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Lots of nervous punters, parting with their shares cheaply and presumably at a loss, prior to confirmation that SFX 01's Covid-19 patient trials are finally underway...Gla holders...Tick Tock!!! :-)

Latest news on Redhill Pharma's Covid-19 patient trials which have remarkable similarities to SFX-01 and its dual action anti inflammatory and anti viral properties, and a great example also of the very high chance of early reporting from SFX-01's phase 2 stage...where encouraging positive data from phase 2 would no doubt see phase 3 stage accelerated to Top line results imho...( Redhill's Top line results expected as early as Q1 2021 ) Gla :-)

Press Releases 2020-11-16

RedHill Biopharma Completes Enrollment for COVID-19 U.S....

16-Nov-2020

RedHill Biopharma Completes Enrollment for COVID-19 U.S. Phase 2 Study with Opaganib - Data Expected in the Coming Weeks

Enrollment completed in the U.S. Phase 2 study evaluating opaganib's safety and initial efficacy signal in 40 hospitalized patients with severe COVID-19 pneumonia

A parallel global Phase 2/3 study with orally administered opaganib for severe COVID-19 is approximately 50% enrolled - on track to enroll all 270 patients and report topline data in Q1/2021

Potential emergency use applications expected as early as Q1/2021

Opaganib's unique dual anti-inflammatory and antiviral activity acts on the cause and effect of COVID-19 disease with host cell targeting, minimizing potential for resistance due to viral mutations  

TEL AVIV, Israel and RALEIGH, NC, Nov. 16, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study. The study is not powered for statistical significance. Topline data is expected in the coming weeks.

 
https://www.pharmiweb.com/press-release/2020-11-16/redhill-biopharma-completes-enrollment-for-covid-19-us-phase-2-study-with-opaganib-data-expected

Some great play SuperS, but not quite the same without the crowd and maybe conditions too easy for Dustin the Machine and co....:-)

SFX-01's first patients administered coming very soon....and so a very exciting period ahead, with early reporting from the phase 2 stage of SFX-01's very likely given that it is a phase 2 and phase 3 combined Covid-19 patient trial...SFX-01's safety profile is already established from Evgen's phase 2 breast cancer and SAH phase 2 trials....and so the Covid-19 phase 2 should be very straightforward...patients are assessed over a 15 day period and 29 day observation.....if Prof Chalmers reports positive interim data on the Phase 2 stage before progressing to the phase 3, then the sp will multi-bag imho....Gla Holders ;-)

PMSL....Do some research FFS instead moaning about mine!!! ;-)

The recruitment criteria are completely different to each other......200 patients enrolled to the bresnsocatib trial confirmed yesterday by Prof Chalmers...and 100 more to go....SFX-01's first patients administered coming very soon....and so a very exciting period ahead, with early reporting from the phase 2 stage of SFX-01's very likely given that it is a phase 2 and phase 3 combined Covid-19 patient trial...SFX-01's safety profile is already established from Evgen's phase 2 breast cancer and SAH phase 2 trials....and so the Covid-19 phase 2 should be very straightforward...patients are assessed over a 15 day period and a 29.day observation. ...On and UP!!! :-)

Patient population ( brensocatib ): Patients will be invited to join the trial if they have been hospitalised and have a positive test result for COVID-19. This trial aims to recruit 300 patients with COVID-19 from 10 hospitals around the UK.

https://stop-covid19.org.uk/home/trial-information/

SFX 01

*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.

"and another due to start soon."

10/11/20

Tayside Clinical Trials Unit

@TASC_TCTU

UKCRC registered CTUs have played a major part in the response to COVID-19 in the UK. 60% of interventional trials have CTU involvement. TCTU currently has one in progress and another due to start soon.

SFX-01 is under evaluation in multiple disease targets...the phase 2 breast cancer results end of last year were outstanding and life changing for some patients....and news is expected soon on their phase 2b patient trials that are in the planning with University of Manchester as well news from Guys and St Thomas' for autism, University of Dundee for NASH as well as the Covid-19 trials where SFX-01 is focused on Acute Respiratory Distress Syndrome and news also expected from University of Rochester in New Yorkfor CDK....not to menion Jim Mellon's $250k investment into SFX-01's anti-aging and longevity properties along with $10.5m milestones and royalties thereafter.....and so all in all....Evgen's prospects and potebtial look stuuning, especially from their current derisory £10m market cap.....Gl ;-)

.and just like Pzifer's vaccine data....early reporting very likely......SFX-01's Covid-19 patient trials poised to commence....and as a phase 2 and phase 3 combined patient trial, it's highly reasonable to assume that phase 2 stage data will be evaluated before the investigators progress to phase 3 stage.....On and UP!!! ;-)

RNS Number : 8922E
Evgen Pharma PLC
11 November 2020


Evgen Pharma plc

("Evgen" or the "Company")



Comment on COVID-19 vaccine announcement



Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, notes the recent news that Pfizer have announced the first interim analysis of a Phase III COVID-19 vaccine. Evgen believe that multiple approaches will be needed to curtail this virus and the progress announced earlier this week is a hugely positive development.



As previously announced, Evgen have entered into a Phase II/III trial with the University of Dundee to investigate whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ("ARDS") including, but not exclusively in patients with suspected COVID-19. The Company confirms that this study is poised to commence recruitment, as announced on 23 October 2020 and will be providing a further update shortly.



The Phase II/III STAR trial (SFX-01 Treatment for Acute Respiratory Infections) has received all the necessary regulatory approvals needed to proceed and patient recruitment will begin shortly. Supplies of SFX-01 have already been delivered to the centre.



Dr Huw Jones, Evgen CEO, commented: "We are pleased to see such progress on a potential vaccine against COVID-19. Recently ARDS has been heavily associated with COVID-19 as it affects the respiratory tract, but it is and will remain a condition in its own right long after we have beaten the pandemic and will continue to be a huge problem for patients. There is a considerable unmet need for effective treatments for ARDS and the outcome of our study will hopefully show how we can use SFX-01 in a serious respiratory condition regardless of the infective agent involved."

How nanoparticles attack brain tumors

Castro consulted with Lahann’s team in the university’s Biointerfaces Institute and began working on a nanoparticle delivery system. Study authors say a protein called human serum albumin is one of the few molecules in blood that successfully crosses the barrier.

The protein became the building block for the new nanoparticles, which utilize synthetic molecules to link the human serum albumins. The team then attached the STAT3 inhibitor and a peptide called iRGD. This compound acts as a tumor homing device for the cancer-killing nanoparticles.

Mice in the initial study received several doses of the nano-prescription over three weeks. The results reveal that mice responding to the treatment saw their survival length jump from 28 days to 41 days. The Michigan team’s second study added radiation therapy to the mix. It’s in this trial where the seven of eight mice made it through and were diagnosed tumor-free.

Researchers are hoping their synthetic protein nanoparticles will soon provide doctors with a new option for destroying currently “undruggable” tumors.

"Sulforaphane is a naturally occurring Nrf2 activator noted for its anti-inflammatory mechanisms and ability to quickly cross the blood-brain-barrier. "

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

Nanoparticles create ‘miracle’ treatment for deadly brain tumors

10/11/20

ANN ARBOR, Mich. — For scientists treating diseases in the brain, crossing the body’s natural barriers to this organ is the most difficult task to complete. Now, scientists at the University of Michigan say nanoparticles are allowing them to break through the nearly impenetrable blood-brain barrier. The achievement is giving cancer researchers the opportunity to deliver a new and game-changing drug to kill brain tumors.

Glioblastoma is the most common and deadliest form of brain cancer in adults. Cases of the illness continue to rise in several countries. The average survival length for patients with glioblastoma is about 18 months. Less than five percent of patients live longer than five years after their diagnosis.

The nanoparticle breakthrough delivers medication intravenously into the patient. These particles, which house the cancer cell-killing drug, are able to slip past the blood-brain barrier and target malignant tumors forming in the brain.

Along with a combination of radiation, the Michigan team says seven of eight mice given this treatment survived their cancers. More importantly, when those seven mice had a recurrence of glioblastoma, their immune systems prevented the cancer from growing back. Each mouse was able to do this without needing further treatments or radiation.

“It’s still a bit of a miracle to us,” says co-senior author Joerg Lahann in a university release. “Where we would expect to see some levels of tumor growth, they just didn’t form when we rechallenged the mice. I’ve worked in this field for more than 10 years and have not seen anything like this.”
Teaching the body how to beat cancer

Researchers say infusing nanoparticles with cancer drugs not only delivered a lethal blow to the main brain tumor, but also helped the patient’s immune system to recognize and attack cancer cells.

“This is a huge step toward clinical implementation,” says study co-author Maria Castro. “This is the first study to demonstrate the ability to deliver therapeutic drugs systemically, or intravenously, that can also cross the blood-brain barrier to reach tumors.”

Castro adds she’s known for five years how she wanted to attack brain cancer, but needed a way to do it. The R.C. Schneider Collegiate Professor of Neurosurgery says her approach stops a specific signal cancer cells broadcast. This signal, STAT3, tricks immune cells into letting cancer inside the patient’s brain.

Castro’s treatment inhibits STAT3, allowing the immune system to eliminate cancer cells which are now exposed to the body’s defenses. The only catch was developing a method to safely get this inhibitor beyond the blood-brain barrier.

Lol....I've had 19 crimes several times...:-)

Ps I was up at Denbies Vineyard this morning, on a beautiful sunny morning, an area of outstanding natural beauty near Box Hill, and the same chalk geology as the Champagne region of France...Hic...;-)

Lol...I'll let you off then...I'm on the Red...Star Man....just waiting for the rocket...:-)

I'm only interested in copy and pasted documented information releavant to the prospects at hand and not the opinions of dumbwits that troll these share forums.....A MULTI-BILLION DOLLAR CHINESE PHARMA HAS A DIRECT INTEREST IN SFXSFX-01's DEVELOPMENT THROUGH THE OWNERSHIP OF THE INTELECTUAL PROPERTY THAT EVGEN AND SFX-01 EXISTS!!!!

Read it first and then criticise if there's something you don't like!!!! ;-)

and why the fcuk should i explain the obvious....i'm merely posting documented information that has relevance to Evgen's prospects....dumbwit!!! ;-)

Lol..superson...are you thick or what??? A multi-billion dollar Chinese Pharma has a direct interst in SFX-01's development...what bit don't you get or understand...that iv'e just highlighted that the majority of pi's were no doubt unaware ???

-- The patent application providing protection around novel analogues based on sulforaphane, and entitled "Sulforaphane-Derived Compounds" is granted in Australia, China, Europe, Japan and the US and pending in Canada.

During the year composition of matter SFX-01 patents were granted both in Japan and Europe with a product claim for a complex of sulforaphane and alpha-cyclodextrin. The Group has long held broad compositional patent protection in the United States since patent grant in 2011 and in Canada since grant in 2014.

Furthermore, new composition of matter filings have been made which, if successful, would add a further 20 years of patent life to the key patent family.

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

Using Money munch analysis of any news coming out regarding Evgen and then adding his now famous spin (see his 9000 plus posts on a multitude of shares) this would be viewed as good news in the world of Moneymunch.

Kingalf......the desperate clueless numptie is Damn right for once...ha ha ha ha ...Gla ;-)

Raybow PharmAgra deal that Evgen licensed the exclusive worldwide rights to SFX-01 and its analoguges.

04 Nov, 2019, 07:07 GMT

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BREVARD, North Carolin, Nov. 4, 2019 /PRNewswire/ -- Raybow Pharmaceutical, a global pharmaceutical chemistry services provider, has acquired US-based PharmAgra Labs.

Raybow is a global provider of outsourced pharmaceutical process development and manufacturing services. Headquartered in Taizhou, China, the company employs 1,400+ worldwide. PharmAgra is a custom chemical research and development company located in Brevard, NC with current services that include custom synthesis, process development and optimization and analytical services.

The PharmAgra acquisition expands the global footprint of Raybow and gives it close proximity to the company's growing US customer base. The Brevard facility will become the headquarters and R&D center for North American operations. It will be supported by sales and marketing offices in Los Angeles, CA, Princeton, NJ and Copenhagen, Denmark.

Raybow CEO Mr. Bin Wang commented, "We are excited to welcome the PharmAgra team since this is an excellent fit for both companies. Raybow's European and US clients will appreciate the option for contract services within the U.S. The PharmAgra team has a proven track record established during their 20 years of custom synthesis services. Coupled with existing capacity ranging from grams to multi tons, we now have the flexibility to accommodate all of our clients' phase-appropriate outsourcing activities on multiple continents."

Raybow is planning an expansion project at the PharmAgra site, adding additional capacity and personnel in the Brevard area.

Peter Newsome, co-founder of PharmAgra Labs observed, "Our future with Raybow fits perfectly with our long-term goal of providing increased chemistry capabilities for our clients in all industries."

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perhaps the biggest piece of near term news, which has been overlooked , would be the 20 year patent extension.....confirmation news would be massive and would add significant UPside imho....Gl ;-)

15/6/20

INTELLECTUAL PROPERTY UPDATE

Our IP portfolio continues to be strengthened with a number of key patents being granted. The current status of the intellectual property portfolio is as follows:

-- From the "parent" patent family entitled "Stabilised Sulforaphane" patents are granted in Australia, Canada, EU, US, Japan and Hong Kong.

-- The principal manufacturing patent application, entitled "Methods of Synthesising Sulforaphane" is granted in Australia, China, Europe, Japan and further applications are pending in Brazil, Canada, US and India.

-- A second manufacturing patent which is directed to methods of isolating and purifying sulforaphane or analogues from natural sources has been granted in Europe, US, Japan and China.

-- The patent application providing protection around novel analogues based on sul