LONDON--(BUSINESS WIRE)--MorEx, the oncology biotechnology company, today announced the addition of a fourth trial site in Estonia for the ongoing Phase I head & neck cancer trial of MTL-005, its radiation enhancer. The study has already successfully completed its first safety review at the existing sites in the UK - the Beatson, Guys and St Thomas’ and Weston Park. MTL-005 is a novel copper-containing metalloporphyrin that has the potential to both enhance the effect of conventional radiotherapy regimes and allow a reduction to the radiation dose and associated side effects, whilst maintaining the therapeutic effect. MTL-005 has been granted Orphan Drug status in Europe for the treatment of head and neck cancer in patients receiving radiotherapy.
Radio-enhancers are different from radio-sensitizing drugs. Radio-enhancers act by amplifying the effect of radiotherapy within a cell; radio-sensitizers, for example certain cytotoxic drugs, make cells more sensitive to the effects of radiotherapy, often in a non-selective way that can lead to side effects. MTL-005 appears to be pharmacologically inactive and it has shown a good side effect profile in pre-clinical studies.
According to MorEx Chairman Professor John Caldwell, MTL-005 fits the ideal profile of a radio-enhancer and would be easily incorporated into existing treatment regimes: “Despite recent advances in the delivery of radiotherapy, tumours still recur in around half of patients treated with the intent to cure. MTL-005 has a high affinity for tumours relative to normal tissue: it is cleared rapidly from blood but remains in tumours for more than 2 months after a single dose. Furthermore, the dose regime for MTL-005 is simple: a single infusion given 3-5 days prior to the start of radiotherapy will act as a radiation enhancer throughout a 5-7 week therapeutic regime. The current trial is focussed on establishing safety and tolerability and if successful, we anticipate a relatively fast and straightforward clinical development pathway at relatively low cost, with the potential for Breakthrough/Fast Track designation in the US.”
MorEx is looking to out-licence MTL-005 for both head & neck cancer and other solid tumour indications. MTL-005 is protected by a strong patent family, MorEx has established freedom to operate and MTL-005 has excellent patent protection out to at least 2030. Caldwell also revealed that the CMC package for MTL-005 is essentially complete, with established GMP manufacture to quantities sufficient for the first orphan indication and a very stable formulation.