Pharmagenesis, a research and development company developing novel anticancer therapies, has begun clinical trials in the U.S. for PG490-88Na, a derivative of a compound from an herb widely used in Chinese medicine.

In preclinical studies, PG490-88Na reduced tumor growth, or caused marked regression or complete eradication of human tumors implanted into mice. PG490-88Na appeared in those preclinical studies to have direct anti-cancer effects, and to potentiate effects of commonly prescribed chemotherapy drugs such as 5-FU, Camptosar (irinotecan) and Taxol (paclitaxel).

The U.S. trials are being conducted at two sites, the Cancer Therapy & Research Center (CTRC) in San Antonio, Texas and at the University of Colorado Cancer Center in Denver, Colorado.

"Beginning U.S. trials for PG490-88Na is an important corporate and clinical milestone for Pharmagenesis," said Nicholas Druz, chairman and CEO, Pharmagenesis. "We believe in the efficacy of PG490-88Na and the other drugs we have developed from extracts of herbs for the treatment of cancer and we are extremely pleased that two prestigious cancer centers are willing to study this new therapeutic approach."

Preclinical pharmacology studies have shown that treatment with PG490-88Na can significantly inhibit growth of a broad range of human tumor cells in culture and implanted into mice. PG490 released from PG490-88Na appears to kill cancer cells by inducing a process termed 'apoptosis' -- the programmed instructions for appropriate cell death genetically encoded into all cells. Certain cancer cells cause their often fatal effects because they lack or ignore this programmed cell death, and keep growing, invading and killing the normal tissues around them. Studies of the Pharmagenesis drug suggest it induces apoptosis in cancer cells -- but not normal cells -- by inhibiting activity of a transcription factor NF-kB which can prevent 'apoptosis.' Scientists at Pharmagenesis hope that blocking the ability of tumors to escape death will improve patient survival.

A Phase I open-label study is accruing patients with advanced solid tumors who have failed standard therapy. The patients will be sequentially assigned to receive intravenous infusions of PG490-88Na at escalating dose levels. Cancer is second only to heart disease as a cause of death in the United States, accounting for approximately one in four deaths. Solid tumors are responsible for the majority of these deaths. Although there have been significant advances in the medical treatment of certain cancers, the overall five-year survival rate for all cancers has improved by only about 10 percent in the past 20 years.