Member Info for Moneymunch

This would sky rocket if they confirmed they were now developing a Sulphoraphane based Covid-19 treatment. Gla ;-)

Evgen’s pipeline is based on their proprietary Sulforadex® technology. Sulforadex®, is a means of synthesising and concurrently stabilizing sulforaphane (and synthetic sulforaphane analogues). Sulforaphane is a naturally occurring compound found in broccoli, cabbage and other brassica, although pure sulforaphane is an unstable oily liquid, which needs to be stored at -20C.

A significant and growing amount of academic research has demonstrated multiple potential medicinal uses of sulforaphane, however this work has been conducted either with frozen botanical extracts containing unstable sulforaphane, or ambient temperature botanical extracts containing glucoraphanin, the chemical precursor of sulforaphane. Despite the continued academic interest, the inherent unstable nature of sulforaphane has prevented any meaningful progress towards commercial clinical development.

Evgen Pharma’s Sulforadex® technology unlocks the medical and commercial potential of sulforaphane (and related novel analogues) by synthesising a stable, solid form, active pharmaceutical ingredient. Lead product, SFX-01, is a patent-protected complex of sulforaphane and alpha-cyclodextrin in a stable powder.

11/3/20
Corona virus – can nutrition help?

This winter’s flu season has taken a dramatic turn with the arrival and rapid spread of the Covid-19 corona virus. A few weeks ago I highlighted some of the key nutrients we need for all-round immune support. These nutrients are essential in the fight against flu. But is there any evidence to say nutrition can help fight coronaviruses?

The short answer to this question is yes! In a fascinating paper from the US, researchers explore the interactions between compounds in foods and the way our immune system deals with RNA viruses – including coronaviruses.

The compounds in question include:

– Ferulic acid: an antioxidant found in many different plants

– Phase 2 inducers like sulforaphane (Phase 2 is one of the detoxification pathways in the liver; it requires plenty of glutathione, one of our most important antioxidant nutrients)

– The minerals zinc and selenium

– Anthocyanin compounds in Elderberry

– Phycocyanobilin in Spirulina: a type of cyanobacteria grown on freshwater lakes and sold as powder, tablets, or capsules

These compounds have multiple benefits for our immune defences, mainly through their modulating effects on immune cells and signalling molecules, and by providing powerful anti-inflammatory and antioxidant protection in the lungs and airways.

A new programme of internationally-leading COVID-19 research

STOPCOVID is an extensive new cross-sector, cross-discipline, experimental medicine research programme aimed at developing and re-purposing treatments for COVID-19 patients. Through this research we will aim to reveal and target the mechanisms controlling the harmful lung injury, inflammation and failure of repair that occur in severe COVID-19 disease.

We will operate across sectors; including funding from the medical research charity LifeArc, collaborations with international pharmaceutical companies, and direction and input from the Medicines and Healthcare products Regulatory Agency (MHRA) to help expedite the process of drug evaluation.

The programme combines scientific disciplines, from inflammation biology and chemistry to engineering and experimental medicine clinical studies. This will allow us to attempt to change the course of the disease and prevent the lung damage in patients with COVID-19 that leads to respiratory failure. This has the potential to reduce the need for ventilators and save lives. Discoveries will be immediately fed into national and global clinical trials networks, including RECOVERY, and to our partners.

Disease and drug discovery

To fully understand COVID-19 disease we will collect patient samples, tissue and clinical data from patients in primary care and in hospitals, both with local protocols and in co-ordination with the UK-wide GenOMICC and ISARIC 4C (Clinical Characterisation of COVID-19 Consortium) studies. This will provide evidence for the best approaches to prevent the damaging inflammatory pathways that lead directly to lung injury. It will also enable laboratory testing of large collections of new and existing drugs that can target these pathways.

Rapid early phase experimental medicine studies

Based on expert knowledge of the pathways controlling inflammation, we will undertake clinical studies using the most promising drug candidates from existing clinical trials (including from collaborating pharmaceutical companies), and repurposed drugs - those already in use in humans for other conditions - that can modify these inflammatory pathways. Studies will be performed in primary care and/or in the hospital setting and include imaging in patient's lungs, in real time, to see the effects of drugs delivered. Findings will be fed into the UK national framework provided by the ISARIC 4C Consortium and the RECOVERY adaptive trial platform.

https://www.ed.ac.uk/inflammation-research/stopcovid/treatments

Every chance that TILS IL-6 inhibitor TZLS-501 could be included in the following fast track trials, infact i'd be amazed if it wasn't given the drugs potential with its dual mechanism with distinct advantages over Sanofi's IL-6 Kevzara and Roche's IL-6 Actemra, both already in Covid patient trials, and if Sanofi report postive trial data expected within 2 weeks, then the interest and value in TILS IL-6 inhibitor will rise significantly and TZLS-501's inclusion in these trials would almost be a certainty imho ....Gla ;-)

BBC NEWS

Coronavirus: Drugs to be tested on lungs of ICU patients

Medicines will be tested in the lungs of patients in intensive care in order to fast track new treatments for Covid-19.

The "STOPCOVID" initiative at Edinburgh University is to use existing drugs provided by leading drug companies and smaller biotech firms.

The team has unique expertise in administering drugs in the lung and assessing if tissues heal.

The project has been given the backing of top scientific and medical advisors.

The system involves sending medicines to the outermost portion of the lung, which are the areas that are damaged and inflamed among those with severe symptoms of Covid-19.

The researchers are also able to see whether the drug is working using a fibre-optic camera inserted into the lung and so-called "chemical probes" inserted into the area, which indicate whether the damaged tissue is becoming less inflamed.

"Normally it would take months to get a single drug into a clinical trail. We are trying to do this in weeks," Prof Dhaliwal says.

"We want to get our results out there as fast as possible so that any promising drugs can be put into clinical trials straight away."

https://www.bbc.co.uk/news/health-52295898

In summary, issuers must notify without delay major new developments that may affect their business if the development may lead to a substantial share price movement. Issuers must also notify without delay information concerning a change in financial condition, performance or expectation of performance if the change would be likely to lead to a substantial share price movement.

There are exclusions from these notification requirements relating to impending developments and matters in the course of negotiation, such as acquisitions or disposals. There is also a power for the UKLA to grant a dispensation from these requirements where the disclosure to the public of information might prejudice the company's legitimate interests

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 It's a strange one because TILS acquired TZLS-501 from Novimmune, and Novimmune was acquired by SOBI, who as far as I know has no connection with Bristol Myers Squibb, and so why did the CEO refer to them as the Royalty partner??? Gla :-)

Tiziana Acquires IL-6R mAb Candidate from Novimmune

January 3, 2017

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U.K. biotech Tiziana Life Sciences negotiated an exclusive license to Novimmune’s fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody, NI-1201, in return for undisclosed upfront, milestone, and future royalty payments.

Tiziana maintains that in contrast with other anti-IL-6R mAbs, such as Roche’s Actemra® (tocilizumab), which exert their effects predominantly through binding to a membrane-bound receptor, NI-1201 acts both on membrane-bound IL-6R and on soluble IL-6R and is also able to deplete IL-6 circulating in blood. The firm believes that the unique mechanism of action of NI-1201 could also complement its own fully human oral anti-CD3 mAb candidate foralumab (NI-0401).

“We view NI-1201 as a potential game-changer for addressing the high unmet need of autoimmune and inflammatory diseases” commented Gabriele Cerrone, Tiziana chairman. “The acquisition of NI-1201 not only strengthens our business strategy of developing novel fully human mAbs to treat life-threatening inflammatory diseases such as nonalcoholic steatohepatitis (NASH) and rheumatoid arthritis, but also expands our potential to leverage the pioneering work we are doing with foralumab, the oral anti-CD3 mAb to treat autoimmune and inflammatory diseases.”

........

Sobi acquire Novimmune in deal worth more than £400 million

Published on 13/06/19

Swedish rare disease specialist Sobi has agreed to buy Swiss firm Novimmune ion a deal worth more than £400 million.

The deal will see Sobi gain access to world class R&D facilities in the area of immunology. The deal worth 515 million Swiss francs will see Novimmune hand over IP relating to the antibody Emapalumab alongside the experimental immune-oncology drugs NI-1701 and NI-1801.

“The acquisition of emapalumab and related assets is an important step in the transformation of Sobi in becoming a global leader in rare diseases,” says Guido Oelkers, Sobi President and CEO.

http://www.pharmafile.com/news/523223/sobi-acquire-novimmune-deal-worth-more-400-million

Less than two weeks before Sanofi's initial patient trials are expected for their Il-6 inhibitor, positive results will send TILS sp soaring. Gla holders....Hold on tight and enjoy the ride!!! :-)

" We're reconsidering the AIM delisting as there was no liquidity when that decision was taken in January but that's quite different now".

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Positive trial data from Regeneron and Sanofi's IL-6 inhibitor Kevzra, expected end of this month could send TILS sp soaring. Gla :-)

Regeneron Pharmaceuticals Inc. and Sanofi

DRUG

Kevzara

The biotechnology drug targets a pathway known as interleukin-6 or IL-6, which can affect inflammation. It's already approved for rheumatoid arthritis and could help very sick Covid-19 patients in respiratory distress.

LATEST NEWS

Regeneron and Sanofi started a late-stage U.S. study that's expected to enroll up to 400 patients, and results may become available at the end of April. Further studies outside the U.S. are also expected.

COMPANY

Roche Holding AG, Chugai Pharmaceutical Co.

DRUG

Actemra, alone or in combination with the flu drug Avigan

Actemra is an arthritis medication that also targets IL-6, like Kevzara does.

LATEST NEWS

Roche, working with the FDA and BARDA, in April started a late-stage trial in over 300 hospitalized Covid-19 patients with severe pneumonia.

https://www.bloomberg.com/features/2020-coronavirus-drug-vaccine-status/

and Bristol Myers Squibb have a direct interest in TILS IL-6 inhibitor TZLS-501's development for Covid-19.... Gla ;-)

SMALL MOLECULE PAN CDK INHIBITOR

Complex heterogeneity in HCC due to multiple etiological agents; Need for broad spectrum approach

Orally bioavailable small molecule with potent anti tumor activity in a wide range of animal models

Inhibitor of kinases associated with cancer cell growth including CDK 1 , CDK 2 , CDK 4 CDK 5 , CDK 7

CLINICAL DATA FROM MILCICLIB

Trial design : Oral administration (100 mg/day, consecutive 4 days a week in a 4 week cycle).

Total patients 30 to be enrolled. Duration 6 months

Primary end point: safety Secondary end points: PFS, ORR & TTP

Exploratory: AFP and miRNA profiling Compassionate use : Upon request of patients with EC approval

Trial complete: Data from 28 out of 31 evaluable sorafenib resistant HCC patients

14 patients completed treatment as per protocol

Nine approved for compassionate use. Seven patients completed
9, 9, 10, 11, 13, 13 and 16 months, respectively.

No drug related deaths in the trial

Treatment was well tolerated

Adverse events were manageable

Time to progression 5.9 months out of 6 months duration of trial

Stabilized Disease (SD) 61%

Clinical Benefit Response 64% and src family kinases

Inhibits signaling pathways for hepato carcinogenesis

Well tolerated in 316 patients

Improved toxicity profile over the current standard of care anticipated

CLINICAL DATA SUGGEST MILCICLIB OVERCOMES GEMCITABINE RESISTANCE KEY FINDINGS FROM PHASE 1 STUDY

1.
Milciclib well tolerated with manageable side effects in patients with refractory solid tumors
2.
Oral treatment in combination with gemcitabine demonstrated clinical activity in
patients who were non responder to existing chemotherapeutic drugs
3.
Recommended Phase 2 dose (RPD) found to be 80mg/m 2 /day for milciclib and
1000mg/m 2 /day for gemcitabine
4.
Overall response rate was 36%
5.
Results suggest further evaluation in other solid cancers either as monotherapy or
combo therapy

PATIENTS RAPIDLY ACQUIRE RESISTANCE TOWARDS CHEMOTHERAPIES

THYMIC CARCINOMA AND THYMOMA UPDATES

Two Phase 2 trials with Milciclib in US, Italy and France

Trial 006: Thymic carcinoma and Thymoma mixed population (72 patients)

Trial 007: Thymic carcinoma and Thymoma mixed population (30 patients

Rare cancers with very few cases: Orphan Disease Indications

Positive clinical data

Primary endpoint (progression free survival) and secondary endpoint (overall survival) met in both trials separately

Thymic carcinoma is an aggressive metastatic cancer and it has no approved therapy

Milciclib as a single agent met primary as well as secondary endpoints in thymic carcinoma in both trials

Under compassionate use, few patients continued the treatment for over five years

Seeking guidance from FDA/EMA regarding conditional marketing approval

An Innovative Platform in Oral , nasal and inhalation for Antibody Administration
Distinct Approaches for Treatment of Crohn’s disease, progressive multiple sclerosis and COVID 19.

THE MULTI BILLION DOLLAR MARKET FOR CROHN’S DISEASE AND NASH

Foralumab (Anti CD 3 ) for NASH and Crohn’s Disease

NASH global market ~ $35 B/year

Crohn’s Disease market: $10B /year by 2025

Oral/nasal delivery is a novel, completely differentiated approach

Strong IP on the ‘Revolutionary’ approach with significant market potential

................

Milciclib for Liver Cancer

HCC ($1.5B /year by 2022): Medical need for a safer and effective drug with higher responder rates

Milciclib: An oral drug with completely differentiated MOA and long term safety

Superior safety profile

................

NASAL ADMINISTRATION

Phase 1 trial completed for related neurodegenerative diseases such as Progressive Multiple Sclerosis (Pro MS) .

Phase 2 trial in Pro MS to start shortly.

ORAL ADMINISTRATION

Successfully completed Phase 1 trial with orally administered Foralumab Phase 2 trial in Crohn’s Disease to start shortly.

INHALATION ADMINISTRATION

GMP manufacturing and inhalation delivery development.

THE ONLY FULLY HUMAN ANTI CD 3 MAB IN CLINICAL TRIALS

Approved by the FDA for solid organ transplantation immuno suppression 11 CD 3

SPECIFIC MONOCLONAL ANTIBODIES IN CLINICAL DEVELOPMENT

.........................

Progression of COVID 19 leads to cytokine storm and eventually to respiratory failure.

Proprietary technology for direct delivery to lungs

The primary cause of deaths in COVID 19 patients is cytokine storm leading to hyperinflammation in lungs

Effective therapeutic approach could be to rapidly deplete excessive levels of IL 6 in lungs

Anti IL 6 receptor mAbs such as Actemra ® (Roche) and Kevzera ® (Sanofi/Regeneron) have been successfully used in China, Italy and other countries to treat COVID 19

TZLS 501, a fully human anti IL 6 receptor mAb , has distinct advantages over the other mAbs Dual mechanism of action i.e., inhibiting both membrane bound and soluble IL 6 receptors

Only anti IL 6 receptor mAb that rapidly depletes circulating levels of IL 6

Our proprietary inhalation technology delivery of TZLS 501 directly to lungs may provide immediate relief to COVID 19 patients

Aerosol formulation in a handheld inhaler/nebulizer device is for ease of use, specifically for children and senior citizens

The aerosol formulation is based on our proprietary technology for stabilization of Foralumab, which has successfully completed 2 phase 1 clinical studies with oral and nasal administration

MILCICLIB

A PAN CDK INHIBITOR FOR TREATMENT OF HEPATOCELLULAR CARCINOMA AND SOLID TUMORS

HCC is a complex and heterogenous cancer associated with multiple etiological factors

Newer treatment approach with broad spectrum action is needed to address heterogeneity of HCC

and for those that were unduly worried about a AIM delisting.....Boom time ahead!!! Gla ;-)

"We're reconsidering the AIM delisting as there was no liquidity when that decision was taken in January but that's quite different now". ....;-)

Every chance that TZL-501 could be included in the following fast tracke trials, infact i'd be amazed if it wasn't...Gla ;-)

BBC NEWS

Coronavirus: Drugs to be tested on lungs of ICU patients

Medicines will be tested in the lungs of patients in intensive care in order to fast track new treatments for Covid-19.

The "STOPCOVID" initiative at Edinburgh University is to use existing drugs provided by leading drug companies and smaller biotech firms.

The team has unique expertise in administering drugs in the lung and assessing if tissues heal.

The project has been given the backing of top scientific and medical advisors.

The system involves sending medicines to the outermost portion of the lung, which are the areas that are damaged and inflamed among those with severe symptoms of Covid-19.

The researchers are also able to see whether the drug is working using a fibre-optic camera inserted into the lung and so-called "chemical probes" inserted into the area, which indicate whether the damaged tissue is becoming less inflamed.

.........................

Up to 150 researchers are involved in the study. As well as clinicians, the team also includes scientists and engineers who have dropped their normal projects to work on the STPCOVID project.

"Normally it would take months to get a single drug into a clinical trail. We are trying to do this in weeks," Prof Dhaliwal says.

"We want to get our results out there as fast as possible so that any promising drugs can be put into clinical trials straight away."

https://www.bbc.co.uk/news/health-52295898

Lol John, that's immaterial as far as sentiment is concerned, anyone betting short will be the toast . Gl ;-)

Absolutely massive news....Roll on tomorrow...Ker-ching!!!:-)

Ps God help anyone betting short!!!

Bristol Myers is TILS Royalty partner for TZLS-501!!! Gla ;')

A good chance that TILS could be involved in these trials, and maybe one of the reasons they're speaking with Proactive Investors this evening. Gla :-)

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to work closely with the team to fast track any potentially successful work while following due diligence. Any drugs that provide positive early results will be rolled out as part of national and international clinical trials through the UK Trials Platform.

STOPCOVID has secured £2 million funding from LifeArc, a medical research charity. It aims to raise a total of £15 million from the private sector. Discussions are continuing with other potential partners.

BBC NEWS

Coonavirus: Drugs to be tested on lungs of ICU patients

Medicines will be tested in the lungs of patients in intensive care in order to fast track new treatments for Covid-19.

The "STOPCOVID" initiative at Edinburgh University is to use existing drugs provided by leading drug companies and smaller biotech firms.

The team has unique expertise in administering drugs in the lung and assessing if tissues heal.

The project has been given the backing of top scientific and medical advisors.

The system involves sending medicines to the outermost portion of the lung, which are the areas that are damaged and inflamed among those with severe symptoms of Covid-19.

The researchers are also able to see whether the drug is working using a fibre-optic camera inserted into the lung and so-called "chemical probes" inserted into the area, which indicate whether the damaged tissue is becoming less inflamed.

'Stop lung inflammation'

The system was developed as part of a research project to treat a variety of lung disorders. But, according to Prof Kev Dhaliwal, of Edinburgh University, it is ideal for testing new drugs to combat the current pandemic.

"Currently 50% of patients who are admitted to intensive care with the Covid-19 die. The key to improving those odds is to stop that lung inflammation from occurring is absolutely crucial," he told BBC News.

The team has a list of anti-inflammatory and anti-microbial drugs that it plans to test on those in critical care. Many of those are involved are clinicians treating Covid-19 patients.

"It's been humbling to see the response," says Prof Dhaliwal. "No one is asking for any extra money - they just voluntarily got on with it - working all hours seven days a week."

"We have an incredible scientific community and they are galvanizing themselves to slow down this dreadful disease and save lives."

Up to 150 researchers are involved in the study. As well as clinicians, the team also includes scientists and engineers who have dropped their normal projects to work on the STPCOVID project.

"Normally it would take months to get a single drug into a clinical trail. We are trying to do this in weeks," Prof Dhaliwal says.

"We want to get our results out there as fast as possible so that any promising drugs can be put into clinical trials straight away."

Scientists working together

The team believes new therapies could be discovered and implemented before a vaccine becomes widely available by repurposing medicines for other conditions that are already in clinical use or are currently being tested.

The initiative will be based at Edinburgh BioQuarter, which will bring together scientists from the Centre for Inflammation Research, clinical research teams in NHS Lothian and University of Edinburgh, regulatory teams, and clinical trial networks. Drug manufacturing facilities on site will allow for quick testing of potential treatments.

The Medicines and Healthcare produ

https://truthcomestolight.com/2020/04/05/sulforaphane-as-a-treatment-for-covid-19/