Yisheng Biopharma Announces Completion of Phase I Clinical Study of a Novel Hepatitis B Vaccine with PIKA Adjuvant
BEIJING, Nov. 21, 2016 /PRNewswire/ -- Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological therapeutics, today announced the completion of Phase I clinical trial of PIKA Hepatitis B vaccine, an investigational vaccine designed to provide both prophylactic and therapeutic benefits against hepatitis B virus infection. This vaccine candidate is a proprietary product independently developed by Yisheng Biopharma, using its own toll-like receptor-3 (TLR-3) agonist technology platform ("PIKA"). This technology was named a "National Key Medicine Innovation" in 2013 and funded by the National Ministry of Science and Technology of China. The PIKA adjuvant platform has been demonstrated with good safety profile in multiple clinical trials of Yisheng's rabies vaccine.
Hepatitis B is a potentially life-threatening viral infection that attacks the liver and can cause both acute and chronic disease. An estimated 240 million people globally are chronically infected with the virus. More than 686,000 people die every year due to complications of hepatitis B, including cirrhosis and liver cancer. Hepatitis B can be prevented by effective vaccines.
The Phase I clinical study was conducted at the Singapore General Hospital (SGH) and Changi General Hospital (CGH) in Singapore, and the trial enrolled 32 healthy volunteers. This randomized, double blind, active-controlled, dose escalation study was to evaluate the safety, tolerability and immunogenicity of the investigational PIKA hepatitis B vaccine. PIKA hepatitis B vaccine is a three-dose vaccine with the full course completed within two months, as opposed to three-dose vaccination of the standard licensed products within 6 months.
Dr. Zhongkai Shi, who is overseeing the clinical program in Singapore, commented, "We are pleased with the results of this study in which PIKA hepatitis B vaccine exhibited good safety and tolerability. We are also encouraged by the observation of the robust immunogenicity among the human subjects immunized with the PIKA hepatitis B vaccine."
Dr. Shi continued, "PIKA's potent anti-viral and robust immune-stimulating capability makes PIKA platform well suited for the development of both preventive and therapeutic vaccine against Hepatitis B virus. Such encouraging data is setting up good foundation to initiate a Phase II clinical study with expanded study population and to further evaluate the clinical safety, immunogenicity and efficacy of the investigational vaccine. We are looking forward to updating the progress on these fronts as it moves forward. This phase 1 data further demonstrates the broad potential of our PIKA adjuvant platform and we are committed to developing a broad pipeline of products to address unmet medical needs."
About PIKA Adjuvant Technology and Hepatitis B VaccinePIKA adjuvant technology is a proprietary technology developed in-house at Yisheng Biopharma, which is delivering toll-like receptor-3 (TLR-3) agonist molecules to activate the innate immune cells, such as dendritic cells, macrophages and NK cells. PIKA adjuvant is formulated as a component of PIKA-adjuvant based hepatitis vaccine.
About Yisheng Biopharma Co., Ltd.Yisheng Biopharma Co., Ltd. is a biopharmaceutical company headquartered in Beijing, China, focusing on the research, development, manufacturing and sales and marketing of immunological therapeutics in oncology, immunology and infectious diseases, with approximately 1000 employees in China, the USA and Singapore. www.yishengbio.com
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SOURCE Yisheng Biopharma Co., Ltd.