But do we know anything about how ONCY are planning to make their virus survive while in circulation?
The answer is coming,...interesting to note that systemic studies on our friends the mice, gave pretty good remission results from multiple tumor sites.
Even single injections intratumorally and elsewhere result in high levels of the virus appearing in blood samples for many days after injection.
Oncolytics Biotech Receives Approval To Initiate UK Phase I Cancer Trial Investigating Systemic Delivery of REOLYSIN(R)
CALGARY, Feb. 27 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ:ONCY) announced today that it has received a letter of approval from
the UK regulatory authorities (Medicines and Healthcare products Regulatory
Agency or MHRA) for its Clinical Trial Exemption (CTX) to begin a Phase I
clinical trial to investigate the systemic delivery of REOLYSIN(R) as a
treatment for patients with advanced or metastatic solid tumours. The
principal investigator for the study is Dr. J. de Bono of the Royal Marsden
Hospital.
"This clinical trial will be the first to examine the systemic delivery
of REOLYSIN(R), which is expected to result in delivery of the virus
throughout the body to both the primary tumour and metastatic disease sites,"
said Dr. Brad Thompson, President and CEO of Oncolytics. "The approval of this
trial is the culmination of an extensive program in the areas of manufacturing
and preclinical toxicology."
This clinical trial is an open-label, dose-escalation Phase I study in
which REOLYSIN(R) will be administered intravenously to patients diagnosed
with advanced or metastatic solid tumours that are refractory to standard
therapy (has not responded) or for which no curative standard therapy exists.
The primary objective of the study is to determine the maximum tolerated dose
(MTD), dose limiting toxicity (DLT) and safety profile of REOLYSIN(R).
Secondary objectives include the evaluation of viral replication, immune
response to the virus and any evidence of antitumour activity. The enrolment
in this study is expected to be up to forty evaluable patients and will depend
upon the number of dose levels tested.
2/14/2003 7:30:30 AM News Release Index
Oncolytics Biotech Inc. Announces Completion of Animal Toxicology Program Examining Systemic Delivery of REOLYSIN®
CALGARY, Alberta, February 14, 2003 -- Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (‘Oncolytics’) today announced the successful completion of its animal toxicology program examining the systemic delivery of REOLYSIN®.
"Each route of administration of a drug must be examined for toxicology in animals before filing applications with regulatory agencies to start human clinical trials,” said Dr. Brad Thompson, Oncolytics’ President and CEO. “Oncolytics has now successfully completed nine toxicology studies examining three different routes of administration of REOLYSIN® and the product appears to be well tolerated in all three animal species to which it has been systemically administered.”
In the most recently completed study, small primates received REOLYSIN® daily via intravenous infusion for a period of 28 days. At the maximum daily dose used in the study, each primate received daily from 10 to 100 times the expected maximum single human dose per unit of body weight. The product was well tolerated and no product-related serious adverse events were observed.
3/26/2002 News Release Index
Animal Model Study Demonstrated Reovirus as an Effective Treatment for Breast Cancer
CALGARY, Alberta, March 26, 2002 -- Oncolytics Biotech Inc. (TSE: ONC, NASDAQ: ONCY) (‘Oncolytics’) announces the publication of a research paper entitled “Reovirus Oncolysis of Human Breast Cancer” by Norman et. al (Human Gene Therapy, Vol. 13, March 20, 2002), which examined the use of the reovirus as a treatment for breast cancer in animal models. Oncolytics is currently developing a formulation of the human reovirus REOLYSIN®, as a potential therapeutic against Ras-activated cancers.
The study examined two animal models of breast cancer to demonstrate the effectiveness of the reovirus in causing tumour regression. In the first model, human breast cancer cells were implanted over the mammary fat pad of the SCID/NOD mice. After a tumour had been established, a single injection of the reovirus caused a continuous regression of the tumour during a thirty-day observation period. In the second animal model, independent tumours were established on both flanks of the mice (bilateral model). After the tumours had been established, a single injection of the reovirus into only one tumour resulted in complete regression of both the injected and non-injected tumours over thirty-two days.
The research group also examined the ability of the reovirus to infect and to kill breast cancer cell lines. Widespread cell killing was seen in all five established breast cancer cell lines and in one surgical specimen. No cell killing was observed in two cell lines established from normal breast tissue.
“The reovirus clearly demonstrated effectiveness in this study,” said Dr. Matt Coffey, Vice President, Product Development and one of the co-authors of the study. “In the bilateral animal model, the reovirus levels were approximately the same in the injected and non-injected tumours over the last half of the study, and reovirus was detectable in the blood throughout the investigation. These results support our plans to start human trials in which REOLYSIN® will be administered systemically.”
Breast cancer is the most common cancer in women, accounting for about 31% of new cases. The American Cancer Society estimates that there will be 203,500 new cases of breast cancer diagnosed and 39,600 deaths in 2002 in the United States. While the five-year relative survival rate for local breast cancer is 96%, the survival rate for metastatic disease is only 21%.
8/8/2001 News Release Index
Oncolytics Biotech Inc. Announces Further Results of REOLYSIN(R); Systemic Treatment of Cancer in Animal Models
CALGARY, ALBERTA, AUG 8, 2001 (CCN Newswire via COMTEX) -- Oncolytics Biotech Inc. ('ONC' or 'the Company') (TSE:ONC) reported today that Dr. Patrick Lee and his research group at the University of Calgary have concluded further studies in animal models, successfully demonstrating the systemic administration of REOLYSIN(R) for the treatment of cancer. This work complements initial work presented at the American Association of Cancer Research (AACR) meeting earlier in 2001.
'These results are an exciting additional indication that REOLYSIN(R) can be administered systemically in animals with an immune system for the treatment of cancer,' said Dr. Matt Coffey, Vice President of Product Development for Oncolytics. 'Dr. Lee and his colleagues have shown that REOLYSIN(R) can be used systemically as a mono or sole therapy. In addition, strategies to allow REOLYSIN(R) to be used systemically in animals with very high immune responses to the virus have now been demonstrated. This is a clear example of the feasibility of repeat administrations of REOLYSIN(R). We have previously demonstrated in animals that immune status does not affect tumour regression in animals that have had REOLYSIN(R) administered directly into tumours. '
Dr. Lee and his colleagues earlier reported in an immune competent mouse model, that REOLYSIN(R) administered intravenously (IV) led to a significant reduction in tumour volume and that co-therapy with cyclosporine or cisplatin further reduced tumour size.
This current work explored the degree of involvement of the immune system in potential systemic REOLYSIN(R) therapy, and those conditions in animals that may benefit from co-therapy with immune suppressants. Dr. Lee's group found in animals not pre immunized against the reovirus, that systemic administration of REOLYSIN(R) was effective in reducing tumour size in mouse models with solid tumours. Animals pre hyperimmunized (immunized to levels significantly higher than those seen as a result of a normal infection or treatment with reovirus) showed no significant tumour regression when treated with REOLYSIN(R) alone. However, animals pre hyperimmunized with the reovirus and subsequently pulse co-treated with REOLYSIN(R) and either cyclosporine or cyclophosphamide demonstrated the same level of tumour reduction as the unimmunized animals treated with REOLYSIN(R) alone. |
