Fexapotide BPH Phase 3 Clinical Trial Results Published in World Journal of Urology
HASBROUCK HEIGHTS, N.J., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reports today that the results of Phase 3 clinical studies of Fexapotide Triflutate undertaken from 2009-2016 are now published in World Journal of Urology.
The article is entitled "Fexapotide Triflutate: Results of Long-Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" and is authored by 17 leading U.S. urologists:
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).
The full peer review publication is available online on the World Journal of Urology’s website.
World Journal of Urology is a prestigious top-tier international peer review journal specialized in clinical urology.
According to the new publication, "In conclusion, data from these 4 U.S. studies show statistically significant long-term improvement in BPH symptoms and objective outcomes including significant reduction in spontaneous AUR as well as the addition of BPH surgery;” and “FT is well tolerated with an excellent safety profile. Hence, FT is a safe and efficacious clinic based treatment for BPH involving an intraprostatic injection that requires only a few minutes to administer, with no catheter nor anesthesia requirements. FT injectable represents a novel, first in class BPH treatment modality."
The lead author of the article, Dr. Neal Shore, said, "FT represents a new first in class treatment for patients with lower urinary tract symptoms and BPH. FT administration via direct intraprostatic injection is ideally suited for the urology clinic. The collective trial data demonstrates both short and long-term safety for FT; moreover, the long-term efficacy data demonstrates its major potential as an alternative to conventional daily oral BPH medications."
Dr. Ronald Tutrone, a co-author of the report, said, "The co-authors and urologists with whom I have spoken and who have attended presentations of data are very impressed with the results. I personally know of countless patients who will benefit from this new, non-surgical treatment."
Reprints of the article will also be available later from Nymox upon request after reprints become available from the publisher.
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 recent sectional Annual Meetings in 2017 in Scottsdale, AZ (North Central AUA November 15, 2017); Havana, Cuba (New York AUA November 6, 2017); Naples, FL (South Central AUA November 27, 2017) and Savannah, GA (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.
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Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties 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 clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on Fexapotide, Nymox's commercialization plans and efforts 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 actual results to differ from those expressed in these forward-looking statements, 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.
Source: Nymox Pharmaceutical Corporation
Posted: January 2018