Open Orphan #ORPH presents at Total Market Solutions & Proactive Investors’ One2One Forum, London

Open Orphan, a European-focussed, rare and orphan drug consulting services platform, is pleased to announce that on Wednesday 18th September the Company will be attending and presenting at Total Market Solutions, Moorgate, at 12:30pm and will also be attending and presenting at Proactive Investors’ One2One Forum at Chesterfield Mayfair Hotel, London, W1J 5EB from 18:00 onwards.

Cathal Friel, Open Orphan’s Chief Executive Officer, will be in attendance throughout both events and will be presenting to update existing and potential investors on the Company’s business plans for 2019-2020.

The events will provide an opportunity for investors to hear about the progress being made by the Company following the reverse takeover of Venn Life Sciences and the potential for Open Orphan moving forward.

A link to the presentation will be made available on the Company website following the event.

For further information on the events, please visit the respective event websites:

–      https://total-market-solutions.com

–      https://www.proactiveinvestors.co.uk/events 

 

Enquiries:

Open Orphan Plc Tel: +353 1 5499 341
Cathal Friel, Chief Executive Officer

Arden Partners (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7614 5900
John Llewellyn-Lloyd / Ruari McGirr / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker) Tel: +353 (0)1 679 6363
Anthony Farrell (Corporate Finance)

Camarco (Financial PR) Tel: +44 (0)20 3757 4980
Tom Huddart / Billy Clegg / Daniel Sherwen

Notes to Editors:

Open Orphan plc is a European-focussed, rare and orphan drug consulting services platform. The Company consists of four elements: a European clinical research organisation and consultancy; an orphan drug services business; a Virtual Rep and Data Access Platform consisting of physicians and key opinion leaders; and a Health Data Platform to partner with Patient Advocacy Groups. The Company is targeting rapid growth in one of the fastest growing sectors in the global pharmaceutical industry targeting under-supplied treatment for life threatening or very serious diseases and rare disorders.

Tiziana Life Sciences #TILS Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Tiziana Life Sciences Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers.

A breakthrough approach for treatment of autoimmune and inflammatory diseases

London, 16 September, 2019– Tiziana Life Sciences plc (NASDAQ:TLSA and AIM: TILS), a clinical stage biotechnology company focused on developing targeted drugs for cancer and inflammatory diseases, is pleased to announce (further to the announcement made on 1 May 2019) that the U.S. Food and Drug Administration (FDA) has allowed the initiation of a Phase I clinical trial in healthy volunteers using a novel oral enteric-coated capsule formulation of Foralumab, a fully human monoclonal antibody (mAb), in collaboration with the Brigham and Women’s Hospital (BWH), Harvard Medical School, Boston, MA. We believe this is the first clinical trial in which Foralumab will be administered orally to healthy subjects. Our objective is to develop orally administered Foralumab for treatment of autoimmune and inflammatory diseases.

The scientific rationale for this approach was originally discovered by Dr. Howard Weiner, professor at the Brigham and Women’s Hospital, Harvard Medical School. Dr. Weiner discovered that oral or nasal administration of anti-CD3 mAb induces mucosal tolerance to upregulate T regulatory cells (Tregs) capable of providing site-targeted immunomodulation to suppress inflammation. Therefore, this scientific concept could be effective for the treatment of a variety of autoimmune and inflammatory diseases1-5.

“The therapeutic approach of oral administration with Foralumab greatly enhances our ability to treat neurodegenerative and inflammatory diseases. We have also explored the nasal administration of Foralumab for the treatment of progressive MS. We believe nasal and oral administration with Foralumab opens innovative avenues to treat inflammatory and autoimmune diseases by inducing different classes of Tregs. Thus, mucosal activation stimulating Tregs is a physiological mechanism which we think might be safer than other treatment approaches,”commented Dr. Weiner.

Cited References

  1. Wu HY, Maron R, Tukpah AM, Weiner HL. Mucosal anti-CD3 monoclonal antibody attenuates collagen-induced arthritis that is associated with induction of LAP+ regulatory T cells and is enhanced by administration of an emulsome-based Th2-skewing adjuvant. J Immunol. 2010; 185(6):3401-3407.
  2. Ochi, H.,et al.,Oral CD3-specific antibody suppresses autoimmune encephalomyelitis by inducing CD4+CD25-LAP+ T cells. Nature Medicine 2006: 12: (6); 627-635
  3. Lior Mayo, Andre Pires Da Cunha, Asaf Madi, Vanessa Beynon, Zhiping Yang,Jorge I. Alvarez, Alexandre Prat, Raymond A. Sobel, Lester Kobzik, Hans Lassmann, Francisco J. Quintana and Howard L. Weiner. IL-10-dependent Tr1 cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation. Brain 2016: 139; 1939–1957
  4. Chantal Kuhn, Rafael M. Rezende, Andre Pires da Cunha, Fabrice Valette, Francisco J. Quintana, Lucienne Chatenoud, Howard L. Weiner. Mucosal administration of CD3-specific monoclonal antibody inhibits diabetes in NOD mice and in a preclinical mouse transgenic for the CD3 epsilon chain. Journal of Autoimmunity (2016) 76: 1-8
  5. Ogura M, et al., Prevention of human xenograft rejection with oral anti-CD3 mAb. Clinical Immunology 183: 2017; 240-246

About Howard Weiner

Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer’s disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.

About Harvard Medical Centre

Brigham and Women’s Hospital (BWH, “The Brigham”) is located adjacent to Harvard Medical School, of which it is the second largest teaching affiliate.  It is the largest hospital of the Longwood Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. Brigham and Women’s Hospital conducts the second largest hospital-based research program in the world, with an annual research budget of more than $630 million.  Pioneering milestones include the world’s first successful heart valve operation and the world’s first solid organ transplant.

About Autoimmune Diseases and Foralumab

Autoimmune diseases constitute a major medical problem and include diseases such as multiple sclerosis, type 1 diabetes, rheumatoid arthritis and inflammatory bowel disease. Other diseases, that have inflammatory components include diseases such as NASH, atherosclerosis and stroke. The induction of regulatory cells at mucosal surfaces by the oral or nasal administration of antigens has been shown to treat a large variety of autoimmune and inflammatory diseases in animal models with minimal toxicity. Foralumab was developed by Novimmune and has been acquired by Tiziana Life Sciences PLC. Foralumab (formerly NI-0401) is thus far the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn’s disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of foralumab.

In a humanized mouse model (NOD/SCID IL2γc-/-) developed in Dr Kevan Herold’s laboratory, it was show that while targeting the T cell receptor, orally administered foralumab modulates immune responses of the T cells, enhances regulatory T cells and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of regulatory T cells.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to milciclib, the Company is also developing foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ’seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority

 

For more information go to http://www.tizianalifesciences.com

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

 

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

 

+44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner

 

+44 (0)20 7213 0883
Shore Capital (Nominated brokers)

Antonio Bossi / Andy Crossley

 

+44 (0)20 7408 4050

 

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

Quoted Micro 16 September 2019

NEX EXCHANGE

Good Energy (GOOD) continues to refocus on the small business market and services, such as electric vehicle charging. The renewable energy supplier increased revenues from continuing operations by 3% to £63.5m. Higher cost of sales were offset by lower overheads. Pre-tax profit edged up from £2.4m to £2.5m. Disposals helped to reduce net debt to £35.5m. The dividend was increased by 10% to 1.1p a share. There was a surge in feed in tariff (FiT) customers prior to the closure of the scheme earlier this year, but domestic supply customers declined.

IFA consolidator AFH Financial (AFHP) has made two more acquisitions. Twickenham-based Mulberry Independent Financial Advisers will cost up to £5.3m, while AE Garment Independent Financial Services will cost up to £1.9m. There is an initial total cash outflow of £3.3m. Following the deals, AFH has assets under management of £5.6bn.  

World High Life (LIFE) joined NEX on 12 September. The investment company intends to acquire businesses involved in medicinal cannabis and related products, including nutraceuticals and cosmetics. There is enough cash in the company to assess acquisitions and undertake due diligence. Chairman and chief executive David Stadnyk has been involved in the cannabis sector in Canada since 2012 and he helped to develop the regulations for the sector.

Bracken Trading 1.5% preference shares (BRAC) have started trading on NEX. Bracken is involved in lending in the residential property sector and also operates two solar farms. The quotation is expected to provide finance through the placing of additional preference shares. So far £10,000 worth have been issued. Bracken has repurchased ordinary shares valued at £9m. A pre-tax profit of £1.46m was generated in 2018.

Rutherford Health (RUTH) is raising a further £12.5m at 176p a share from LF Woodford Equity Income Fund and Woodford Patient Capital Trust.

EPE Special Opportunities (ESO) increased its NAV by one-fifth to 245.5p a share, helped by a strong recovery in the share price of fully listed-Luceco (LUCE) and that business is continuing to improve its trading.

LED lighting and electrical accessories supplier Luceco increased interim revenues by 10% to £82.7m and gross margin improved from 26% to 35%. That enabled Luceco to return to profit in the period. Underlying pre-tax profit was £6.1m. An interim dividend of 0.6p a share was announced and the dividend payout percentage will be raised from 20% to 25%. There have been manufacturing efficiency improvements in China and UK retail demand has rebounded. The main profit improvement was in the wiring accessories division, but both LED lighting and portable power divisions returned to profit. There has been director share buying following the results.

Kyler Hardy has been appointed as chief executive of Imperial X (IMPP) and Emma Priestley and Kyle Hookey have also joined the board. Hardy has a 12.5% stake and Priestley owns 5.4%. Palace Trading Investments has sold 4,615,000 shares at 2p each, leaving it with 685,000 shares.

Equatorial Mining and Exploration (EM.P) has raised £500,000 at 0.01p a share, which includes £95,000 of shares to pay creditors. Director Michael Staten has converted £82,500 of convertible debt into shares. He subsequently sold 550 million shares at the 0.1p conversion price.

Vi Mining (VIM) says Jilde Zeitlin has stepped down as chairman and he will be replaced as non-executive chairman by David Summer. Allan Rowley will take over as chief executive from Summer and he will remain finance director.

AIM  

Eddie Stobart Logistics (ESL) says that DBAY adviser has made a bid approach. The chief executive left last month after a review of accounting policies. Trading in the shares was suspended at 71p.

Pensions and financial services provider STM Group (STM) reported a decline in interim profit, but there should be a full year improvement from £4m to £4.4m. The Carey acquisition is being integrated and a new brand name will be announced soon. The balance sheet is strong and STM is seeking further UK-based acquisitions.

Cybersecurity consultancy and software company ECSC (ECSC) reported flat interim revenues of £2.6m because growth in managed services was offset by lower consultancy income. The loss was lower and ECSC could move into profit in the second half even though revenue forecasts have been trimmed. Consultancy revenues are growing again.  

Filta (FLTA) is continuing to integrate the Watbio grease management services acquisition. The benefits are beginning to show through, but not as fast as hoped. The core fryer management services franchise business continues to prosper. There was a dip in interim profit and full year profit could be flat this year. Even so, the interim dividend was raised 39% to 1p a share.  A jump to £3.1m is forecast for 2020 as the full benefits of the Watbio acquisition come through.

Property finance provider Urban Exposure (UEX) had a solid first half but the second half is always stronger. Deals in legal due diligence should mean that more than £700m of loans will be provided this year. The main uncertainty is timing. Loan to value is around 45%. There is 29p a share of cash in the balance sheet and loans worth 53p a share. Even excluding intangibles, NAV is 85p a share.

Credit hire and legal services both grew strongly in the first half for Anexo (ANX) although the start-up costs of the new Bolton office reduced the profit contribution from legal services. It will take time for the new fee earners to get up to speed. Anexo is still on course to improve full year pre-tax profit from £16.1m to £23m.

MAIN MARKET

Haynes Publishing (HYNS) increased revenues by 7% to £36.2m in the year to May 2019. Pre-tax profit improved from £2.9m to £3.5m. Net cash almost doubled to £4.9m and the dividend is maintained at 7.5p a share. Digital and technical data generates the majority of revenues. First quarter revenues are 9% ahead.  

Icon Labs (ICON) has acquired the IP of Gay Star News, which runs a website focused on LBGTI news and events and it is number three in the market. The media business paid £1 to a company owned by Iconic Labs director David Sefton, who bought the asset after the previous owner went into liquidation. There is a further £33,000 payable to the liquidator, though. A management services agreement has been agreed with Medium Channel Marketing along with a £150,000 loan and in return Iconic has been issued a 24% stake in the company. The agreement will generate fees of at least £25,000 a month. MCM is acquiring student-focused publisher Tab Media. European High Growth Opportunities took advantage of the good news to reduce its stake from 5.79% to 4.29%.

Tex Holdings (TXH) wants shareholder approval to move from the premium list to the standard list. This means that it will no longer be eligible for the FTSE Fledgling index. A company associated with director ARR Burrows will provide Tex with up to £7m of loan facilities after the company failed to find an alternative funder to replace its overdraft facility.

OTHER MARKETS 

Fashion On Screen has agreed a $55m loan facility with The Ambient Partnership Group that will help to finance its films and on acquisitions. The facility can be drawn down over The Vienna Stock Exchange-listed film company raised £100,000 when it floated and has also received an investment from Twickenham Studios. Some of the finance will be used to film REVolution, a film based on the kidnapping of racing driver Juan Fangio in Cuba before the 1958 Cuban Grand Prix. Pre-production is set to begin, and the film could be completed in time for a cinema release in 2020.

Andrew Hore 

The Appliance of Life Science Looks Exciting for this On-the-Nose Medical Explorer.

by Malcolm Stacey

Hello, Share Troopers. Previously, I’ve written on the huge potential of life science companies which explore antibodies and antibody substitutes in the fight against serious conditions like cancer. Allow me to put another such firm before you. Tiziana Life Sciences plc (TILS) is biotechnology outfit which uses antibodies to find new treatments for inflammatory diseases and cancers.

The company has just announced good news which sent the share price alight this week. The company has demonstrated that antibodies administered through the nose show promising results. The antibody, called Foralumab proved itself to be well tolerated in all sizes of dose.

I’m thick so can’t undertones the words from the company, but you may fare better. So here they are. ‘Importantly, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which is capable of inducing site-targeted immunomodulation to elicit anti-inflammatory effects.’ So now you know.

Apparently, this new data is consistent with the findings of numerous pre-clinical studies. This latest project was conducted at Harvard Medical School in the USA. A pretty prestigious venue, wouldn’t you agree? Nearly 30 volunteers took part. Examination of the patients showed positive immune effects.

The hope is that Foralumab might in the future be used to treat neurodegenerative diseases, including multiple sclerosis. There is now much more incentive to push on with further studies. So there is more work to be done before we reach the licensing stage. Nevertheless, the firm is pretty excited by the results. And so is the city as the share price rose by a third on the news. And when the penny drops that jolly trend could continue.

As usual with medical pioneers, investors take the risk of treatments always under strict scrutiny to fall at the last fence. And there’s rarely any dividend paid. But the rewards, especially for the treatment of serious conditions can be immense, both financially and in terms of moral satisfaction.

And now let’s celebrate the company’s success in the Punter’s Return.

View the article on ShareProphets website here

Open Orphan (ORPH) CEO Cathal Friel Presentation at Shares London

Open Orphan CEO Cathal Friel Presentation at Shares London. Cathal provides an update of companys business plans for 2019-2020.

IMC Exploration Group Plc Mineral Resource Estimate

JORC-compliant Inferred Mineral Resource Estimate on IMC’s licence area at Avoca, Co. Wicklow, Ireland (PL 3850) 

CSA Global Pty Ltd (CSA Global) has completed a Mineral Resource Estimate (MRE) for IMC’s Avoca[GA1]  historic mine site project located in Co. Wicklow, south-east[GA2]  Ireland.

The sample density has allowed the MRE to be classified as an Inferred Resource and is reported in accordance with the JORC Code (2012).  The classification of the MRE was carried out taking into consideration the volumes of the spoil heaps, the nature and spacing of the sampling and density data.  The MRE is presented below.

Inferred Mineral Resource estimate (all tonnages reported with no cut-off grade applied)

Spoil Heap Tonnes (kt) Cu (%) Pb (%) Zn (%) Au (g/t) Ag (ppm)
Forest of Gold 2 0.57 4.31 0.83 5.2 64
Tigroney Lower East 19 0.44 0.68 0.37 0.6 13
Tigroney North 158 0.18 0.12 0.04 0.1 3
Subtotal (Tigroney East) 178 0.29 0.62 0.20 0.7 11
Mt Platt 852 0.13 0.37 0.12 0.2 7
Cronebane 841 0.13 0.43 0.16 0.4 10
TOTAL 1,871 0.14 0.42 0.14 0.3 9

Source: CSA Global (2019)

The MRE is based on data from 14 sample pits, dug with an excavator and reflecting representative vertical intervals throughout the spoils’ heaps.

Samples were taken from each sample pit sample stockpile and used to calculate an in-situ bulk density of 1.59t/m3 (assumed to be a wet bulk density). The total tonnage of dumps in Tigroney East, Mount Platt and Cronebane was calculated at 1.871 million tonnes.

An average sample grade for Cu (%), Pb (%), Zn (%), Au (g/t) and Ag (g/t) was assigned to each spoil heap based upon the sample grades from the relevant pit(s).

Mineralogical testing is ongoing and results will be reported when they become available.

There is further potential to increase the tonnage and grade of the MRE by conducting further investigations including basal topography surveying as well as the investigation of other spoil heaps present in the area, particularly at West Avoca.

IMC is to establish an environmental clean-up operation to remove metals from the existing mine waste at the project site.

IMC’s Chairman, Eamon O’Brien, commented, “The Mineral Resource Estimate for our spoils and tailings project in Avoca, Co. Wicklow is of great significance. There is further potential to increase the tonnage and grade, not only on this site but also on other spoil heaps within IMCs licence areas.  The scale of this opportunity at Avoca is transformational for IMC and its shareholders.  The Mineral Resource Estimate is a significant development and further validates the Company’s strategy.  Work continues and the Directors believe this represents an exciting time for the Company and its shareholders.”

Consent to release the report dated September 2019 “JORC compliant Inferred Mineral Resource Estimate on IMC’s licence area at Avoca, Co. Wicklow, Ireland (PL 3850)”, announcing the Mineral Resource, was given by David Williams, Principal Resource Geologist at CSA Global Pty Ltd.

Eamon P. O’Brien,
Executive Chairman,

Dublin, 10th September 2019 
The Directors of IMC, after due and careful enquiry, accept responsibility for the contents of this announcement.

REGULATORY ANNOUNCEMENT ENDS.

Contact Details:

Kathryn Byrne: +353 85 233 6033
IMC Exploration Group plc
Graham Atthill-Beck: +44 20 7464 4091 / +44 750 643 4107 / +971 50 856 9408 / Graham.Atthill-Beck@kbrl.co.uk
Brinsley Holman: +44 20 7464 4098 / Brinsley.Holman@kbrl.co.uk
Keith, Bayley, Rogers & Co. Limited

Catenae Innovation (CTEA) – Trading Update

Catenae (AIM: CTEA), the AIM quoted provider of digital media and technology, announces that, following the announcement  released by the Company on 18 July 2019, despite its investment and sales initiative, revenue in the second half of its financial year will be below management expectations. The Company’s targeted sectors are depressed with a reluctance to commit to investment, especially in the wider context of the economic slow-down and current political uncertainty with regards to Brexit.

Consequently, losses for the year will be higher than expected. However, given the recent corporate restructuring and a resultant significant lowering of overheads, the Board is confident in the future of the business.

The Company continues to carefully manage its working capital position and will need to raise further capital in the near future. Further announcements will be made in due course. 

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for release of this announcement on behalf of the Company was Guy Meyer, Interim Chief Executive Officer of the Company.

 

For further information:

  Catenae Innovation Plc

  Guy Meyer

Tel: 020 7929 7826

 

  Cairn Financial Advisers LLP, Nominated Adviser

  Liam Murray / Jo Turner

 

Tel: 020 7213 0880

 

  Turner Pope Investments (TPI) Limited, Broker

  Andrew Thacker

 

Tel: 020 3621 4120

 

 

 

Alan Green discusses Cadence Minerals #KDNC, Tiziana Life #TILS, JD Sports #JD & Itaconix #ITX on the Vox Markets podcast

Alan Green discusses Cadence Minerals #KDNC Amapa project, Tiziana Life Sciences (AIM: #TILS, Nasdaq: #TLSA), JD Sports #JD and Itaconix #ITX on the Vox Markets podcast. The interview is 14 minutes 28 seconds in.

Time to Fillyaboots with ECR Minerals (AIM:ECR) as Victoria Gold Projects continue to evolve and gold attracts record investments.

Time to Fillyaboots with ECR Minerals (AIM:ECR) as Victoria Gold Projects continue to evolve and gold attracts record investments.  

  • High grade assays at Timor
  • Exploration underway at Avoca
  • Whole of bag testing results at Creswick
  • Record breaking month for gold
  • Time to Fillyaboots

 For those keen on regular progress updates, Australia-focussed mining company ECR Minerals (AIM: ECR) hits the mark by keeping investors up to date with their every move on Twitter. Of late, the three major developments over August at Timor, Avoca and Creswick projects have focussed attention, driven as much as anything by the rising demand for gold amid dwindling macroeconomic conditions.

1) High grade assay results demonstrate potential for Timor Gold Project to follow in the footsteps of Maryborough goldfield

The first of these was an impressive set of rock chip sampling results at the Timor project, which gave ECR investors plenty to smile about at the beginning of the month.

High grade gold assays of 22.6 g/t and 26.3 g/t were recorded respectively from Shaw’s Reef and Anglo-Saxon Reef prospects.

Mined to 152m depth, ECR revealed that Shaw’s Reef had produced 11,465 ounces at a grade of 20.93 g/t Au. Meanwhile, four samples from the Anglo-Saxon Reef averaged 8.12 g/t Au.

Not bad eh? Well on top of that, the reconnaissance had also “discovered the Brilliant / Northumbria reef and its extensive gold workings, including an old open cut” ..according to CEO Craig Brown.

“This prospect area extends over a length of approximately 500m and is up to 80m wide and assays from 13 samples indicate widespread low-grade gold mineralisation.”

These results indicate that Timor may well follow on from the historical success of the Maryborough Goldfield.

Maryborough, which lies within the area covered by the Timor license, previously produced over 640,000 ounces of gold from hard-rock and alluvial sources, with 220,000 ounces mined from hard-rock operations at an average grade of 14g/t gold.

Northumbria Reef open cut

2) Avoca Exploration Underway

In addition to Timor, there was plenty of news forthcoming from ECR’s other Victoria sites. On the 14th of August the Company announced it had begun exploration at Henry’s Hill within the Avoca gold project license area.

The company now has active exploration works underway at four projects within the Victorian goldfields region, including Bailieston, Creswick, Timor and now Avoca.

“We are delighted to be highly active in the Victoria Goldfields region, at a time when the area is attracting considerable interest from larger companies and investors” commented Craig Brown.

Previously seven samples have been taken from the roadside reserve at Henry’s Hill, with three of these returning 5.1, 1.4 and 1.3 g/t gold.

With land access permission secured from the landowner and ever keen to keep the ball rolling, ECR will be commencing soil geochemistry and field mapping imminently.

3) Whole of bag testing results at Creswick:

Now for Creswick, the one we’ve all been waiting on. This is ECR’s strategic priority, with potential to be a multi-million ounce gold deposit.

Craig Brown and his team have been quick to try to progress the project and understand the impact of the nuggety nature of it’s gold deposits – conducting whole-of-bag testing in order to gain more representative results than from the original 2 kg assays.

Despite delays due to inclement weather at Victoria, ECR were happy to announce that work was underway and generating important results from the gravity and electrostatic concentration (GEC) of gold process, constructed under the guidance of the highly accredited resource geologist Keith Whitehouse.

GEC uses the dual processes of gravity and chargeability, which not only sounds rather impressive, but is capable of removing coarse, fine and ultrafine particles of gold from the RC samples.

According to Craig Brown.. “the results so far have demonstrated significant variability from the original assays, demonstrating that the small sample size can overstate and understate results.”

“Notably the original 44.63 g/t assay from the 2 kg sample from CSR006 (15-16 m) is increased to 63.03 g/t.”

To help support the process, ECR have appointed mining geologist and geometallurgist Dr Simon Dominy. With over 25 years’ experience Dr Dominy looks to be the man to help ECR evaluate their results, review the sampling process and guide future exploration & project development work at Creswick.

Gold sets record breaking highs

From a timing standpoint, ECR have hit the metaphorical bullseye considering the rapid rise in demand for safe-haven gold. Investors ploughed almost $5bn into the precious metal in August amid ongoing trade tensions and diminishing macroeconomic conditions, taking it to its highest level since April 2013.

Prices have remained high moving into September, with levels closing at US$1,551 a troy ounce on Wednesday the 4th of September. Analysts see no sign of prices dipping either.

Bloomberg Intelligence (BI) have said that US gold prices could be set for new record highs. Meanwhile Goldman Sachs upgraded its 6-month gold forecast at the beginning of August to $1,600 an ounce as trade tensions continue to escalate.

According to BI senior commodity strategist Mike McGlone:

“The dollar price of gold is on far more stable ground than it was about a decade ago. Some combination of sustained greenback strength and rapid stock-market appreciation should be necessary to suppress the metal’s price … Bottoming with the Federal Reserve’s interest-rate hike in 2015, the gold price appears to be situated for brighter days,” McGlone said in a September update.

Worsening economic data and the fast approaching Brexit deadline have also pushed the price of gold in British Pounds and Euros to new record highs.

The UK gold price in Pounds per ounce was up more than 50% from the eve of the UK’s vote to leave the EU back in June 2016, hitting £1279 on Tuesday the 3rd of September.

Time to Fillyaboots

All said, while ECR could be accused of being slightly trigger happy with their posts on Twitter, the reality is that the company have a lot to talk about.

As well as gold’s strength, with active exploration underway at four sites in Victoria and with nine exploration licences in the highly prospective Yilgarn region, ECR Minerals are certainly a company worth your attention if you’re looking to join the gold rush.

Each month the company continues to materially progress its projects, with August no exception. Timor’s high grade assay results give plenty of hope, putting a solid floor under the Company valuation, whilst recent exploration at Avoca demonstrates yet again that ECR are not resting on their laurels.

Finally, and of most importance thorough testing appears to be fully underway at Creswick, meaning ECR are moving ever closer to understanding the true value of their potential multi million ounce gold deposit. And with a market cap at just GBP3.5m, there has never been a better time to fillyaboots with this ambitious gold explorer.

By Harry Dacres-Dixon

 

Sources:

Gold Prices To Hit $1,575 In 3 Months, $1,600 In 6 Months – Goldman Sachs

Gold prices to pick off U.S. dollar high next – Bloomberg Intelligence

Investors pile into gold as trade conflict rumbles on

Gold Price Hits Fresh UK and Euro Highs as Brexit Rebels Fight No.10, German Factories Prepare for ‘No Deal’

ECR Minerals #ECR – High Grade Gold Assays – Timor Gold Project – Australia

ECR Minerals #ECR – Exploration Commences at Henry’s Hill – Avoca Gold Project – Australia

ECR Minerals plc (ECR) Progress Update – Creswick Gold Project Australia

Tiziana Life Sciences #TILS Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Tiziana Life Sciences plc

Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers

New York, 10 September 2019 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to report Phase 1 clinical data demonstrating that nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), was well-tolerated at all doses. Importantly, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which is capable of inducing site-targeted immunomodulation to elicit anti-inflammatory effects. These clinical data are consistent with the findings from numerous pre-clinical studies.1-3

This Phase 1 trial, conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind, placebo-controlled, dose-ranging study with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days in healthy volunteers for the treatment of progressive multiple sclerosis (pMS). 18 subjects received Foralumab treatment and 9 patient received placebo. All nasal doses were well tolerated. Biomarker analysis showed significant positive immune effects, that were most prominent in the 50 mg cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses.

Major Highlights

  • Treatment was well-tolerated and no drug-related safety issues were reported at any of the doses.
  • No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge. The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared to the placebo.
  • Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS).
  • Treatment at 50 mg stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ.
  • Taken together, these results suggest stimulation of Tregs that are needed to provide clinical benefits

“Nasal administration of Foralumab is a revolutionary approach to treat patients with neurodegenerative diseases such as progressive MS (pro-MS) and amyotrophic lateral sclerosis (ALS). Extensive data from animal studies with intranasal delivery of anti-CD3 demonstrate that this route of administration induces anti-inflammatory and immunomodulatory effects. This study demonstrates for the first-time that nasally administered Foralumab, at the identified optimal dose of 50 mg, induces immunomodulatory effects capable of providing clinical benefit to treated subjects.This is a major accomplishment providing the scientific rationale to move forward with further clinical development of nasally administered Foralumab in patients with neurodegenerative diseases,”commented Dr. Howard L. Weiner, a member of scientific advisory board of Tiziana Life Sciences. He added that “both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying immunomodulation. Our immediate focus is on developing Foralumab for treatment of pro-MS.”

“The demonstration of the positive immunomodulatory effects provides the scientific rationale to move forward with further studies in the pro-MS population”,stated Dr. Tanuja Chitnis, the study PI at the Brigham and Women’s Hospital.

“We are very pleased with what we believe is the first-ever demonstration that nasally administered Foralumab is not only well-tolerated, but it also exhibited significantly positive immunomodulatory effects that are indicative of stimulation of Tregs. We are excited as these results provide the scientific rationale for the nasal and oral treatment with Foralumab, our core proprietary platform technologies which could potentially revolutionize treatment with antibodies”stated Kunwar Shailubhai, CEO & CSO of Tiziana.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

About Foralumab

Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn’s disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

Preclinical studies on nasal and oral administration with Anti-CD3 mAbs

Preclinical and clinical studies have shown that mucosal induction of Tregs by oral or nasal administration of anti-CD3 mAbs is an innovative approach to treat autoimmune and anti-inflammatory diseases (Kuhn and Weiner 2016)4. Nasally administered anti-CD3 mAbs were shown to ameliorate disease in an animal model of multiple sclerosis by inducing IL-10+LAP+(latency-associated peptide) T cells3, demonstrating nasal anti-CD3 mAbs as a new approach to treat progressive forms of multiple sclerosis and other types of chronic CNS inflammation. Additionally, nasally administered anti-CD3 mAbs suppressed lupus in lupus-prone mice (BWF1) by inducing IL-10 and TGF-β dependent mechanisms associated with a suppression of IL-17 and IL-21 pro-inflammatory cytokines5.    

About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), crohn’s disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions.  Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ’seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

Cited References

  1. Weiner HL et al. Oral tolerance. Immunol Rev. 2011; 241(1):241-259
  2. Ochi H, Abraham M, Ishikawa H et al. New immunosuppressive approaches: Oral administration of CD3-specific antibody to treat autoimmunity. J Neurol Sci 2008; 274(1- 2):9-12
  3. Mayo, L et al. IL-10-dependent TrI cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation. Brain. 2016: 139; 1939-1957
  4. Kuhn C. and Weiner HL. Therapeutic anti-DC3 monoclonal antibodies: from bench to bedside. Immunotherapy 2016; 8(8):889-906
  5. Wu, H.Y, Quintana, F.J and Weiner, H.L. Nasal Anti-CD3 Antibody Ameleorates Lupus by Inducing an IL-10-Secreting CD4+CD25-LAP+ Regulatory T cell and Is Associated with Down-Regulation of IL-17+CD4+ICOS+CXCR5+ Follicular Helper T Cells. J Immunol 2008; 181:6038-6050

 

 

For further enquiries:

 

Tiziana Life Sciences plc                                                                +44 (0)20 7495 2379 Gabriele Cerrone, Chairman and founder

 

 

Cairn Financial Advisers LLP (Nominated adviser)                     +44 (0)20 7213 0883

Liam Murray / Jo Turner

 

Shore Capital (Broker)

Andy Crossley / Antonio Bossi

 

  +44 (0)20 7601 6125

 

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

I would like to receive Brand Communications updates and news...
Free Stock Updates & News
I agree to have my personal information transfered to MailChimp ( more information )
Join over 3.000 visitors who are receiving our newsletter and learn how to optimize your blog for search engines, find free traffic, and monetize your website.
We hate spam. Your email address will not be sold or shared with anyone else.