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June 11, 2014
10:19 EDTNYMXNymox reports new safety data for Phase 3 BPH drug
Nymox Pharmaceutical announced new clinical data supporting the positive safety profile of NX-1207, the company's lead compound in late Phase 3 testing for prostate enlargement, or benign prostate hyperplasia, BPH. "Recent pharmacokinetic studies using a newly developed highly sensitive blood test for NX-1207 have shown that the drug is undetectable in the blood post-injection, providing strong evidence that the drug, once injected into the prostate, remains confined to the prostate and thus unable to affect other organs such as the liver, kidneys, heart, or testes" the company said. These results are consistent with the pharmacological profile of the drug and with the extensive body of safety data from the more than 1,000 men treated with the drug to date demonstrating the absence of any significant drug-related side effects. In addition, men treated with NX-1207 have not displayed any signs of an allergic or other immune reaction to the drug either on first injection or repeat injection. Extensive clinical immunogenicity testing of men in the company's pivotal Phase 3 trials and Phase 3 repeat injection safety studies have found no evidence of anti-drug antibody formation after exposure to the drug. The company will present more detailed scientific data from these studies at upcoming medical conferences, it said.
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July 22, 2014
09:32 EDTNYMXNymox announces positive efficacy results in Phase 3 trial of NX-1207
Nymox announced new positive efficacy data for U.S. Study NX02-0022, the company's repeat injection study of NX-1207 for BPH. Analysis of symptomatic improvement from repeat injection over a 1 to 2 year period showed a mean improvement of 8.2 points in the AUA BPH Symptom Index Score. Evaluation of safety data from this study confirmed that NX-1207 reinjection treatment was well-tolerated by patients, did not impair sexual function, and has not shown any drug-related significant side effects. Participants in the clinical trial consisted of 160 consecutively treated men who had previously completed participation in an NX-1207 trial for BPH and who volunteered for a subsequent open label injection of NX-1207.
July 15, 2014
09:31 EDTNYMXNymox completes enrollment for second BPH re-injection study
Nymox Pharmaceutical announced the closing of enrollment for Study NX02-0022, the company's second re-injection Phase 3 clinical trial of the safety and efficacy of NX-1207 for the treatment of enlarged prostate. The NX02-0022 study enrolled patients who had previously participated in an earlier NX-1207 BPH study, and in the new trial these men received a second open-label injection of NX-1207. The study used a new lyophilized formulation of NX-1207 that has longer stability stored at room temperature. An interim analysis of the new efficacy data from the NX02-0022 study will be reported within the next few weeks.

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