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Phase III Clinical Trial for Virulizin Expanded
In addition to approximately 40 clinical sites and several new major cancer centers throughout the United States, the company has expanded the trial to 10 major oncology centers in Canada and Mexico. Participating Canadian centers include McGill University in Montreal and the Cross Cancer Center in Edmonton Alberta. In Mexico it will include the National Cancer Institute of Mexico and the National Medical Center in Mexico City, which are two of Latin America's leading oncology centers.
The Virulizin(R) Phase III clinical trial examines the drug in a first-line treatment setting in combination with gemcitabine, the only agent currently approved for the treatment of advanced pancreatic cancer. The same clinical trial also examines Virulizin(R) in combination with 5-flurouracil as a second line treatment option for patients that become resistant or intolerant to gemcitabine treatment.
"We are very pleased to be a part of the Virulizin(R) Phase III clinical trial of first-line treatment of advanced pancreatic cancer," said Dr. Richard Just, Scripps Cancer Center, San Diego, California. "Virulizin(R) shows promise as a well-tolerated immunotherapeutic drug for a devastating disease that is characterized by very few new treatment options."
Ongoing clinical study sites for Virulizin(R) are located throughout the U.S., such as New York, California, Florida, Michigan, Louisiana, and Ohio.
Details of the Phase III clinical study design and contact information have been posted on major oncology and pancreatic clinical trial web sites to facilitate awareness of the clinical trial in the health-care community.
"We are very impressed with the enthusiasm of our clinical investigators and study staff in our Phase III clinical program for Virulizin(R). Expansion of this trial to important oncology centers in Canada, Mexico, and the addition of new US sites is not only important for our clinical trial milestones, but is also central to our longer term global business strategy to have a strong presence in international markets, and the international oncology community," said Dr. Jim Wright, CEO, Lorus.
The US Food and Drug Administration awarded Virulizin(R) orphan drug status and fast track status for the treatment of pancreatic cancer. The drug has been approved in Mexico for the treatment of malignant melanoma, where it is commercially available through Mayne Pharma, Lorus' marketing partner in Latin America.