Dr. Gaylis was of the opinion that NX-1207 was "an attractive novel therapy for BPH and for local low risk prostate cancer."
Dr. Freedman said "I think that NX-1207 is an out-of-the-box treatment like nothing else. There has never been an easier treatment for this affliction."
Dr. Gambla said that NX-1207 "is the least minimally invasive therapy I am aware of."
The first pivotal Phase 3 U.S. study of NX-1207 for BPH (NX02-0017) completed enrollment in November 2012; the second (NX02-0018) in April 2013. Overall, NX-1207 is being evaluated in six large studies, including two safety reinjection studies (NX02-0020 and NX02-0022), a European pivotal study (ERNEST) being conducted by Recordati S.p.A, the Company's European partner, and a U.S. Phase 2 prostate cancer study (NX03-0040). The Company previously successfully completed four Phase 1 and Phase 2 clinical trials of NX-1207 for BPH as well as over ten additional follow-up studies.
The Symposium presented further scientific data on the results of immunological testing of patients who received NX-1207. Current data shows no evidence of antibody formation against NX-1207 or hypersensitivity to NX-1207 in men. In addition, updated pharmacokinetic studies have provided further evidence to corroborate the absence of systemic toxicities for NX-1207. To date, the safety profile of NX-1207 has been excellent.
NX-1207 is a novel patented drug developed by Nymox which is currently in late stage Phase 3 trials for benign prostatic hyperplasia (BPH) and Phase 2 for localized prostate cancer. NX-1207 is injected into the sector of prostate to be treated by a urologist in a clinic setting. The procedure does not require catheterization, anesthesia, or sedation, takes only a few minutes and involves little or no pain or discomfort to the patient. In multi-center U.S. clinical trials for BPH to date, a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs. Follow-up studies have shown evidence of long lasting benefit with a significant proportion of men who received a single dose reporting improvement in BPH symptoms without other treatments for up to 7½ years.