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AS Clinical Trial

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Joined: Nov 2011

Has any one heard of or have an opinion on the Nymox's U.S. Phase 2 Clinical Trial of NX-1207 for localized T1c prostate cancer ? It's an intraprostatic injection of NX-1207 of 0 ( control), 2.5 or 10 mg and f/u over various time intervals. It's an NCI sponsored Study recruiting patients who are currently on AS. I believe the NX 1207 must belong to the family of 5 alpha reductase inhibitors ( Avodart, Proscar etc)or a close analog.
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hopeful and opt...
Posts: 2331
Joined: Apr 2009

( if you can copy and paste information about the clinical trial it is appreciated), however here is a presentation about the drugs use for benign prostate cancer

Source: Nymox Pharmaceutical Corporation
Date: May 21, 2012 09:30 ET
New Positive Data on NX-1207 Presented at Symposium and Panel Discussion at American Urological Association Annual Meeting
Panel Discussion Highlights New Treatment for BPH
HASBROUCK HEIGHTS, N.J., May 21, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report on the presentation of new positive data at a high-level symposium and panel discussion held Sunday at the Annual Meeting of the American Urological Association in Atlanta, GA. The symposium was held between 3:00 and 4:00 pm EDT on Sunday. The well-attended symposium highlighted the ongoing clinical development program for NX-1207 for the treatment of benign prostatic hyperplasia (BPH) and featured expert panel discussions on the new therapy. The symposium, "Clinical studies of NX-1207: Phase 3 injectable for BPH" was chaired by Ronald F. Tutrone Jr., MD, FACS of Towson, MD. Panel members included Barton Wachs, MD, FACS of Long Beach, CA, Nicholas Franco MD of Naples, FL and Mohamed Bidair MD of San Diego, CA.

A new research report was presented at the NX-1207 symposium, authored by Dr. Barton Wachs, Dr. Sheldon Freedman of Las Vegas, NV, Dr. Barrett Cowan of Denver, CO, and Dr. Neal Shore of Myrtle Beach, SC. The new data concerned outcome analyses of single-injection NX-1207 after 4 ½ years in 45 patients. Subjects in the NX-1207 2.5 mg cohort had mean improvements in their BPH symptoms that reached statistical significance (p < .0001). According to the report "NX-1207 is an office-based" procedure involving only a few minutes to administer associated with minimal discomfort and no catheter requirement," and "results at 52-56 months after a single treatment indicate statistically significant symptomatic improvement and a very acceptable safety profile."

According to Dr. Tutrone, "NX-1207 for the treatment of enlarged prostate allows the urologist to treat their BPH patients with a single in-office injection procedure that requires no anesthesia or catheter, has virtually no adverse effects and has substantial efficacy. The patient can return to work the same day as the injection and can have lasting efficacy up to many years. Urologists have long awaited a new treatment paradigm that does not require daily oral medications or invasive surgical procedures yet affords the patient a safe and effective treatment that may give them long term relief from the symptoms of an enlarged prostate. It has a very strong possibility of becoming a first-line therapy for the treatment of enlarged prostate." Dr. Tutrone is Director of Research at Chesapeake Urology Associates and Chief of Urology at the Greater Baltimore Medical Center.

According to Dr. Franco, "Nymox NX-1207's combination of office convenience and painless efficacy will make it very popular to the vast majority of urologists. It will be easy to incorporate into a normal day's schedule." Dr. Franco is a well known U.S. clinical investigator and expert in prostate diseases based in Naples, FL.

Dr. Wachs said, "NX-1207 uniquely establishes the concept of treating an enlarged prostate by direct injection, which make more sense than any other type of therapy, drug or surgery. Direct injection is the wave of the future." Dr. Wachs is a highly respected urologist who has been the recipient of numerous awards.

Dr. Bidair added, "The first thing one recognizes about NX-1207 is its ease of use. It is well tolerated, has a minimum of side effects, and minimal discomfort." Dr. Bidair is a well known clinical investigator with extensive clinical research experience.

NX-1207 is also being tested in Phase 3 for BPH in Europe in collaboration with Recordati SpA, Nymox's European partner.

Phase 2 studies of NX-1207 for low grade localized prostate cancer have begun in the U.S. in 2012.

Completed Phase 2 studies have shown that a single administration of NX-1207 resulted in symptomatic improvements which reached statistical significance compared to double-blinded placebo and study controls. Patient-reported improvements in the standardized BPH symptom score were on average 8 to 10 points at 90 days as compared to the approximately 3 to 5 points reported on average for currently approved BPH drugs. The drug is administered by a urologist in an office setting in a brief procedure that does not require anesthesia, sedation, or catheterization and involves little or no pain or discomfort. NX-1207 treatment has not been found to have the sexual, blood pressure, or other side effects associated with the use of the approved drugs for the treatment of BPH. Follow-up studies have shown clinical efficacy effects lasting up to 7 years after a single treatment.

BPH is one of the most commonly diagnosed diseases in the male U.S. population. The condition can seriously impact the health and quality of life of older men and can lead to acute urinary retention, incontinence, and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.

More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.

This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.

CONTACT: For Further Information Contact:
Roy Wolvin
Nymox Pharmaceutical Corporation

VascodaGama's picture
Posts: 3371
Joined: Nov 2010

You may also check details on this planned AS Trial;


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