Thema: Studie: Phase I/II Hirntumor-Studie with REOLYSIN®.
Studie: Phase I/II Hirntumor-Studie with REOLYSIN®.
Matthias[a]
08.07.2002 23:41:16
CALGARY July 3, 2002 --
Oncolytics Biotech Inc. has started a Phase I/II brain cancer clinical trial with REOLYSIN®.
The study is expected to enrol approximately 38 patients who have been diagnosed with recurrent malignant glioma, an aggressive and deadly form of brain tumour. Recurrent malignant glioma is often characterized by activation of the RAS pathway, and REOLYSIN®, developed from the naturally occurring reovirus, has been shown to infect and kill cancer cells with these mutations.
"Beginning this study is a significant milestone for Oncolytics and for the treatment of this persistent disease," said Dr. Brad Thompson, President and CEO of Oncolytics. "In various pre-clinical animal studies conducted to date, we have seen promising tumour response and lifespan extension with reovirus, so we are hopeful about using reovirus as a potential treatment in humans for this type of tumour."
Research published in the June 20, 2001 issue of the Journal of the National Cancer Institute showed that mice treated with a single injection of reovirus experienced benefits including complete tumour regression in 20 of 23 treated animals and a statistically significant increase in survival. Reovirus killed cancer cells from 19 of 24 established glioma cell lines and from all nine glioma surgical specimens.
Study Parameters
In the dose escalation or Phase I portion of the Phase I/II trial, patients with a variety of recurrent malignant gliomas will be enrolled. In the Phase II portion of the trial, patients with recurrent glioblastoma multiforme, the most aggressive glioma, will be treated with doses of REOLYSIN® determined by the results of the Phase I study.
About Brain Cancer
Malignant brain tumours occur in approximately 40,000 patients in North America and Europe each year, survival rates are low and the probability of tumour recurrence is high. The standard treatment for patients with newly diagnosed malignant gliomas is surgery, followed by radiation therapy and occasionally systemic chemotherapy.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of the human reovirus (REOLYSIN®) as a potential cancer therapeutic. Oncolytics' researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells derived from many types of cancer including breast, prostate, pancreatic and brain tumours. Research has also yielded successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that there were no toxicology-related issues with the administration of the reovirus, and that the reovirus demonstrated activity in injected tumours. Oncolytics' Phase I/II brain cancer trial is running concurrently with the Company's T2 prostate cancer trial, which will enroll up to 45 patients in Canada.
Individuals interested in learning about eligibility requirements should contact Oncolytics at 403.670.7377, or visit Oncolytics' website at www.oncolyticsbiotech.com
This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Company's belief as to the potential of REOLYSIN® as a component of the treatment for recurrent malignant Glioma and other cancers, and the Company's expectations as to the design, timing and success of its planned clinical trial programs, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.
FOR FURTHER INFORMATION PLEASE CONTACT:
For Canada:
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7370
Fax: 403.283.0858
cwardonc@aol.com
For Canada:
The Equicom Group Inc.
Jason Hogan
20 Toronto Street
Toronto, Ontario M5C 2B8
Tel: 416.815.0700 ext. 222
Fax: 416.815.0080
For United States:
The Investor Relations Group
Gino De Jesus or Dian Griesel, Ph.D.
50 Pine Street, 6th Floor
New York, NY 10005
Tel: 212.825.3210
Fax: 212.825.3229
theproteam@aol.com
Oncolytics Biotech Inc. has started a Phase I/II brain cancer clinical trial with REOLYSIN®.
The study is expected to enrol approximately 38 patients who have been diagnosed with recurrent malignant glioma, an aggressive and deadly form of brain tumour. Recurrent malignant glioma is often characterized by activation of the RAS pathway, and REOLYSIN®, developed from the naturally occurring reovirus, has been shown to infect and kill cancer cells with these mutations.
"Beginning this study is a significant milestone for Oncolytics and for the treatment of this persistent disease," said Dr. Brad Thompson, President and CEO of Oncolytics. "In various pre-clinical animal studies conducted to date, we have seen promising tumour response and lifespan extension with reovirus, so we are hopeful about using reovirus as a potential treatment in humans for this type of tumour."
Research published in the June 20, 2001 issue of the Journal of the National Cancer Institute showed that mice treated with a single injection of reovirus experienced benefits including complete tumour regression in 20 of 23 treated animals and a statistically significant increase in survival. Reovirus killed cancer cells from 19 of 24 established glioma cell lines and from all nine glioma surgical specimens.
Study Parameters
In the dose escalation or Phase I portion of the Phase I/II trial, patients with a variety of recurrent malignant gliomas will be enrolled. In the Phase II portion of the trial, patients with recurrent glioblastoma multiforme, the most aggressive glioma, will be treated with doses of REOLYSIN® determined by the results of the Phase I study.
About Brain Cancer
Malignant brain tumours occur in approximately 40,000 patients in North America and Europe each year, survival rates are low and the probability of tumour recurrence is high. The standard treatment for patients with newly diagnosed malignant gliomas is surgery, followed by radiation therapy and occasionally systemic chemotherapy.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of the human reovirus (REOLYSIN®) as a potential cancer therapeutic. Oncolytics' researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells derived from many types of cancer including breast, prostate, pancreatic and brain tumours. Research has also yielded successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that there were no toxicology-related issues with the administration of the reovirus, and that the reovirus demonstrated activity in injected tumours. Oncolytics' Phase I/II brain cancer trial is running concurrently with the Company's T2 prostate cancer trial, which will enroll up to 45 patients in Canada.
Individuals interested in learning about eligibility requirements should contact Oncolytics at 403.670.7377, or visit Oncolytics' website at www.oncolyticsbiotech.com
This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Company's belief as to the potential of REOLYSIN® as a component of the treatment for recurrent malignant Glioma and other cancers, and the Company's expectations as to the design, timing and success of its planned clinical trial programs, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.
FOR FURTHER INFORMATION PLEASE CONTACT:
For Canada:
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7370
Fax: 403.283.0858
cwardonc@aol.com
For Canada:
The Equicom Group Inc.
Jason Hogan
20 Toronto Street
Toronto, Ontario M5C 2B8
Tel: 416.815.0700 ext. 222
Fax: 416.815.0080
For United States:
The Investor Relations Group
Gino De Jesus or Dian Griesel, Ph.D.
50 Pine Street, 6th Floor
New York, NY 10005
Tel: 212.825.3210
Fax: 212.825.3229
theproteam@aol.com
Matthias[a]
