12.09.2003 - In March 2003 Pharmexa submitted an application to start a clinical phase I trial with the company's HER-2 AutoVac(TM) Protein vaccine to the US health authorities. The application was among other things based on very promising preclinical results, where injections with HER-2 AutoVac(TM) Protein induced antibody levels comparable to therapeutic levels of the monoclonal antibody Herceptin. Herceptin is being marketed with great success for the treatment of metastatic HER-2 positive breast cancer by the international pharmaceutical companies Roche and Genentech.
The clinical trial, which takes place at two US breast cancer centres in Cleveland and Pittsburgh, includes 10 patients with breast cancer. The primary objective of the trial is to evaluate the safety of the HER-2 AutoVac(TM) Protein vaccine. In addition, the ability of the vaccine to activate a specific immune response against cancer cells expressing the HER-2 protein will be evaluated.
Recruitment of patients to the trial has now been completed according to schedule and all 10 patients have started treatment. Based on this, Pharmexa expects to be able to announce preliminary data from the trial before the end of the year.
Message posted by: Frank S. Zollmann
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