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Bioven Begins Phase III Trial of Cuban NSCLC Vaccine in UK

Published: 20 September 2012

Malaysian pharma company Bioven, which has a unit in Aberdeen, Scotland, has announced the start of its pivotal Phase III trial of Cuban developed non-small-cell lung cancer drug CimaVax-EGF in the United Kingdom.

IHS Global Insight Perspective



The start of the Phase III clinical trial of Cuban non-small-cell lung cancer (NSCLC) drug CimaVax-EGF in the United Kingdom is crucial for a possible approval of the drug by UK regulators and, if trial results are positive, could enhance the chances of marketing agreements and strengthen the bonds between Cuba and the UK.


Although the approval of CimaVax-EGF in the UK and possibly the European Union can only be foreseen in the medium term, if trials are successful, this could change the way Cuban drugs are viewed around the world.


If Phase III trials show positive results, there is a good chance CimaVax-EGF may be considered for approval in the UK and EU through the European Medicines Agency. Future approval could revolutionise NSCLC treatment in the EU as well as leading the way towards highly successful partnership agreements between Cuba and the EU.

The Aberdeen, Scotland, based subsidiary of Malaysian pharma company Bioven has announced the start of its pivotal Phase III trial of Cuba's Centre of Molecular Immunology (CIM)-developed non-small-cell lung cancer (NSCLC) drug CimaVax-EGF in the United Kingdom.

The vaccine is based on active immunotherapy whereby an individual's immune response is manipulated to release its own antibodies against the oncogene EGF (epidermal growth factor). Its over-activation can induce malignant transformation of a normal cell, signalling inhibition of apoptosis, cell proliferation, angiogenesis, metastasis, and tumour-induced proinflammatory and immunosuppressive processes.

Bioven's CEO Steve Drew, cited by company sources, stated that the firm is starting Phase III clinical trials of CimaVax-EGF following the green light from the European Medicines Agency (EMA) based on good efficacy data. According to Bioworld Today, the Phase III trial is being led by Marianne Nicholson of the Aberdeen Royal Infirmary, who is also chair of the UK National Cancer Research Institute's Lung Clinical Studies Group.

According to company sources, Bioven is also looking for approval in India. Drew also hinted at a possible future approval of the drug in the United States, adding: "There is little doubt that the international profile of Cuba's biotech sector has been held back by the country's strained relationship with the US." Drew said Bioven has had some engagement with US physicians and patients' groups, and has also talked to the US FDA."It takes time, but there are ways around the hurdles," he said, adding: "We are hoping to conduct part of the Phase III in the US." According to company sources, in Phase III, patients with stage III and IV lung cancer will be vaccinated with the CimaVax-EGF before, during, and after chemotherapy. The 438-patient study will be open-label and non-blind.

Outlook and Implications

The announcement of the start of Phase III trials of CimaVax-EGF in the UK has been long awaited in the world of cancer research since it may lead to a new treatment option across the UK and, subsequently, the European Union. The drug is innovative as it is based on the concept of inducing EGF deprivation by active immunotherapy, which is an emerging concept developed by Cuban researchers that involves manipulating an individual's immune response to release its own antibodies against the EGF, reducing tumour size or preventing its progression

CimaVax-EGF is a therapeutic vaccine, which was developed entirely in Cuba by CIM and is already licensed in Cuba for use in adult patients with stage IIIB/IV NSCLC. Outside of Europe, the vaccine is in the process of approval in Argentina, Brazil, Colombia, Ecuador, and Paraguay; is registered in Cuba and Peru; and is currently being tested in Canada, China, and Malaysia. Plans are under way to undertake trials in other countries in Europe and Thailand. In terms of marketing agreements, a perspective approval of the drug in the UK may lead to successful partnership agreements between the UK and Cuba, and subsequently between Cuba and other countries in the EU, which would highly benefit the country from an economic perspective and provide the EU with a potential new cancer treatment. Furthermore, the possibility of trials being carried out in the US in the medium term could revolutionise the commercial relationships between the two countries and strengthen their commercial bonds.

If Phase III trials show positive results, there is a good chance CimaVax-EGF may be considered for approval in the UK and, subsequently, the EU via the EMA. The EMA gave the go ahead for this latest Phase III trial based on good efficacy data drawn from the Phase II trial that began in the UK in December and concluded last month (see Cuba: 1 December 2011: Cuban Lung Cancer Vaccine to Be Tested in UK).

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