Nymox Pharmaceutical's NX-1207 human clinical trials for HCC demonstrate favorable safety data

Mar 31 2010

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) outlined today the Company's development program for the Company's lead drug candidate, NX-1207, currently in Phase 3 trials in the U.S. for the treatment of benign prostatic hyperplasia (BPH). The drug has been successful in a series of blinded controlled multi-center U.S. clinical trials where it has been found to produce improvements that are about double that reported for currently approved BPH drugs. Positive results from animal studies have shown the potential for the use of high dosages of NX-1207 for the focal treatment of clinically localized prostate cancer and of primary liver cancer (hepatocellular carcinoma or HCC).

"The clinical trials of NX-1207 in humans to date have demonstrated an excellent safety profile for NX-1207, with no known serious drug side effects," said Paul Averback MD, CEO of Nymox. "This favorable safety data will be an advantage in the clinical trials for the treatment of prostate cancer and liver cancer. There is a serious unmet need for a safer option for the treatment of localized prostate cancer without causing impotence or other sexual side effects. We are also looking forward to advancing NX-1207 for the treatment of primary liver cancer."

Prostate cancer is the most common cancer in men. The American Cancer Society estimates that in 2009 alone an estimated 192,280 men in the U.S. will have been newly diagnosed with prostate cancer and 27,360 will die from it. It is estimated that some 1.8 million American men are living with a diagnosis of prostate cancer. Approximately 90 percent of prostate cancers are confined to the prostate gland and thus potential candidates for localized treatment. Men diagnosed with localized prostate cancer face difficult choices ranging from watchful waiting (active surveillance) with no treatment to one of the several current methods of treatment, most of which have side effects.

There is a large unmet need for new treatments for HCC, the cause of about 90% of primary liver cancer cases in adults. Worldwide, primary liver cancer is the sixth most common cancer but because of very poor survival rates is the third leading cause of cancer-related deaths. Each year, more than 600,000 people are diagnosed with primary liver cancer and approximately 600,000 die of the disease. Liver cancer is most common in the Far East with more than 400,000 cases diagnosed each year in China, South Korea, Japan and Taiwan. The incidence of HCC is increasing in the U.S. and the EU, primarily due to HCC associated with hepatitis C infection, a major risk factor for the cancer.