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Annual production potential between 50 and 100 million doses

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Rome, 22 April (beraking latest news Salute) – “If the experimentation proceeds according to plan, we expect to complete it after the summer”. This was stated by Antonella Folgori, president of ReiThera, clarifying, in relation to what emerged in recent days from some media, that the biotech ReiThera is “strongly committed to phase 2-3 of the clinical trial, launched last month, of the Grad- Cov2 against Covid-19 based on the proprietary technology of the adenovirus isolated from the gorilla, a technology similar to that of other vaccines already approved by the European Medicines Agency (Ema) “.

“The experimentation is proceeding at full speed – underlines Folgori – with the aim of continuing the development of the Grad-Cov-2 vaccine. We have found a strong adhesion and participation in the phase 2 study, thanks to the commitment of the numerous clinical centers and experimenters. involved, to the support of Invitalia and Inmi Spallanzani, as well as the dedication of the ReiThera team “.

The enrollment of the 900 volunteers – explains ReiThera – was in fact completed in a few days, and the vaccination as well as the monitoring of volunteers are proceeding as per protocol in the 26 clinical centers throughout the country. Preliminary safety and immunogenicity data generated in the first few weeks after vaccination will be evaluated by an independent committee in order to promote expansion to the next phase 3. The phase 3 study design will have to adapt to a health, epidemiological and social context in rapid evolution and ReiThera will take advantage of the opinion and guidelines dictated by the regulatory agencies.

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As evidence of the strong commitment in the development of its Grad-Cov-2 vaccine, the company has already invested, since 2020, in the expansion of the pharmaceutical factory in Castel Romano through the construction of a new large-scale production area equipped with bioreactors with a total capacity of 3,000 liters with an annual production potential of between 50 and 100 million doses.

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