Key Developments For Nymox Pharmaceutical Corporation
Nymox Pharmaceutical Corporation (NYMX.O) (Consolidated Issue listed on NASDAQ Capital Market)
Nymox Pharmaceutical Corp.'s NX-1207 to be Clinically Tested For Prostate Cancer
Nymox Pharmaceutical Corp. announced that NX-1207, the Company's lead drug in development, has been shown to produce strongly positive and repeatable results in laboratory studies of human prostate cancer. In addition, local injection of NX-1207 showed activity in animals with transplanted human prostate carcinoma. The NX-1207 used in these studies is a different formulation and a much higher dosage from that of NX-1207 used to treat benign prostatic hyperplasia (BPH). NX-1207 has been tested in humans since 2003 for benign prostatic hyperplasia (BPH), and has been shown thus far to have an excellent safety profile, with no known serious drug side effects seen in studies to date. The laboratory studies of prostate cancer were conducted over a 2-year period, using human prostate cancer cell lines and numerous different standard well-established methods. The Company intends to advance NX-1207 into human clinical trials for the focal treatment of localized prostate cancer.
Nymox Pharmaceutical Corp.'s NX-1207 Shows Major Effect On Liver Cancer
Nymox Pharmaceutical announced that NX-1207, the Company's drug in development, has been shown to repeatedly produce strongly positive results when given to animals with hepatocellular carcinoma (HCC). In the experimental studies, the cancers were significantly reduced in size after 2 local injections of NX-1207. The rodents in the studies had transplanted human HCC, a standard model for cancer research. These animals had an average tumor burden reduction of close to 50% after 20 days. The NX-1207 used in these studies is a different formulation and a higher dosage from that of NX-1207 used to treat benign prostatic hyperplasia (BPH). The Company intends to advance NX-1207 into human clinical trials for the treatment of HCC.
Nymox Pharmaceutical Corp. Announces Start of Second Phase 3 Trial For NX-1207 For BPH
Nymox Pharmaceutical Corp. announced that NX02-0018, the second Phase 3 U.S. clinical trial for NX-1207, the Company's investigational drug for BPH, has begun screening and enrolment of patients. The protocol and patient materials for Trial NX02-0018 have been officially approved by the Investigational Review Board. The Company currently has agreements with 60 investigational sites in the U.S. for Phase 3 trials of NX-1207, and expects the number of clinical trial sites to be increased to up to 100 investigational sites.
Nymox Pharmaceutical Corp. Announces Initiation of Phase 3 Trials for NX-1207 for BPH
Nymox Pharmaceutical Corp. announced that NX02-0017, the first Phase 3 U.S. clinical trial for NX-1207, the Company's investigational drug for BPH, has been given Investigational Review Board approval to begin. Screening and enrollment of patients will formally begin in the next 2 weeks. The Company will undertake 2 pivotal Phase 3 U.S. clinical trials for NX-1207, with a total of 1000 patients. The protocol and patient materials have been officially approved by the Investigational Review Board. Currently there are agreements with 60 investigational sites in the U.S. The Company expects the number of clinical trial sites to be increased to up to 100 investigational sites. The most experienced BPH clinical research centers and many of the largest urology practices in the U.S. will be participating. The Phase 3 trials for NX-1207 will test the safety and efficacy of the drug treatment of BPH as compared to placebo. Efficacy will be determined by symptomatic improvement, using the American Urological Association BPH Symptom Index, which measures the severity of the irritative and obstructive urinary symptoms of BPH, including frequency, urgency, intermittency, hesitancy, sensation of incomplete voiding, weak stream, and nocturia. The trials will also investigate the drug's effect on prostate volume, urinary maximum flow rate, and several other pertinent measurements.
Nymox Pharmaceutical Corp. Announces New Positive Results From Study Of NX-1207
Nymox Pharmaceutical Corp. announced new positive results from a long term outcome study of NX-1207 for benign prostatic hyperplasia (BPH). The study evaluated symptomatic progress of U.S. patients involved in the Company's two initial 2003 Phase 1-2 studies of NX-1207. Patients treated with NX-1207 were followed-up on an unselected and as available basis and assessed for symptomatic improvement, treatment outcomes, and durability of efficacy 64 months after treatment. Data was available for 75% of the subjects in the initial studies. Overall, 67% of the patients in the new outcome study treated with NX-1207 reported no current drug treatment for their BPH and had a mean improvement of 11 points in AUA Symptom Score. In addition, 46% of the patients reported no other approved treatments at any time for their BPH since their original treatment with NX-1207, with a mean improvement of 13 points. This sustained improvement in BPH symptom score after NX-1207 treatment compares favorably to the 3.5 to 5 points reported in published studies of currently approved BPH drugs, which, unlike NX-1207 treatment, require uninterrupted, daily administration to be effective. NX-1207 has entered its Phase 3 development program, the last stage before filing with the FDA for approval. The drug involves a new targeted approach to the treatment of BPH. NX-1207 is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs.
