Less than a year after announcing the acceleration of its program, Genocea Biosciences has announced it is ready for clinical trials of its T-cell herpes vaccine.
The trial, starting in the third quarter, will involve 150 people with HSV-2 infection, but otherwise in good health. Primarily aimed at measuring safety and immune response, the trial will also examine shedding and the presence duration and severity of lesions.
The move to first stage human trial represents five years of research into T cell technology, in conjunction with the University of California at Berkeley and the Harvard Medical School’s program ATLAS (AnTigen Lead Acquisition System).
Genocea CEO Chip Clark said: “at this point, we have 5 vaccines in our pipeline, and that is a big achievement for our company. We made these and we also created 2 vaccines for HSV-2, and vaccines for bacterial illnesses (Chlamydia, Streptococcus) and protozoa (malaria). Our program ATLAS gives us a big advantage.”
According to Genocea’s Chief Medical Officer, Dr. Seth Hetherington, data from this trial should be available during the first quarter.
Herpes Drugs: GSK Subjected to the Largest Fine Ever
British pharmaceutical company GlaxoSmithKline (GSK), the manufacturer of herpes drugs Zovirax and Valtrex has been subjected to the largest fine ever imposed on a drugs company.
Among GSK’s many products are Wellbutrin, an anti-depressant and Avandia, used in the treatment of diabetes. In a lawsuit involving ten of the company’s drugs, GSK admitted withholding important safety information about Avandia from the Food and DrugAdministration (FDA).
Earlier, severe concerns had been expressed about the drug both in the United States and in Europe, the European Medicines Agency (EMA) recommended its withdrawal from the market as long ago as 2010.
GSK further admitted bribing physicians to prescribe Wellbutrin for unauthorized use, including the treatment of children. Attorney Carmin Ortiz explained GSK’s conduct in stark terms: “The company bribed doctors to prescribe GSK medication with every type of elite entertainment, like Hawaiian vacations and speaking tours and tickets to celebrities concerts.”
We’ll never know how much harm was done by withholding information about the risks involved in prescribing Avandia to certain vulnerable patients. We’ll never know if prescribing a potent anti-depressant to children will cause lifelong psychiatric and psychological damage.
We do know that the company was fined a record $3bn. GSK announced that its profits amounted to nearly $9bn.
Worldwide, pharmaceuticals are one of the fastest growing and most profitable areas of business. A fine, albeit of record proportions, will have minimal impact. What is needed is real justice for the people damaged by the criminal behavior of those responsible.
If you or I were to purposefully or recklessly cause death or psychological damage to a child or a vulnerable person, we would go to prison. When will the US justice system catch up with the facts?