Prostate
Cancer Study - Derma Vax (DNA Vaccine delivery)
This Phase I/II study is being conducted at the Department of Oncology, University Hospital Uppsala, Sweden in collaboration with the Department of Oncology and Pathology, Karolinska Institutet, Stockholm. The study has been approved by the Swedish Medical Product Agency and is currently recruiting and treating patients. The objective is to evaluate a DNA vaccine coding for the rhesus prostate specific antigen (rhPSA) and electroporation in patients with relapsed prostate cancer. In addition to assessing the feasibility and safety of the rhesus PSA vaccine administered intradermally in combination with electroporation, the study will also identify optimal application parameters for the Derma Vax™ DNA vaccine delivery system as well as identify the variation in human skin resistance to be used in future trials as a quality measure of the electric field applied. The PSA-specific immune responses induced by the vaccine will be evaluated. Cyto Pulse has licensed the DNA vaccine.
Colorectal
Cancer Study - Derma Vax (DNA Vaccine delivery)
This Phase I/II study conducted by the Department of Oncology-Pathology at the Karolinska Institutet/Karolinska University Hospital, Solna, Sweden in collaboration with the Swedish Institute for Infectious Disease Control at Karolinska Institutet,will evaluate the delivery of a DNA vaccine which expresses Carcinoembryonic Antigen (tetwtCEA). The primary objective of the study is to assessment the safety and immunogenicity of intradermal electrovaccination of tetwtCEA DNA in patients with colorectal cancer. The long term goal 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 the study will be open to subjects categorized with AJCC Stage II or III colorectal cancer that has had resection of the primary tumour without evidence of remaining macroscopic disease. The CEA-specific immune responses induced by the vaccine will be evaluated at the Karolinska Institutet. Cyto Pulse is licensing the DNA vaccine.
Tolerance
Study - Derma Vax (DNA Vaccine delivery)
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.
HIV Study - Derma
Vax (DNA Vaccine delivery)
This Phase I study will be conducted at the Department of Venhälsan, Karolinska Institutet/South Stockholm General Hospital in collaboration with the Department of Virology at The Swedish Institute for Infectious Disease Control, Karolinska Institutet. The phase I trial will assess the safety and feasibility of administering plasmid DNA carrying multiple HIV-1 genes together with dermal electroporation using Derma Vax™. The HIV-specific immune responses induced by the vaccine will be evaluated at the Swedish Institute for Infectious Disease Control/Karolinska Institutet. Pre-clinical studies have been encouraging and have shown that intradermal electroporation with Derma Vax™ increases both the cell mediated and humoral immune responses over injection with plasmid DNA alone.
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 the Center for Vaccine Development, University of Maryland School of Medicine, 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 two 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.
