The Nikolai Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences has prepared a report of a pivotal clinical study of REFNOT titled “The study of REFNOT safety, tolerability and effectivenessin patients with squamous cellcarcinoma of head and neck (I phase)”. 15 patients with malignant tumors of head or neck were included in the study. The oncologists have established good clinical and biological tolerability of REFNOT when it was injected intratumorally to the patients with squamous cell carcinoma of head and neck in a wide range of dosages.
The study of REFNOT titled “The study of REFNOT safety, tolerability and effectivenessin patients with squamous cell carcinoma of head and neck (I phase)” is a I phase pivotal clinical study.
Study objective: the main objective was to evaluate the safety and tolerability of the REFNOT product therapy when it was injected intratumorally; the additional one was to evaluate the antitumor efficiency of the REFNOT product for the patients with malignant tumors of head and neck.
The research was conducted in the Russian Cancer Research Center named after Nikolai Blokhin of the Russian Academy of Medical Sciences. The primary investigator was the head of the head and neck tumor department, Doctor of Medical Sciences, professor V.L. Lyubaev.
15 patients with malignant tumors of head or neck were included. All patients fully complied with the research protocol. The specialists have concluded, that the clinical and biological tolerability of the REFNOT product when injected intratumorally to the patients with squamous cell carcinoma of head and neck in the dose range of 100000 to 800000 units is good.
Furthermore, no significant adverse events were noted in the course of research. The absence of dose-dependent toxic potential is proved. The dosage no less than 800000 units can be considered maximum allowable.
In order to evaluate the medical product effects more thoroughly it is recommended to conduct clinical studies of the II and III phases on the greater amount of patients.
Date: March 2005 г.
The study of REFNOT titled “The study of REFNOT safety, tolerability and effectivenessin patients with squamous cell carcinoma of head and neck (I phase)” is a I phase pivotal clinical study.
Study objective: the main objective was to evaluate the safety and tolerability of the REFNOT product therapy when it was injected intratumorally; the additional one was to evaluate the antitumor efficiency of the REFNOT product for the patients with malignant tumors of head and neck.
The research was conducted in the Russian Cancer Research Center named after Nikolai Blokhin of the Russian Academy of Medical Sciences. The primary investigator was the head of the head and neck tumor department, Doctor of Medical Sciences, professor V.L. Lyubaev.
15 patients with malignant tumors of head or neck were included. All patients fully complied with the research protocol. The specialists have concluded, that the clinical and biological tolerability of the REFNOT product when injected intratumorally to the patients with squamous cell carcinoma of head and neck in the dose range of 100000 to 800000 units is good.
Furthermore, no significant adverse events were noted in the course of research. The absence of dose-dependent toxic potential is proved. The dosage no less than 800000 units can be considered maximum allowable.
In order to evaluate the medical product effects more thoroughly it is recommended to conduct clinical studies of the II and III phases on the greater amount of patients.
Date: March 2005 г.