Oncolytics Biotech(R) Inc. Announces Start of Enrolment in U.S. Phase 2 Melanoma Cancer Clinical Trial
"We have seen some very encouraging results in our clinical trials using REOLYSIN in combination with other therapies in metastatic melanoma patients," said
"In our local administration REOLYSIN and radiation studies, all of the evaluable melanoma patients (10) had stable disease or better in the target lesion, (three partial responses, one significant minor response and six stable disease). These results, combined with preclinical work demonstrating that in vivo combination treatment resulted in markedly reduced tumour growth compared to single agent treatments, provided the rationale for our collaborators to explore a Phase 2 combination study for patients with metastatic melanoma."
"Today, few effective treatment options exist for patients with advanced malignant melanoma," said
The trial (REO 020) is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. It is anticipated that up to 43 patients will be treated in the study.
Eligible patients include those with metastatic, malignant melanoma who have failed one or more prior therapies, or those who are not considered to be a candidate for standard, first-line treatment.
The primary objective of the Phase 2 trial is to measure the objective response rate (partial response (PR) and complete response (CR)) to the treatment combination. The secondary objectives are to assess progression-free survival (PFS) and overall survival (OS) for the treatment regimen in the study population, to assess disease control rate (CR + PR + stable disease (SD)) and duration in the study population, and to assess the safety and tolerability of the combination treatment.
This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.
About Melanoma
Cancer of the skin is the most common of cancers, probably accounting for at least half of all cancers. Melanoma accounts for less than 5% of skin cancer cases but causes a large majority of skin cancer deaths. The American Cancer Society estimates that about 68,720 new melanomas will be diagnosed in the
About Oncolytics Biotech Inc.
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 1/2 and Phase 2 human trials using REOLYSIN, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics, please visit www.oncolyticsbiotech.com
The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at
This press 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 expectations related to the U.S. Phase 2 combination REOLYSIN/paclitaxel and carboplatin clinical trial for patients with metastatic melanoma, and the Company's belief as to the potential of REOLYSIN as a cancer therapeutic, 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 tolerability of REOLYSIN outside a controlled test, 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 and uncertainties related to the regulatory process. 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, except as required by applicable laws.
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For further information: Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403) 283-0858, [email protected]; The Equicom Group, Nick Hurst, 325, 300 5th Ave. SW Calgary, Alberta, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916, [email protected]; The Investor Relations Group, Erika Moran, 11 Stone St, 3rd Floor, New York, NY 10004, Tel: (212) 825-3210, Fax: (212) 825-3229, [email protected]
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