A new clinical formulation extracted from a botanical may provide physicians with a new tool in treating aggressive late-stage breast cancer.

The oral anti-cancer drug BZL101, developed by Bionovo Inc., is derived from the Asian botanical herba Scutellaria Barbata. Bionovo researchers believe the herb’s main agent has the ability to specifically identify and target malignant cells, leaving normal cells intact and healthy.

BZL101 works by eliciting a cancer cell’s innate mechanism of self-suicide, or apoptosis. The drug selectively releases Apoptosis Inducing Factor-1 (AIF1) from a cancer cell’s mitochondrial membrane. AIF then moves to the cell’s nucleus, disintegrating the DNA structure, and fragmenting and killing the cancer cell.

Bionovo’s scientists have shown that although AIF exists in all cells, this protein-translocation process can be elicited exclusively in cancer cells while avoiding normal cells. “In the cell, AIF is responsible for killing cells that don’t perform their intended functions or cells that are not in their proper place such as cancer cells which lose functions through mutations and invade local and distant tissues,” said Dr. Isaac Cohen, Bionovo’s President and CEO.

Researchers at The University of California at San Francisco and the Komen/UT Southwestern Breast Cancer Research Program at University of Texas Southwestern Medical Center recently completed a phase I study on BZL101. They reported favorable data from these trials at the 28th Annual San Antonio Breast Cancer Symposium.

As described at the symposium, from the initial study of 21 patients with advanced metastatic breast cancer, 16 patients were evaluated for final results. It was concluded that four of the 16 patients had stable disease for greater than 90 days and three of the 16 had stable disease that lasted more than 180 days. Five patients in the trial had objective tumor regression. All 16 patients demonstrated little to no side effects from the drug.

Debu Tripathy, M.D., Director of the Komen/UT Southwestern Breast Cancer Research Program at UT Southwestern Medical Center, commented: “We are encouraged by the results of this study, which underscore BZL101 as an effective new oral treatment for the more than 45,000 women diagnosed each year with the aggressive late-stage of this disease.”

“While safety was the primary endpoint of the trial, it is worth noting that BZL101 showed elements of clinical efficacy similar to what we have observed in early-stage studies of currently marketed therapies. Future studies are planned to explore the drug further,” said Dr. Tripathy.

Breast cancer is the second leading cause of cancer death, with more than 200,000 new cases each year.

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