FDA approves clinical trial of Cuban lung cancer vaccine
pharmafile | November 1, 2016 | News story | Manufacturing and Production, Sales and Marketing | Cuba, US, Vaccine, cimavax, clinical trials
The thawing of relations between the US and Cuba has allowed a pioneering treatment for non-small cell lung cancer to be tested in the US. The clinical trials will examine the efficacy of the vaccine, which has previously shown improvement in overall survival in comparison with the control group. The figures can be broken down to 12.4 months of median survival in those receiving the vaccine against 9.4 months in the control group.
The clinical trial will be held at the Roswell Park Cancer Institute in Buffalo, with 60 to 90 patients who had previously been treated for advanced NSCLC given the vaccine. The vaccine, named CimaVax, targets the epidermal growth factor receptor, which is ‘overexpressed’ in approximately 40% to 80% of NSCLCs. The vaccine prevents binding of the endogenous epidermal growth factor to the receptors and thereby denies the tumour the growth factor.
The vaccine has been developed over the course of 25 years and it has so far been used to treat roughly 4000 patients worldwide. Though it has been touted as breaking new ground, in terms of treatment, it is likely to be used in combination with other therapies to extend median survival in patients.
“This ground-breaking trial at Roswell Park is the result of our historic partnership with Cuba, and is a testament to New York’s storied legacy as a national leader in progress and innovation,” New York governor, Andrew Cuomo announced upon the news. “With Roswell Park at the forefront of world-renowned medical research, we are this much closer to making a breakthrough that will combat cancer and save lives. This latest milestone marks another chapter in Buffalo’s success story, and we look forward to seeing the impacts of this partnership resonate in New York and across the nation.”
Ben Hargreaves
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