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Tolerance Study
(Derma Vax™)
The study will be conducted by investigators at the National Institute on Aging and will assess the safety and tolerability of the Derma Vax™ Clinical Intradermal Electroporation System in healthy subjects. Pain rating, skin irritation scores and variations in skin resistance will be evaluated. The results of this study will help support the design of future clinical studies using Derma Vax™ to treat serious or life-threatening diseases.
Prostate Cancer
(Derma Vax™)
This phase I/II study will evaluate a DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) delivered using electroporation in subjects with relapsed prostate cancer. This study will assess the feasibility and safety of a novel vaccination and Derma Vax™ in vivo electroporation (EP). Outcome measures include optimal EP application parameters, variations in human skin resistance and immune response induced by electroporation-enhanced vaccine delivery. This study will be conducted by investigators from the department of Oncology at the University Hospital Uppsala, Sweden in collaboration with the Cancer Center Karolinska, Stockholm. Cyto Pulse is a co-inventor and has licensed the DNA vaccine from the other joint inventors.
NSC Lung Cancer
(Derma Vax™)
This Phase I/Ib clinical study will be conducted by investigators at the National Institute on Aging in collaboration with the University of Maryland Greenebaum Cancer Center. Subjects with Stage IB or II Non-Small Cell Lung Cancer (NSCLC) will receive an anti-tumor plasmid based vaccine in the adjuvant setting delivered using the Derma Vax™ in vivo electroporation system. The primary objectives will be to determine the safety and toxicity of the vaccine and delivery method, and the efficacy of vaccination as determined by immunologic parameters. Subjects will be monitored for duration of disease free survival or time to relapse. Cyto Pulse is licensing the DNA vaccine.
Colorectal Cancer
(Derma Vax™)
This Phase I study conducted by the Microbiology and Tumor Center (MTC) at Karolinska Institute, Sweden in collaboration with the Cancer Center Karolinska will evaluate the delivery of a DNA vaccine which expresses Carcinoembryonic Antigen (CEA66). The primary objective is to identify a viable immunotherapy treatment for subjects with colorectal carcinoma. The vaccine will be delivered using the Derma Vax™ in vivo electroporation system and will be offered to subjects categorized with AJCC Stage II or III colorectal cancer. Cyto Pulse is licensing the DNA Vaccine.
HIV
(Derma Vax™)
This phase I study conducted under the oversight of the Swedish Institute for Infectious Disease Control Virology, Immunology & Vaccinology at the Venhalsan, Department of Clinical Science and Education, Sodersjukhuset will evaluate an adjuvant of electroporation on plasmid DNA containing HIV-1 genes. Intradermal electroporation has been found to increase the cell mediated and humoral responses over injection with plasmid DNA alone. The primary objective of this study is to determine if Derma Vax™ in vivo electroporation will increase the immunogenicity of intradermal administration thus minimizing the dose amount and number of injections required. 24-36 healthy male subjects will be recruited.
Tolerance Study (no vaccine)
(Easy Vax™)
This study is sponsored by the National Institute of Allergy and Infection Diseases (NIAID) and will be conducted by PAREXEL International, Clinical Pharmacology Research Unit in Baltimore, MD. Investigators will assess the safety and tolerability of the Easy Vax™ Clinical Epidermal Electroporation (EE) System in Healthy Male and Female Subjects. The magnitude of pain perception due to epidermal electroporation using three different doses and dosing areas will be measured. In addition, electrical properties of the skin and skin irritation will be observed. The Easy Vax™ device is a two component delivery system containing a mobile electric field generator hand piece and disposable micro-needle arrays.
Dengue
(Easy Vax™)
Cyto Pulse Sciences, Inc. is currently conducting a preclinical safety and efficacy study evaluating a tetravalent Dengue DNA Vaccine administered to 28 rhesus macaques using the Easy Vax™ Clinical Epidermal Electroporation System. Antibody and T-Cell responses will be evaluated followed by a wild-type virus challenge. The definitive measure of vaccine efficacy is the ability of vaccinated monkeys to resist live virus challenge. Data obtained from this study and those that preceded it will support future phase I clinical studies. The vaccine was developed by Cyto Pulse.
