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Approval From The Swedish Medical Products Agency To Start A Clinical Trial Using A Xenogenic PSA DNA Vaccine

August 18, 2017

Cyto Pulse Sciences, a leading producer of electric field based, intradermal DNA Vaccine delivery systems, today announced approval by Swedish regulatory authorities to begin a Phase I/II study of DNA vaccination in patients with recurring prostate cancer. The trial will investigate the safety of a xenogenic DNA vaccine delivered by the Derma Vax™ intradermal electroporation system. The vaccine, which encodes Prostate Specific Antigen (PSA) from a Rhesus Macaque, was developed jointly by Cyto Pulse and the Karolinska Institute and has been licensed to Cyto Pulse.

The clinical trial will be conducted at the Department of Oncology at Uppsala University Hospital. Principal Investigator Jeffrey Yachnin, M.D., Ph.D., said, "After several years of planning, we are very pleased to be able to offer our patients the possibility to participate in this landmark study."

"This is a significant step forward for our DNA vaccine delivery system, Derma Vax™," said Richard Walters, Cyto Pulse CEO. "The Derma Vax™ delivery system is designed to be safe, effective and with an emphasis on maximum comfort for the patient. We are hopeful that the treatment will prove to be effective."

Uppsala University Hospital is Sweden's oldest university hospital and is characterized by activities that always look for new, innovative solutions. The hospital makes the best use of new technology, new scientific findings and new ways of working in order to solve medical problems and to continuously improve patient care. Today, the hospital is one of the country's most complete regional hospitals, with around 40 departments and more than 8,200 employees. Additional information on Uppsala University Hospital is available at their website, akademiska.se.

Cyto Pulse Sciences, Inc. is a biomedical device and treatment development company commercializing technology to produce and deliver new medicine therapeutics (DNA/RNA) for: cancer treatments (immunotherapy), protection against infectious diseases (prophylaxis therapy) and the correction of genetic defects (gene therapy). This innovative technology is used to discover and produce therapeutics such as monoclonal antibodies and polynucleotide vaccines and to deliver DNA and RNA vaccines. Additional information on Cyto Pulse Sciences, Inc. is available at the company's website, cytopulse.