Pharmexa obtains approval for breast cancer vaccine trial in Russia

By Lisa Kerner

Erie, Pa., Jan. 11 - Pharmexa A/S has obtained the required regulatory approvals for the phase 2 trial with the HER-2 Protein AutoVac breast cancer vaccine in combination with the adjuvant QS-21 in Russia, paving the way for patient enrollment to begin there.

Also, the first patients have begun treatment at study sites in Poland, according to a company news release.

Patients in the phase 2 trial will receive four initial immunizations over a six-week period with 1.25 milligram HER-2 Protein AutoVac formulated with Alhydrogel adjuvant and mixed with QS-21 adjuvant, followed by booster immunizations every four weeks for up to 26 weeks.

The trial will be carried out at 10 to 15 cancer research centers in Poland, Romania and Russia. Each center will recruit 40 patients with active HER-2 positive breast cancer, said the company.

Pharmexa, with headquarters in Horsholm, Denmark, specializes in the field of active immunotherapy and vaccines for the treatment of serious chronic and infectious diseases, including cancer, rheumatoid arthritis, bone degeneration and Alzheimer's disease, HIV, influenza, hepatitis and malaria.

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