Riboxx Pharmaceuticals announces the set-up of a Regulatory Affairs and GMP Manufacturing Advisory Committee
Radebeul, Germany, 7th May 2013 – Riboxx Pharmaceuticals GmbH (Riboxx) today announced that it has established a Regulatory Affairs and GMP Manufacturing Advisory Committee consisting of experts from the respective fields with the aim to perform clinical safety studies on its novel Toll-Like Receptor 3 agonist, Riboxxim®.
The committee members are:
Dr. Philip Bedford – a clinical and regulatory development and project management specialist with more than 25 years’ experience in both vaccine companies and blue-chip pharmaceutical companies. Dr Bedford will be responsible for providing strategic advice on the pre-clinical and clinical safety studies of Riboxxim®.
Dr. Stefan Blesse – a drug development and regulatory expert with more than 15 years of CTD and eCTD submission experience for different disease indications worldwide. Dr. Blesse has been involved in European (CP, DCP, MRP) and US (IND, NDA) procedures with submissions at CDER and CBER, that conduct of national and central scientific advices at EMA and FDA. Dr. Blesse will be responsible for the preparation of the regulatory dossier and submission for the clinical studies of Riboxxim®.
Dr. Werner Stüber – a manufacturing and QA specialist with almost 30 years project experience from research to late stage development with “big pharma” and biotech and CMOs, with main focus in API and product manufacturing and QA, including GMP audits, of service providers. Dr. Stüber will co-ordinate the CMC management as well as the quality system implementation and supervision of the GMP manufacturing of Riboxxim®.
Dr. Jacques Rohayem, CEO of Riboxx said:
“We are delighted to be working with these highly experienced specialists in regulatory affairs and manufacturing. Their insight and expertise will be valuable in helping Riboxx to bring Riboxxim® to the next phase of development, which is the first human safety clinical study. This study will create considerable value for our technology and will enhance our ability to partner Riboxxim® with vaccine and pharmaceutical companies.”
About Riboxx Pharmaceuticals GmbH
Riboxx Pharmaceuticals GmbH is a company focused on the development of molecules targeted to Toll-like Receptor 3 (TLR3), with a direct application as vaccine and immunotherapy adjuvants. The company engineers and manufactures Riboxxim®, agonists of TLR-3, to the highest possible quality standards. Today, Riboxx has on-going collaborations with both academic and industrial partners to advance the application of Riboxxim® in vaccination and immunotherapy. The company is headquartered in Radebeul, Germany. More information can be found at www.riboxx-pharma.com .
The proprietary TLR3 agonist of Riboxx, Riboxxim®, is a class of synthetic, highly pure and precisely defined nucleic acids molecules manufactured by TENPORA®, a proprietary process of Riboxx. These molecules are capable of triggering innate immune responses through TLR-3 activation, enabling novel immunization approaches both in prophylactic vaccines (e.g. against infections) and in therapeutic vaccines (e.g. against cancer), as well as immunotherapies for cancer and infectious diseases.