The decision to expand the protocol to include Virulizin, an immunotherapeutic product, as a first line combination therapy with gemcitabine resulted from conversations with the Food and Drug Administration (FDA) to finalize the design of the Phase III study.

Gemcitabine is the current standard treatment for pancreatic cancer.

The new Phase III clinical protocol provides for first line therapy with Virulizin(R) combined with gemcitabine to be evaluated in comparison to treatment with gemcitabine alone.

The study will include a second line treatment for patients who fail gemcitabine treatment. Second line treatment will compare treatment with Virulizin(R), plus the frequently used second line or salvage therapy for pancreatic cancer known as 5-flurouracil (5-FU), with treatment of 5-FU alone.

Virulizin(R) has been shown to be a non-toxic immunotherapy that recruits killer cells, monocytes and macrophages, to attack tumor cells.

In pre-clinical and/or clinical studies, Virulizin(R)has proven to be a safe and effective drug capable of anti-tumor activity in a range of cancer types, such as pancreatic cancer, malignant melanoma and breast cancer.

"The onset of a Phase III clinical program for Virulizin(R), which includes both first and second line treatment, is very promising because it provides a great deal of flexibility in our clinical study due to start this year," said Dr. Jim A. Wright, Ph.D., president of Lorus. "In the light of the recent meeting with the FDA, we believe that this approach should provide the best opportunity to determine the potential of Virulizin(R) as a treatment for pancreatic cancer. In addition, this new protocol would greatly increase the market potential for our product."

The new clinical program, with a recruitment goal of approximately 350 individuals with pancreatic cancer, will designate survival as the primary end point in the study, with clinical benefit and time-to-symptom progression as key end points.

Besides survival, patients will be examined for key clinical outcomes such as pain, weight loss and patient performance. Patients who exhibit disease progression or intolerance in the gemcitabine arm of the study would be offered Virulizin(R) plus 5-FU or 5-FU alone.

To support the eventual submission of a new drug application (NDA) for Virulizin(R) to the FDA, Lorus plans to run a similar, but independent and smaller study in parallel with the first. The revised clinical trial design should enhance patient participation and could decrease the time to complete the study.

"With regard to the devastating nature of pancreatic cancer, many patients are highly resistant to current chemotherapy and radiation treatment, and even modest incremental benefits in survival or improved symptoms are viewed as substantial advances," said Dr. Michael Thirlwell, professor of oncology and medicine and director of oncology at the Montreal General Hospital - McGill University Health Center and lead investigator of Lorus' Phase I clinical trial with Virulizin(R).

Although pancreatic cancer comprises less than 2% of all malignancies, it is the fifth leading cause of cancer-related deaths in Canada and the United States, with the poorest survival rate among all cancer types.

The FDA awards Orphan Drug Status to drugs used in the treatment of diseases that afflict fewer than 200,000 patients annually in the U.S. Virulizin(R) was awarded this status for its potential in the treatment of pancreatic cancer.

Lorus is a biopharmaceutical company focused on the research and development of cancer therapies. Lorus' goal is to capitalize on its research, pre-clinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone or in combination, to successfully manage cancer.

08-Aug-2001