Nymox Reports 5-Year Results From Prospective Randomized Controlled Prostate Cancer Study of Fexapotide Triflutate in 146 U.S. Men
2018-01-22 · Nymox Corporation · original nymox.com ↗
For Further Information Contact: Paul Averback Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.com For Immediate Release: Nymox Reports 5-Year Results From Prospective Randomized Controlled Prostate Cancer Study of Fexapotide Triflutate in 146 U.S. Men Fexapotide Single-Treatment Leads to Long-Term 80% Reduction in Surgery and Radiotherapy Related to Tumor Progression; and 81.3% Reduction in Incidence of Primary Pattern Gleason Grade Increase Compared to Control Group HASBROUCK HEIGHTS, NJ (January 22, 2018) Nymo x Pharmaceutical Corporation (NASDAQ: NYMX) reported today top-line 5-year results from Ny mox's U.S. Study NX03-0040. Study NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S. comprising a highly representative sample of 146 men with the biopsy confirmed diagnos is of T1c prostate cancer, which is the most common type of low grade localized prostate cancer. After 5 years, the study has now shown that high dose Fexapotide 15mg single dosage treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and that both doses of Fexapotide (15mg and 2.5mg) were consistently effective (p=.0003). There were 4.4% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3% (p=.0061). Paul Averback MD, CEO of Nymox, said, "These major new results show the beneficial long-term effect of a single injection of Fexapotide Triflutate. The results are expected to be even better with regimens of additional or multiple treatment administrations if required." In the studies Fexapotide triflutate was administered by a single painless injection directly into the prostate requiring several minutes or less in an office procedure guided by routine ultrasound. The drug was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040; and repeated biopsies every 18 months, serial PSA measurements and long-term follow-up were performed on all consenting treated patients and controls. After 5 years of study, high dose Fexapotide 15mg single treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and both doses of Fexapotide (15mg and 2.5mg) were consistently effective (p=.0003). There were 4.4% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year st udy, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3% (p=.0061). The new study results also indicated that after 5 years of study, all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 69.8% (p=.0002) in Fexapotide 15mg treated patients compared to the randomized control group. Dr. Averback added, "Eight years of other related U.S long-term Phase 3 BPH studies of Fexapotide have shown reduction in new prostate cancer inci dence to 1.2%, compared to previous large BPH studies of earlier drugs where the incidence of prostate cancer is in the 10-20% range. There are therefore 2 different long-term Fexapotide progr ams which have now each independently shown that Fexapotide has a significant and highly beneficial effect for men with prostate cancer." NEWS RELEASE "These strong results clearly support Management's ongoing efforts to advance both of the Company's 2 major projects towards marketing goals. Nymox expec ts to report further on its U.S. development plans for registration trials for low grade prostate cancer. There is a global unmet medical need for more effective prostate treatments without the undesirable side effects of current treatments,” he said. 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 problems post-treatment. In 9 studies, Fexapot ide treatment has been shown to have a negligible significant adverse effect post-treatment on sexual function or testosterone levels. 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. Fexapotide has shown significant long-term benefit for prostate enlargement (benign prostatic hyperplasia, BPH). The recent results of Phase 3 studies of Fexapotide for BPH were communicated in podium and symposium presentations to the American Urological Association at four sectional Annual Meetings in 2017 in Scottsdale (North Central AUA November 15, 2017), Havana, (New York AUA November 6, 2017), Naples (South Central AUA November 27, 2017), and Savannah (Northeastern AUA October 12, 2017). The Company has filed for approval for Fexapotide in Europe for BPH for prostate enlargement in 2017, and the filing was validated in September 2017. For more information please contact [email protected] or 800-936-9669. Forward Looking Statements To the extent that statements contained in this press rel ease are not descriptions of historical facts regarding Nymox, they ar e forward-looking statements reflecting t he current beliefs and expectations of mana gement made pursuant to the safe harbor provisions of the Private Secu rities Litigation Reform Act of 1995, including st atements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to tr eat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements invo lve substantial risks and uncert ainties 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 clinic al drug development process, including the r egulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on Fexapot ide, Nymox's commercialization plans and effort s 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 ac tual results to differ from those expressed in these forward-looking statem ents, 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, 2016, and its Quarterly Reports.
The release as fetched from its publisher. nymox.com ↗