DNA Vaccine Delivery
Technology
Cyto Pulse focuses on the most efficient delivery of DNA vaccines by using electric field pulses to directly transfer DNA into cells in the skin. The basis of this technology, commonly known as electroporation (EP), has proven to have an enormous impact on enhancing immune response in comparison to naked DNA injection into muscle as well as ballistic particle delivery by gene gun. Cyto Pulse has further optimized on standard electroporation by discovering its own novel Pulse Agile® patented waveforms that produce high levels of both neutralizing antibodies and killer T-cells.
Targeting skin cells in particular provides Cyto Pulse with significant advantages over other available intramuscular electroporation systems. While skin contains an abundance of antigen presenting cells (Langerhans cells and dermal cells), these kinds of cells are otherwise sparse in muscle tissue. The length of the electrode needles are also greatly reduced which allows for a significant improvement in patient comfort.
Two clinical vaccine delivery systems have been designed by Cyto Pulse to meet the varying needs of patients worldwide: DermaVax™ and Easy Vax™.
Best suited for when high doses and robust immune responses are desired such as cancer vaccines and gene therapy, the Derma Vax™ system primarily targets the dermis layer of skin. This area is an immune system organ. It utilizes a two-step process where a therapeutic is first injected by hypodermic needle, then followed by insertion of a needle array electrode and pulse sequence delivery. The attributes of the delivery system are:
Delivery Process Insert vaccine into skin using hypodermic needle Insert needle electrode array into skin (2 mm) Apply voltage waveform (1/3 second on time) May be used with topical anesthetics Waveform generator Touch screen user input Computer controlled Compliance
SGS USTC Certified UL 60101-1, IEC 60601-1-2
QPS Certified, CSA 601.1-M90
Electrode is single use, sterile and disposable In summary, the result is a highly tolerable delivery system
Cyto Pulse References:
Prostate Cancer study results
Derma Vax - Clinical trials in progress and planned Uppsala University Hospital and
Department of Oncology and Pathology, Karolinska Institute
Jeffrey.Yachnin, MD, PhD
Pavel Pisa, MD, PhD
Phase I/II start December 2008 in progress
Recurring Prostate Cancer
Department of Oncology and Pathology, Karolinska Hospital and The Swedish Institute for Infectious Disease Control, Karolinska Institute
Maria Liljefors MD, PhD
Britta Wahren, MD, PhD
Phase I/II start October 2009
Recurring Colorectal Cancer
Venhälsan, Södersjukhuset and
The Swedish Institute for Infectious Disease Control, Karolinska Institute
Eric Sandström, MD, PhD
Britta Wahren, MD, PhD
Phase I planned First Quarter 2010
HIV
National Institute on Aging
NIA-Astra Unit, Harbor Hospital, Baltimore
Robert Fenton, MD
Start September 2009 in progress
Tolerability Study
Derma Vax - Research and pre-clinical collaborations National Cancer Institute
Vaccine Branch, Center for Cancer Research
George Pavlakis, MD, PhD
Barbara Felber, PhD
HIV MRC Human Immunology Unit
Weatherall Institute of Molecular Medicine
The John Radcliffe Hospital, Oxford
Tomáš Hanke, PhD HIV Rikshospitalet, Institute of Immunology, University of Oslo Bjarne Bogen, MD, PhD Blood Cancer Experimental Oncology, Cancer Center Karolinska, Karolinska Institute Rolf Kiessling, MD, PhD Breast Cancer Wallace H Coulter Center for Translational Research, University of Miami Pirouz Daftarian, PhD Cancer Clinical Immunology, University Hospital
Uppsala, Sweden
Thomas Tötterman, MD, PhD
Cancer Center for Infectious Medicine Karolinska University Hospital Huddinge
Steven Applequist, Ph.D Optimize T-cell epitopes Ludwig Institute for Cancer Research, Karolinska Institute Krisitian Pietras, PhD
Krisitan Hallemalm, PhD
Tumor Angiogenesis
Best suited for mass-scale prophylactic virus vaccination,
Easy Vax™ primarily targets the epidermis layer of skin. It is a
two component system containing a mobile electric field generator handpiece and disposable micro-needle arrays dry-coated
with DNA. The stable nature of DNA even at non-ideal temperatures allows storage without a cold chain. The sensation from
inserting the micro-needle array is barely perceptible and the pulse delivery sensation is less than that of a hypodermic needle.Cyto Pulse References:
Data sheet
Partners: National Institute of Allergy and Infectious Diseases University of Maryland, Center for Vaccine Development
Human Tolerability Study
