Registration Date 26 Jul 2022
Revision Date 26 Jul 2022



Medicine Pharmaceuticals

anticancer drug

Manufacturer's Description

The application of InnoMedica's technology platform is of particular value in the field of oncology, since even today most cancer patients are still treated with chemotherapy. Conventional drugs are very effective, but only reach the tumor in small amounts, which often causes severe side effects.

With Talidox, InnoMedica packages the proven chemotherapy agent doxorubicin in a liposome. By packaging them in these small nanocarriers, side effects caused by the chemotherapeutic agent circulating in the bloodstream can be reduced and the active ingredient reaches the tumor directly in high concentration. Talidox liposomes are unique in design. They are only half the size of conventional liposomes and therefore penetrate deeper into the tumor. In addition, they have a high number of particles, which leads to better cell uptake. The liposomal nanocarrier protects the active substance doxorubicin, which is why healthy organs are less stressed or damaged. Thanks to this lower burden on the body, comparatively few patients have to discontinue therapy.
Talidox sets new standards in chemotherapy
In November 2018, Talidox was used to treat cancer patients as part of a safety study (phase I/IIa) conducted by the Swiss Association for Clinical Cancer Research (SAKK) in five Swiss hospitals. The aim of the safety study was to determine the tolerated dose of Talidox and to examine the toxicity profile and pharmacokinetics. According to the protocol, 21 patients were treated with Talidox in a first step. With the submission of an amendment to Swissmedic in 2020, the clinical study was expanded to a total of 30 patients by recruiting nine additional participants.

Patients in an advanced stage of the disease who had already received several other therapies, none of which were able to prevent tumor growth, were included in the study. To ensure patient safety, the study was started with low doses. As a result, the first patients only received limited therapy-relevant doses of Talidox. One patient was treated at each dose level. Since no dose-limiting toxicities were found up to a dose of 40 mg/m2, an amendment to further increase the dose was submitted. The other study participants were treated with a dose of 45 mg/m2. After treating 21 patients, it was found that the benefit/side effect profile of Talidox is optimal at a dose of 40 mg/m2, setting the treatment dose at this level. The effective dose for therapy is thus below the maximum dose that can be administered. It is gratifying that Talidox is gentler on the patient compared to other preparations, despite the higher dosage.
tolerance profile
The report on the first clinical study by SAKK proves that the use of Talidox has far fewer severe side effects than conventional chemotherapy. This applies, for example, to heart problems, hair loss, nausea and vomiting. In addition, the side effects associated with the treatment are all controllable and reversible.

Furthermore, there was only one treatment discontinuation in the study due to side effects. In comparison, with conventional chemotherapy, almost 50% of all patients consider stopping the therapy because of side effects. It should also be noted that the patients treated in the clinical study were already in the late stage of the cancer and are therefore generally more susceptible to side effects. The data collected indicate that Talidox can significantly improve the benefit/side effect profile in chemotherapy.