I am long biotech vaccine maker Inovio (NYSEMKT:INO). Checking out past Seeking Alpha articles today, I found INO slammed by EnHydrisPECorp. I want to know the good and bad about my companies, so I read the articles carefully. One, Inovio's Hepatitis C Data: What Does It Really Mean?, seemed to have a strong argument that Inovio's clinical trials are not well designed. It analyzed the open label Phase II trial of ChronVac-C DNA vaccine for hepatitis C virus (HCV). Inovio's ChronVac-C press release stated "initial results do not show a statistically significant difference" between the two arms of the study. However, those given the vaccine (17 patients) did do better than those in the control arm (12 patients).
29 patients is small for a Phase II study, given how easy it is to find HCV patients.
However, I don't buy the EnhydrisPECorp argument that this reflects badly on Inovio management. It was ChronTech's vaccine, admittedly a DNA vaccine of the type Inovio is pioneering. It was ChronVac's study design. It looks, from the results, that a larger study would have a good chance at statistical significance.
ChronTech's ChronVac-C press release is in Swedish, so I used a service to translate it into English:
ChronTech controlled study of ChronVac-C ® provides mixed results
ChronTech has now completed an initial analysis of 12 weeks of treatment with interferon and ribavirin with (n = 17) or without (n = 12) previous vaccination with two monthly doses of 500 ľg ChronVac-C ®, administered with Inovio Medpulser. No serious side effects were noted and the number of moderate adverse events was lower in the vaccinated group than in the non-vaccinated group. At treatment week 12, 71% in the vaccinated group less than 15 international units of HCV RNA compared with 58% in the non-vaccinated group. In the case of patients who were virus negative, 65% of vaccinated HCV RNA negative at week 12 of treatment compared with 58% in the non-vaccinated group. Overall, the study shows a very good security but for a bit of difference in treatment efficacy to be statistically significant.
We obviously have mixed feelings about this result. We had hoped for a larger difference between the groups, but this may be explained by that in this study we chose to give fewer vaccinations than in our previous study. Nevertheless, we must await the ongoing analysis of the vaccine activated immune response before we can draw final conclusions of the study, "says CEO Anders Vahlne CTPS.
For further information, please contact:
Anders Vahlne, CEO and Head of Research, ChronTech Pharma AB
Mobile: +46 709 28 05 28
E-mail: anders.vahlne @ ki.se
ChronTech develops the therapeutic DNA vaccines ChronVac-C ® and ChronVac-B drugs against chronic hepatitis C virus and hepatitis B virus infections, ie chronic infections with jaundice causing viruses which can lead to 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 is also a partner in wound healing ChronSeal ®, and the new platform technology RAS ®. ChronTech share is listed on First North. Remium Nordic AB is Certified Adviser for ChronTech. For more information, see www.chrontech.se
Given the mixed results and the other positive achievements of Inovio, I remain long.