Clinical Trial Investigators Aim to Make Ovarian Cancer Cells “Terminally Ill” By Giving Advanced Ovarian Cancer Patients a Common Virus

Oncolytics Biotech Inc. (“Oncolytics”) announced today that patient enrolment has started in a Phase 1/2 clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous (IV) and intraperitoneal (IP)REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus. … A cell with an activated Ras Pathway, which has lost its ability to “turn off,” leads to uncontrolled cell growth. These mutations along the Ras pathway are found in approximately two-thirds of all human cancers. The virus in REOLYSIN® will invade Ras-activated cancer cells, where the virus is able to replicate until it kills the host tumor cell.  When the cancer cell dies, thousands of progeny virus particles are released, which then proceed to infect and kill adjacent cancer cells.

Oncolytics Biotech Inc. (“Oncolytics”) announced today that patient enrolment has started in a Phase 1/2 clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous (IV) and intraperitoneal (IP) administration of REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus. Reovirus, an acronym for Respiratory Enteric Orphan virus, is generally believed to inhabit the respiratory and bowel systems in humans. Reovirus is found naturally in sewage and water supplies. By age 12, half of all children show evidence of reovirus exposure and by adulthood, most people have been exposed. However, the disease is non-pathogenic, meaning there are typically no symptoms from infections. The link to its cancer-killing ability was established after the reovirus was discovered to reproduce well in various cancer cell lines. Reoviruses are able to replicate only in cancer cells with an activated Ras pathway, without harming healthy cells. The Ras pathway is instrumental in transferring growth signals to the nucleus of a cell, telling the cell when and how to grow-much like an “on-off” switch.

A cell with an activated Ras Pathway, which has lost its ability to “turn off,” leads to uncontrolled cell growth. These mutations along the Ras pathway are found in approximately two-thirds of all human cancers. The virus in REOLYSIN® will invade Ras-activated cancer cells, where the virus is able to replicate until it kills the host tumor cell.  When the cancer cell dies, thousands of progeny virus particles are released, which then proceed to infect and kill adjacent cancer cells. The process is believed to continue until all infected cancer cells with activated Ras pathways have been infected and killed by the reovirus – all without causing the nausea, hair loss and other side effects associated with radiation and chemotherapy. More recently, Oncolytics discovered that tumor antigens generated by this virus may educate the immune system to recognize and kill tumor cells.

The National Cancer Institute (NCI), part of the National Institutes of Health, is sponsoring the trial under its Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of REOLYSIN®. The Principal Investigator is Dr. David E. Cohn, Associate Professor, Division of Gynecologic Oncology at The Ohio State University College of Medicine in Columbus, Ohio.

“REOLYSIN® is an exciting agent to investigate in patients with ovarian cancer,” said Dr. Cohn. “Targeting a specific alteration commonly present in these tumors will hopefully lead to efficacy with minimal toxicity.”

“We are looking forward to working closely with the NCI to examine the effects of using REOLYSIN® with two concurrent methods of administration,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Our REOLYSIN® clinical program has now expanded to include ten Phase 1/2 or Phase 2 trials in the U.S. and the U.K. using REOLYSIN® as a monotherapy or in combination with radiation or chemotherapy.”

In the Phase 1 portion of the trial, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days, as well as an escalating dose of IP REOLYSIN® on days 1-2 every 28 days. In the Phase 2 portion of the study, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days as well as the Maximum Tolerated Dose (MTD) of IP REOLYSIN® from the Phase 1 portion.

The primary objectives of the Phase 1 trial are to determine the safety and tolerability of IV and IP administration of REOLYSIN®, and the MTD of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. The primary objective of the Phase 2 trial is to determine the objective response rate of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian, peritoneal and fallopian tubal carcinomas. The Phase 1/2 trial is expected to enroll up to 70 patients.

[Source: Oncolytics Biotech Inc. Announces Start of Enrolment in Phase 1/2 Ovarian Cancer Clinical Trial with REOLYSIN®, Oncolytics Biotech Inc. News Release, June 10, 2008.]

Additional Information:

2 thoughts on “Clinical Trial Investigators Aim to Make Ovarian Cancer Cells “Terminally Ill” By Giving Advanced Ovarian Cancer Patients a Common Virus

  1. Quand les essais cliniques sur la Reolysine sont ils prévus en France?
    Un médecin oncologue peut-il demander que ses patientes participent à l’étude médicale si elles le demandent ?
    Une patiente française peut elle faire partie de l’étude en Angleterre ou au Canada si elle correspond à la recherche en cours?

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    • Evelyne,

      Let me first translate your questions for our readers. First, you would like to know whether any REOLYSIN® clinical trials are taking place in France. Second, you would like to know if a doctor can request that his patient participate in such a trial. Third, you would like to know if a French patient can participate in a trial held in England or Canada assuming that he or she qualifies for the trial.

      There are six open U.S. clinical trials that are testing REOLYSIN®. Click here for a list. The U.S. ovarian cancer clinical trial is entitled, “A Phase 1/2 Study of Reovirus Serotype 3 – Dearing Strain (REOLYSIN®) (NSC 729968) in Patients With Ovarian, Primary Peritoneal and Fallopian Tube Carcinoma.” Click here for a copy of the clinical trial protocol. The U.S. ovarian cancer clinical trial is being conducted in Columbus, Ohio at The Ohio State University (OSU) Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. To learn more about the ovarian cancer trial being conducted in Ohio, contact the Clinical Trials Office at the OSU Comprehensive Cancer Center (phone number: 00 + 1 + 614-293-4976; email address is osu@emergingmed.com. My understanding is that sponsors of clinical trials conducted in the U.S. use a case-by-case analysis to determine if non-U.S. citizens can participate.

      The U.K. ovarian cancer clinical trials involving the use of REOLYSIN® are as follows:

      REO 09: Intravenous administration of REOLYSIN® in combination with gemcitabine. This trial is ongoing but I do not know if new patients are being accepted.

      REO 11: U.K. trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin. This trial is ongoing but I do not know if new patients are being accepted.

      REO 12- Clinical trial testing REOLYSIN® and Cyclophosphamide: This trial is ongoing but I do not know if they are recruiting any new patients.

      I did not find any Canadian or French trials testing REOLYSIN® on ovarian cancer patients. Click here to see a list of worldwide REOLYSIN® trials. As a precaution, I would contact Oncolytics, the company that developed REOLYSIN®, and determine whether or not Canada and France are conducting REOLYSIN® trials. The Oncolytics contact information is as follows:

      Oncolytics Biotech Inc.
      Cathy Ward
      210, 1167 Kensington Cr NW
      Calgary, Alberta T2N 1X7
      Tel: 00 + 1 + 403.670.7377
      Fax: 00 + 1 + 403.283.0858
      cathy.ward@oncolytics.ca

      Your ability to participate in a U.K. clinical trial as a French foreign national is dependent upon the clinical trial protocol restrictions, U.K. regulatory law, and/or international treaty or agreement. For example, France and the U.K. are both members of the European Economic Area (EEA) and European Union (EU). To review the U.K. National Health Service (NHS) rules regarding medical treatment and cost reimbursement with respect to residents from EEA member states CLICK HERE. The general advice provided by the NHS is as follows:

      “First, you should discuss your plans with your doctor before you make any travel or medical arrangements. They will refer you to your local health commissioner who will discuss the options available to you and will confirm the following:

      * Which treatments they are prepared to fund, and what level of funding would be available.
      * Exactly how much you will be reimbursed.
      * That you fully understand the conditions under which you will be treated abroad.
      * Any programme of after-care or follow-up treatment you might require upon your return to the UK.

      If going to an EEA country, there are two routes for obtaining NHS funding. You can use the E112 form issued by the Overseas Healthcare Team (Newcastle) or, alternatively, you can go under Article 49 of the EC treaty. Your local commissioner can advise you on which option is better for the type of treatment you require. Each option works in a slightly different way.”

      Evelyne, I hope you find this information helpful or at least a helpful beginning. If you have any additional questions, please contact me.

      Best Regards,

      Paul

      _____________________________________________________________________________
      FRENCH TRANSLATION

      Evelyne,

      Laisser me traduit premièrement vos questions pour nos lecteurs. Premier, vous aimeriez savoir si n’importe quel REOLYSIN® les procès cliniques interviennent en France. Deuxième, vous aimeriez savoir si un médecin peut demander que son malade participe dans un tel procès. Le tiers, vous aimeriez savoir si un malade français peut participer dans un procès tenu en Angleterre ou Canada supposant qu’il ou elle qualifie pour le procès.

      Il y a six les procès cliniques, américains et ouverts qu’essaient REOLYSIN®. Cliqueter ici pour une liste. Le cancer ovarien américain procès clinique est autorisé, « UNE Phase 1/2 Etude de Sérotype de Reovirus 3 – Dearing la Tension (REOLYSIN®) (NSC 729968) dans les Malades Avec Peritoneal et le Carcinome de trompe de Fallope Ovariens et Primaires ». Cliqueter ici pour une copie du protocole d’essai clinique. Le cancer ovarien américain procès clinique est dirigé dans Columbus, Ohio à L’Ohio Université de l’état (OSU) le Centre de Cancer Complet – le Centre Anticancéreux de James et Solove Préparent l’Institut. Pour apprendre plus du procès ovarien de cancer est dirigé dans l’Ohio, contacter le Bureau de Procès Clinique à l’OSU le Centre de Cancer Complet (le numéro de téléphone : 00 + 1 + 614-293-4976; adresse e-mail est osu@emergingmed.com. Ma compréhension est que les sponsors de procès cliniques dirigés dans les Etats-Unis utilisent un cas-par-l’analyse de cas pour déterminer si non-U. le S. les citoyens peuvent participer.

      L’U.K. cancer ovarien procès cliniques impliquant l’usage de REOLYSIN® sont comme suit :

      REO 09 : L’administration intraveineuse de REOLYSIN® dans la combinaison avec gemcitabine. Ce procès est continu mais je ne sais pas si les nouveaux malades sont acceptés.

      REO 11 : U.K. le procès utilisant l’administration intraveineuse de REOLYSIN® dans la combinaison avec paclitaxel et carboplatin. Ce procès est continu mais je ne sais pas si les nouveaux malades sont acceptés.

      REO 12- le procès Clinique essayant REOLYSIN® et Cyclophosphamide : Ce procès est continu mais je ne sais pas s’ils recrutent de nouveaux malades.

      Je n’ai pas trouvé de Canadien ou les procès français essayant REOLYSIN® sur les malades de cancer ovariens. Cliqueter ici pour voir une liste de REOLYSIN mondial® les procès. Comme une précaution, je contacterais Oncolytics, l’entreprise qui a développé REOLYSIN®, et déterminer si Canada et France dirigent REOLYSIN® les procès. Les informations de contact d’Oncolytics sont comme suit :

      La Biotechnologie d’Oncolytics Inc. La Section de Cathy 210, 1167 Kensington Cr NW Calgary, le Téléphone de
      1X7 DE T2N d’Alberta : 00 + 1 + 403.670.7377 Fax : 00 + 1 + 403.283.0858 cathy.ward@oncolytics.ca

      Votre capacité à participer dans un U.K. le procès clinique comme un français étranger national est dépendant sur les restrictions de protocole d’essai cliniques, U.K. la loi régulatrice, et/ou le traité ou l’accord international. Par exemple, France et l’U.K. sont les deux membres du Secteur Economique européen (EEA) et Union européenne (UE). Pour réexaminer l’U.K. Le Service national de Santé (NHS) les règles quant au traitement médical et le remboursement de coût par rapport aux habitants des états de membre d’EEA CLIQUETER ICI. Le conseil général fourni par le NHS est comme suit :

      « Premier, vous devriez discuter vos projets avec votre médecin avant que vous faites n’importe quel voyage ou n’importe quels arrangements médicaux. Ils vous référeront à votre commissaire local de santé qui discutera les options disponibles à vous et confirmera le suivre :

      * Quels traitements qu’ils sont préparés subventionner, et quel niveau de subvention serait disponible. * Exactement combien vous serez remboursé. * Que vous comprenez entièrement les conditions sous lesquelles vous serez traité à l’étranger. * N’importe quel programme de traitement de suivi médical ou suite vous pourriez exiger sur votre retour au Royaume-Uni.

      Si allant à un pays d’EEA, il y a deux routes pour obtenir de subvention de NHS. Vous pouvez utiliser l’E112 forme distribuée par les Services médicaux Etrangers Associe (Newcastle) ou, comme alternative, vous pouvez aller sous l’Article 49 du traité de CE. Votre commissaire local peut vous conseiller sur lequel option est meilleur pour le type de traitement que vous exigez. Chaque option travaille dans une façon légèrement différente ».

      Evelyne, j’espère que vous trouvez ces informations serviables ou au moins un commencement serviable. Si vous avez des questions supplémentaires, s’il vous plaît me contacter.

      Les meilleurs Egards,

      Paul

      S’il vous plaît me pardonner pour toutes erreurs de traduction

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