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Nymox
Pharmaceutical Corporation
is pleased to announce its lead drug
candidate, NX-1207, has not shown any evidence of eliciting an immune reaction
in men treated with intraprostatic injections of the drug. Extensive clinical
immunogenicity testing of men in the Company's pivotal Phase 3 trials
(NX02-0017 and NX02-0018) and Phase 3 repeat injection safety study
(NX02-0020) showed no evidence of antidrug antibody formation. Periodic safety
monitoring reviews of the NX-1207 trials to date have shown no evidence of any
allergic reaction to the drug either on first injection or repeat injection.
Positive immunogenicity testing of NX-1207 is an important step in the
Company's drug development program. The results are consistent with the
pharmacological and pharmacokinetic profile of the drug and augment the
extensive safety experience with the drug in men with over 1,000 men having
received the drug to date.
The Company will present more detailed scientific data from these studies at
upcoming medical conferences. NX-1207 is in late stage Phase 3 development in
the U.S. for the treatment of benign prostatic hyperplasia (BPH), a common
condition of older men associated with growth in prostate size as men age. The
Company's NX02-0017 pivotal Phase 3 trial has completed enrollment. Phase 3
trial activities of NX-1207 for BPH have begun in Europe sponsored by
Recordati S.p.A., the company's European licensing partner. In the BPH studies
to date, a single dose of NX-1207 has been found to produce symptomatic
improvements about double that reported for currently approved BPH drugs
without causing the sexual or cardiovascular side effects associated with
those drugs.
NX-1207 is also being evaluated for the treatment of low risk localized
prostate cancer where NX-1207 is administered directly into the area of the
prostate where the cancer was detected. A U.S. Phase 2 study (NX03-0040) for
that indication is in progress.
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