Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Corporate Update
Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is now able to provide an update on the Company's assets and other corporate matters.
NXP002
NXP002, a new form of tranilast, is the Company's pre-clinical lead asset and a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis ("IPF").
As announced on 25 November 2021, positive data was received from initial pre-clinical studies. In vitro studies demonstrated NXP002's feasibility for formulation as a simple and stable solution with suitable properties for delivery via nebulisation.
In vivo studies evaluated NXP002's pharmacokinetics when delivered by nebulisation. Results demonstrated that NXP002 can be efficiently delivered to the lung.
Further in vivo studies evaluated the pharmacodynamics of NXP002 when delivered by nebulisation. This study showed that inhaled NXP002 could dose-dependently regulate the production of inflammation and fibrosis-relevant cell mediators in response to a lipopolysaccharide ("LPS") challenge.
Following the results of these studies, a final planned pre-clinical study was commissioned to assess the duration of action with the gap between inhaled NXP002 and the LPS challenge extending from 30 minutes, as in the first study, in various stages up to eight hours. However, the Contract Research Organisation ("CRO") undertaking the study had a protocol failure, voiding the study. The CRO repeated the study as per the protocol.
The repeat study has recently concluded. The results, however, were inconsistent with the first in vivo study at all time points and also with the oral control. In the opinion of the Company and its development advisers, no positive or negative conclusions could be drawn from this study.
The Company, in consultation with the CRO, has therefore decided to move forward with further studies, including evaluation of a new formulation. New studies will examine both the pharmacokinetics of NXP002 as an inhaled product and further test its efficacy in repeat LPS challenge studies. The timing of results from this study is dependent upon the availability of slots with the CRO and is expected on or before Q1 2023.
NXP004
The Company has previously demonstrated the enhanced performance of NXP004 compared to olaparib's free form. Subsequently, additional pre-formulation studies have been completed confirming the superiority of the Company's recently patented cocrystal forms and a lead cocrystal has been selected to enter drug product development. Further updates will be announced in due course.
NXP001
Following the Company's signing of an exclusive global licensing agreement with Oxilio Ltd ("Oxilio") for NXP001 on 13 September 2021, Oxilio continues to progress this asset. NXP001 is a proprietary new form of aprepitant which is currently marketed for cancer chemotherapy induced nausea a
Fintech company Tintra PLC announced its plans in March to develop the world’s first built for purpose Web 3.0 banking platform to power the metaverse. This platform would be a financial and regulatory infrastructure built upon the technologies and concepts of the upcoming third generation of the internet, where websites and apps will be able to process information in a smart human-like way through technologies. This includes machine learning (ML), Big Data, and decentralised ledger technology (DLT), - making it the first bank capable of functioning operationally within the digital realm of the metaverse. This would enable financial and regulatory communication layers between currently siloed metaverse projects, as well as provide a bridge to off-chain, traditional regulatory, and financial systems. Following this announcement, the firm’s valuation has increased significantly, recently having announced share issue details of the latest receipt of a $2 million private funding round. Thus valuing the company in the private market at least at $100 million and attracting the attention of private investors including large private equity firms.
Tintra’s plans for a “borderless” approach are equally as impressive, with their aims to revolutionise the regulatory environment through end-to-end AI-driven technologies, making access to the global marketplace as seamless in Africa, Latin America or Asia as it is in Europe or the United States, democratising payments for emerging market economies. The fast growing firm has recently been granted approval to start trading in Mauritius, marking the beginning of its expansion across Africa. In delivering a decentralised technology platform, that democratises finance across the world, Tintra makes their work in the metaverse not only interesting for its implications within fintech, but also for its impacts on emerging market development. Utilising AI to remove human prejudice against emerging markets is certainly something that also seems to have caught the attention of the fintech world, with many eager to see its implementation.
Metaverse investments are still fairly novel, meaning that precise predictions on them at this stage is difficult. On Meta’s Q1 2022 earnings call CEO Mark Zuckerberg told shareholders that the company’s steep investments in XR and metaverse technologies should exponentially flourish within the next decade. This is naturally explained by the metaverse’s inevitable long term trajectory. Therefore, it will be compelling to see with time Tintra’s trailblazing plan for strategic growth and its breakthrough in finance, technology, and regulation.
https://www.thecorporatelawjournal.com/finance/tintra-and-the-future-of-fintech
This current situation goes massively in iqai’s favour. Would be good to see IB zero gad fast tacked through the fda process to help with this problem.
Updated May 13, 2022
The ACR Committee on Drugs and Contrast Media, within the ACR Commission on Quality and Safety, is aware of the current global shortage of iodinated contrast media. The following statement offers some recommendations on how providers may address this emergency locally. The recommendations are not exhaustive or prescriptive. They are intended as a resource for imaging providers and their institutions to continue to provide high-quality patient care during times of shortage of contrast media. Providers and administrative leaders are encouraged to incorporate sound clinical judgment in all decisions affecting patient care.
The ACR recognizes that this is a rapidly evolving situation. Guidance may be revised as circumstances continue to change.
Practices with questions regarding the GE contrast media shortage are encouraged to contact their local GE diagnostic pharmaceutical representative who will have the most current information.
https://www.acr.org/Advocacy-and-Economics/ACR-Position-Statements/Contrast-Media-Shortage
Strong interest in presentations given by Schmainda lab (MCW) members at this week's
@ISMRM
meeting in London. In particular were
@IQAI_IB
's quantitative Delta T1 (patent-pending) and MR DSC perfusion-derived "FTB" mapping approaches. Next week, we will be at
@TheASNR
in NYC.
https://twitter.com/IQAI_IB/status/1524014636730826752
Greybadger ? What do you mean pps? companies house is still showing as active for dr Andrew James Bowen
Major Highlights
· Early in 2021, we aligned and focused resources to accelerate the development of IB Zero G™, the Artificial Intelligence (AI) model for generating simulated "with contrast" images using non-contrast (0% gadolinium) images as input. The effort included the labelling of many datasets necessary to be used to perfect the AI model. Sufficient progress was made throughout the year and a 510(k) application to the US FDA is in now in preparation with submission for approval anticipated in May '22.
· Last April 2021, we announced the sponsorship of a Phase I clinical trial. The trial follows a successful pre-clinical study that showed that the potential therapeutic compound Gallium Maltolate (GaM) shrunk glioblastoma (GBM) cells in animal models. In June 2021, the FDA approved the investigational new drug (IND) application for GaM and the treatment of the most aggressive form of brain cancer, GBM, and the first-in-human trial of an oral form of GaM has now commenced in the USA.
· In April 2021, a $3 million grant was awarded in collaboration with Professor Kathleen Schmainda, PhD, from the Medical College of Wisconsin (MCW). The National Institutes of Health (NIH)-funded grant will be used to validate and translate an AI model that can detect infiltrating tumour cells before they are visible on standard imaging. This would represent the ultimate in early detection.
· In June 2021, we were awarded a US patent for the AI technology contained in IB Zero G™. This 0% contrast media dose approach has the potential of offering remarkable benefits which include a more comfortable patient experience, more productive radiology departments, and reduced risks associated from the long-term, albeit uncertain, side effects of repeated GBCA use.
· In September 2021, we received a European patent for IB's "dual-echo" technology. Previously patented in the US, this technology combines MR scanner data acquisition and post-processing to generate two unique sets of data that currently require two independent MR exams. In addition, the technology eliminates the need for the commonly accepted "pre-load" dose of gadolinium-based contrast agent and minimizes other imaging artefacts inherent with this type of imaging. The advancement of this technology is being done in collaboration with the Barrow Neurological Institute under a funded NIH grant. An additional aim of the grant is to harmonize this approach across all major scanner platforms.
· In November 2021, MD Anderson Cancer Centre (University of Texas, Houston) adopted IB Clinic - container edition. MD Anderson is consistently ranked as the #1 cancer centre in the USA and is a recognized leader in using cutting edge technologies in an attempt to improve patient outcomes. This installation again underscores the significance of the automated and quantitative capability of IB Clinic - container edition.
Lots to look forward to!
GLA
IB Neuro's advanced MR imaging has been shown repeatedly to distinguish tumor from treatment using MRI data alone. Automated & quantitative, enables direct longitudinal comparison too.
PET superior to MRI for meningioma treatment planning via
@AuntMinnie
https://twitter.com/IQAI_IB/status/1518590548860452864
We should get confirmation of $2m receive, by end of next week. As 30 days are up
“The funds due under the Subscriptions are contracted to be received within 30 days, at which point an update announcement will be made”.
Richard Shearer, Tintra CEO, said, "This investment from the family of a renowned New York based private equity professional is perhaps the strongest validation we have yet received of the substance and future of our model and execution plans.
The board of directors of Tintra (the "Board") is pleased to confirm that further to the announcement of 7 March 2022 (the "Announcement"), that it has received the subscription agreements under the current funding round for a further US$2,000,000 (the "Subscriptions"). As set out in the Announcement, these are the Family of the private equity professional based in New York City, who has already agreed to invest $250,000, and consists of two investments of $1,000,000 each by separate limited liability companies. This brings the total investment by the Family or related entities to US$2,250,000, not the $2,275,000 provided in the Announcement. The investment has no conditionality.
https://virtualtrials.org/newsarticle.cfm?item=7231…
"This exciting clinical trial has recently opened for patients with relapsed or refractory Glioblastomas. The
@AlMusella
Foundation has funded early work on this drug, and we had a webinar about it. See..."
https://virtualtrials.org/video2021.cfm?video=202105
Nice recognition for Kathleen Schmainda PhD,
@aimbe
Fellow, and her involvement in the Phase I Clinical Trial by The American Institute for Medical and Biological Engineering.
With over a decade of experience in quantitative brain tumor imaging analysis, including analysis for several national multi-center trials, Imaging Biometrics will provide image analysis solutions for evaluating the response to GaM. "We are working with an excellent team of scientists and clinicians, and everyone is eager to move this study forward," says Michael Schmainda , CEO of Imaging Biometrics.
The trial, being conducted at Froedtert & the Medical College of Wisconsin, is currently accepting participants and has an anticipated completion date of December 2025.
Results from pre-clinical research show iron-like compound holds promise for treating patients with glioblastoma, an aggressive brain cancer
MILWAUKEE , April 8, 2022 /PRNewswire/ -- A novel therapy studied at the Medical College of Wisconsin (MCW) Cancer Center has led to a clinical trial for the treatment of glioblastoma, a rare and aggressive form of brain cancer, yet the most common primary brain tumor in adults.
Despite decades of research globally, only incremental gains have been made to extend or enhance quality of life for patients with glioblastoma. Treatment options are limited and typically include a combination of surgery, radiation therapy, and chemotherapy. Now, a new clinical study open at Froedtert & the Medical College of Wisconsin will evaluate an alternative treatment that is administered orally.
The treatment evolved from years of research led by Christopher Chitambar, MD, and his lab to study iron-dependent processes in cancer biology and the mechanisms by which gallium compounds target iron metabolism and block malignant cell growth. In preclinical studies, Drs. Chitambar and Kathleen Schmainda, PhD, discovered that gallium maltolate (GaM) significantly slowed the growth, and reduced the size, of glioblastoma.
GaM, originally developed by Harvard and Stanford educated scientist Lawrence R. Bernstein, PhD, is an orally available form of the metal gallium, which, in the body, shares many chemical properties with the highly oxidized form of iron, called Fe(III). Numerous studies examining the relationship between iron and cancer show that increased levels of iron in the body can be associated with increased cancer risk and severity, because cancer cells depend on iron to multiply and spread. Because of gallium's similarity to Fe(III), it enters cancer cells instead of iron, preventing their multiplication.
"The discovery that GaM has anticancer activity against glioblastoma in pre-clinical studies is extremely exciting; it opens the door for developing it as a drug for treatment of glioblastoma in patients," says Christopher Chitambar, MD, Emeritus Professor of Medicine and Biophysics, Division of Hematology and Oncology at MCW. "The anticancer mechanism of GaM applies to other solid tumors as well," he adds.
Jennifer Connelly, MD, Associate Professor of Neurology at MCW, is Principal Investigator (PI) of the clinical trial with Dr. Chitambar serving as co-PI and Chair. Both are long-standing collaborators with Kathleen Schmainda, PhD, a co-founder of Imaging Biometrics, LLC, and a recognized leader in brain tumor imaging. Dr. Bernstein is participating as a co-investigator.
The trial is being sponsored by Imaging Biometrics with supporting grants from the Musella Brain Tumor Foundation and the MCW Cancer Center. Based in Elm Grove, WI, Imaging Biometrics is a wholly owned subsidiary of IQ-AI Ltd.
With over a decade of experience in quantitative brain tumor imaging analysis, including analysis for sever
Experimental: Dose-escalation Phase (1,500 mg)
This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.
Experimental: Dose-expansion Phase
A minimum of six participants will be enrolled in the dose expansion phase for a total of 12 subjects at the recommended phase 2 dose.
Primary Outcome Measures :
1 Maximum-tolerated dose. [ Time Frame: Each 28-day cohort ]This will be determined from the incidence of dose limiting toxicities at each dosage.
Secondary Outcome Measures :
1 Progression-free survival [ Time Frame: 6 months ]This measure is the number of months participants remain free from evidence of disease. Imaging will be done every eight weeks and reported at six months.
2 Overall survival [ Time Frame: 6 months ]Overall survival is determined as the average number of months subjects survived following enrollment.
3 Dose-limiting toxicity [ Time Frame: 28 days for each cohort ]Number of participants experiencing a dose limiting toxicity.
Experimental: Dose-escalation Phase (500 mg)
This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.
Experimental: Dose-escalation Phase (1,000 mg)
This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.
#IQAI $IQAIF
IB Neuro accurately measures cerebral blood volume (CBV) from MRI data (perfusion MRIs) and provides information to help your doctor make a more accurate diagnosis of your tumor and provides more accurate and personalized treatment monitoring
https://twitter.com/kaneinthename/status/1507703944415522825
Shout out to
@VslsKatsaros
for showing the utility of IB’s quantitative FTB maps for accurately monitoring treatment response. This talk was given at the SBMT (Society of Brain Mapping and Therapeutics) that took place in Los Angeles on Sunday.
Delta T1 maps (patent pending) help alleviate "tired eyes" and prevent burnout experienced by radiologists. They can also be used to assess new biomarkers: https://mdpi.com/1542604
Quantitative Delta T1 maps take the guesswork out of pre- and post-contrast reads.
@MDPIOpenAccess
https://twitter.com/IQAI_IB/status/1503763473901277189
An exciting journey begins...
@gbmfoundation
@NBTStweets
@theABTA
@CancerSupportHQ
@CancerHopeNet
@TBCGBrainCancer
@curemotive
@IvyFoundation
@AlMusella
https://twitter.com/IQAI_IB/status/1502362662105194497