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Swedish MPA approves extension of trial for HCC vaccine, Intuvax
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Immunicum AB announced that the Swedish Medical Products Agency and the ethics committee has approved the extension of their phase 1/2 IM-102 clinical trial of Intuvax, allowing up to six more patients to be enrolled and treated for hepatocellular carcinoma.
In the study, patients with HCC will receive Intuvax (Immunicum) as first-line treatment in combination with local chemoembolization or Nexavar (sorafenib, Bayer HealthCare), according to the release. Intuvax is a therapeutic vaccine “injected intratumorally and uses the patient’s own tumor as antigen sources,” according to the Immunicum website.
“By including up to six new patients under the frames of the current study, we save time and money compared to starting a new safety study on Intuvax in combination with first-line therapy in primary liver cancer,” Jamal El-Mosleh, CEO of Immunicum AB, said in the release. “The new setup will give us important information for a possible future phase 2/3 trial in that indication.”
As of November 2015, 10 patients with HCC who experienced previous tumor growth after treatment with local chemoembolization or systemic treatment with sorafenib have been treated with Intuvax. Of these, seven patients had received three scheduled doses, two of which suffered quick progression of HCC prior to the start of treatment and died before second and third doses were given. One other patient received the first of three planned treatment doses and one patient was expected to start treatment before the end of 2015.
No serious side effects related to the vaccine have been observed in the already treated patients.
“The good safety profile that Intuvax has demonstrated in liver cancer now makes it possible for us to target a patient population that can get Intuvax at an earlier stage of the disease, in this case as first-line treatment in combination with either local chemoembolization or with the tyrosine kinase inhibitor Nexavar,” Alex Karlsson-Parra, chief scientific officer of Immunicum, said in the release. “Thus, the study gives us the opportunity to investigate the potential synergistic effect of Intuvax in combination with local chemoembolization or with systemic treatment with Nexavar.”
Disclosure: El-Mosleh and Karlsson-Parra are employed by Immunicum AB.