Updated on 4 January 2016
The Phase I clinical study was conducted at the SingHealth Investigational Medicine Unit (IMU) in Singapore
Singapore: Yisheng Biopharma, China based biopharmaceutical company, has recieved positive topline results from Phase I clinical trial of PIKA rabies vaccine, an investigational vaccine designed to provide accelerated immune response against post-exposure rabies virus infection.
PIKA rabies vaccine is developed by using a novel double-strand RNA analog which acts as a toll-like receptor-3 (TLR-3) agonist to the activation of the innate immune cells. This project was named a "National Key Medicine Innovation" in 2013 and funded by the National Ministry of Science and Technology of China.
The Phase I clinical study was conducted at the SingHealth Investigational Medicine Unit (IMU) in Singapore, and the trial enrolled 37 healthy volunteers to evaluate the preliminary safety and efficacy of the investigational PIKA rabies vaccine. Highlights of the topline results include:
Dr Victor Li, who is overseeing the clinical investigation in Singapore, commented, "We are extremely pleased with the results of this study, which confirms the preclinical study results, PIKA rabies vaccine exhibited good safety profile with no significant difference in terms of side effects in comparison with the control vaccine which is commercially available. We are very encouraged by the observation that 75% of subjects under PIKA rabies vaccine were able to reach seroconversion, a critical life saving benefit against post exposure rabies infection. We also believe that the accelerated regimen using 3 dosings within 7 days could greatly improve the vaccination compliance."
"We are excited to see that this trial confirms and advances the results observed in preclinical studies. In our multiple animal experiments to mimic the scenario of post-exposure infection, animals were first injected with a lethal dose of rabies virus, and then rescued by vaccination using either our PIKA rabies vaccine or the commercially existing vaccines. Only 20 percent of animals survived after being treated with the commercially existing vaccines, however 80 percent of the animals survived after vaccination of our PIKA rabies vaccine," stated by Mr Yi Zhang, chairman, Yisheng Biopharma and the project leader of PIKA adjuvant technology.
Mr Zhang continued, "Such encouraging data is setting up good foundation to initiate a Phase II clinical study with expanded study population and to further demonstrate clinical efficacy and safety under the accelerated vaccine regimen. We are looking forward to updating the progress on these fronts in due course."