Is Nymox The Next Unknown Biotech Turned High Flyer?
Andrew Smith • 17 Comments
Andrew Smith • 17 Comments
Mon, Jun. 27, 12:51 PM
Thu, Jun. 23, 11:00 AM
Wed, Jun. 22, 12:42 PM
Wed, Jun. 22, 11:00 AM
Wed, Jun. 22, 10:54 AM
- Thinly traded micro cap Nymox Pharmaceutical (NYMX +29.2%) heads north on more than a 20x surge in volume in response to its announcement of positive results from its seven-year study of lead drug fexapotide (NX-1207) in men with benign prostate hyperplasia (enlarged prostate) (BPH).
- The study enrolled 995 men across 70 U.S. sites. They were thoroughly evaluated to exclude any prostate cancer prior to treatment in the trial. They were followed for up to seven years (median of five years) after receiving a single transrectal injection of fexapotide.
- The incidence of prostate cancer cases in this group was only 1.3%, much lower than the expected rate of 5 - 20% in the general middle aged/elderly U.S. male population. In a BPH population, major studies have shown the incidence rate to be 20 - 25%.
- The company says the results will support regulatory applications for the BPH indication.
Tue, Feb. 9, 12:48 PM
Tue, Feb. 9, 10:41 AM
- The market's positive money flow notwithstanding, thinly traded nano cap Nymox Pharmaceutical (NYMX +13.3%) is up on increased volume in response to its announcement of positive results from a Phase 2 study, called NX03-0040, assessing lead product candidate fexapotide triflutate (NX-1207) in men with localized prostate cancer. The trial met its efficacy endpoints and showed significant improvements in progression-related outcomes in patients treated with fexapotide.
- The 40-month study commenced in February 2012 at 28 U.S. sites. 147 patients with low grade localized prostate cancer were enrolled. The primary endpoint was the absence of tumors controlled for size in the baseline area. Fexapotide 15 mg showed superiority to control (p=0.002) as did crossover fexapotide 15 mg (p=0.002) and crossover fexapotide overall (p=0.014).
- The fexapotide 15 mg cohort experienced a 75.5% reduction in prostate cancer progression after 18 months compared to control (p=0.0055) and a 71.7% reduction overall (p=0.014). There was also an 84.8% reduction in surgery or radiotherapy instituted for cancer progression compared to placebo (p=0.014) in the 15 mg group.
- Fexapotide is administered directly into the prostate via a transrectal injection that does not require anesthesia or sedation.
- The company says it will announce its plans for advancing the clinical development of fexapotide for the treatment of prostate cancer at a later date.
Mon, Jan. 11, 12:43 PM
Oct. 29, 2015, 12:53 PM
Oct. 29, 2015, 12:02 PM
- Micro cap Nymox (NYMX +27.8%) is up on a 3x surge in volume in response to its announcement that patients with low grade prostate cancer in a Phase 2 clinical trial who switched over to treatment with NX-1207 (fexapotide triflutate) from placebo experienced superior long-term outcomes compared to those who did not change (cross-over). The data are the initial 18-month follow-up results from the study, called NX03-0040. The cross-over arm consisted of 35 subjects.
- Based on biopsy progression, no patients who switched to NX-1207 (15 mg or 2.5 mg) required biopsy progression-related surgery or radiotherapy while an undisclosed proportion in the placebo cohort did (p<0.03). In addition, re-biopsies of all patients in the NX-1207 cohort all showed absence of tumor compared to the baseline of positive biopsies for all. This was, again, statistically superior to placebo (p<0.03), but the actual proportion for the latter is not provided.
- The company intends to report full results from NX03-0040 later this quarter.
Oct. 13, 2015, 12:45 PM
Oct. 1, 2015, 12:40 PM
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Nymox Pharmaceutical Corp. operates as a biopharmaceutical company, which specializes in the research and development of products for the aging population. Currently, it markets NicAlertTM and TobacAlertTM, tests that use urine or saliva to detect use of tobacco products. The company develops... More
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