HORSHOLM, Denmark, Sept. 10, 2003 (PRIMEZONE) -- Summary: Recruitment of patients to the US phase I breast cancer trial with Pharmexa's (Other OTC:PMXAY) HER-2 AutoVac(TM) Protein vaccine has now been completed.
Preliminary results are expected before the end of the year.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.
About breast cancer and existing therapies Breast cancer is the most prevalent form of cancer among women and the single most common cause of death among women in Denmark. Every year approximately 4,000 Danish women are diagnosed with breast cancer. The primary treatment in Denmark and other countries is surgery and/or radiation therapy and if indicated pharmacological therapy with chemotherapy and hormone therapy. There is a great need for better treatment options.
Approximately 20-30% of all women with breast cancer have an aggressive cancer form where the cancer cells display a significant increased number of so-called HER-2 receptors on the cell surface. This significantly increased number of HER-2 receptors stimulates the uncontrolled growth of cancer cells and is therefore generally associated with a poor prognosis for the patient. Currently there is a drug on the market called Herceptin that works by targeting the HER-2 protein. This drug has achieved status as first line treatment for metastatic breast cancer in the United States and has within a few years realised annual sales of more than 500 million dollars.
Pharmexa's HER-2 AutoVac(TM) Protein vaccine is directed towards the same target as Herceptin but there are significant differences: Pharmexa's vaccine leads to antibody production against HER-2 by the patient's own immune system and these antibodies are expected to be more effective than artificial antibodies, which are given intravenously to the patient as in the case with Herceptin.
Additional information: Soeren Mouritsen, telephone +45 4516 2525 Jakob Schmidt, telephone +45 4516 2525
Note to editors: Pharmexa A/S (CSE:PHARMX) is a leading company in the field of active immunotherapy for the treatment of serious chronic diseases. Pharmexa's proprietary AutoVac(TM) technology platform is broadly applicable, but the company has focused its resources on a number of cancer forms and chronic inflammatory diseases, with research and development programs targeted towards breast cancer, rheumatoid arthritis and bone degeneration. Collaborative agreements include Schering-Plough and H. Lundbeck.
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