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The Angeles Clinic and Research Institute Initiates Global Phase 3 Clinical Trial for New Melanoma Drug

Posted on: Monday, 7 January 2008, 12:00 CST

A patient at The Angeles Clinic and Research Institute is the first to enter a global, pivotal Phase 3 clinical trial for treating advanced melanoma. The experimental drug, Elesclomol, attacks cancer in an entirely new way and has shown promise in treating metastatic melanoma, delaying progression of the disease and possibly prolonging the lives of patients.

Elesclomol has a completely new and distinct mechanism of action from other cancer therapies as it induces a potent stress response in cancer cells, driving programmed cell death and enhancing the activity of chemotherapy. In November 2006, Elesclomol received Fast Track designation from the FDA for development in metastatic melanoma. A recent study led by Dr. Steven O'Day of The Angeles Clinic and Research Institute showed that giving Elesclomol in addition to chemotherapy more than doubled the amount of time patients survived without progression of their cancer. Currently, the average time patients survive following diagnosis of metastatic melanoma is only six to nine months. Elesclomol is being developed by Synta Pharmaceuticals, which is sponsoring the trial.

"To date, the clinical data we have seen for Elesclomol have shown a positive benefit to patients suffering from metastatic melanoma and provide a strong scientific basis for initiating this Phase 3 study," said Steven O'Day, MD, Chief of Research and Director of the Melanoma Program at The Angeles Clinic and Research Institute and principal investigator of the study. "Patients and physicians have few effective treatment options for metastatic melanoma today and the promise of a novel drug candidate is welcome in the melanoma treatment community.

"The research program for melanoma exemplifies our commitment to advancing the understanding and treatment of cancer, while providing our patients with compassionate care," said Lawrence D. Piro, MD, Chief Executive Officer of The Angeles Clinic and Research Institute. "Clinical trials are an integral part of the comprehensive care program at The Angeles Clinic and Research Institute, as they offer a chance for the best care to today's patients while advancing toward continued improvements for future patients."

Melanoma, the most deadly form of skin cancer, arises from melanocytes, the pigment-producing cells of the skin. If diagnosed and surgically removed while localized in the outermost skin layer, melanoma is potentially curable; however, for patients with metastatic disease the prognosis is poor with limited available treatments and an expected survival of only six to nine months.

According to the American Cancer Society, melanoma accounts for approximately five percent of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,200 people will die from melanoma this year in the U.S. alone. The incidence of melanoma has increased more rapidly than any other cancer during the past ten years. Melanoma has a high incidence in California, and particularly in Los Angeles County. Of the 60,000 Americans diagnosed each year, nearly 10% are in California and more than 20% of the cases in California occur in Los Angeles County.

Elesclomol is the first in a new class of cancer therapies called oxidative stress inducers. It works by increasing the amount of reactive oxygen species (ROS), such as hydrogen peroxide and superoxide, in cells. When the level exceeds the antioxidant capacity of cells, the cells are in a state of oxidative stress. Elesclomol kills only tumor cells because the additional stress introduced pushes cancer cells, but not healthy cells, over the critical threshold. Melanoma is one of several cancer types that are known to operate at a higher level of oxidative stress and therefore would be expected to be more vulnerable to this mechanism of action.

The clinical trial of Elesclomol is one of several cutting-edge cancer studies being conducted at The Angeles Clinic and Research Institute. Patients at The Angeles Clinic and Research Institute are eligible to participate in clinical trials as part of the Clinic's integrated cancer care approach, which creates an environment for state-of-the-art therapy individualized for each person. Cancer patients work with their physician to become aware of clinical trials so that the patient can make an informed decision about whether to participate in a clinical trial.

About the Angeles Clinic and Research Institute

The Angeles Clinic and Research Institute, located in Los Angeles, is internationally recognized in cancer research, providing the best experimental and traditional treatments. The Melanoma Center at The Angeles Clinic specializes in the comprehensive treatment of all types and stages of melanoma. For more information, please visit http://www.theangelesclinic.org.

Source: Business Wire

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