CTRC Enrolls First Patients In Phase II Study; Living Virus Destroys Cancer Cells In Sarcoma Patients

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 21 Jul 2007 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The Cancer Therapy & Research Center Institute for Drug Development, in collaboration with Oncolytics Biotech Inc., a biotechnology company, has enrolled the first two patients in a new Phase II clinical study for patients with various types of sarcomas that have metastasized to the lung. CTRC is one of only three sites in the United States, and the only in Texas, enrolling patients. The novel anti-cancer therapy, REOLYSIN(R), is a living virus, not a chemotherapy drug, that is toxic to cancer cells but not harmful to normal cells. This novel therapy, using a living virus, is the first of its kind available at CTRC.

According to Monica Mita, MD, principal investigator at the CTRC Institute for Drug Development, REOLYSIN(R)'s name was derived from the human reovirus, a mild virus that occurs naturally in the environment.

"This novel therapy has shown success because the reovirus replicates in and destroys the cancer cells within the patient's body," said Mita. "Cancer cells have several molecular and genetic abnormalities. In normal, healthy cells, the reovirus is unable to reproduce because of an enzyme named PKR. The enzyme is suppressed in cancer cells, and therefore the reovirus can replicate in the cancer cell and kill it."

"REOLYSIN(R) typifies the true targeted therapy approach that seeks to use fundamental differences between cancer and normal cells as the basis for effective anti-cancer approaches and we are thus very excited about the this study," said Francis Giles, MD, director of the CTRC Institute for Drug Development.

Eligible patients are those who have a bone or soft tissue sarcoma that has spread to the lung and who are deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumors, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.

The second patient to enroll in the study was diagnosed with breast cancer in April 2005 and 11 months later received an additional diagnosis for a rare form of sarcoma. A specialist at the Dana-Farber Cancer Institute in Boston referred her to CTRC, where Mita suggested the REOLYSIN(R) study. After discussing it with her family and doctor, she decided it was the best treatment option for her.

"This new therapy gives me another option in the fight against my cancer," said the 35-year-old mother of three who travels to San Antonio for treatment with her husband and children. "Before coming to CTRC, I had already been through one chemotherapy cycle for this disease, and I got the impression that no one really knew what to do with me or how to treat my cancer. REOLYSIN(R) was a less toxic option for me."

"We are delighted, but not surprised, with the rate of accrual at the CTRC Institute for Drug Development," said Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. "As an evolving oncology company, the placement of Oncolytics' very innovative and sophisticated studies is of critical importance and we are delighted to have the CTRC Institute for Drug Development as our collaborator. This study is expected to yield information that will guide the late stage clinical development program for REOLYSIN(R)."

REOLYSIN(R) demonstrated success against tumors during earlier phases of scientific testing. This study (REO 014) is a Phase II, open-label, single agent study with the primary objective of measuring tumor responses and the duration of those responses, and of describing any evidence of anti-tumor activity. REOLYSIN(R) will be given intravenously to patients for five consecutive days. Patients may receive additional five-day cycles of therapy every four weeks for a maximum of eight cycles. Up to 52 patients will be enrolled in the study.

Located in San Antonio, Texas, the Cancer Therapy and Research Center (CTRC) is one of the nation's leading academic research and treatment centers, serving more than 4.4 million people in the high-growth corridor of Central and South Texas including Austin, San Antonio, Laredo, and the Rio Grande Valley. CTRC, through its research partnership with the University of Texas Health Science Center at San Antonio (UTHSCSA), created the San Antonio Cancer Institute (SACI), one of a few elite cancer centers in the country to be named a National Cancer Institute (NCI) Designated Cancer Center, and is one of three in Texas. CTRC handles more than 120,000 patient visits each year and is a world leader in developing new drugs to treat cancer. The CTRC Institute for Drug Development (IDD) is internationally recognized for conducting the largest oncology Phase I clinical drug trials program in the world. Sixteen of the cancer drugs most recently approved by the Food & Drug Administration underwent development or testing at the IDD. For more information visit our website at http://www.ctrc.net.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of Phase I and Phase II human trials using REOLYSIN(R), its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics, please visit http://www.oncolyticsbiotech.com.

Cancer Therapy and Research Center
http://www.ctrc.net