On March 1, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that a Symposium on Fexapotide Triflutate studies will be held at the Annual Meeting of the American Urological Association Mid-Atlantic Section, in Amelia Island FL March 3 (Press release, Nymox, MAR 1, 2018, View Source [SID1234524310]).

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The symposium, "Long-Term Safety and Efficacy of First in Class Injectable for BPH" will be chaired by Ronald Tutrone MD FACS of Baltimore MD. The other panel members at the Symposium will be Mohamed Bidair MD of San Diego CA, James Bailen MD FACS of Louisville, KY and Richard Levin MD FACS of Baltimore MD.

The clinical trial results for Fexapotide treatment of BPH were recently published in the World Journal of Urology (View Source) in a peer review report entitled "Fexapotide Triflutate: Results of Long-Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" which was authored by 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). Please see also NCBI PubMed.gov; MDLinx; Reuters Health Information Feb 20, 2018; Medscape Urology News & Perspective; and others, re the World Journal of Urology peer review report on the Fexapotide trials.

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).

The Symposium will present detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and significant efficacy for the treatment of BPH. In addition, scientific data supporting the safety and efficacy from non-clinical and laboratory testing and analysis will be demonstrated. The main presentation will be followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

For more information please contact [email protected] or 800-936-9669.

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.

On March 1, 2018 Varian (NYSE: VAR) reported that Gary Bischoping, chief financial officer, and J. Michael Bruff, senior vice president of investor relations, will present at the Barclays Global Healthcare Conference in Miami, scheduled for 9:00 a.m. ET on March 14, 2018 (Press release, Varian Medical Systems, MAR 1, 2018, View Source [SID1234524331]).

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Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/inv­estors.

On March 1, 2018 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, reported the start of a Phase 3 global, multi-center, open-label clinical trial to evaluate the efficacy and safety of intratumoral IMO-2125 in combination with ipilimumab (Yervoy) versus ipilimumab alone in subjects with anti-PD-1 refractory melanoma (NCT03445533) (Press release, Idera Pharmaceuticals, MAR 1, 2018, View Source [SID1234524649]). The initiation of the Phase 3 trial follows the announcement that IMO-2125 was granted Fast-Track designation by the U.S. Food and Drug Administration, a designation designed to expedite the development and review of drugs with the potential to treat serious or life-threatening conditions such as refractory metastatic melanoma.

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Results presented at the 2017 European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) meeting from the completed phase 1 portion of the ongoing Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab (NCT02644967) show the combination to be well-tolerated over the entire range of IMO 2125 doses tested, with biopsy evidence for dendritic cell activation followed by infiltration of tumor specific immune cells. These results included 9 patients treated with the Recommended Phase 2 Dose (RP2D) of 8mg of which 4 (44%) achieved RECIST v1.1 responses, including one durable Complete Response (CR), with 6 of 9 (67%) patients experiencing disease control (CR, PR, or SD ≥ 12 weeks).

"For our advanced melanoma patients who have not benefited from anti-PD-1 therapy and in BRAF mutant melanoma, BRAF targeted therapy, there are very few, limited options available today," stated Ahmad Tarhini, M.D., Ph.D, Director, Melanoma and Skin Cancer Program, Cleveland Clinic Taussig Cancer Institute. "I am encouraged by the data that has been demonstrated to date with IMO-2125 and am hopeful that this Phase 3 trial offers hope to this large group of patients whose treatment options are very limited."

"We are excited to initiate the ILLUMINATE 301 Trial, grateful to our advisors who have worked with us to design this pivotal trial and very encouraged by the enthusiasm of investigators to participate in the study. We look forward to working together to conduct and complete this trial, so that we may bring IMO-2125 to the market as soon as possible for patients who are not benefiting from anti-PD-1 therapy," stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer.

ILLUMINATE 301 Trial Design
ILLUMINATE 301 is planned in approximately 80 sites, across 10 countries, and expected to enroll approximately 300 subjects with advanced melanoma who have confirmed disease progression while on nivolumab (Opdivo) or pembrolizumab (Keytruda). Subjects will be randomized into two treatment arms (IMO-2125 in combination with ipilimumab vs. ipilimumab monotherapy). Subjects must have histologically confirmed metastatic melanoma with measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), Stage III (lymph node or in transit lesions) or Stage IVA, IVB, or IVC disease, and at least one lesion that is accessible for injection.

This Phase 3 study is being performed to provide definitive evidence for superiority of the IMO-2125 and ipilimumab combination over ipilimumab. The reported overall response rate for ipilimumab monotherapy following anti-PD-1 therapy is 13%1. The primary endpoint family includes overall survival and overall response rate. For more information on the study and patient qualifications, visit www.ideraclinicaltrials.com.

About IMO-2125
IMO-2125 is a toll-like receptor (TLR) 9 agonist that received orphan drug designation from the US Food and Drug Administration (FDA) in 2017 for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors in refractory melanoma patients. Currently approved immuno-oncology treatments for patients with metastatic melanoma, specifically check-point inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy making them so-called "refractory." The combination of ipilimumab and IMO-2125 appears to activate an immune response in these patients who have exhausted all options. Intratumoral injections with IMO-2125 are designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths. The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016. Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.

Intrexon has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Intrexon, 2018, MAR 1, 2018, View Source [SID1234524278]).

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Ziopharm has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Ziopharm, 2018, MAR 1, 2018, View Source [SID1234524335]).

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