Corporation (Nasdaq: NYMX) announced today new positive outcome results from
the Company's ongoing prospective trial of NX-1207 for the treatment of low
grade localized prostate cancer. These are the first clinical patient
treatment outcome results for this trial. A controlled comparison was
conducted of patients who required and received radiation and surgery
treatments for their cancer based on blinded post-treatment upgraded
evaluations of their pre-treatment initially positive lower grade cancers. The
study found after up to 22 months for NX-1207 single-injection treated
patients there was an 85% reduction compared to controls in the proportion of
patients who had upgraded blinded biopsy results in the treated area and went
on to require and receive radiation therapy and/or prostatectomy (surgery).
Long-term clinical outcome is considered to be a highly important measure of
drug treatment efficacy. 146 patients were enrolled in the NX03-0040 Phase 2
U.S. trial and either randomized to one of two doses of NX-1207 (2.5 mg or 15
mg) or to active surveillance (no treatment). The drug was injected into the
area of the prostate where the cancer was detected and repeat biopsies were
then performed on all patients, treated and controls. Follow-up studies are
being conducted of all patients in the study to monitor outcome and safety
data. The patients in the new study results were followed for up to 22 months
Previously reported study results showed that patients with NX-1207 treatment
had significantly less Gleason grade progression, lower average PSA levels,
lower numbers of biopsy cores showing greater malignancy, and lower total
volume of more malignant cancer compared to controls.
To date, NX-1207 has had an excellent safety profile as both a treatment for
benign prostatic hyperplasia (BPH) and localized low-risk prostate cancer. In
the current trial, a new high dose of drug (15 mg) was safely used without
drug-related adverse effects. NX-1207 has shown safety in repeat injection
studies (NX02-0020 and NX02-0022). The drug does not lead to immune responses
such as antibody formation which can cause significant drug toxicity and/or
limit usage to single treatments due to drug neutralizing effects.
Paul Averback MD, CEO of Nymox, said, "These new results show the potential of
NX-1207 to offer men with low-risk prostate cancer a significant tangible
benefit in terms of avoidance of radiation and/or surgery and the related
risks, discomforts, and permanent side effects. We emphasize that these
results are based on a single injection only. A similar convenient treatment
regimen with multiple injections is to be expected to offer even more benefit,
which we hope to be able to demonstrate as soon as possible. If these positive
results can be further validated, NX-1207 may prove to offer a new safe option
for a painless way to deal with a major problem for many men."
NX-1207 is in Phase 3 development in the U.S. and Europe for benign prostatic
hyperplasia (BPH) also referred to as prostate enlargement, a common
affliction of middle-aged and elderly men, affecting up to half of men over
the age of 50. The Company's European partner for BPH is Recordati S.p.A.
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