020) peer review journal article in the World Journal of Urology (View Source) documenting the very promising clinical results of Fexapotide Triflutate in treating men with early prostate cancer. We look forward to advancing this program into pivotal registrational trials."
The recent peer review publication is entitled "Prospective Evaluation of Fexapotide Triflutate Injection Treatment of Grade Group 1 Prostate Cancer: Four Year Results". The authors are Neal Shore, Myrtle Beach, SC; Steven A. Kaplan, New York, NY; Ronald Tutrone, Baltimore, MD; Richard Levin, Towson, MD; James Bailen, Louisville, KY; Alan Hay, Salem, OR; Susan Kalota, Tucson, AZ; Mohamed Bidair, San Diego, CA; Sheldon Freedman, Las Vegas, NV; Kenneth Goldberg, Lewisville, TX; Frederick Snoy, Albuquerque, NM; Jonathan I. Epstein, Baltimore, MD.
The Fexapotide (FT) prostate cancer study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites. Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years. Patients randomized to FT were treated with a single one-time targeted injection of FT, either 2.5mg or 15mg. Statistical comparisons were made over time of the proportions of subjects and untreated controls who progressed to higher Gleason grade and/or invasive treatments instituted with prostatectomy, radiotherapy, or chemotherapy. Important clinical highlights from the study include:
FT treatment reduced cancer progression (-67.7%) compared to controls (3 years, FT 15mg, p<.02, pooled FT p=.0265).
FT treatment group had reduced (-54.7%) incidence of surgery, radiotherapy or chemotherapy (4 years, FT 15mg p<.02; pooled FT p=.0374).
At 4 years the incidence of surgery, radiotherapy or chemotherapy with increased Gleason grade was significantly reduced (FT 15mg -73.3% p=.0059, pooled FT p=.0064).
Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg). Safety data showed no serious adverse events related to FT during the study.
FT is a pro-apoptotic proprietary drug which promotes natural programmed cell death (apoptosis) in prostatic glandular cells which compose the prostate cancer. FT has been safely administered to men in clinical trials in the U.S. involving over 1700 patients and controls treated for BPH or prostate cancer. FT has completed Phase 3 studies for BPH and further studies of FT for prostate cancer are planned in the near future.