BioVex

New Research Proves Cancer-Fighting Virus can Kill Tumor Cells Without Harming Healthy Tissue

LOS ANGELES (Reuters) - Researchers have shown for the first time that a single intravenous infusion of a genetically engineered virus can home in on cancer, killing tumor cells in patients without harming healthy tissue. Scientists have been intrigued for decades with the idea of using viruses to alert the immune system to seek and destroy cancerous cells. That interest has taken off in recent years as advances in genetic engineering allow them to customize viruses that target tumors. The field received a boost in January when biotech giant Amgen Inc agreed to pay up to $1 billion for BioVex, the developer of experimental cancer-fighting virus OncoVex. But the only "oncolytic virus" so far approved by a regulatory agency is for treatment of head and neck cancer in China. In a study published in the journal Nature on Wednesday, scientists at institutions including the University of Ottawa and privately held biotech company Jennerex Inc said a small, early-stage trial of experimental viral therapy JX-954 found that it consistently infected tumors with only minimal and temporary side effects. The experimental virus will next be tested in a mid-stage trial of patients with liver cancer. "With chemotherapy you get drastic side effects," said Dr. John Bell, chief scientific officer at Jennerex and senior scientist at the Ottawa Hospital Research Institute. "Patients on this treatment only had 24-hour flu symptoms, and nothing after that." The trial, which involved 23 patients with various types of advanced cancer, was designed to assess the safety of [...]

Oral Cancer Foundation News Team - A2011-09-01T10:59:03-07:00September, 2011|Oral Cancer News|

BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer

Source: PR Newswire Author: Staff WOBURN, Mass., Sept. 15 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses [...]

Charlotte Parker2009-09-16T16:29:05-07:00September, 2009|Oral Cancer News|

BioVex agrees SPA with the FDA for a pivotal phase III study with OncoVEX (GM-CSF) in head and neck cancer

Source: news.prnewswire.com Author: press release BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX . In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are [...]

Oral Cancer Foundation News Team - A2009-09-15T14:20:04-07:00September, 2009|Oral Cancer News|