Virusinjectie (REOLYSIN) bij prostaatkanker en kwaadaardige glioma's (hersentumoren) lijkt veelbelovend en producent krijgt toestemming voor fase II en III trials na goede resultaten. Overzicht van trials.

26 december 2010: Inmiddels wordt Reolysin veelvuldig toegepast, ook bij hersentumoren. Er lopen vele studies, Klik hier voor overzicht van Reolysin bij solide tumoren

14 januari 2005: Op vraag hoe ver de trials zijn met Reolysin kregen we het volgende korte antwoord:

I can't comment on what our CEO may or may not have said, but the Company did have an expectation that we might have one or more NCI trials underway in 2004. (key words might and expect) However, the NCI did ask us to run some preclinical studies in advance of any trials, which are nearing completion. The Company continues to make progress in getting these and other trials underway.

Cathy Ward
Director, Communications
Oncolytics Biotech Inc.
210-1167 Kensington Cres. NW
Calgary, AB, T2N 1X7

d.d. 14 december 2003: Bron website van oncolytics
Een trouwe bezoeker stuurde ons deze tip, waarvoor dank.

Virusinjectie bij prostaattumoren en hersentumoren (kwaadaardige glioma's) lijkt een veelbelovende aanpak aldus resultaten uit fase I studies. Het bedrijf oncolytics heeft inmiddels toestemming van de FDA gekregen om fase II studies op te zetten met hun middel REOLYSIN, zowel bij prostaatkanker als bij kwaadaardige Glioma's. Lees hieronder korte persberichten gehaald/gekopieerd van hun website over klinische trials met REOLYSIN.

T2 Prostate Clinical Trial

An Evaluation of the Efficacy of Intraprostate Administration of REOLYSIN® for the treatment of T2 Prostate Cancer Prior to Definitive Surgery

The company was approved to start a multi-institutional non-randomized clinical study to determine the pathological response to intralesional REOLYSIN®. Enrollment began in April 2002.

The primary objective of this study is the evaluation of the pathological response to intralesional REOLYSIN® in patients undergoing definitive surgery. The study will also serve to add to the safety/tolerability profile of REOLYSIN® administration in humans.

Up to 45 evaluable males with documented T2 prostate cancer will be enrolled. Stage T2 prostate cancer refers to cancer clinically or grossly, limited to the gland. All patients must be medically able to undergo prostatectomy (removal of the prostate).

The treatment will consist of a single intralesional prostate injection of REOLYSIN®. Patients will be followed post injection for 3 weeks prior to definitive prostatectomy. At the time of prostatectomy a complete pathological review of the injected area will be undertaken.

Interim Results
There was evidence of viral activity in five of six patients and there were no safety concerns, from either a clinical or histopathological perspective, in all six patients. The results were presented March 28th, 2003 at a conference on "Oncolytic Viruses As Cancer Therapeutics" held in Banff, Alberta.

The preliminary data showed clear histopathological evidence of apoptotic tumour cell death, one measure of viral activity, in four of the six patients. In a fifth patient, the PSA level dropped by 53% and the prostate gland shrank by 67% from just prior to treatment to the time of surgical removal. There was no evidence of viral activity in the sixth patient. In all six patients, there was no histopathological evidence of any viral effect on healthy prostatic tissue.

Phase I Study (Completed)

Phase I Clinical Trial Results indicate REOLYSIN® has good safety profile

Trial description
A Phase I clinical trial of 18 terminal cancer patients with progressive (actively growing) cancers that had failed to respond to conventional treatments. The study examined the administration of escalating dosages of REOLYSIN® directly into a subcutaneous (underneath the skin) tumour. The primary objective of the study was to determine the safety (dose-limiting toxicity) and maximum tolerated dose of REOLYSIN®. Oncolytics announced final results of the study March 21, 2002.

Results
None of the patients receiving REOLYSIN® experienced any serious adverse events related to the virus, nor were there any dose-limiting toxicities detected in any patient.

The secondary outcome was tumour response. Eleven of 18 patients (61%) showed evidence of viral activity with tumour regression ranging from 32% to 100%. (Viral activity is defined as a transitory or lasting tumour regression of at least 30% measured in two dimensions against the tumour size prior to injection on the first day of treatment.) Clinically, tumour response is classified in one of four ways:

Progressive disease - tumour growth of greater than 25%
Stable disease - change ranges from growth of less than 25% to a reduction of less than 50%
Partial response - a reduction of greater than 50% but there is still detectable tumour
Complete response - no tumour can be detected
Patients are considered to be evaluable for clinical response only if they return for all follow-ups. In 11 of 17 evaluable patients, the injected tumours were classified as stable disease on day 28 after the first, and in some cases the only injection of REOLYSIN®. By day ninety-eight, at the conclusion of the trial, five of 10 evaluable patients still had tumour responses (four stable disease, one partial response). In addition, evidence of remote tumour response was also noted in several patients, suggesting a potential role in the treatment of metastases.
Dr. Don Morris of the Alberta Cancer Board and the University of Calgary presented this image of a patient from the Phase I clinical trial on the evening of March 28, 2003 at the Oncolytic Viruses as Cancer Therapeutics conference held in Banff, Alberta.

The picture on the left was taken pretreatment and the picture on the right was taken post treatment. This was graded as a partial response.

Glioma Clinical Trial

A Phase I/II Clinical Trial to Evaluate Dose Limiting Toxicity and Efficacy of Intralesional Administration of REOLYSIN® for the Treatment of Patients with Histologically Confirmed Recurrent Malignant Gliomas

This clinical trial application received approval to proceed in Canada. Patient enrollment began in Summer 2002.

Study Objectives:
To evaluate the dose limiting toxicity, efficacy and anti-tumour effect of intralesional administration of REOLYSIN® in patients with malignant glioma with evaluable disease which is progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy.

Study Population:
i. Phase I will accrue 12 - 24 evaluable patients with a malignant glioma. Patients with a first, second or third recurrence will be eligible.
ii. Phase II: Phase I criteria will be fulfilled with the following exceptions: A maximum of 14 evaluable patients and, only patients with a first recurrence of glioblastoma multiforme will be eligible.

Interim Safety Results
After treating the first six patients, amendments to the clinical protocol were developed by an independent data safety monitoring board, the study investigators, and Oncolytics to enhance the measurement of the safety and efficacy of REOLYSIN® in the intended patient population in future studies. These changes have been reviewed and approved by Health Canada.

Determination of the safety of REOLYSIN® is the primary purpose of the Phase I study. The study is examining the use of a single, intratumoural injection of REOLYSIN®, delivered using imaging-guided surgery, in patients with malignant glioma that has recurred despite other treatments, including surgery and radiation therapy. After treatment with REOLYSIN®, the Phase I patients are monitored and evaluated for safety for a period of six months. REOLYSIN® appeared to be well tolerated when surgically delivered into the brain during the treatment of the first six patients enrolled in the study. Four of the six treated patients were alive at the conclusion of their six-month safety follow-ups.

For More Information:
Although Oncolytics Biotech Inc. is the sponsor for this clinical trial, the company does not have any influence or control over who is chosen for enrollment into this study. The decision is based on criteria set for this study, agreed to by Health Canada, and then used by the principal investigator responsible for this clinical trial. If you are interested in participating in this study, please click here for the eligibility requirements, print them, and take them to your physician or oncologist. If your physician or oncologist feels you may be a potential candidate for the clinical trial, please have them contact Oncolytics.

FOR FURTHER INFORMATION PLEASE CONTACT:

For Canada:
Oncolytics Biotech Inc.
Brad Thompson
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7377
Fax: 403.283.0858
info@oncolyticsbiotech.com

For Canada:
The Equicom Group Inc.
Joanna Longo
20 Toronto Street
Toronto, Ontario M5C 2B8
Tel: 416.815.0700 ext. 233
Fax: 416.815.0080
jlongo@equicomgroup.com

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