ChronTech receives permissions for starting a controlled phase IIb clinical study of ChronVac-C® in combination with standard-of-care
Based on the promising results from patients with chronic hepatitis C virus infection who after vaccination with ChronVac-C® delivered by Inovios Medpulser DDS underwent standard-of-care treatment, ChronTech filed applications to start a phase IIb clinical trial. In the phase IIb clinical study patients with genotype 1 chronic hepatitis C will be grouped to receive, or not to receive, two vaccinations with ChronVac-C® delivered by Inovios Medpulser DDS immediately followed by standard-of-care treatment with ribavirin and interferon. The study has now received approval from the Swedish Medical Products Agency and from the local ethical committee.
As was previously reported seven patients chronically infected with hepatitis virus-C (HCV) of genotype 1 who participated in the now completed ChronVac-C®-study have received treatment with standard-of-care for chronic infection with HCV, i.e. interferon combined with ribavirin. More than 70 % of the patients responded rapidly on the treatment with <50 virus copies/mL blood already after four weeks (so called rapid viral response). These good results were maintained and 5/6 of the patients who now have completed their treatment were cured, i.e. they were free of the virus six months after completed therapy. Based on these good results ChronTech filed applications to the Swedish Medical Products Agency and to the local ethical committee for the permission to do a follow-up phase IIb clinical study where vaccination and standard-of-care treatment is given according to a standardised protocol to 20 patients and in which the outcome is compared to that of 12 patients receiving standard-of-care alone. Permission has now been granted from both agencies.
“If we can repeat the earlier good results in this phase IIb study there is certainly a possibility that vaccination with ChronVac-C® before treatment with interferon and ribavirin will become a part of the standard-of-care therapy for patients with chronic hepatitis C-virus infection. Particularly, we hope that vaccination will result in a considerable shortening of time for the interferon and ribavirin treatment”, says Dr. Anders Vahlne, CEO of ChronTech Pharma AB.
Dr. J. Joseph Kim, Inovio’s president and CEO, said: “We are encouraged by the phase I/II results showing the improved cure rate in patients who received the HCV vaccine followed by SOC drug therapy. Any improvement to the HCV standard of care response rates would be well-received by the HCV patients and practitioners. We are pleased to collaborate in this advancement of ChronVac-C®, using Inovio’s innovative delivery technology, into Phase II.”
For more information, please contact:
Anders Vahlne, CEO and Head of Research, ChronTech Pharma AB
Tel: +46 8 5858 1313, mobile phone: +46 709 28 05 28,
E-mail: anders.vahlne@ki.se
About ChronTech
ChronTech develops the therapeutic DNA vaccines ChronVac-C® and ChronVac-B drugs against chronic hepatitis C virus and hepatitis B virus infections, i.e. chronic infections with jaundice causing viruses which can lead to liver cirrhosis and liver cancer. ChronTech has also developed and further develops a patent pending new type of injection needle for a more effective uptake of DNA vaccines. ChronTech also have part ownership in the wound healing therapy ChronSeal®, and in the new platform technology RAS®. The ChronTech share is admitted to trade on First North. Remium AB is Certified Adviser for ChronTech. For more information, please visit: www.chrontech.se
In the event of any discrepancy between the Swedish and English versions of this press release, the Swedish version will take precedence.