Positive data announced for Reolysin in head and neck cancers

Source: www.empr.com Author: staff Oncolytics Biotech announced positive top line data in its double-blinded randomized Phase 3 clinical study examining Reolysin in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers. Reolysin is a proprietary formulation of the human reovirus. A first analysis compared the relative percentages of patients in the test and control arms with tumors that had either stabilized or exhibited shrinkage. For the purposes of this endpoint, the definition of tumor stabilization was restricted to 0% growth only. Of the 105 total patients with evaluable metastatic tumors, 86% (n=50) of those in the test arm of the study exhibited tumor stabilization or shrinkage, compared with 67% of patients (n=55) in the control arm. This was statistically significant, with a p-value of 0.025. A second analysis examined the magnitude of tumor response on a per patient basis using a comparison of percentage tumor shrinkage at six weeks in each patient with evaluable metastatic tumors. This analysis showed that Reolysin in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumors, yielding a p-value of 0.03

2012-12-23T08:28:26-07:00December, 2012|Oral Cancer News|

Head And Neck Cancer Chemotherapy Efficacy Boosted By Human Virus

Source: MedicalNewsToday.com Preliminary data from a trial published in Clinical Cancer Research shows that a harmless human virus that occurs naturally could potentially boost the effects of two standard chemotherapy drugs in some cancer patients. Oncolytics Biotech Inc. developed a new drug, RT3D that will be marketed under the trade name of Reolysin. The drug is based on a virus, i.e. reovirus type 3 Dearing that is commonly found in the respiratory and gastrointestinal tracts of almost every adult without causing any symptoms. RT3D can grow and kill certain types of cancer cells, but it does not grow in normal cells. Earlier trials whereby patients were injected with only the virus displayed limited effectiveness, however, the team discovered that the effects of platin and taxane-based chemotherapy on tumor cells seemed to be magnified by RT3D. Dr Kevin Harrington and his team decided to start a clinical trial in which they examined intravenous RT3D in combination with chemotherapeutics carboplatin and paclitaxel in 31 patients with advanced cancers that had become unresponsive to standard treatments. They conducted an initial Phase I study in patients with a variety of advanced cancers, which demonstrated that the drug combination was safe, with generally mild side effects that were consistent with chemotherapy alone. The best responses were observed in patients with head and neck cancers, including tumors of the nasal cavity, eye, tongue, gums, lip, cheeks, voice box and esophagus. Worldwide, each year about 650,000 people are diagnosed with squamous cell cancer of the head and [...]

2012-04-03T10:50:41-07:00April, 2012|Oral Cancer News|

Harmless virus could be an answer to cancer

Source: www.dailyfinance.com Author: Melly Alazraki You'd think that infecting a cancer patient with a virus would be the last thing a doctor would want to do. But what if it was a virus that attacks and kills cancer cells? That's exactly the premise that led to the founding of Oncolytics Biotech, a Calgary-based biotechnology company. It's about to begin Phase 3 trials that could pave the way for a marketable cancer treatment based on this technology in two years, says CEO Dr. Brad Thompson (pictured) in an interview with DailyFinance. "We're working on a product that is widely applicable to quite a few indications of cancer and is based on a naturally occurring virus that's commonly found in the environment and that happens to have a preference of growing in cancer cells as opposed to growing in normal tissue." It's called a reovirus (short for Respiratory Enteric Orphan virus), and it's a type which most people pick up by age 12 through inhalation or contact that causes few or no health problems. But when the virus enters cancer cells, it kills them. On-Off Switch Viruses, naturally, prefer cells that can't fight them off. And these cancer cells all have a common characteristic: They have a certain growth pathway, called the Ras pathway, turned on. "If a cell doesn't have that pathway turned on, nothing happens, so it's like an on-off switch for the virus's growth," Thompson explained. In the human body, very few normal cells have that Ras pathway turned [...]

2010-02-06T12:11:49-07:00February, 2010|Oral Cancer News|

Oncolytics Biotech Inc. announces issuance of 33rd U.S. patent

Source: www.benzinga.com/press-releases Author: press release Oncolytics Biotech Inc. ("Oncolytics") today announced that it has been granted its 33rd U.S. Patent, # 7,608,257, entitled "Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells With a Virus." The patent claims cover methods of using reovirus in combination with currently approved chemotherapeutic agents to treat patients that are refractory to those chemotherapeutic agents alone. "This patent supports our expanding clinical program, including our first Phase III study, looking at Reolysin(R) in combination with a range of chemotherapeutic agents," said Mary Ann Dillahunty, Vice President of Intellectual Property for Oncolytics. "Many of our studies enroll patients that did not previously respond to chemotherapy, including our Phase III study in patients with platinum refractory head and neck cancers." About Oncolytics Biotech Inc. Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using Reolysin(R), its proprietary formulation of the human reovirus.

Oncolytics’ Phase III borrows adaptive design in SPA trial

Source: www.bioworld.com Author: Catherine Hollingsworth Oncolytics Biotech Inc. reached agreement with the FDA on the design of a Phase III trial of Reolysin in head and neck cancer, marking the first such agreement for an intravenously administered oncolytic virus. The Phase III trial will be conducted in two stages and will cost an estimated $15 million, Matt Coffey, Oncolytics' chief operating officer, told BioWorld Today. The Calgary, Alberta-based company has the cash to get through the first half of the study on its own, but it hopes to secure a partner to take Reolysin the rest of the way, he said. The trial uses an adaptive design in which "the endpoint is not fixed going in," CEO Brad Thompson said during a conference call. He said it was "a major advantage" getting the FDA to sign off on the study design up front under a special protocol assessment. Thompson said that the adaptive design already is in use in the area of infectious disease, and he said he believes that there will be "a big push" by the FDA for more adaptive trials to be conducted in oncology. The trial will assess the intravenous administration of Reolysin with the chemotherapy combination of paclitaxel and carboplatin vs. chemotherapy alone. The drug likely will be studied in about 275 patients whose cancer has progressed while on or after prior platinum-based chemotherapy. The first stage of the trial is nonadaptive and is designed to enroll 80 patients. The second stage is adaptive, and [...]

Combination of chemo and common virus continues to show remarkable results in advanced cancer patients

Source: www.newswise.com Author: press release Chemotherapy—as any cancer patient will tell you—is not for the faint of heart, but it can kill many forms of cancer. Some form of chemotherapy, originally discovered as a cancer treatment almost seventy years ago, is still routinely prescribed for most types of the disease. The treatment works by targeting fast-growing cells, like those typically found in rapidly growing tumors. But while chemotherapy can shrink tumors, they often grow back and become resistant, or refractory to chemotherapy. To combat this resistance, chemotherapy is now often used in combination with other treatments that have different mechanisms for attacking and killing cancer cells. But doctors must be cautious when combining treatments to ensure that the regimen does not become too toxic for patients to tolerate. The goal is to introduce drugs that can be used synergistically with chemotherapy to not only extend life, but to provide cancer patients with good quality of life while undergoing treatment. One such complimentary drug may be Reolysin®, now being developed from the naturally occurring reovirus, by Oncolytics Biotech Inc. The reovirus preferentially replicates in cancer cells with an activated RAS pathway, while sparing normal cells. Approximately two thirds of all cancers have an activated RAS pathway, including most metastatic disease. Viral replication within cancer cells causes them to burst open, releasing more virus to infect other cells. Reolysin is demonstrating impressive results in clinical trials on its own, but particularly in combination with certain chemotherapeutics. Recently, Oncolytics announced positive results from [...]

Oncolytics Biotech(R) Inc. collaborators present positive head and neck results in phase I/II combination

Source: pr-canada.net Author: press release Oncolytics Biotech Inc. announced that interim clinical results from its Phase I/II U.K. trial of Reolysin(R) combined with paclitaxel/carboplatin for patients with advanced cancers were presented at the Fifth International Meeting on Replicating Oncolytic Virus Therapeutics. The meeting is being held in Banff, Alberta from March 18th to 22nd, 2009. The principal investigator for the trial is Dr. Kevin Harrington of The Institute of Cancer Research. To date, fifteen head and neck cancer patients have been treated in the Phase I/II trial. All but one patient had prior platinum treatment. Of 12 patients evaluable for clinical response, five have experienced Partial Response (PR) and four have experienced Stable Disease (SD) ranging from two to six months. For patients who have been followed for at least six months since their initial treatment, the median progression-free survival (PFS) is currently six months, while the overall survival is currently seven months. The literature suggests that platinum refractory patients typically have a PFS of approximately two months and a median survival ranging from 4.5 to 6.5 months. The overall survival figure may evolve as many of the patients are still alive. "In patients previously treated with platinum agents, where the response rate (PR and Complete Response (CR)) is generally in the 3-10% range, a response rate of 42% and a 75% clinical benefit rate (SD, PR, and CR) are dramatic," said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics. The Phase I/II trial has two components. The first is [...]

Virus accomplice helps drugs fight cancer

Source: www.newscientist.com Author: Andy Coghlan A virus that harmlessly infects most people at some time in their lives appears to help anti-cancer drugs destroy tumours, or at least keep them in check. Known as a reovirus, it destroys tumour cells because they lack the cellular machinery that keeps the virus in check in healthy cells. Results released last week from two studies in which patients with head and neck cancer were injected with the virus alongside anti-cancer drugs reveal that cancers either stopped growing or shrank in almost all recipients. Furthermore, the patients had cancers that had become resistant to all existing therapies. "Some patients had very aggressive tumour shrinkage of as much as 95%," says Brad Thompson, CEO of Canadian company Oncolytics Biotech, which has been developing the virus as a product called Reolysin. In one trial, led by Kevin Harrington at the Royal Marsden Hospital in London, 8 out of 9 patients responded positively after the virus plus two standard anti-cancer drugs, paclitaxel and carboplatin, had been infused into their bloodstream. In four, tumours stopped growing, and in another four, tumours shrank dramatically. In the other trial, also near London at the Royal Surrey Hospital, 9 out of 11 patients responded well after receiving the virus plus the anti-cancer drug docetaxel. Genetic flaw Taken together, the results suggest the virus does help in some way. "Usually, only 10% of patients respond when the cancer comes back and they're having their second course of treatment," says Thompson. The virus [...]

2008-11-07T14:05:54-07:00November, 2008|Oral Cancer News|

Oncolytics reports positive results from phase I/II cancer studies

Source: www.pharmaceutical-business-review.com Author: staff Oncolytics Biotech has announced positive interim results in its Phase I and Phase II UK combination Reolysin and paclitaxel/carboplatin clinical trials for patients with advanced cancers. Four of the responding patients continue on study, while a fifth patient is too early to evaluate for response, the company said. These results appear to confirm preclinical evidence of synergy for Reolysin and platinum/taxane combinations. A US Phase II trial has now been opened in this patient population utilizing this regimen. The Phase I trial has two components. The first is an open-label, dose- escalating, non-randomized study of Reolysin given intravenously to patients with paclitaxel and carboplatin every three weeks. In this portion of the trial, standard dosages of paclitaxel and carboplatin are delivered to patients with escalating dosages of Reolysin intravenously. The second component of the trial includes the enrollment of a further nine patients at the top dose of Reolysin in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumors such as melanoma, lung and ovarian that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The Phase II trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative [...]

2008-11-04T13:40:52-07:00November, 2008|Oral Cancer News|
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