December Update 2018
Thanks to the successful financing round of CHF 10.25 million in May 2018, the InnoMedica team reached an important milestone with Talidox with the start of the clinical trial and made strategically relevant progress in clinical development and raw material procurement for Talineuren:
- Start of Phase I clinical trial and treatment of first patients with Talidox
On November 12th, 2018, the first cancer patient was treated with Talidox at the cantonal hospital St. Gallen. The objective of this study is to test the tolerability and to determine the optimal treatment dose by means of a gradual dose escalation.
- Preclinical study on long-term efficacy of liposomal chemotherapy shows less risk of relapse
InnoMedica’s liposomal formulation of doxorubicin (Talidox) and docetaxel was able to completely suppress tumor growth in one third of the cases in preclinical studies and prevent tumor growth even after the treatment had ended.
- Swissmedic has announced the prospect of facilitating the preclinical and clinical testing of Talineuren
In a response to a Scientific Advice inquiry, Swissmedic states that toxicological testing of the drug in only one single species is accepted and that, in a first Phase I clinical trial, simultaneous use in patients with different indications (Parkinson’s, Huntington’s, ALS) is considered viable in principle. If promising preclinical data can be obtained for the indication Huntington’s disease, Talineuren could apply for orphan drug status.
- Letter of intent signed with Swiss GM1 manufacturer TRB Chemedica
A long-term collaboration with the GM1 manufacturer is considered strategically important for successful clinical translation and large-scale manufacturing of the Talineuren product. InnoMedica regards the collaboration as a crucial advantage for product development and marketing of the drug.
- Expansion in Marly and consolidation of the company
InnoMedica is further expanding its infrastructure in Marly, investing in the automation of filling processes and driving moderate personnel growth in order to produce Talidox for clinical applications and at the same time develop additional pipeline products.
- Additional authorized capital available
With an expected cash reserve of approximately CHF 12 million at the end of 2018, InnoMedica is well financed for the time being. However, InnoMedica plans to procure the remaining CHF 21.35 million in good time in order not to jeopardize what it has achieved by insufficient liquidity.
A detailed description of InnoMedica’s progress in the second half of 2018 can be found in the newsletter.
The recruitment of patients for the clinical trial with Talidox by SAKK oncologists has started well and the treatment of the second patient was completed on schedule in early December. This is in line with the assumption that the hurdles to participation in a trial with Talidox are likely to be lower for both patients and physicians, as Talidox uses a known compound, doxorubicin. The liposomal packaging is expected to offer benefits with only a moderate risk. After the cantonal hospitals of St. Gallen and Chur, Talidox has also been delivered to the Ospedale Regionale di Bellinzona e Valli. Two more hospitals, the Inselspital in Bern and the University Hospital Basel, will follow step by step.
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