The company announced Monday that the its U.S. long-term extension prospective double-blind phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BPH (benign prostatic hyperplasia) have successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo. Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant, related molecular side effects in the 2 studies.
Following this clinical success Nymox now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories.
One of the key benefits from this study was the reduced incidence of surgery. Subjects in phase 3 studies NX02-0020 and NX02-0022 with 1 or 2 injections of fexapotide had statistically significant reduction of BPH surgery within 24 months of fexapotide treatment.
Another important point from the study was that it had a median duration of 3.5 years from a single injection treatment. Also there was a statistically significant higher proportion (64%) of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects versus the control group.
Some of the other projects in which this biopharmaceutical company engages are the research and development of products for the aging population; it offers NicAlert and TobacAlert tests that use urine or saliva to detect use of tobacco products; and it sells AlzheimAlert, a proprietary urine assay that aids physicians in the diagnosis of Alzheimer’s disease.
Shares of Nymox were up about 109% at $2.65 on Monday afternoon. The stock has a consensus analyst price target of $10.25 and a 52-week trading range of $0.33 to $5.75. The company has a market cap of about $99 million.
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