Nymox Pharmaceutical Corp. (NYMX)

Breaking News: 5/31/2016

Sexual Function Improves in First-Line Patients Given Fexapotide Treatment in Nymox U.S.

BPH Long-Term Clinical Trials


Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce statistically significant clinical trial results showing that the Company's prostate enlargement (BPH) and prostate cancer drug Fexapotide Triflutate produced clinically important improvements in sexual function in first-line patients who received Fexapotide in the Company's U.S. long-term clinical trials. 

 

Nymox has previously reported the absence of significant sexual or other side effects from Fexapotide treatment of prostate enlargement or prostate cancer based on 15 years of clinical research in prospective randomized trials in the U.S.  However actual improvement in sexual function (which is very different from absence of debilitating sexual side effects) is a newly reported and important finding.

Patients in the Company's Phase 3 Fexapotide U.S. trials were administered a validated standardized Sexual Function Questionnaire (SFQ) at baseline, in the first 12 months, and at long-term after a single injection in the Phase 3 pivotal trials NX02-0017 and NX02-0018, and prior to re-injection in Phase 3 studies NX02-0020 and NX02-0022. The trial data demonstrated several lines of prospective randomized double blind evidence indicating sexual function improvement. At 12 months after treatment in the first-line previous treatment-naive patients (n=370), there was a statistically significant improvement from baseline in Fexapotide treated subjects (p<.0001), while placebo showed no improvement from baseline. In first-line previous treatment-naive subjects with SFQ long-term assessments (12-51 months after treatment, n=156), the Fexapotide treated subjects had statistically significant improvement compared to placebo. Placebo treated patients at long-term showed worsening of sexual function (mean -0.88 points) while Fexapotide treated patients showed improvement (+0.64 points, p=.0049). The percentage of first-line previous treatment-naive patients in the study with pre-existent sexual dysfunction (baseline SFQ ≤3 points) who ended the study improved and no longer with self-reported sexual dysfunction (SFQ ≥4 points) was statistically significant (p<.05) while there was no change in the placebo group.

Paul Averback MD, CEO of Nymox said, "The findings newly reported today add another important dimension to the advantages of Fexapotide treatment for BPH. In addition to absence of sexual side effects, there is now statistically significant prospective clinical trial evidence of sexual functional improvement in men with prostate enlargement given Fexapotide."

Nymox has previously reported the absence of significant sexual or other side effects from Fexapotide treatment of prostate enlargement or prostate cancer based on 15 years of clinical research in prospective randomized trials in the U.S.  In over 1700 individual treatments with Fexapotide or placebo, there have been no significant side effects linked to the drug, and no significant evidence of sexual side effects. This is in marked contrast to traditional approved treatments for BPH. Alpha blocker drugs and 5-alpha reductase inhibitor oral medications for BPH are well known to commonly produce sexual and other side effects that limit these older drugs' usefulness and tolerability for patients. It is not uncommon for patients on oral medications to suffer from chronic loss of libido, impotence, ejaculatory dysfunction, and many other problems. Increased prostate cancer risk has also been attributed to some of the older approved medications. Surgical treatments for BPH are usually effective for urination problems but permanent ejaculatory problems such as retrograde ejaculation are common and surgical side effects and pain can be distressing.

The sexual function improvement data for Fexapotide will be presented in greater detail at medical meetings in the U.S. later this year.

Fexapotide Triflutate is Nymox's first in class injectable treatment for BPH and low grade localized prostate cancer. The drug is given as a virtually painless injection with no anesthesia, analgesia or catheterization, and is an office procedure which takes a few minutes to administer.

On May 3, 2017 Nymox announced that it had filed for marketing approval in Europe for Fexapotide Triflutate for the treatment of prostate enlargement (BPH benign prostatic hyperplasia).

Nymox's lead drug Fexapotide has been in development for over 15 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).

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.
 

  NYMOX Files For Marketing Approval For Fexapotide Triflutate in Europe       Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce today that the Company has filed to seek approval for marketing authorization for Fexapotide Triflutate in five European countries, comprising the Netherlands, the UK, Germany, France and Spain. This first filing for Fexapotide Triflutate is for the indication of treatment of the symptoms of BPH (benign prostatic hyperplasia; prostate enlargement).

 

"Fexapotide has the real potential to alter the way BPH will be treated in the future. There is a major unmet medical need for a safe and efficacious treatment method for the many men who suffer from this age-related malady," said Dr. Paul Averback, CEO of Nymox.

"This first filing represents a major corporate milestone for the development of Fexapotide. We are extremely pleased to achieve this milestone which is based on intensive work carried out by our teams and many expert collaborators over the past 15 years," Dr. Averback added.

Erik Danielsen, Nymox's CFO added, "Going forward, we expect to announce further regulatory filings for approval in additional important jurisdictions around the world as well as corporate initiatives supporting our pre-commercialization efforts.  We now plan to significantly step up our communication programs with both the medical as well as the financial communities. Today's important step forward will be followed up by additional strategic business development activities."

Fexapotide has been in development by Nymox for 15 years. Clinical trials have shown long-term symptomatic improvement, long-term reduction in the need for BPH surgery, long-term reduced prostate cancer risk, and an excellent long-term safety profile with no sexual side effects in comparison to available drug treatments. Fexapotide Triflutate is administered at an office visit and consists of a single painless injection that takes a few minutes or less, with no requirements of anesthesia, or analgesia or catheterization. There are none of the typical sexual and other distressing side effects seen with conventional BPH treatments.

BPH is highly prevalent in middle aged and elderly men, affecting millions of men world-wide. Existing medical treatments for BPH generally provide temporary relief only, and are commonly discontinued by patients due to side effects and little efficacy. Surgical treatments are effective but often have permanent retrograde ejaculation as a result, and other problems and risks are associated.

Nymox will hold a teleconference call for shareholders next week. Further details regarding the teleconference will be announced in advance of the call.

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.

 

      Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com

Nymox Provides Update on Fexapotide Development
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) provided an update today on the Company's development activities for Fexapotide Triflutate, its new drug for prostate enlargement. The Company is very pleased with the progress it has made, which is in line with its previous timeline announcements. The Company now expects to submit its initial filing seeking approval for Fexapotide Triflutate in the next few weeks. Nymox intends to provide fuller details at the above time.

 

For more information please contact info@nymox.com or 800-936-9669.
 

Share Ownership per 20-F, 3/30/2017.

As of March 30, 2017, the number of common shares owned or controlled by directors and senior officers of the Corporation were as follows:

		Common Shares			Percentage of Common
		Owned and			Shares Owned and
Name		Controlled			Controlled
Paul Averback, M.D.		18,181,448			37.0%
Paul Averback, M.D., Trustee		607,0311			1.2%
James G. Robinson		2,167,550			4.4%
David Morse, Ph.D.		396			*
Erik Danielson		400,000			0.8%

* Denotes less than 1%.
1) As joint trustee of a family trust.

 

 

GlobeNewswire•November 29, 2016
 

Nymox Reports Additional Positive Results From Completed Fexapotide BPH

Phase 3 Studies Showing Significant Early Response and First-Line Efficacy

 

 

HASBROUCK HEIGHTS, N.J., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) is pleased to announce that new Phase 3 prospective randomized clinical trial results have confirmed that patients who received fexapotide as their initial treatment for BPH (prostate enlargement) had superior efficacy results as early as 10 days compared to control patients who received placebo or who had prior history of other BPH medical treatments. These new Phase 3 results indicate that fexapotide in these trials was highly efficacious for first-line treatment of BPH.

These findings are from analysis of the Company's extensive U.S. Phase 3 trials NX02-0017, NX02-0018, NX02-0020 and NX02-0022 including long-term follow-ups that were undertaken from 2009 to 2016. These important results come on top of many other positive results including successfully reaching long-term primary efficacy endpoints, that have previously been reported. The present prospective randomized trial results are new findings. 390 treatment naive patients with no past treatments for BPH had improvements greater than previously treated BPH patients as early as 10 days post-treatment (p<.02) and at one month (p<.04), 3 months (p<.001), six months (p<.001), one year (p<.01) and at long-term (3.5 years) follow-up (p<.003). The levels of mean change from baseline pre-treatment ranged from 6.49 to 8.88 points improvement in the AUA BPH Symptom Score. These previously untreated patients who received a single injection of fexapotide 2.5 mg also had statistically significant superior improvements compared to patients who received placebo treatments, as early as 10 days post-treatment (p<.001) and at several time points also including the long-term (3.5 years) follow-up extension (p<.001).

Dr. Paul Averback, CEO of Nymox said, "It is important to have now demonstrated for Nymox's fexapotide, both 1. that it leads to an early onset of clinically noticeable improvement; and 2. that it works well long-term as a first-line therapeutic for men who have not tried other treatments before. There is a major unmet need for a convenient, safe and efficacious treatment for countless men worldwide with BPH who are unhappy with their symptoms and who may be unhappy with their available choices."

Traditional BPH treatments have very undesirable side effects, particularly causing frequent problems with ejaculation and overall sexual function, as well as many other limiting side effects. Pills for BPH usually need to be taken permanently to remain effective and surgical treatments for BPH often produce permanent distortions of ejaculation as well as other risks. Middle aged and elderly male patients often need a safer and more effective way to manage these extremely common life problems.

Nymox's lead drug fexapotide has been in development for over a decade 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 conducted at the same highly regarded treatment centers under rigorous trial scrutiny and performed strictly at arms-length by top teams of clinical investigators across the country, 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 aim of the crossover study was to determine the clinical benefit fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as to their placebo treatment, and who subsequently required additional medical and/or surgical treatment. In that study long-term outcomes were determined in 391 patients who were given double blind placebo injections, followed by crossover to other treatments at the patients' discretion. The numbers of blinded placebo patients who subsequently received surgical treatment during the next 2-3 years for their BPH symptoms were then prospectively analyzed.

 

For the earlier fexapotide Phase 3 long-term cancer incidence analysis, the men in the study received fexapotide or placebo for the treatment of their prostate enlargement (BPH) symptoms. All men were thoroughly evaluated at expert urological testing investigational centers to exclude any prostate cancer prior to qualifying for enrollment in the studies. The participants were followed for up to 7 years (median of 5 years) after treatment. The study analyzed all cases of prostate cancer that were subsequently diagnosed. The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%. The data analysis from the Nymox fexapotide study showed a statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population. By comparison, for example in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% (and 22.7% in controls) as recently reported in a large U.S. study published in the Journal of Urology (Volume 196; 3, 2016). The quoted study was in a population of middle aged and elderly men without prostate cancer, similar to the Nymox study population.

Nymox recently announced (October 11, 2016) positive long-term results in 344 patients who were given a single repeat fexapotide treatment after initial blinded treatment with fexapotide or placebo. Patients were followed for 2 to 6.5 years (mean 4.2 years) after initial treatment and showed long-term statistically significant symptomatic improvement (mean improvement of 6.5 points in the AUA BPH Symptom Score) compared to Phase 3 patients who received placebo alone (p<.001). Repeat injection was found to be safe with no significant drug related toxicities or side effects found in the study.

Nymox has completed the execution of seven Phase 3 U.S. BPH clinical protocols, including 2 prospective randomized multicenter single injection double blind clinical trials; 2 U.S. repeat injection clinical trials; and 3 U.S. blinded long-term clinical trial extension studies. In addition, a number of Phase 3 safety and clinical pharmacology studies and analyses have been completed.

For more information please contact info@nymox.com or 800-936-9669.

Nymox Wins Big on Late-Stage Trial
 

Nymox Pharmaceutical Corp. (NYMX) shares jumped following positive results from its late-stage prostate cancer trial. The company announced successful new study results from the long-term repeated injection group from the U.S. Phase 3 trials for fexapotide, in late stage development for enlarged prostate (BPH) and for localized prostate cancer.

In the new study, long-term outcomes were determined in 344 patients who were given a single repeat fexapotide treatment after initial blinded treatment with fexapotide or placebo. Patients were followed for 2.0 to 6.5 years (mean 4.2 years) after initial treatment.

All treatment failures were included in the analysis. Results have now shown that there was long-term statistically significant symptomatic improvement compared to Phase 3 patients who received placebo alone. Repeat injection was found to be safe, with no significant drug-related toxicities or side effects found in the study.

In earlier reported Phase 3 studies, it was shown that fexapotide reduces the long-term need for surgery by up to 82% to 95% compared to approved conventional BPH treatments. Data indicate that fexapotide shows significant efficacy against prostate cancer as a therapeutic, and in addition has been shown in Phase 3 to reduce the risk of prostate cancer when fexapotide is used to treat BPH. This is in comparison to some conventional BPH treatments in routine clinical use today, which on the other hand increase prostate cancer risk and which have these many other well-known undesirable side effects.

Paul Averback M.D., CEO of Nymox, commented:

These prospective long-term study results in reinjected patients clearly demonstrate that fexapotide leads to clinically meaningful long-term symptomatic improvements in BPH patients with minimal treatment, and without the worrisome and bothersome toxicities of conventional BPH treatments such as retrograde ejaculation, and increased cancer risk.

Excluding Tuesday’s move, Nymox has underperformed the broad markets, with the stock down about 1% year to date. Over the past 52 weeks, the stock is down 11%.

Shares of Nymox were last seen up 17% at $3.81, with a consensus analyst price target of $10.25 and a 52-week trading range of $1.62 to $5.79.

 

Nymox Reports Successful New Phase 3 Long-Term Fexapotide Repeat Injection BPH Trial Results: Lasting Symptomatic Improvement...

Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce successful new study results from the long-term repeated injection group from the U.S. Phase 3 trials for fexapotide, the Company's lead compound in late stage development for enlarged prostate (BPH) and for localized prostate cancer. The aim of the study was to determine the safety and clinical benefit fexapotide can provide to men who were given a second injection of fexapotide for their prostate enlargement (BPH).  In the new study long-term outcomes were determined in 344 patients who were given a single repeat fexapotide treatment after initial blinded treatment with fexapotide or placebo. Patients were followed for 2 to 6.5 years (mean 4.2 years) after initial treatment. All treatment failures were included in the analysis. Results have now shown that there was long-term statistically significant symptomatic improvement (mean improvement of 6.5 points in the AUA BPH Symptom Score) compared to Phase 3 patients who received placebo alone (p<.001). Repeat injection was found to be safe with no significant drug related toxicities or side effects found in the study.

"These prospective long-term study results in reinjected patients clearly demonstrate that fexapotide leads to clinically meaningful long-term symptomatic improvements in BPH patients with minimal treatment, and without the worrisome and bothersome toxicities of conventional BPH treatments such as retrograde ejaculation, and increased cancer risk," said Dr. Paul Averback MD, CEO of Nymox. "Our earlier reported Phase 3 studies have shown that fexapotide reduces the long-term need for surgery by up to 82-95% compared to approved conventional BPH treatments. Data indicates that fexapotide shows significant efficacy against prostate cancer as a therapeutic, and in addition has been shown in Phase 3 to reduce the risk of prostate cancer when fexapotide is used to treat BPH. This is in comparison to some conventional BPH treatments in routine clinical use today which on the other hand increase prostate cancer risk, and which have these many other well known undesirable side effects,” he said.

Nymox's lead drug fexapotide has been in development for over a decade 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 conducted at the same highly regarded treatment centers under rigorous trial scrutiny and performed strictly at arms-length by top teams of clinical investigators across the country, 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 aim of the crossover study was to determine the clinical benefit fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as to their placebo treatment, and who subsequently required additional medical and/or surgical treatment. In that study long-term outcomes were determined in 391 patients who were given double blind placebo injections, followed by crossover to other treatments at the patients' discretion. The numbers of blinded placebo patients who subsequently received surgical treatment during the next 2-3 years for their BPH symptoms were then prospectively analyzed.

For the earlier fexapotide Phase 3 long-term cancer incidence analysis, the men in the study received fexapotide or placebo for the treatment of their prostate enlargement (BPH) symptoms. All men were thoroughly evaluated at expert urological testing investigational centers to exclude any prostate cancer prior to qualifying for enrollment in the studies. The participants were followed for up to 7 years (median of 5 years) after treatment. The study analyzed all cases of prostate cancer that were subsequently diagnosed. The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%. The data analysis from the Nymox fexapotide study showed a statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population. By comparison, for example in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% (and 22.7% in controls) as recently reported in a large U.S. study published in the Journal of Urology (Volume 196; 3, 2016). The quoted study was in a population of middle aged and elderly men without prostate cancer, similar to the Nymox study population.

Nymox has completed and fully financed the execution of seven Phase 3 U.S. BPH clinical protocols, including 2 prospective randomized multicenter single injection double blind clinical trials; 2 U.S. repeat injection clinical trials; and 3 U.S. blinded long-term clinical trial extension studies. In addition, a number of Phase 3 safety and clinical pharmacology studies and analyses have been completed. The Company expects to file for approvals in the next 1-2 quarters.  The Company also expects to report further analyses and results when available in the near future. The Company will publish the findings of the fexapotide clinical trials in peer review medical journals as well as in presentations at medical and urological meetings.

For more information please contact info@nymox.com 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, 2015, and its Quarterly Reports.

                  Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com 

Nymox reports 2Q loss
https://www.sec.gov/Archives/edgar/data/1018735/000117625616000641/exhibit99-1.htm

NASSAU, Bahamas (AP) _ Nymox Pharmaceutical Corp. (NYMX) on Monday reported a loss of $3.8 million in its second quarter.

The Nassau, Bahamas-based company said it had a loss of 8 cents per share.

The biopharmaceutical company posted revenue of $150,000 in the period

Outstanding Share Data

As at August 16, 2016, there were 46,145,419 common shares of Nymox issued and outstanding, as well as, 6,519,500 share options are outstanding, of which 6,519,500 are currently vested. There are 548,529 warrants outstanding. In addition, the convertible notes are convertible into 2,007,504 common shares.

Nymox Announces Private Placements of $2.24 Million

Erik Danielsen, CFO of Nymox said, "This additional funding from long-term supportive shareholders provides an extra cash cushion for our regulatory filing preparation activities currently underway. We are extremely pleased with the support we get from many of our long-term shareholders who share our assessment that the Company's near-term prospects are excellent. Our fact-based confidence in Nymox's future is also reflected in the significant ongoing buying of our shares in the open market by long-term shareholders and officers and directors of the company."

Nymox recently announced that long-term BPH studies of the Company's lead drug fexapotide showed excellent safety and efficacy results, in addition to a dramatic reduction in the long-term incidence of prostate cancer in the BPH studies compared to the expected incidence from comparable patient studies in the literature. Fexapotide treated patients also had significantly reduced long-term prostate cancer incidence compared to placebo-treated BPH patient controls.

Nymox CEO Paul Averback M.D. stated last week that further clinical trial results for fexapotide were expected to be reported in the very near future.

For more information please contact info@nymox.com or 800-936-9669.

The men in the study received fexapotide or placebo for the treatment of their prostate enlargement (BPH) symptoms. All men were thoroughly evaluated to exclude any prostate cancer prior to qualifying for enrollment in the studies. The participants were enrolled at over 70 top well-known U.S. urological investigational centers, and were followed for up to 7 years (median of 5 years) after treatment. The study analyzed all cases of prostate cancer that were subsequently diagnosed. The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%.  The new data analysis from the Nymox fexapotide study has now shown the statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population.

"These results are astonishingly good. Other drug treatments and controls tested in similar studies have been associated with a prostate cancer incidence 10 times higher than the results reported today by Nymox for fexapotide. This is truly good news. The data strongly indicate that in addition to benefit for BPH symptoms, fexapotide will also help to prevent cancer in these patients," said Dr. Ronald Tutrone, one of the Principal Investigators in the Nymox Fexapotide Prostate Cancer and BPH studies. Dr. Tutrone is Chief of the Division of Urology, Greater Baltimore Medical Center; Medical Director of Chesapeake Urology Research Associates and Chairman of the William E. Kalhert Endowment for Urological Research.

Fexapotide is a safe and painless single injection treatment given in the urologist's office. The drug is in Phase 3 for BPH and Phase 2 for prostate cancer. It has been tested in over 1700 drug and placebo treatment administrations in the U.S.  As a treatment for BPH, fexapotide shows long-term efficacy without the safety risk and side effect concerns or added cancer risk associated with currently approved BPH treatments. As a treatment for prostate cancer fexapotide was found to lead to highly statistically significant reduction in disease progression in a large 147 patient multi-year Phase 2 study of U.S. men with low grade cancer.

Dr. Paul Averback, CEO of Nymox said, "The new results now add a third dimension to fexapotide utility: clinical prostate cancer prevention. The drug has now demonstrated statistically significant prospective long-term outcome data showing dramatic reduction in the incidence of newly diagnosed prostate cancer after minimal BPH treatment with fexapotide. Nymox announced in Q3 last year that it will seek regulatory approvals for fexapotide for BPH based on the long-term BPH safety and efficacy data announced Q3 last year. We believe that the exciting new prostate cancer prevention results reported today will add to the evidence in fexapotide's favor towards our goal of widespread major benefit for middle-aged and elderly men."

Dr. Averback added, "We are extremely grateful to the thousands of people who have been part of these clinical trials. The Company also thankfully acknowledges our shareholders for their long-term commitment that supports these studies." 

For more information please contact info@nymox.com 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, 2015, and its Quarterly Reports.

Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com

 

DIRECTOR JAMES ROBINSON CONTINUES TO BUY ON THE OPEN MARKET.
2,907,050  SHARES OWNED AS OF 8/11/2016. 

Annual and Transition Report (foreign Private Issuer) (20-f)

The following table sets out as of March 30, 2016, the number of common shares owned and controlled by Dr. Paul Averback, the President and CEO of Nymox and a member of the Nymox board of directors, and by all directors and officers as a group.

The above shareholders have the same voting rights as all other shareholders. The percent of class of common shares held by Dr. Paul Averback is 34.6% as of March 30, 2016 (29.7% as of March 31, 2015; 32.7% as of March 14, 2014).

All shareholders of Nymox stock have the same voting rights. Other than Dr. Paul Averback and the individuals above, Nymox does not know of any other shareholders that beneficially own or hold dispositive power over more than 5% of its shares.

According to information furnished to Nymox by the transfer agent for the common shares, as of March 16, 2016, total shares outstanding were 43,869,810; there were 189 holders of record of the common shares and 5,366 beneficial shareholders in total. Of these, 59 were holders of record of the common shares and 4,514 were beneficial shareholders with addresses in the United States and such holders owned an aggregate of 21,990,266 shares, representing approximately 61.30% of the outstanding shares of common stock.

HASBROUCK HEIGHTS, N.J., Feb. 09, 2016 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) today announced results from the completion of the Company's U.S. 40 month (18 month outcomes) localized prostate cancer Phase 2 NX03-0040 clinical trial of fexapotide triflutate (NX-1207). The study successfully met its pre-determined endpoints. Cancer progression clinical outcomes were significantly improved in the fexapotide treated patient groups.

Results from the completed 18 month outcome study after a single injection of fexapotide included the following:

• Absence of tumors (Primary Endpoint) controlled for size in baseline area: fexapotide 15 mg superior to control (p=.035); crossover fexapotide 15 mg superior to control (p=.002); crossover fexapotide overall superior to control (p=.014).
   
  75.5% reduction in biopsy proven prostate cancer Gleason upgrades (pathological progression) after 18 months in fexapotide 15 mg treated patients compared to control (p=.0055). 71.7% reduction in prostate cancer Gleason upgrades in fexapotide treated patients overall (p=.0045 vs controls).
   
  84.8% reduction after 18 months in surgery or radiotherapy instituted for prostate cancer Gleason upgrade (biopsy worsening) in fexapotide treated patients overall compared to control group (p=.014).
   
  54.8% reduction after 18 months in surgery or radiotherapy instituted for all causes with or without prostate cancer Gleason upgrade in fexapotide 15 mg treated patients compared to control (p=.026).
   
  Significant improvement for fexapotide patients compared to controls in 4 out of 4 Secondary Endpoints. Tumor volume reduction in the treated area, combined dosages (p=.04); tumor volume change in prostate overall, fexapotide patients overall (p=.014); median tumor grade outcome in the treated area, all dosages (fexapotide median benign, vs control median Gleason 3+3), and superior median tumor grade in prostate overall, fexapotide 15 mg vs controls.
   
  Consistent safety results with no significant drug-related adverse events and no significant related sexual adverse events.
   
  Overall superior results for the fexapotide 15 mg dose compared to the 2.5 mg dose (dose-response).
   
  Other statistically significant improvement outcomes in fexapotide patients compared to controls, to be presented comprehensively at medical meetings.

"These results demonstrate that a single targeted office injection of fexapotide has led to statistically significant improvement in outcomes with much less surgery or radiotherapy required after 18 months. This means a reduction in patient discomfort, and a reduction in permanent side effects and life changes when the more invasive treatments are required," said Paul Averback, CEO of Nymox.

Dr. Averback added, "Based on these outcomes, we believe there are exciting potential patient benefits from one or more painless fexapotide office injections for this common and distressing condition."

The Company will report at a later date concerning its plans for moving the compound forward toward the market for this important medical problem.

For more information please contact info@nymox.com 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, 2014, and its Quarterly Reports.
Contact:

                                          Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com   

Nymox Announces Additional $2.1 Million Equity Financing
HASBROUCK HEIGHTS, NJ (February 4, 2016) Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today private placement equity investment of US$2.1 Million. The investment was at $2.00 per share with no warrants. The investment was made by long-term Nymox shareholders. The Company has now closed private placements totalling $3.4 Million since November 5.

Erik Danielsen, Nymox Chief Financial Officer, said "We are very pleased with this equity infusion in these market conditions. The Company has strong long-term supporters who are very excited about our business plans, and who share our enthusiasm about near-term milestones. We are particularly pleased to have raised $3.4 Million since November 5. This will allow the Company to continue to aggressively move our projects forward without delay."

For more information please contact info@nymox.com 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, 2014, and its Quarterly Reports.
Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com

Nymox Provides Update From Shareholders Annual General Meeting December 16, 2015.

HASBROUCK HEIGHTS, N.J., Dec. 17, 2015 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) is pleased to report an update on the Corporation's business as of December 16, 2015. At the Company's AGM in Nassau, the following highlights were presented:

• The Company is moving forward with the activities of preparing for filing for approval of fexapotide triflutate (NX-1207) 2.5 mg for the treatment of prostate enlargement (BPH). The Company is pleased with the solid progress that has been made. The date(s) of anticipated filing will be reported in due course.

Dr. Paul Averback, CEO said "Our management team has over the past several months been very focused on taking the necessary steps that will allow our Company to file for regulatory approvals for fexapotide triflutate in various markets. We expect to provide an update in the near future with regard to the filing for approval for our BPH drug fexapotide triflutate."

Phase 3 trial results for fexapotide showed excellent safety profile and after 3.5 years statistically significant increased improvement in symptom scores vs placebo; statistically significant increases in responder rates vs placebo; statistically significant decrease (after 2 years) in need for surgery vs placebo; and statistically significant better nocturia outcomes vs placebo. Fexapotide is associated with a decrease in prostate cancer risk. By comparison, some commonly used approved BPH treatments have been linked to increased cancer risk. Fexapotide has enhanced compliance and patient convenience compared to oral medications. Fexapotide is given as a single painless office treatment injectable. Approved oral medications generally involve daily pills intended for the rest of the patient’s life.

• The 18 month low grade localized prostate cancer trial of fexapotide 2.5 mg and 15 mg has been completed, and results are nearing completion of analysis. The timing of reporting of results is on target and top-line data will be presented in the very near future.

In corporate developments, Richard Cutler of Houston, TX was appointed to the Board of Directors. Richard Cutler is a graduate of Brigham Young University and Columbia University School of Law. Mr. Cutler has worked at several major national law firms, and in 1996, formed Cutler Law Group in Newport Beach, California and subsequently Atlanta, Georgia and Houston, Texas, a firm which specializes in corporate and securities law, as well as international business transactions. Dr. Averback, Randall Lanham, Professor David Morse, and James G. Robinson were re-appointed to the Board of Directors. Paul McDonald has retired from the Board. The Company gratefully acknowledges Mr. McDonald's steadfast, popular and highly valued solid service on the Board of Directors since 2006.

With reference to the Company’s quarterly financial filings, the international clients of Cutler & Co. have been acquired by transfer of responsibility to Thayer & O’Neal of Houston, Texas.  Due to this recent transfer the Company’s quarterly filings have been slightly delayed and will be filed in the very near term.

Nymox Reports Results of Prospective Cross-Over Study of Fexapotide Treatment for Prostate Cancer 
HASBROUCK HEIGHTS, NJ (October 29, 2015) Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today that long-term randomized cross-over data from the Company's  trial of fexapotide triflutate for low grade localized prostate cancer has shown statistical significance in efficacy compared to controls. The study results indicate that randomized control subjects who subsequently switched to fexapotide had long-term outcomes significantly superior to control patients who did not change (cross-over) to fexapotide treatment. 
These results are the initial 18 month follow-up results for the fexapotide trial for prostate cancer to be reported. The cross-over study arm of NX03-0040 consisted of 35 subjects. Based on biopsy progression the proportion of patients who progressed on biopsy and required biopsy progression-related surgery or radiotherapy in the cross-over group (0%) at 18 months was significantly less than in the control group (p<.03). 
The cross-over group patients received randomized fexapotide 15 mg or 2.5 mg in a single treatment targeted toward the positive baseline cancer focus identified in initial positive biopsies. There were no cases in either of the 2 fexapotide dosage level treatment groups with biopsy progression at 18 months (p<.03). 
In addition to the positive clinical progression results, the primary endpoint of the study (re-biopsy absence of tumor in the initially positive biopsy baseline area of the prostate) also reached statistical significance (p<.03) in the cross-over study. At the 18 month assessments, the post-treatment biopsy taken from the treated area of the prostate which was initially positive at baseline, showed absence of tumor (tumor presence in re-biopsy of baseline positive focus n=0) in the cross-over treated patients, which was statistically significant compared to controls (p<.03). 
The Company expects to report results from its long-term NX03-0040 low grade localized prostate cancer study in the fourth quarter. 
One of the major problems with current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, or brachytherapy) is the relatively high incidence of reported sexual dysfunction post- treatment. In 9 studies, NX-1207 treatment has been shown to have no significant adverse effect post-treatment on sexual function or testosterone levels. 
For more information please contact info@nymox.com or 800-936-9669. 

Nymox Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint. Company Plans to File For Regulatory Approvals For Fexapotide Triflutate (NX-1207). 
HASBROUCK HEIGHTS, NJ (July 27, 2015) Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today that the Company's U.S. long-term extension prospective double-blind Phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BPH have successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo. Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant related molecular side effects in the 2 studies (n=978). 
The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories. 
The Company will present a public webinar and conference call today July 27 at 4:30 p.m. EDT (see below).  
The primary endpoint variable of the long-term study was improvement in the AUA BPH Symptom Score which was statistically significant (p<.02) in fexapotide-treated patients compared to placebo, at a median duration of 42 months (3.5 years) after a single double-blind injection treatment of fexapotide vs. saline placebo. In addition, responder analysis for the primary endpoint variable met the prespecified endpoint (p<.01). All subjects from both studies with 2 years or more duration follow-up after a single painless injection were eligible, however all documented treatment failures of any duration in the studies from day 1 onward were also included in the data as treatment failures. Patients were followed double-blind up to 65 months (5.4 years) after a single injection. 
Highlights of the pivotal Phase 3 extension top-line results are summarized as follows: 
• Median duration of 3.5 years from a single injection treatment mean improvement of 5.3 points in AUA BPH Symptom Score. Statistically significant (mean p<.025; median p<.02) vs saline placebo injection. 
• Mean improvement of 7.1 points in AUA BPH Symptom Score (primary endpoint variable) after median duration of 3.5 years in first-line BPH treatment of fexapotide treated subjects (p<.025 vs placebo). 
• Patient responder rate: Statistically significant higher proportion (64%) of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects  vs controls (p<.005). 
• Improvement of nocturia: Percentage of patients with stabilization or improvement of frequency of nocturia in fexapotide treatment superior to placebo (p<.03). 
The Company also reported on new Phase 3 data of lowered incidence of surgery in patients in Phase 3 studies NX02-0020 and NX02-0022. 
• Reduced incidence of surgery: Subjects in Phase 3 studies NX02-0020 and NX02-0022 with 1 or 2 injections of fexapotide had statistically significant reduction of BPH surgery within 24 months of fexapotide treatment (1.7% incidence of surgery in 2 years) (p<.02 vs placebo). 
In addition, the following advantages of the new drug are highlighted:
• Safety profile highly superior to existing treatments. Minimal or no sexual, hormonal or cardiovascular or other debilitating side effects.  
• Reduced cancer risk in Phase 2 data: U.S. Phase 2 data showing therapeutic effect of fexapotide on prostate cancer. Phase 2 data showed fexapotide treated low grade localized prostate cancer (Gleason 3+3 or less) had statistically significant less progression compared to controls. By comparison, some commonly used older approved BPH treatments have been linked to increased cancer risk. 
• Enhanced compliance and patient convenience compared to oral medications. Fexapotide is given as a single painless office treatment injectable. Older approved oral medications generally involve daily pills intended for the rest of the patient’s life.  

Nymox July 27 Webcast of New BPH Clinical Trial Results Posted Online 
HASBROUCK HEIGHTS, NJ (July 28, 2015) Nymox’s (NASDAQ:NYMX) July 27th webcast of news and discussion by experts of the Company's new clinical trial results can be viewed at http://limelightdc.com/clientarea/nymox_investor_webcast_7_15/player_vod.html. The link is also available at the Company's website. .
 

NYMOX GENERAL INFORMATION:
Nymox Pharmaceutical Corporation specializes in the research and development of therapeutics and diagnostics, with a particular emphasis on products targeted for the unmet needs of the aging population. The Company’s new drug for benign prostatic hyperplasia (BPH) is in Phase 3 development. Nymox has drug technology for other indications such as E. coli infection, Alzheimer’s disease, oncology, and infectious disease.

BPH is a chronic condition that is a common affliction of older men. There is an unmet medical need for an effective treatment for BPH without the side effects associated with currently approved drugs or the complications associated with surgical procedures.

NX-1207 is administered by a urologist in an office setting without the need for anaesthetics or sedation or for catheterization.  Patients report little or no pain or discomfort from the procedure.  Open label follow-up studies have shown evidence of long lasting benefit from NX-1207 treatment with a significant proportion of men who received a single dose of NX-1207 reporting maintained improvement in BPH symptoms without other treatments for up to five years or more.

BPH is one of the most commonly diagnosed diseases in the male U.S. population. The condition can seriously impact the health and quality of life of older men and can lead to acute urinary retention, incontinence, and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.

The Company offers NicAlert^® and TobacAlert^® tests for measuring tobacco product exposure.

Nymox has rights to several hundred patents and patent applications through the world covering a wide range of scientific and medical fields, technologies, and applications.  The Company has research interests in protein markers, subcellular pathology, cell death, cell proliferation, clinical models, genetic expression, morphology, and drug screening design, assays, and development.  Nymox maintains an active interest in scientific collaborations and has a lengthy history of working together with prominent researchers around the world.

Nymox’s stock is traded on NASDAQ under the symbol NYMX. The Company has two subsidiaries, Nymox Corp. and Serex Inc., and facilities in Hasbrouck Heights, NJ and Montreal, QC.