On October 9, 2018 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported its important new long-term clinical trial results from the Company’s 146 patient Phase IIb NX03-0040 Fexapotide (FT) U.S. study for low grade localized prostate cancer (Press release, Nymox, OCT 9, 2018, View Source [SID1234529926]). All patients in the 78 month study had greater than or equal to 56 months from the time of enrollment, with a range of 56 to 78 months. After 78 months, the data shows that men who received the high dose Fexapotide 15mg single dosage treatment had a 73% reduction in the need for surgery or radiotherapy associated with much more favorable biopsy Gleason results compared to controls (p=.0024). There were 5% patients in the entire Fexapotide group (high dose and low dose) who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81% (p=.0037).
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In the low grade localized prostate cancer trial reported today, Fexapotide triflutate (FT) was administered by a single painless injection directly into the prostate in a simple procedure requiring several minutes or less in an office setting without sedation or anesthesia, and guided by routine ultrasound. FT was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040. The patients were then biopsied after 6 weeks and then every 18 months, along with serial PSA measurements and long-term follow-up. After 78 months of study, high dose FT 15mg single treatment resulted in 73% less surgery or radiotherapy associated with Gleason grade progression (p=.0024), and both doses of FT (15mg and 2.5mg) as a group were overall effective (p=.0037). The 15mg dose was more effective than the lower dose. There were 5% patients in the entire FT group who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81% (p=.0037). After 78 months all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 65.4% (p=.0014) in FT 15mg treated patients compared to the randomized control group. Numerous other parameters were significantly better in the FT treated groups compared to controls. Study NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S. with 146 men with the biopsy confirmed diagnosis of T1c prostate cancer, which is the most common type of low grade localized prostate cancer.
The Company expects to publish full details from this prostate cancer trial in peer review publications as well as participation in upcoming scientific presentations.
Paul Averback, CEO of Nymox, said, "These exciting new results confirm and expand the evidence for the beneficial long-term effect of a virtually painless and safe minimal administration of Fexapotide Triflutate to men with low grade localized prostate cancer. The risk of prostate cancer progression is very significantly reduced in these U.S. clinical trials, based on objective evidence from biopsies and surgery. It is important to emphasize that Fexapotide has also been shown to be associated with a major reduction in the incidence of new prostate cancer in men suffering from BPH (benign prostatic hyperplasia). This additional evidence comes from patients who received FT for their BPH in Nymox’s long-term studies of 977 men with BPH in the U.S. as part of Nymox’s pivotal Phase 3 BPH clinical program. Both 1) the long-term data reported here today involving treatment of biopsy established low grade localized cancers, and 2) the long-term prevention of new confirmed cancer in BPH patients reported previously, together indicate that FT has shown significant efficacy in men for the treatment and prevention of prostate cancer, without the risks and undesirable side effects generally associated with treatment of these conditions."
Dr. Averback added, "These strong results clearly support Management’s ongoing efforts to advance both of the Company’s 2 major clinical programs towards marketing goals. Nymox has taken the first steps toward an anticipated meeting with regulatory authorities concerning planning for registration trials for low grade prostate cancer. There is a global unmet medical need for more effective prostate treatments without the undesirable risks and often permanent side effects of current treatments."
The Company recently published and reported on the long-term safety of re-administration of Fexapotide based on re-injection studies NX02-0020 and NX02-0022 involving 344 men given Fexapotide re-injections in 2 Phase 3 multi-year re-injection safety trials. Re-injection safety data is a key necessity for injection treatments. It is expected for prostate cancer treatment that follow-up and intermittent re-treatments will be needed and desirable for many if not the majority of men who require treatment.
Low grade localized prostate cancer (T1c) represents approximately half of prostate cancers that are diagnosed, and is a very common treatment problem. The Nymox study reported today involves patients with initially Gleason grade 3+3 or lower. These patients are found to have these tumors by biopsy which is usually instituted after finding abnormalities in PSA levels, and/or after abnormal digital rectal examination of the prostate, and/or after the patient has experienced lower urinary tract symptoms or other changes.
Low grade localized prostate cancer represents a therapeutic challenge. Because of its slow growth and low initial level of malignancy, doctors and patients are often reluctant to proceed to invasive surgical treatments or radiotherapy due to the unpleasant and often permanent side effects these treatments cause in the genitourinary tract, such as sexual functional issues and/ or urinary issues. Eventually if and when the tumor progresses, invasive surgical and/or radiotherapeutic procedures become necessary, with greater risk due to the progression. Occasionally the tumors become highly malignant after variable lengths of time. These risks cause understandable anxieties and distress and many men prefer to advance to invasive therapy before running these risks of higher grade cancers.
It is widely acknowledged that a treatment alternative that can destroy or ablate the low grade cancers of the prostate without the dreaded side effects and morbidities, would be a great addition to the armamentarium of the urologist for the benefit of these patients. FT is the leading contender to deliver chemical ablation of low grade localized cancers of the prostate, without major safety risks, and to be capable of safe multiple treatments when necessary. Low grade cancers of the prostate are frequently multifocal and should be expected to require retreatments for the different cancer foci; for cancer foci that are not fully ablated; and for new cancerous foci that develop.
FT is Nymox’s first in class injectable treatment for BPH and low grade localized prostate cancer. The drug is given as a virtually painless injection with no anesthesia, analgesia or catheterization, and is an office procedure which takes a few minutes to administer. FT has been in development for BPH (prostate enlargement) for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 977 U.S. men with BPH to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical BPH program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover FT in the trial, as compared to patients who did not receive FT but instead received crossover conventional approved BPH treatments. The recent results of Phase 3 studies of Fexapotide for BPH were published earlier this year in the World Journal of Urology (May, 2018, Volume 36, Issue 5, pages 801-809) and communicated in numerous podium and symposium presentations to the American Urological Association, most recently at the Annual Meeting of the AUA in San Francisco on May 20, 2018.
Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of prostate cancers are initially considered low risk. One of the major problems with the main current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, brachytherapy) is the relatively high incidence of serious sexual and other problems post-treatment. In 9 studies, Fexapotide treatment has been shown to have a negligible significant adverse effect profile post-treatment and no significant adverse effects on sexual or other functions or testosterone levels.