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Nymox
Pharmaceutical Corporation
announced today new positive outcome
results from the Company's ongoing prospective NX03-0040 trial of NX-1207 for
the treatment of low grade localized prostate cancer. Clinical outcomes were
determined at 8 months from the initial treatments. 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 8 months for NX-1207 single-injection treated patients that
there was a statistically significant reduction compared to controls of more
than 75% (p=.002) in the proportion of patients who had upgraded blinded
biopsy and laboratory results and went on to require and receive radiation
therapy and/or surgery. The new results also indicated that the NX-1207
treated patients had 67% less progression to surgery and/or radiotherapy
compared to controls (p=.008) for all reasons (including elective surgery
and/or radiotherapy with no biopsy or laboratory upgrades).
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. The drug was injected into the area of the prostate where the
cancer was detected and repeat biopsies were then performed on all patients,
drug treated and controls. The patients in the active surveillance group in
the study who were eligible could elect crossover drug treatment after their
first follow-up rebiopsy. Follow-up studies are being conducted of all
consenting patients in the study to continue to monitor outcome and safety
data.
These new findings extend the previously reported study results which showed
that patients with NX-1207 treatment after 2 months had less clinical
progression and 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.
Prostate cancer is the most commonly diagnosed cancer in men, other than skin
cancer, and is the second leading cause of cancer death for men. An estimated
233,000 cases will be newly diagnosed in the U.S. in 2014 with approximately
50% of them being initially considered low risk.
NX-1207 is in Phase 3 development in the US and Europe for benign prostatic
hyperplasia (BPH) also referred to as prostate enlargement, a common condition
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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