The tumour treatment is based on findings by the founder of company about stem cells, regulation of their differentiation and tumourigenesis and causes differentiation and apoptotic elimination of tumour cells with a selectivity perfectly sparing the normal stem cells and progenitor cells that are commonly damaged by conventional chemotherapy-radiotherapy. Phase II clinical investigations have shown an unprecedented therapeutic efficacy in human subjects with cutaneous and internal tumours. Unlike the majority of existing tumour treatments, the new treatment does not rely on exertion of genotoxicity for apoptotic elimination of tumour cells and is effective irrespective of the organ of origin, stage or DNA-damage responsiveness of tumour. Besides the safety due to the non-genotoxicity and selectivity of treatment, human subjects treated and followed up for long term has also shown a desirable safety profile.

The treatment was described originally with a publication in patent literature. As indicated in the original description, the treatment can be used for cutaneous and internal tumours where Hedgehog/Smoothened (Hh/Smo) signalling is utilized for inhibition of differentiation and for inhibition of apoptosis of tumour cells and a pharmaceutically acceptable compound that selectively inhibits Hh/Smo signalling is suitable for use in treatment. Several such compounds were known and used for various purposes in prior art. Post-published investigations have independently verified that any pharmaceutically acceptable selective inhibitor of Hh/Smo signalling can be used to carry out the described treatment and that the originally described invention and therapeutic use are not inherently present in prior art. Provision of highly beneficial therapeutic results for men and women having various inoperable tumours has also been confirmed.

Evolutionarily conserved features of the eukaryotic genetic material's structure and of human physiology make the genotoxic tumour treatments inherently unsafe. Vast clinical data, including the increased risk of secondary tumours directly due to genotoxic treatments, point out to their therapeutic shortcomings and serious undesirable effects. Present treatment, on the other hand, is a rational non-genotoxic intervention directed selectively to the essential alterations of tumour cells during tumourigenesis and has been shown to have objectively advantageous therapeutic efficacy.

Innovative Aspects:
The invented tumour treatment is unlike any other previously known in that it eliminates tumour cells irrespective of the organ of origin and stage of tumour, including metastatic. Non-genotoxicity of the treatment adds to its desirable safety profile and opens a previously unavailable therapeutic window particularly to those patients having an inoperable tumour unresponsive to the conventional chemotherapy-radiotherapy due to mutations and epigenetic changes affecting DNA-damage response. A large proportion of tumour patients fall into this latter category. The treatment is a rational intervention designed to target essential differences identified between the normal cells and tumourigenic cells having stem cell features. Objective phase II clinical data shows desirable therapeutic efficacy never achieved before. Patents have been obtained worldwide and are pending. An advantageous freedom-of-operation exists for the patented technology. Contributing to the progression and well being of human kind through scientific and technological advances is a core value of the company and it is open to those sharing the same value.

 

Patents/Rights: Patent(s) granted

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