Reolysin
Encyclopedia
Reolysin is a formulation of reovirus
that Oncolytics Biotech
is developing for the treatment of various cancers and cell proliferative disorders. Reolysin is classified as a oncolytic virus
, a virus that preferentially lyses cancer cells. A phase III trial for head and neck cancer is ongoing.
Reovirus was noted to be a potential cancer therapeutic when early studies on reovirus suggested it reproduces well in certain cancer cell lines. It has since been shown to replicate specifically in cells that have an activated Ras (a cellular signaling pathway that is involved in cell growth and differentiation) with very little effect in cells that do not have active Ras pathways. Reovirus replicates in and eventually kills Ras-activated tumour cells, and as cell death occurs, progeny virus particles are then free to infect surrounding cancer cells. This cycle of infection, replication and cell death is believed to be repeated until all tumour cells carrying an activated Ras pathway are destroyed. Activating mutations of the Ras protein and upstream elements of the Ras protein may play a role in more than two thirds of all human cancers,including most metastatic disease, which suggests that Reolysin may be an effective therapeutic for many Ras-activated tumor types and potentially for some cell proliferative disorders.
Clinical trials have demonstrated that Reolysin may have activity across a variety of cancer types when administered alone and in combination with other cancer therapies.
2011 phase II results for pancreatic cancer
.
Oncolytics Biotech
is conducting a phase III trial examining Reolysin in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The phase III trial is being conducted in multiple jurisdictions. October 2009, Oncolytics reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the study design, making Oncolytics one of the first companies to reach an agreement with the FDA on a phase III trial design for an intravenously-administered oncolytic virus
under the Special Protocol Assessment (SPA)
process February 2010, gained UK MHRA approval to conduct the trial June 2010, Begian approval for the trial July 2010, a no-objection letter from Health Canada First enrollment due when ?
Reoviridae
Reoviridae is a family of viruses that can affect the gastrointestinal system and respiratory tract. Viruses in the family Reoviridae have genomes consisting of segmented, double-stranded RNA...
that Oncolytics Biotech
Oncolytics Biotech
Oncolytics Biotech Inc. is a Canadian company headquartered in Calgary, Alberta, that focuses on the discovery and development of pharmaceutical products for the treatment of human cancers...
is developing for the treatment of various cancers and cell proliferative disorders. Reolysin is classified as a oncolytic virus
Oncolytic virus
An oncolytic virus is a virus that preferentially infects and lyses cancer cells; these have obvious functions for cancer therapy, both by direct destruction of the tumour cells, and, if modified, as vectors enabling genes expressing anticancer proteins to be delivered specifically to the tumor...
, a virus that preferentially lyses cancer cells. A phase III trial for head and neck cancer is ongoing.
Mechanism of action
Reovirus, an acronym for Respiratory Enteric Orphan virus, generally infects mammalian respiratory and bowel systems. Most people have been exposed to reovirus by adulthood; however, the infection does not typically produce symptoms.Reovirus was noted to be a potential cancer therapeutic when early studies on reovirus suggested it reproduces well in certain cancer cell lines. It has since been shown to replicate specifically in cells that have an activated Ras (a cellular signaling pathway that is involved in cell growth and differentiation) with very little effect in cells that do not have active Ras pathways. Reovirus replicates in and eventually kills Ras-activated tumour cells, and as cell death occurs, progeny virus particles are then free to infect surrounding cancer cells. This cycle of infection, replication and cell death is believed to be repeated until all tumour cells carrying an activated Ras pathway are destroyed. Activating mutations of the Ras protein and upstream elements of the Ras protein may play a role in more than two thirds of all human cancers,including most metastatic disease, which suggests that Reolysin may be an effective therapeutic for many Ras-activated tumor types and potentially for some cell proliferative disorders.
Completed trials
Reolysin has successfully completed a number of phase I and II clinical trials across a variety of cancer types. Reolysin was being evaluated in phase II clinical trials in melanoma, pancreatic, lung, ovarian, and colorectal cancers.Clinical trials have demonstrated that Reolysin may have activity across a variety of cancer types when administered alone and in combination with other cancer therapies.
2011 phase II results for pancreatic cancer
Pancreatic cancer
Pancreatic cancer refers to a malignant neoplasm of the pancreas. The most common type of pancreatic cancer, accounting for 95% of these tumors is adenocarcinoma, which arises within the exocrine component of the pancreas. A minority arises from the islet cells and is classified as a...
.
Ongoing trials
The Company is conducting phase II trials in a range of indications including squamous cell carcinoma of the lung, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. The Company is also conducting a phase I trial in colorectal cancer.Oncolytics Biotech
Oncolytics Biotech
Oncolytics Biotech Inc. is a Canadian company headquartered in Calgary, Alberta, that focuses on the discovery and development of pharmaceutical products for the treatment of human cancers...
is conducting a phase III trial examining Reolysin in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The phase III trial is being conducted in multiple jurisdictions. October 2009, Oncolytics reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the study design, making Oncolytics one of the first companies to reach an agreement with the FDA on a phase III trial design for an intravenously-administered oncolytic virus
Oncolytic virus
An oncolytic virus is a virus that preferentially infects and lyses cancer cells; these have obvious functions for cancer therapy, both by direct destruction of the tumour cells, and, if modified, as vectors enabling genes expressing anticancer proteins to be delivered specifically to the tumor...
under the Special Protocol Assessment (SPA)
FDA Special Protocol Assessment
A Special Protocol Assessment is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval....
process February 2010, gained UK MHRA approval to conduct the trial June 2010, Begian approval for the trial July 2010, a no-objection letter from Health Canada First enrollment due when ?