Positive Phase I Trial Results for Pevion Biotech Ltd.'s and Bio Life Science's Breast Cancer Vaccine

Bern, June 22, 2009 – Pevion Biotech and Bio Life Science today announced positive phase I clinical trial results for their jointly developed virosome-based breast cancer vaccine. The trivalent vaccine was found to be safe, well tolerated and immunogenic in patients moderately over-expressing the HER-2/neu oncoprotein.wh The candidate vaccine, consisting of three peptide epitopes of HER-2/neu attached to virosomes, represents a novel approach to cancer immunotherapy. The vaccine is intended to protect breast cancer patients from tumor recurrence following treatment of the primary tumor. In a phase I clinical study the breast cancer vaccine was administered to 10 patients with advanced breast cancer at the Medical University and General Hospital of Vienna. Each patient received three vaccinations over a period of 2 months. The trial was overseen by an external independent safety data review committee.

The vaccine was generally well tolerated and no vaccine-related serious or severe adverse effects were reported. The vaccine induced a strong immune response against the individual peptide antigens as well as the HER-2/neu protein in 8 out of 10 patients. Twelve months post-vaccination, seven patients showed stable disease. Two patients had progressive disease at 5 and 7 months, respectively, and one patient died from the underlying disorder. Following the positive outcome in terms of safety and immunogenicity, the trial advanced to its next stage in which a higher dose regimen is currently being tested.

Commenting on today’s announcement, Thomas Stauffer, CEO of Pevion Biotech, said: ”Two validated elements were combined to bring forth an innovative cancer vaccine candidate: BioLife Science’s peptide antigens originating from the HER-2 protein and Pevion Biotech’s market-approved virosome-based carrier platform, which is known to elicit high-quality B cell responses against a wide variety of antigens and even in elderly people” Professor Christoph Zielinski, Department of Medicine I, Medical University Vienna, commented: “The passive immunization of breast cancer patients with monoclonal antibodies has been a big step forward in the treatment of this disease. Our promising clinical results with respect to the active immunization of breast cancer patients demonstrate the vaccine’s excellent capacity to elicit tumor-specific immune responses using the body’s own immune system.”

About breast cancer

Breast cancer is the second leading cause of cancer death in women, exceeded only by lung cancer. It is estimated that in 2009 more than 200,000 new cases of invasive breast cancer will be diagnosed among women in the United States. Breast cancer incidence rates have continued to rise since 1980, although the rate of increase slowed in the 1990s, compared to the 1980s. The treatment usually consists of a combination of surgery, chemotherapy, radiation and hormonal (anti-estrogen) therapy. In addition, immunotherapy with monoclonal antibodies are often a routine part of today’s clinical care.

About Pevion Biotech

Pevion Biotech is a privately owned Swiss biopharmaceutical company focusing on the preclinical and clinical development of vaccines to prevent/treat infectious diseases and cancer. For its vaccine development, the company uses its virosome-based technology which is already validated by two registered and marketed vaccines. The combination of the virosome technology with novel or clinically validated antigens substantially reduces the known risk in biopharmaceutical product development and permits the targeting of diseases for which so far no appropriate treatment is available. Pevion Biotech’s product candidates address diseases of unmet medical needs, including prophylactic or therapeutic vaccines against breast cancer, candidiasis, RSV and influenza.

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