Navigation Links
Oncolytics Biotech Inc.'s REOLYSIN(R) Exceeds Primary Statistical Endpoint in U.S. Phase 2 Sarcoma Study
Date:12/11/2008

CALGARY, Dec. 11 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that it has exceeded the primary statistical endpoint in its multi-centre Phase 2 clinical trial to evaluate the intravenous administration of REOLYSIN(R) in patients with various sarcomas that have metastasized to the lung.

"The proportion of patients on study with significant, durable, clinically meaningful responses is highly encouraging," said Dr. Frank Giles, Director of the Institute of Drug Development, the Cancer Therapy and Research Center at the University of Texas Health Science Center, San Antonio, Texas. "This very novel agent has delivered a positive answer to its first critical efficacy question."

To meet the statistical endpoint, at least three out of 52 patients had to experience stabilization of disease or better for more than six months. Of 33 evaluable patients treated to date, five have experienced stable disease for periods greater than six months, including one patient who has maintained stable disease for more than 16 months. An additional 10 patients have experienced stable disease for periods ranging from three to six cycles (cycle = 28 days). Twelve patients are continuing on study, including the five patients who have been stable for more than six months.

    -------------------------------------------------------------------------
    Tumour Type                 Months on Study         Best Response
    -------------------------------------------------------------------------
    Synovial sarcoma            16*                   SD
    -------------------------------------------------------------------------
    Ewing's sarcoma              9*                   SD
    -------------------------------------------------------------------------
    Osteosarcoma                 9*                   SD (tumour resection
                                                        after cycle 4)
    -------------------------------------------------------------------------
    Chordoma                     6*                   SD
    -------------------------------------------------------------------------
    Unspecified Spindle Cell     6*                   SD
    -------------------------------------------------------------------------
    * patients still on study

"We are very pleased to have met the statistical endpoint in our first U.S. Phase 2 study, particularly in such a difficult-to-treat form of cancer," said Dr. Brad Thompson, President and CEO of Oncolytics. "The interim data indicate that REOLYSIN(R) is active in various types of metastatic sarcoma, and that late-stage clinical trials are justified."

Sarcomas are malignant tumors growing from connective tissues, such as cartilage, fat, muscle, or bone. According to the American Cancer Society, only 16.3% of patients with distant spread of sarcoma live longer than five years. There is an unmet medical need for effective treatments for patients with this type of disease.

Clinical Trial Design

The trial (REO 014) is a Phase 2, open-label, single agent study whose primary objective is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity of intravenous, multiple dose REOLYSIN(R) in patients with bone and soft tissue sarcomas metastatic to the lung. REOLYSIN(R) is delivered intravenously to patients at a dose of 3x10(10) TCID(50) for five consecutive days, every 28 days. Up to 52 patients will be enrolled in the study.

Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.

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 I/II 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 www.oncolyticsbiotech.com

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 II sarcoma clinical trial and the Company's belief as to the potential of REOLYSIN(R) 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(R) as a cancer treatment, the tolerability of REOLYSIN(R) outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN(R), 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.


'/>"/>
SOURCE Oncolytics Biotech Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Oncolytics Biotech Inc. Announces Issuance of 23rd U.S. Patent
2. Oncolytics Biotech Inc. Reports Positive Interim Results of U.K. Phase Ia/Ib Combination REOLYSIN(R) and Radiation Clinical Trial
3. Media Advisory - Oncolytics Biotech Inc. to Present at BioPartnering Europe
4. Media Advisory - Oncolytics Biotech Inc. to Present at BIO InvestorForum 2007
5. Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN(R) in Combination with Cyclophosphamide
6. Oncolytics Biotech Inc. Collaborators to Present Positive Interim Results of U.K. Phase Ia/Ib Combination REOLYSIN(R) and Radiation Clinical Trial
7. Oncolytics Biotech Inc. Announces 2007 Third Quarter Results
8. Media Advisory - Oncolytics Biotech Inc. to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
9. Media Advisory - Oncolytics Biotech Inc. to Present at Toronto CFA Society
10. Oncolytics Biotech Inc. Announces Issuance of 24th U.S. Patent
11. Oncolytics Biotech Inc. to Present at Annual Vaccine Production Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... and LAGUNA HILLS, Calif. , Oct. ... Cancer Research, London (ICR) and University ... SKY92, SkylineDx,s prognostic tool to risk-stratify patients with multiple myeloma ... MUK nine . The University of Leeds ... partly funded by Myeloma UK, and ICR will perform the ...
(Date:10/10/2017)... ... 2017 , ... San Diego-based team building and cooking events company, Lajollacooks4u, has ... The bold new look is part of a transformation to increase awareness, appeal to ... period. , It will also expand its service offering from its signature gourmet cooking ...
(Date:10/10/2017)... 10, 2017 International research firm Parks Associates announced ... at the TMA 2017 Annual Meeting , October 11 in ... residential home security market and how smart safety and security products impact ... Parks Associates: Smart Home ... "The residential security market has ...
(Date:10/9/2017)... DIEGO , Oct. 9, 2017  BioTech ... biological mechanism by which its ProCell stem cell ... critical limb ischemia.  The Company, demonstrated that treatment ... amount of limbs saved as compared to standard ... the molecule HGF resulted in reduction of therapeutic ...
Breaking Biology Technology:
(Date:3/28/2017)... , March 28, 2017 The ... Hardware (Camera, Monitors, Servers, Storage Devices), Software (Video Analytics, ... Region - Global Forecast to 2022", published by MarketsandMarkets, ... 2016 and is projected to reach USD 75.64 Billion ... and 2022. The base year considered for the study ...
(Date:3/24/2017)... 24, 2017 The Controller General of Immigration from ... Abdulla Algeen have received the prestigious international IAIR Award for the ... Continue Reading ... ... Controller Abdulla Algeen (small picture on the right) have received the IAIR ...
(Date:3/23/2017)... The report "Gesture Recognition and Touchless Sensing Market by Technology (Touch-based ... to 2022", published by MarketsandMarkets, the market is expected to be worth USD ... 2022. Continue Reading ... ... ...
Breaking Biology News(10 mins):