New Clinical Trial - Graves' disease, thyroid cancer and control of TSHR activity

[lynmynott]

Thyroid UK has been approached about a clinical trial investigating a new drug for Graves’ disease and wondered if you or anyone else you know might be interested in taking part:

"Illingworth Research Group Ltd is coordinating this phase I study - clinicaltrials.gov/ct2/show.... - investigating a potential new drug, K1-70, to treat patients who have Graves’ disease, thyroid cancer, and patients who would benefit from controlling thyroid stimulating hormone receptor (TSHR) activity.

K1-70 is a fully human antibody targeting the TSHR. K1-70 competes with TSH and patients’ TSHR autoantibodies preventing activation of the TSHR and thereby reducing the stimulation of the thyroid and the production of thyroid hormones.

The study is Sponsored by AV7 Ltd. A Safety Review Committee found the drug to have been safe and well-tolerated in the patients treated so far.

A further 8 patients with Graves’ disease are needed to complete this study. Travel to and from the study sites is provided from a patient’s chosen location, as well as accommodation for patients travelling from far.

Main Inclusion Criteria:

•age 18-75 years, male or female

•have Graves' disease and are being treated with anti-thyroid medications OR not treated with anti-thyroid medications (due to side-effects) and who are clinically and biochemically euthyroid or hyperthyroid

•have a body mass index (weight [kg]/height [m]2) between 18.5 and 35.0 kg/m2

Main Exclusion Criteria:

•current or chronic history of liver disease

•history of cancer within the last 5 years except localised skin cancer

•Graves' orbitopathy with clinical activity score >3/7

•evidence of optic neuropathy and/or corneal breakdown

•significant systemic infection

•history of recurrent or current infection

•splenectomy

•recently had major surgery or plan major surgery

•had thromboembolic event due to a blood clot in the last 12 months

•have clinically significant laboratory tests

•a clinically significant allergic condition (excluding hay fever)

•currently receiving corticosteroids

•smoke more than 10 cigarettes (or its equivalent) per day

•history of drug abuse

•pregnant women and male subjects with pregnant female partners

If you would like some more information or are interested in taking part please contact the Volunteer Services team at the Medicines Evaluation Unit on 0800 655 6553 and quote “study MEU 15/304”.

They will be able to answer any questions you may have and book you in for a more in-depth discussion.

Thank you for taking the time to read this message and for forwarding it on to anyone you think might benefit."

[jimh111]

I’ve little knowledge of Graves’ but this drug seems to be potentially very useful if it inhibits the activities of Graves’ antibodies. It could be used to prevent hyperthyroidism (by stopping the antibodies stimulating the thyroid). Thus, patients may avoid thryoidectomy or ablation by RAI.

It might also reduce the effects of the antibodies on the eyes which would be a great advance. Also, Graves’ antibodies can suppress TSH (the pituitary has TSH receptors) which leads to some patients being undermedicated because their TSH goes inappropriately low.

Clearly we have to treat new drugs with caution but this seems to have potential.