| Frequently Asked Questions (FAQ) |
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1. What is a virus?
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2. How do viruses behave?
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3. What is the reovirus?
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4. Where does the reovirus come from?
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5. How were its cancer-killing properties discovered?
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6. Why doesn’t the reovirus infect normal cells?
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7. Why does the reovirus kill cancer cells?
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8. How is reovirus administered to patients?
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9. Why isn’t REOLYSIN® available to people yet?
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10. Is REOLYSIN® available through programs such as
Canada’s Special Access Program?
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11. How long does the clinical trial process take?
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12. Why are your patient populations relatively small?
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13. How many trials will you have to do before making the product available to people with cancer?
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14. Will REOLYSIN® be available to children in clinical trials?
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15. What is the status of current and upcoming trials?
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16. When will updates be issued?
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17. What kind of results do you look for in your clinical trials?
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18. What is planned next for REOLYSIN®?
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19. Oncolytics has recently financed with private placements and bought deals. What are the major differences?
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20. What are End of Phase II meetings?
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21. What types of research does Oncolytics sponsor with academic and medical researchers?
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22. Are the NCI-sponsored trials enrolling?
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23. Will the NCI fund more than two trials?
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24. Why are you sponsoring two, concurrent, 14-patient, REOLYSIN® plus paclitaxel and carboplatin trials for patients with head and neck cancers in the U.K. and the U.S.?
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| 1. What is a virus? |
| A virus is a submicroscopic organism that can multiply only inside living host cells. It has a non-cellular structure lacking any intrinsic metabolism and usually comprising DNA or RNA molecules inside a protein coat. While the better known viruses are pathogenic (meaning they cause disease) many do not. |
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| 2. How do viruses behave? |
| Viruses need to infect living cells to multiply. They typically invade a cell, then take over the cell’s manufacturing capabilities so that they may replicate. Replicated viral particles then invade surrounding cells. |
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| 3. What is the reovirus? |
| Reovirus is an acronym for Respiratory Enteric Orphan Virus. The reovirus is a naturally occurring virus to which most of us have been exposed in our lifetime. It is a non-pathogenic virus, meaning that it is not usually associated with any illness. Between 70 and 100 per cent of the population show signs of previous reovirus infection, which is usually confined to the respiratory or gastrointestinal systems in the body. |
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| 4. Where does the reovirus come from? |
| Reovirus is found naturally in shallow pools of water, lakes or streams or in the sewage system. |
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| 5. How were its cancer-killing properties discovered? |
| The reovirus was identified almost half a century ago, but was found to be a fairly benign virus. Because of its safety profile, it has been used for decades by scientists interested in studying how viruses infect human cells. Through the 1990s, graduate students and professors working at the University of Calgary discovered through a series of experiments that the reovirus appeared to have an ability to infect and kill many types of cancer cells, without affecting normal, healthy cells. More recently, a secondary immune effect has been observed. |
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| 6. Why doesn’t the reovirus infect normal cells? |
| It enters normal cells, but when this happens, an anti-viral response mechanism is turned on and the virus is quickly eliminated. Anyone injected with reovirus is usually able to clear it completely from the body in about two weeks. |
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| 7. Why does the reovirus kill cancer cells? |
| Scientific studies have demonstrated that approximately two-thirds of all human cancer cells have an activated Ras pathway, one of the most common set of mutations leading to cancer. An activated Ras pathway leads to a constant barrage of growth signals to the cell, causing uncontrolled growth. In cells with an activated Ras pathway, the anti-viral response appears to be turned off. When reovirus infects one of these cancer cells, it is able to replicate and eventually kill the cancer cell. Up to 5,000 progeny virus particles can then infect and kill surrounding cancer cells. Theoretically, the cycle of infection, replication and cell death will continue until there are no longer any Ras-activated cancer cells accessible. More recently, Oncolytics has discovered that tumour antigens generated by viral oncolysis may educate the immune system to recognize and kill tumour cells. |
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| 8. How is reovirus administered to patients? |
| Oncolytics is pursuing a three-pronged approach to developing REOLYSIN®: localized administration using REOLYSIN® as a monotherapy; systemic administration using REOLYSIN® as a monotherapy; and, combination therapy using REOLYSIN® with radiation or chemotherapy. |
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| 9. Why isn’t REOLYSIN® available to people yet? |
| Experimental drugs are not usually available to people outside clinical trials, except in rare cases. REOLYSIN® must be approved for sale by the regulatory agencies before it is made widely available to people. |
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| 10. Is REOLYSIN® available through programs such as
Canada’s Special Access Program? |
| The Company will not approve requests for treatment with REOLYSIN® through programs such as the SAP. Oncolytics treats only those patients who qualify for enrollment in its clinical trials. |
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| 11. How long does the clinical trial process take? |
| It varies, depending on the numbers of patients required for the trials and the kinds of results that are observed. |
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| 12. Why are your patient populations relatively small? |
| The trials that have been completed, and those that are underway, are designed to show that REOLYSIN® is safe and well tolerated. Another endpoint is to observe the effect on tumour cells. The patient populations in these trials are sufficient to meet these endpoints. |
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| 13. How many trials will you have to do before making the product available to people with cancer? |
| That depends on the results of the current trials and how those results are interpreted by the appropriate regulatory agencies. |
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| 14. Will REOLYSIN® be available to children in clinical trials? |
| The Company is not currently accepting children into its clinical trials, although our Phase II sarcoma trial will consider participants who are 16 years of age and over. |
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| 15. What is the status of current and upcoming trials? |
| Oncolytics has completed various Phase I and Phase II clinical trials in Canada, the U.S. and the U.K., and is currently conducting eight Phase I/II or Phase II clinical trials with REOLYSIN® in the United Kingdom and the United States. In October 2009, the Company announced it had reached agreement under the Special Protocol Assessment process with the U.S. FDA on the design of a Phase III trial using REOLYSIN in combination with paclitaxel and carboplatin for patients with platinum-refractory head and neck cancers. |
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| 16. When will updates be issued? |
| Trial updates are generally issued at the conclusion of a trial and when new trials are approved by the various regulatory agencies. |
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| 17. What kind of results do you look for in your clinical trials? |
| Depending on the trial, we look for a number of endpoints, including tumour responses and safety and tolerability of REOLYSIN® treatment. |
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| 18. What is planned next for REOLYSIN®? |
The Company intends to focus its clinical trial program on the evaluation of the effectiveness of REOLYSIN® as a potential treatment for a variety of cancer indications, including head and neck, melanoma, and lung cancers. The Company also expects to initiate a Phase III trial using REOLYSIN in combination with paclitaxel and carboplatin for patients with platinum-refractory head and neck cancers.
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| 19. Oncolytics has recently financed with private placements and bought deals. What are the major differences? |
Companies can finance their activities with many different types of financial structures. Oncolytics (“ONC”) has recently entered into transactions for the sale of its securities utilizing two different structures – Private Placements and Public Offerings, on a bought deal basis.
In these transactions, we have generally issued units which are comprised of one common share and one-half of a common share purchase warrant.
These two financing structures have the following characteristics:Private Placements are sales of securities from treasury to qualifying investors, generally by way of subscription agreements. The securities issued by us are not freely tradeable (i.e. they are subject to a hold period which must expire prior to the holder being permitted to sell the securities on the stock exchanges on which our common shares are traded), with the hold period determined by the jurisdiction of, and exemptions available to ONC.
Public Offerings are sales of securities from treasury through an investment banker pursuant to which we must file a prospectus (the selling document) with the securities commissions in which the securities are being sold and receive a receipt therefor.
Many Public Offerings are transactions that are marketed by an investment banker(s) on a “best efforts” basis. That is, there is no commitment on behalf of the investment banker(s) to purchase the securities from ONC.
On the other hand, a Public Offering on a "bought deal" basis is a transaction where the investment banker initially purchases the securities for its own account, with the price established at the time of acceptance of the transaction. As a consequence, the investment banker takes the marketing risk of selling the securities of ONC to others. |
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| 20. What are End of Phase II meetings? |
| These are meetings with the US Food and Drug Administration (FDA) at which the Phase II clinical results and other preclinical and manufacturing information are reviewed, with emphasis on preparation for the requirements needed to obtain the final approval for marketing. An End of Phase II meeting must be held before a company can submit the protocols for its Phase III pivotal trials to the FDA's Special Protocol Assessment (SPA) process. In October 2009, Oncolytics announced it had reached an agreement with the U.S. Food and Drug Administration (FDA) under the SPA process for the design of a Phase III trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. |
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| 21. What types of research does Oncolytics sponsor with academic and medical researchers? |
| Oncolytics has active research collaborations ongoing at Universities and research hospitals in Europe, the US, and Canada. The main focus of this research is to investigate various elements that may provide insight into the use of the reovirus. Some areas under investigation by researchers are the interaction of the immune system and the reovirus, the use of the reovirus as a co-therapy with existing chemotherapeutics and radiation, the use of new RAS active viruses as potential therapeutics, and to investigate new uses of the reovirus in therapy. Oncolytics provides clinical grade REOLYSIN for use in research as well as direct research support in many cases. The Company encourages the researchers to present the results or publish them, and will draw attention to these events when they occur. The Company provides product for use in research, a common practice in the pharmaceutical industry, as basic research institutions do not have the capability to produce and certify product that is free of contaminants such as other microorganisms or chemicals. |
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| 22. Are the NCI-sponsored trials enrolling? |
| The NCI's Phase II Melanoma trial and the Phase I/II ovarian, peritonial and fallopian tube cancer trials are both underway. |
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| 23. Will the NCI fund more than two trials? |
| That is up to the NCI. Under our Clinical Trial Agreement, the NCI has expressed interest in sponsoring multiple clinical trials with REOLYSIN®. |
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| 24. Why are you sponsoring two, concurrent, 14-patient, REOLYSIN® plus paclitaxel and carboplatin trials for patients with head and neck cancers in the U.K. and the U.S.?
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| The data from one trial alone would not provide enough data on this treatment combination in head and neck patients to allow the Company to make decisions on future directions for Phase III randomized studies. Conducting two concurrent studies in two separate jurisdictions provides the Company with sufficient information to make these decisions. |
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