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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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