SA News • Fri, Nov. 14
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Fri, Nov. 14, 10:14 AM
Mon, Nov. 3, 12:49 PM
Mon, Nov. 3, 9:29 AM
Mon, Nov. 3, 9:13 AM
Mon, Oct. 6, 12:46 PM
Fri, Oct. 3, 1:53 PM
- The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted against recommending regulatory approval of SonaCare Medical's Sonablate 450 for the treatment of recurrent prostate cancer in patients previously treated with external beam radiation therapy. The device utilizes high intensity focused ultrasound (HIFU) to ablate tissue.
- The panel's rejection was due to the fact that Sonacare's clinical trial data were based on an interim analysis of the first 100 patients in a planned 200-patient study. The company obviously believed the data were compelling enough to proceed with its submission prior to the conclusion of the study but the reviewers felt otherwise.
- The panel voted 7-3 against (1 abstention) recommending that the treatment was safe if used as intended; 9-2 against recommending that the treatment was effective if used as intended and 10-0 against recommending that the benefits outweigh the risks.
- Briefing docs
- Prostate cancer therapy-related tickers:(TKAI -2.1%)(MDVN +1.2%)(NYMX +4.8%)(EXEL -0.3%)(PGNX +2.8%)(MRK +1.8%)(ADXS +2.7%)(EBS +1.8%)(EDAP +3%)(ISIS +2.1%)(NVGN)(DNDN +0.7%)(ISR +1.4%)(OGXI +0.4%)
Wed, Sep. 10, 1:37 PM
- In an analysis of clinical outcomes at eight months in a 146-patient Phase 2 clinical trial evaluating the safety and efficacy of Nymox's (NYMX +3.9%) drug candidate for low grade localized prostate cancer, NX-1207, the proportion of patients who required and received radiation and/or surgery was 75% less in the NX-1207 cohort compared to placebo. The results were statistically significant (p=0.002). Also, the proportion of NX-1207-treated patients who progressed to surgery or radiotherapy for all reasons was 67% less than placebo (p=0.008).
- NX-1207 patients received a single injection of either 2.5 mg or 15 mg directly into the area of the prostate where cancer was detected. Surveillance of the treatment group is ongoing.
- NX-1207 is also being developed as a treatment for benign prostatic hyperplasia.
Mon, Aug. 11, 10:09 AM
- Nymox Pharmaceutical Corp. (NYMX +1.1%) Q2 results: Revenues: $752.3K (-10.4%); Operating Expenses: $1.5M (-33.9%); Operating Loss: ($779.3K) (+47.3%); Net Loss: ($820.3K) (+44.5%); Loss Per Share: ($0.02) (+50.0%); Quick Assets: $81.2M (-72.5%); Cash Burn (1H): ($3.4M) (-32.7%).
- No financial guidance given.
Mon, Aug. 11, 10:09 AM
Tue, Jul. 22, 2:13 PM
- In an interim analysis of efficacy data in a repeat injection study of Nymox's (NYMX +2.8%) investigational drug NX-1207 for benign prostatic hyperplasia (BPH), subjects showed a mean improvement in AUA BPH Symptom Index Score of 8.2 points (n=160). The results compare favorably to the mean improvement of 7.6 points demonstrated in the company's first reinjection trial.
- NX-1207 is being evaluated as a treatment for BPH and prostate cancer. It is administered via a transrectal injection that does not require anesthesia or sedation. Patients will undoubtedly prefer a small bore syringe.
Tue, Jul. 15, 11:29 AM
- Patient enrollment is complete in Nymox Pharmaceuticals' (NYMX -0.4%) second re-injection Phase 3 clinical trial evaluating the safety and efficacy on NX-1207 as a treatment of enlarged prostate or benign prostatic hyperplasia (BPH). In the first re-injection study, patients demonstrated a mean symptomatic improvement in the AUA BPH Symptom Score of 7.6 points.
- NX-1207 is administered by injection directly into the prostate gland. It is currently being assessed in five Phase 3 trials and one Phase 2 trial.
Thu, May. 15, 9:51 AM
Wed, Apr. 30, 11:32 AM
- The good: Nymox Pharmaceuticals' (NYMX -6.4%) cancer drug NX-1207 delivers positive top-line results in a Phase 2 clinical trial in patients with low grade prostate cancer. Subjects receiving a single injection into the prostate gland had less evidence of cancer progression in the treated area than untreated patients as determined by Gleason grade. There was a statistically significant reduction in the number of higher grade malignancy in biopsy cores versus controls.
- The bad: The trial's primary efficacy endpoint of the number of subjects with undetectable prostate cancer as determined by negative biopsies 45 days post treatment could not be assessed due a high percentage of false negative repeat biopsies. Almost 69% of the study subjects had evidence of a very small tumor (>=5% of their positive biopsy). 85% of this subgroup had negative second biopsies thus preventing analyses.
- The ugly: The time and cost of the trial were wasted. The firm currently seeks a pharmaceutical partner to fund the further development of the drug for low grade prostate cancer.
Sep. 9, 2013, 12:46 PM
Aug. 22, 2013, 3:24 PM
- Nymox Pharmaceuticals (NYMX +3.1%) says the Safety Monitoring Committee's most recent review of safety data for NX-1207, its drug candidate to treat benign prostatic hyperplasia, found no significant safety concerns to date.
- NX-1207 is currently is in Phase III development in the U.S. and in the E.U. by licensing partner Recordati SpA.
- The drug has so far shown none of the adverse sexual side effects associated with previously approved medical and surgical treatments for BPH.
- Both Phase III trials have completed enrollment and treatment and patient evaluation is continuing at over 70 urology investigative sites across the U.S.
Aug. 14, 2013, 3:53 PM
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Nymox Pharmaceutical Corp along with its subsidiaries is a biopharmaceutical corporation, engaged in research and development of diagnostics and drugs for brain disorders and diseases of the aged with an emphasis on Alzheimer's disease.
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