Beacon Trch Ltd is initiating a proposal submission to a the Horizon 2020 call SC1-PM-09-2016, deadline April 13th. The proposal will entail a phase II clinical study, led by the clinical trial sponsor (Musli Thyropeutics Ltd, Israel). They are in the process of building the consortium and have already engaged English and Israeli hospitals. You will find a short synopsis of the proposed clinical approach below.
They are seeking medical centers with specialists in oncology and endocrinology, which may be interested in this project, and participate in the clinical trial.
PROPOSED SUBMISSION UNDER THE SC1-PM-09-2016 TOPIC
Metastatic brain tumours arising from systemic cancer affects 170,000 people in the United States each year.
Metastasis to the brain is the single most frequent neurologic complication of several common neoplasms, including lung cancer, breast cancer, and melanoma.
Brain metastases often have a devastating impact on patients' quality of life and are fatal if not controlled.
Brain metastases are generally associated with a poor prognosis, regardless of treatment. Overall median survival is 3 to 8 months among patients who receive some type of anti-tumour treatment for brain metastases.
As early as 1896 a relationship between the thyroid gland and cancer was proposed. Since then, much experimental, clinical and epidemiological effort has been directed at defining and clarifying this controversial relationship.
Recently, a growing body of evidence supports the observation of improved survival in individuals with hypothyroidism.
In 2005 a binding site for T4 was discovered on the avb3 integrin which is highly over-expressed in many aggressive cancers including brain metastases.
The combination of clinical and epidemiological evidence with the newly discovered receptor lead us to suggest that the induction of a hypothyroxinemia state might be associated with a more favourable prognosis in cancer patients.
We assume that by induction of hypothyroxinemia, proven by thyroid function tests, a longer TTP, PFS, OS, high RR, and a better QOL can be achieved for the patients.
This proposal aims to evaluate this hypothesis by performing a phase II clinical study for cancer patients with brain metastases (regardless of the primary tumor). The intended consortium will include the sponsor (Musli Therapeutics Ltd.), Rambam Medical Center (Israel), 2-3 additional prominent medical centres and a CRO.
Yoram Bar-Zeev
Beacon Tech LTD
48, Begin Road
Tel-Aviv 6618004
Israel
Office: +972-8-9100.710 ext.402
Fax: +972-8-9100.713
Mobile: +972-54-593.9355
email: ybz@beacontech.eu
web: www.beacontech.eu
skype: ybzybz
