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CanSino Biologics Inc. and the contract research organization OCT Clinical have launched the vaccination of their first volunteers.
This month, the first group of volunteers participating in an international Phase III clinical trial received the fisrt dose of the vaccine candidate Ad5-nCoV, co-developed by CanSino Biologics Inc. (“CanSinoBIO”) (SHSE: 688185, HKEX:06185) and Beijing Institute of Biotechnology, Academy of Military Medical Science.
At the moment, the volunteers are doing well. None of them have shown any side effects. According to clinical regulations, study participants will be under direct supervision for the first 28 days after vaccination and will have to undergo four interim face-to-face examinations at treatment centers. According to expert forecasts, during this period, the vaccinated subjects will develop an antibody and cellular immune response to COVID-19. The volunteers will also have to undergo a control examination after six months.
OCT Clinical’s president Dmitry Sharov said, "We are extremely honored to be able to contribute to this vaccine research and eventually help combat the pandemic. Our in-depth local expertise and experience of over 15 years allow us to accomplish project milestones in a timely manner. All volunteers will be vaccinated in the short run."
The clinical trial of Ad5-nCov is being carried out in compliance with the Declaration of Helsinki and appropriate clinical practices. The Ad5-nCoV vaccine uses a platform of an adenoviral vector carrying the S-protein of the coronavirus. This vector acts as a delivery vehicle, while the S-protein acts as genetic information, which should trigger an immune response.
ADDITIONAL INFORMATION
About OCT Clinical
OCT Clinical is the leading CRO in Europe, with operations in Central and Eastern Europe and the CIS region. With a team of over 150 professionals, the company provides a full range of high-quality clinical research services for phase I-IV and BE studies. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. OCT’s experienced team delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development. Since 2005, OCT Clinical Trials has worked on over 300 full-service and functional service projects in more than 20 therapeutic areas. Learn more at www.OCT-ClinicalTrials.com
OCT Clinical, a CRO operating in 12 countries, was selected as a principal CRO, responsible for the full range of activities for the vaccine trial, including medical writing, regulatory and logistic support, project management, subject enrollment, site monitoring, data management and biostatistics.
About CanSino Biologics Inc.
Incorporated in 2009, CanSinoBIO (SHSE: 688185, HKEX:06185) commits to research, production and commercialization of innovative vaccines for China and global public health security. It possesses four integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination and formulation. As of today, it has established a robust pipeline of 16 vaccines covering 13 diseases, including a globally innovative Ebola virus vaccine approved in 2017 as well as the investigational Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector).
Additional information can be found online at www.cansinotech.com
OCT Clinical is now operating under Palleos Healthcare brand name.
“The merger will undoubtedly create significant synergies, not just doubling but squaring the expertise of both companies”, Philip Räth, Ph.D., managing director at Palleos, said in the release.
“OCT Clinical is proud to join forces with palleos healthcare, as it has an excellent reputation in the industry it serves. Now we can offer tailored solutions to our clients to meet their diverse clinical research needs and accelerate the time of bringing their products to market”, Dmitry Sharov, CEO at OCT Clinical.
