Clinical trial Metastatic ER+ w progression on hormonal therapy

Husband11

There is an interesting phase II clinical trial underway in Europe to test a man made, stabilized version of sulforaphane, a broccoli derivative, in metastatic ER+ breast cancer patients along with conventional treatments. Its called sulforadex, or SFX-01.

https://clinicaltrials.gov/ct2/show/NCT02970682

Detailed Description:

The trial is a phase 2, parallel group design in patients with ER positive metastatic breast cancer.

This study will be a multicentre study conducted over an 18 month period. Patients who are taking either a third generation AI, tamoxifen or fulvestrant and have a documented evidence of progressive disease after achieving a best response of stable disease (for at least 6 months) or an objective response of CR or PR on the current treatment indicating the development of secondary resistance to current therapy will be entered into the study having undergone a screening period to continue receiving the same treatment with the addition of SFX-01.

At least 60 patients will be enrolled into one of three arms in a 1:1:1 ratio, i.e. 20 patients per arm. Enrolment will be based on current treatment.

Treatment Arm A: All patients will continue to receive their AI and, at the start of the study (D1), patients will additionally take SFX-01.

Treatment Arm B: All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will additionally take SFX-01

Treatment Arm C: All patients will continue to receive fulvestrant 500 mg IM in 28 day Cycles and, at the start of the study (D1), patients will additionally take SFX-01.

Patient participation will include a Screening Phase, a Treatment Phase, and a Follow-up Phase of up to 28 weeks post D1 of dosing. The Screening Phase will be up to 28 days prior to enrolment. The Treatment Phase will extend from enrolment until the patient is discontinued from study treatment. The Follow-up Phase will be a maximum of 28 weeks and extend from the time of study entry until 30 days after the patient discontinues trial therapy.

From investor data:

SFX-01 in breast cancer
Breast cancer is the biggest cause of cancer deaths in women worldwide. In around 75% of breast cancers, the hormone oestrogen plays a key part in tumour growth. Such tumours express the oestrogen receptor (ER+) and, if the cancer is metastatic, endocrine therapy is the main treatment. It is thought that hormone independent cancer stem cells are implicated in metastasis, thereby explaining the occurrence of metastasis during hormone therapy.

Evgen Pharma is very fortunate to have been working with the Cancer Research UK Manchester Institute since 2012. Earlier this year, this collaboration resulted in the presentation of promising data showing SFX-01 reducing the number of cancer stem cells in patient-derived breast cancer tissue in xenograft models. The xenograft studies used a combination of hormone therapy and SFX-01, with the role of SFX-01 being to mop up the cancer stem cells. The data was presented at the American Association of Cancer Research annual conference in Philadelphia in April 2015.

A Phase IIa clinical trial of SFX-01 and hormone therapy is expected to begin recruiting in Q3 calendar year 2016 at Manchester's Christie Hospital NHS Foundation Trust and supporting sites in the North West of England. The trial, in about 40 patients with ER+ metastatic breast cancer, will be placebo controlled and will use tumour growth retardation as its primary endpoint. A Company announcement will be issued when the first patient is dosed in the trial, which is expected to complete at the end of 2017. The trial is designed to create the opportunity for an early efficacy signal after which a larger Phase IIb trial could be conducted.

A poster from a 2018 European conference:

http://evgen.com/wp-content/uploads/2018/01/EVG-SFX-01-and-Stat3-Poster-Jan18-2018...pdf

It would appear to be working.

https://markets.ft.com/data/announce/full?dockey=1323-13244889-3QVQBOT0A8HUKTQJGGQL6I4A9E

Prior to entry to the STEM trial, patients must have previously responded to their current hormone therapy for at least six months but then present with progressive disease, thereby demonstrating the start of resistance to the hormone therapy. Once entered into the trial, patients continue to receive their hormone therapy in addition to SFX-01 and have regular scans through to week 24. Patients discontinue the trial when one of the scans shows disease progression or at week 24.

The Company announces today that the first patient to enter the STEM trial is now approaching week 24, having demonstrated no disease progression for three consecutive scans. On this basis, the Company has initiated a compassionate use programme, so that patients can continue to receive SFX-01 after week 24.