HASBROUCK HEIGHTS, N.J., Dec. 19, 2018 (GLOBE NEWSWIRE) -- Following the Nymox (NYMX) Annual General Meeting yesterday (December 18, 2018), Nymox management discussed many significant 2018 events and commented on key operational milestones coming up in 2019.
Some of the more important accomplishments in 2018 included: 1) Important finding of sustained long-term benefit of Fexapotide Triflutate in early-stage prostate cancer; 2) Presentation and peer review publication of Phase III clinical trial results of pivotal Fexapotide BPH studies; 3) Pre-NDA meeting for Fexapotide in BPH; 4) Strong financial backing by long-term shareholders; 5) Manufacturing scale-up; 6) Two lines of evidence for Fexapotide benefit in prostate cancer in men: Preventative data in men being treated for BPH with Fexapotide; as well as long-term significant therapeutic data in low grade prostate cancer patients receiving Fexapotide targeted to their early stage prostate cancer; and 7) Additional extended intellectual property protection for the Company's main products.
Paul Averback, CEO and President of Nymox said, "Nymox management is extremely pleased with the substantial progress we have reported in the past year, and Nymox will certainly be reporting numerous milestones in the coming year. In the past year the clinical trial results for Fexapotide Triflutate BPH clinical trials were published in a major international urology journal. This past year the Company completed financing that will support our activities for several years without the need for further dilutions. Developments in scale-up, in intellectual property, in regulatory activities and in general and administrative functions were reported. Moving forward now to the present, Nymox will file marketing applications in the US and in the EU for Fexapotide Triflutate for BPH, and we will report these developments as they progress. The Company's Fexapotide Triflutate BPH studies were published in an extensively detailed publication co-authored by 17 leading clinical trial investigators, in the World Journal of Urology. We expect that other additional new and important peer review publications will be published in the near future. The Company is particularly pleased about the status of its ever expanding intellectual property portfolio that in our view has greatly added to the financially important periods of exclusivity for our unique products."
Dr Averback said, "Nymox has the benefit of strong shareholders who understand our mission and the extreme challenges for any first in class drug development project involving the need for long-term data. The shareholders that we speak with are very familiar with the reality that no other company before Nymox or after, has succeeded to complete full enrollment in US Investigational sites for even one, let alone two, Phase 3 U.S. studies for a BPH injectable. This monumental task required over 4 years to reach full accrual, and the required long-term assessments and reinjection safety studies together added many additional years. The patience and support of our shareholders has been fundamental in allowing the Company to undertake such a daunting program, where others have consistently fallen short despite major efforts. We thank our shareholders for the key contribution they have made, without which this would not have been possible."
Dr Averback added, "We continue to stress the extreme relevance of 1. Our reinjection safety data which required 2 additional Phase 3 studies involving 351 patients, undertaken with long-term follow-up from 2011 until 2016 and which have shown a) that there is no discernible significant risk with repeated injections, and b) that importantly there is indeed added efficacy with additional treatments; 2. The long-term patent protection of our key technologies; and 3. Our completion of the necessary studies for the stated filings that will be announced in the near future."
Nymox will be scheduling an Investor conference call early in 2019 at the appropriate time in order to elaborate further where possible on the upcoming targeted milestones.
Management reviewed some of the key accomplishments of the past 4 quarters:
- Important Finding of Benefit in Early-Stage Prostate Cancer: Reporting strong and clinically highly relevant, long-term (up to >6 years) follow-up phase II data in men diagnosed with early-stage prostate cancer. The study data showed highly favorable non-progression of the disease in the majority of FT treated men, resulting in over 80% reduction in the number of men needing either surgery or radiation therapy due to a biopsy confirmed increase in their Gleason score (i.e. a more aggressive cancer) as well as similar levels of clinical benefit for Fexapotide treatment in other measures of cancer progression compared to controls.
- Presentation and Publication of Phase III Clinical Trial Results: Pivotal clinical results from the Company’s four (4) phase III trials were published in a highly respected international journal of urology: The World Journal of Urology. The data was discussed at two AUA meetings in the past 12 months following on many earlier presentations on Fexapotide by leading researchers in presentations at meetings of the American Urological Association in Q2 2017.
- Pre-NDA meeting for Fexapotide Triflutate in BPH: Following the Pre-NDA meeting with FDA, the Company‘s has announced the decision to finalize its regulatory documentation and file for approval in the United States.
- Strong Backing By Long-Term Shareholders: Raising in excess of $18M of equity capital at attractive terms mostly from long-term, existing supportive shareholders. Obtaining sufficient funding to complete regulatory filings in Europe and the U.S. and prepare for commercialization.
- Manufacturing Scale-Up: Successfully achieving manufacturing scale-up milestones for FT, required for anticipated clinical demand upon approval.
- Important Prostate Cancer Incidence Benefit in Men Being Treated for BPH: Two different lines of evidence showing cancer inhibitory effects of Fexapotide treatment: 1. Reporting significantly reduced long-term new incidence of prostate cancer in FT treated patients with BPH, in addition to 2. The benefits of direct treatment of low grade prostate cancer.
Randall Lanham, Nymox Chief Operating Officer commented, “Our entire team is immensely gratified with the progress and achievements to date of the Fexapotide Triflutate program and the growing momentum and endorsement of the drug data and published clinical trial results, by so many prominent urologists.”
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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, 2017, and its Quarterly Reports.
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Nymox Pharmaceutical Corporation