UPDATE: Nymox Announces Positive Immunogenicity Results for NX-1207 BPH Program
Nymox Pharmaceutical Corporation (Nasdaq: NYMX) 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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