Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Lol...anytime rebarm, even a Friday night, it's Tier 2 here and so no more Friday nights with lads at the moment. :-(
Ps positive indications from SFX 01's Covid-19 patient trials will send this into orbit..Gl :-)
MM, have you got nothing better to do on a Friday evening?!! Seriously, really appreciated. Many thanks.
Market opportunity in ER+ metastatic breast cancer
Incidence of ER+ metastatic breast cancer is approximately 130,0001 in US and Europe
CDK4/6 inhibitors are now first line treatment, in combination with hormone therapy
Pfizer (Ibrance®/palbociclib), Novartis (Kisqali®/ribociclib) and Eli Lilly (Versenio®/abemaciclib ) are the key players with billion plus sales - sales forecast to reach c.$9bn by 2021/2
All patients become resistant to CDK4/6 inhibitors
Treatment options post CDK4/6 inhibitors are generally poorly tolerated – treatments which improve quality of life are needed in this terminal population
Potential of SFX-01 to be treatment of choice post CDK4/6 inhibitor failure, extending progression free survival with favourable side-effect profile.
http://evgen.com/wp-content/uploads/2020/07/EVG-Investor-Presentation-06Jul20-FINAL.pdf
The opportunity in metastatic breast cancer
What is the opportunity ?
ER+ breast cancer is the most prevalent breast cancer sub-type (70%
Metastatic breast cancer is incurable with 5-year survival rates of 22%
Patients become resistant to all drugs
SFX-01 is being developed to prevent and/or reverse resistance
Our data on SFX-01 shows prevention of metastases by the STAT3 pathway
And our recent clinical trial was life changing for some patients
.................
SFX-01 can be life-changing
Diagnosed age 40 ER+ Her2- early BC
Received surgery, chemotherapy and tamoxifen
After 5 years diagnosed with pleural nodules
Enrolled into STEM trial May 2017 – tamoxifen + SFX-01
Objective response to treatment, very well tolerated, able to continue her life caring for her 2 young children and husband with head and neck cancer
Entered the extended use programme and had Stable Disease for a total of 448 days, including tumour shrinkage of 63% from baseline
5 patients remained progression free after 1 year of treatment with SFX-01 + ET
..........................
STEM showed that SFX-01 shrinks tumours and halts tumour growth
SFX-01 added to tamoxifen or fulvestrant caused tumour shrinkage
SFX-01 added to endocrine therapy caused tumour stabilisation
........................
Current and planned work programme
All preclinical breast data published in high impact journal in June 2020
Extensive review of clinical pathway to approval close to completion
Supplementary preclinical work required to confirm CDK4/6i “resistance-breaking” hypothesis
New “commercial ready” solid tablet formulation to be completed in H3 2020
Non-dilutive capital e.g. partnering to fund the next trial(s)
Targeting CTA/IND in H1 2021 with first patient first dose in Q2/Q3 2021
http://evgen.com/wp-content/uploads/2020/07/EVG-AGM-presentation-2020-16Jul20.pdf
Go to 24.30 minutes on videao and highlights the potent and effective treatment of Tamoxifen.....a cancer drug developed by Astra Zeneca and University of Manchester. SFx-01's phase 2 breast cancer trials were confirmed by University of Manchester to further improve clinical outcomes of patients prescribed Tamoxifen in combination with SFX-01.....That's a fact!!! Gla ;-)
We're live now on @YouTube
!
Watch the livestream of: Manchester Breast Cancer: How can we predict and prevent breast cancer now? https://youtu.be/tCPSSQAL_gY
https://twitter.com/robclarkelab?lang=en
The original trial link gave detailed information on the make up of the trial, but can't be accessed at the moment aprt from the brief summary below, although i did copy and post the following segment when the link was still open to the full description of the trial. Gl ;-)
Investigating a sample size of 300 subjects, the study will compare outcomes for 300mg SFX-01 taken orally, once daily, plus best standard of care (BSC) versus placebo taken orally, once daily plus BSC. The primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
Main objective of the trial
To compare the effectiveness of a new drug, SFX-01, against placebo for treating patients with suspected COVID19 respiratory infection.
Secondary objectives of the trial
To measure the safety of the new drug, SFX-01, when used to treat patients with suspected COVID19 respiratory infection.
To explore the mechanism by which the new drug is having its effects.
Principal inclusion criteria
18 years of age or older
Community acquired pneumonia (defined as a new radiographic infiltrate on chest x-ray or CT scan in a patient presenting with respiratory symptoms both of which are clinically evident less than 48 hours after hospitalization).
Tested for suspected SARS-CoV-2 infection via RT-PCR or another approved laboratory method
Increased risk of mortality on admission (defined by CURB65 score greater than or equal to 1 or the presence of bilateral radiographic infiltrates)
Treatment can be commenced within 96 hours of hospital admission
Requires hospitalisation but NOT requiring mechanical ventilation at randomization
Participant (or legally authorized representative) provides written informed consent
Able to take oral medication at randomisation
Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures.
"for the avoidance of doubt, this trial permits inclusion of patients presenting with acute respiratory infections whether or not the test for SARS-CoV-2 is positive. Patients can be randomised to the study while awaiting the results of the test for SARS-CoV-2."
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003486-19/GB
...........................................
EU Trials Register
EudraCT Number: 2020-003486-19 Sponsor Protocol Number: 1.002.20 Start Date*: Information not available in EudraCT
Sponsor Name:University of Dundee
Full Title: A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or con...
Medical condition: Community acquired pneumonia with suspected or confirmed SARS-CoV-2 infection
Disease: Version SOC Term Classification Code Term Level
20.1
Can any better researched posters point me towards trial details. All seems a little vague which may explain the poor sp response to what was an excellent confirmatory rns.
I want to know what regulatory body approved the trial. It certainly wasn’t the FDA or EMA. It has implications for interest in and acknowledgement of results. I also want to know end points. How is the trial being measured. All a bit vague for my liking.
Thanks
I want to know