Chemotherapy intelligently packed
In November 2018, InnoMedicas liposomal cancer therapy Talidox was used in patients of the clinical Phase I/IIa trial for the first time. The use of InnoMedica’s technology platform is of particular value in oncology, as most cancer patients today are treated with chemotherapy that reaches the tumor only in small amounts and leads to serious side effects. The cancer drug Talidox, which is based on InnoMedica’s liposomal transport system and biologically targets to the tumor, has the following advantages:
Strong tumor-inhibiting effect
Talidox has been evaluated in several established and scientifically highly relevant cancer models with aggressive breast and ovarian cancer. In all models tested with mice, Talidox has a stronger tumor-inhibiting effect compared to the reference products free doxorubicin and Caelyx (an approved liposomal doxorubicin formulation).
Fewer side effects
The serious side effects of conventional doxorubicin products can be significantly reduced or even completely avoided thanks to the liposomal protective wrapping of Talidox. Conventional doxorubicin treatments cause severe and irreversible damage to the heart muscles, lead to an acute impairment of the blood production and the immune system or cause burn-like, extremely painful inﬂammations of the palms and soles of the feet. Based on a comprehensive toxicological analysis in an animal model, a significant reduction of these side effects is expected in patients treated with Talidox.
Longer treatment cycles
The occurrence of severe side effects often leads to having to discontinue chemotherapy. Lower stress levels on the body with Talidox reduces recovery time between treatment cycles, which can extend treatment time. This increases the chance of a successful treatment for the patient.
InnoMedica has partnered with the Swiss Group for Clinical Cancer Research (SAKK) to conduct the first clinical trial of Talidox. The starting point for the collaboration and initiation of the clinical trial was the joint analysis of Talidox’ preclinical efficacy and toxicity data. The preclinical data set was well received by the SAKK oncologists involved: Talidox is said to have great potential as a new treatment option for cancer patients. Preparatory work for the start of the clinical trial with Talidox was completed in the first quarter of 2018 and the application dossier was handed over to the regulatory authority Swissmedic. Once the study had been approved by Swissmedic, SAKK and InnoMedica immediately started the Phase I/IIa study in five Swiss hospitals. The study provides information on the maximum tolerated dose and side effects
The path to approval
Because Talidox uses doxorubicin, a previously approved drug in a new liposomal formulation, Swissmedic categorized the drug as a known substance with innovation. This speeds up the clinical trial, simplifies the registration process and significantly reduces translation risk.
With Talidox, InnoMedica would like to bring a drug to the clinic which, unlike immunotherapies, is not a costly solution for just a few patients, but permits an effective and gentle treatment of a large number of patients. The reduced stress on the body helps allow longer treatment cycles, which increases the chance of a successful treatment for the patient – and at moderate prices, easing the burden on health care.