On November 7, 2017 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported two data presentations which were held on Fexapotide Triflutate studies at the Annual Meeting of the American Urological Association, New York Section in Havana, November 6 (Press release, Nymox, NOV 7, 2017, View Source;fvtc=4&fvtv=6907 [SID1234521687]). The abstract from the presentation is available at [email protected].
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The Podium presentation was given by Dr. Ivan Grunberger MD FACS, Professor of Clinical Urology, Weill Cornell Medical College and Chief of Urology, NYP Brooklyn Methodist Hospital. The paper was entitled "Prospective Randomized Double Blind Phase 3 Long-Term Results of U.S. Studies of Fexapotide Triflutate For BPH." Co-authors of the Podium presentation were Ronald Tutrone MD FACS of Baltimore MD, Mitchell Efros MD FACS of Garden City NY, Mohammed Bidair MD of San Diego CA, James Bailen MD FACS of Louisville KY, Franklin Gaylis MD FACS of San Diego CA, Barton Wachs MD of Long Beach CA, Richard Levin MD FACS of Baltimore MD, Susan Kalota MD of Tucson AZ, Sheldon Freedman MD FACS of Las Vegas NV, Barry Shepard MD FACS of Garden City NY, Jed Kaminetsky MD FACS of New York NY, Steven Gange MD FACS of Salt Lake City UT and Dr. Grunberger of Brooklyn NY.
Dr. Grunberger said, "Our presentation of the long-term data was very well received by the participants at the NY Section AUA meeting today. I received a lot of positive feedback following the presentation, and a great deal of interest in the use of Fexapotide Triflutate for patients with BPH once available."
The symposium "Fexapotide Triflutate: First in Class Injectable for BPH" was chaired by Dr. Tutrone. The other panel members at the Symposium were Dr. Jeffrey Snyder MD FACS of Denver CO, Dr. Kenneth Goldberg MD FACS of Carrollton TX, and Dr. Grunberger of Brooklyn NY.
Dr. Tutrone said, "I see Fexapotide Triflutate as a first line therapy for men suffering from BPH. It is a quick, painless and safe in-office procedure that takes minutes to do, and does not require a catheter. Its long term efficacy is better than oral medications, and there are no sexual side effects."
At the Symposium detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and efficacy for the treatment of BPH was presented. The main presentation was followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.
Dr. Snyder said, "I am most encouraged by the clinical trial data presented at the NY Section of the AUA meeting in Havana, Cuba today. This compound is a novel and effective approach to caring for men with symptoms of an enlarged prostate. It is my opinion that the drug will enhance the therapeutic armamentarium of urologists worldwide and maintain our expertise in the treatment of prostate disease. "
Fexapotide has been filed for approval in Europe and the filing was accepted for review in September 2017. Nymox’s lead drug Fexapotide has been in development 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 995 U.S. men with prostate enlargement 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 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 Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).