Prof Andy Porter, a key adviser to Bioven in Scotland, and a principal at Grampian BioPartners draws our attention to this important news item.
Bioven (Europe) Limited, the late-stage biopharmaceutical company focused on cancer, is pleased to announce the start of a pivotal Phase III trial of BV-NSCLC-001, the Company's novel therapeutic vaccine for the treatment of non-small cell lung cancer (NSCLC).
The trial will be carried out in multiple centres worldwide and the global study is being led by Dr Marianne Nicolson of Aberdeen Royal Infirmary, a consultant medical oncologist and Chair of the UK National Cancer Research Institute's Lung Clinical Studies Group.
As well as Aberdeen Royal Infirmary, the Edinburgh Cancer Centre has also been approved to participate in the trial along with two other UK centres. The smoking prevalence rate in Scotland in 2010 was 24.2%, compared with 20.0% in England. Correspondingly, the prevalence of lung cancer in Scotland is notably higher than in the United Kingdom more widely, with the incidence rate at 96.1 per 100,000 in Scotland compared with 64.0 per 100,000 in England. When the incidence of cancer is considered across men and women as one group, Scotland remains the only nation in the UK where lung cancer remains the most common cancer.
Following the dosing of the first patient in Aberdeen, a further eight patients have been dosed at a number of approved centres across Europe. A total of more than 400 patients will be enrolled in a number of centres in the UK and overseas. Currently, the Bioven trial is also approved at two other UK centres; Leicester Royal Infirmary and Guy's Hospital in London. At present, no doses have been administered at these two centres, but they are actively screening patients for eligibility.
The management of Bioven are also confident they will receive approval in the near future from the Indian government to undertake a proportion of the trial in several Indian hospitals.
Founded in Malaysia in 2002 and based in Aberdeen, Bioven is a biopharmaceutical company focused on the development and commercialisation of vaccines for cancer. BV-NSCLC-001 was in-licensed from the Centre of Molecular Immunology, Cuba, and has shown encouraging results in earlier Phase II trials where the vaccine more than doubled survival rates compared with standard treatment.
The BV-NSCLC-001 Phase III clinical trial taking place in Aberdeen consists of patients being vaccinated with Bioven's therapeutic vaccination prior to, during and subsequent to chemotherapy. Phase III clinical trial study interim results from an ongoing Phase III Cuban trial (involving vaccination only during and subsequent to chemotherapy), have shown promising results, with the overall survival rates compared to those of current best standard practice, increasing from 30% to over 50% at 12 months.
BV-NSCLC-001 is a novel, therapeutic vaccine targeting the validated epidermal growth factor receptor (EGFR) pathway.
Steven Drew, Bioven's CEO, commented: "We are delighted that Dr Nicolson's team at Aberdeen Royal Infirmary have kicked off our Phase III clinical trial with the first doses of our therapeutic vaccine. We are excited by the prospects for BV-NSCLC-001 as there is a very clear need to improve the treatment of lung cancer."
Dr Marianne Nicolson said: "I am delighted to be clinical head for the global Phase III clinical trial for Bioven. The previous studies have shown promising clinical results regarding the benefits of the therapeutic vaccination and I am hopeful the current Phase III trial will further confirm the efficacy of BV-NSCLC-001."LIFE sciences firm Pharmacells is set to extend its service into Europe and the Middle East as the stem cell specialist enters what is expected to be a rapid period of expansion.
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