Date: 2015-05-19
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Oncolytics Biotech (Canada)
Product: Reolysin® (pelareorep - human reovirus type 3 Dearing strain)
Action
mechanism: oncolytic virus. Reolysin® is a proprietary variant of the respiratory enteric orphan virus (reovirus). The reovirus is non-pathogenic. The reovirus is able to infect and selectively destroy cancer cells. When a normal cell is infected with the reovirus, an antiviral response is activated, which prevents the virus from replicating within the cell. However, inside a cancer cell with one or more mutations on a growth pathway called the Ras pathway, there is an aberrant antiviral response that is unable to prevent the virus from replicating. This abnormality allows the reovirus to multiply to an extent that is fatal to the cancer cell.
In clinical trials, Reolysin® has been shown to be well-tolerated, with patients exhibiting only mild, flu-like symptoms. It has been used alone and in combination with chemotherapy and radiotherapy for various cancers, including head and neck cancers in an ongoing Phase III clinical trial. Oncolytics has supported two sponsored clinical studies assessing Reolysin® in the treatment of ovarian cancer. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of Reolysin® that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with Reolysin® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.
Disease: glioma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back (recurrent) or that have not responded to standard therapy (refractory). A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells. (NCT02444546)
Latest
news: * On May 19, 2015, Oncolytics Biotech announced that following submission to the FDA for review, the Investigational New Drug Application containing the protocol titled \"MC1472: Phase 1 Study of Replication Competent Reovirus (Reolysin®) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors\" is now active. The study sponsor is Mayo Clinic based in Rochester, Minnesota, and the Study Chair is Dr. Richard Bram of Mayo Clinic. The study is an open-label Phase I trial to clarify the safety, and determine possible efficacy, of GM-CSF given prior to administration of intravenous Reolysin® for children with malignant high grade brain tumors. GM-CSF will be administered on days one and two of each cycle with Reolysin® administered on days three, four and five. Cycles will be given every 28 days for up to 12 cycles if patients remain without evidence of tumor progression and without intolerable toxicity. The primary outcome for the nine to 18 patients of the Phase 1 study will be safety and tolerability. Secondary goals include median progression free and overall survival in this patient population. Eligible patients include those between the ages of 10 and 21 with histologically confirmed high grade (grade 3 or 4) primary brain tumor either classified as a glioma (including astrocytoma, anaplastic oligodendroglioma and glioblastoma multiforme), medulloblastoma, atypical teratoid/rhabdoid tumor or primitive neuroectodermal tumor. Patients must have no known curative therapy available and can have had up to two chemotherapy regimens for the brain tumor previously. Oncolytics has conducted three previous clinical studies in adults with brain cancers including gliomas, and has found that Reolysin® can infect a variety of brain tumors when delivered intravenously. In April 2014, the Company announced the findings from a clinical study showing that intravenously delivered Reolysin® can cross the blood brain barrier and a pre-clinical study in animals examining the synergies associated with treatment with GM-CSF prior to administering Reolysin®. The Company has received Orphan Drug Designation from the FDA for the use of Reolysin® in the treatment of malignant gliomas.
