CALGARY, April 4 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (“Oncolytics”) announced today that interim results of its Phase I combination REOLYSIN(R)/radiation clinical trial will be presented this morning at the American Association for Cancer Research (AACR) annual meeting in Washington, D.C. The interim results indicated that the combination of intratumoural REOLYSIN(R) and radiation was well tolerated and that both local clinical responses and early indications of systemic effects were observed. The presentation is entitled “Phase I trial of intratumoral administration of reovirus type 3 (Reolysin) in combination with radiation in patients with advanced malignancies.”
“Indications of activity when combining REOLYSIN(R) with what is generally considered to be a palliative dose of radiation are certainly encouraging,” said Dr. Brad Thompson, President and CEO of Oncolytics. “On the strength of this data, we are currently designing a Phase II combination REOLYSIN(R)/radiation trial, at this radiation dosage, for inclusion in our overall Phase II clinical program. That trial is expected to begin following the completion of the ongoing Phase I trial.”
The Phase I open label study is evaluating the feasibility, safety and anti-tumour effects of intratumoural administration of REOLYSIN(R) in combination with localized radiation therapy in patients with advanced cancers, using two different radiation dosages and schedules. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicities, if any, and the safety profile of REOLYSIN(R) when administered intratumourally to patients receiving radiation treatment. The secondary objective is to examine any evidence of anti-tumour activity. Patients with advanced or metastatic solid tumours that are refractory to standard therapy, or for which no curative standard therapy exists, are eligible. The patients will have a target lesion that has not previously been treated with radiation but for which palliative radiation treatment is indicated. The treatment consists of a constant amount of radiation, in this case 20 Grays, administered in five fractions on consecutive days, and two intratumoural injections of REOLYSIN(R) on days two and four at the following dose escalation levels - 10(8), 10(9) and 10(10) TCID(50).
Preliminary observations in the first seven patients show that the combination of intratumoural REOLYSIN(R) and radiation has been well- tolerated. Most toxicities have been mild, generally grade 1 and 2, and include fever, sweating and skin erythema. One patient in the second cohort developed grade 3 fatigue and grade 2 flu-like symptoms and could not receive the second REOLYSIN(R) injection. There has been no evidence that the REOLYSIN(R) injections exacerbated the acute reactions expected from the radiation. There was also no evidence of viral shedding in the blood, urine, stool or sputum on day eight post-REOLYSIN(R) injection.
Interim analysis has shown evidence of local responses and an indication of systemic effects. Amongst the first five patients that completed treatment, three patients had partial tumour responses. There was one case of progressive disease at one month, one case of stable disease at one month, two cases of partial responses at one, two and three months and one case of stable disease at one and two months, which became a pathological partial response at three months. CT scans from the treated lymph node tumour in the first patient in the trial clearly show the partial response, which has now lasted for over eight months. A metastatic tumour in this patient that was outside the radiation field also showed a partial response.
Oncolytics will host a webcast at 12:00 p.m. ET today, April 4, 2006, to provide a clinical trial update specifically focusing on the interim Phase I combination REOLYSIN(R)/radiation clinical trial results being presented in an oral presentation at the AACR Annual Meeting. The presentation will be available on the Oncolytics website later today.
The live audio webcast will be available at: http://w.on24.com/r.htm?e=21624&s=1&k=60E516ABE1419DCAB6502DB7A33029D1 or through www.oncolyticsbiotech.com. Please connect to the link at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through April 13, 2006. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 21182106.
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 and Phase I/II human trials using REOLYSIN(R), its proprietary formulation of the human reovirus, alone and in combination with radiation. 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 implication of the materials presented at this meeting with respect to REOLYSIN(R), the Company’s expectations related to the results of trials investigating delivery of REOLYSIN(R), 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 schedule, 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.
Oncolytics Biotech Inc.
CONTACT: Oncolytics Biotech Inc.: Cathy Ward, 210, 1167 Kensington Cr NW,Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403) 283-0858,cathy.ward@oncolytics.ca, www.oncolyticsbiotech.com; The Equicom Group:Nick Hurst, 20 Toronto Street, Toronto, Ontario, M5C 2B8, Tel: (416)815-0700 ext.226, Fax: (416) 815-0080, nhurst@equicomgroup.com; TheInvestor Relations Group: Damian McIntosh, 11 Stone St, 3rd Floor, NewYork, NY 10004, Tel: (212) 825-3210, Fax: (212) 825-3229,dmcintosh@investorrelationsgroup.com; RenMark Financial Communications:John Boidman, 2080 Rene Levesque Blvd. W., Montreal, PQ H3H 1R6, Tel: (514)939-3989, Fax: (514) 939-3717, jboidman@renmarkfinancial.com
