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Monthly Archives: April 2022
Global $33+ Billion CAR-T Cell Therapy Markets, 2017-2021 & 2022-2027: Focus on Yescarta, Kymriah, Tecartus, Breyanzi, Abecma – GlobeNewswire
Posted: April 6, 2022 at 2:00 am
Dublin, April 05, 2022 (GLOBE NEWSWIRE) -- The "Global CAR-T Cell Therapy Market, By Product Type, By Tumor Type, By Indication, By Treatment Type, By Targeted Antigen, By End User, By Region, Competition, Forecast and Opportunities, 2017-2027" report has been added to ResearchAndMarkets.com's offering.
The Global CAR-T Cell Therapy Market value in the year 2021 was valued at USD1709 million that is anticipated to grow with CAGR of 64.66% during the forecast period, 2023-2027 to achieve market value of USD33153.30 million by 2027F.
Increasing instances of cancer among the world population and thus increasing death rate due to cancer is driving the growth of the Global CAR-T Cell Therapy Market in the upcoming five years. Rapidly growing clinical trial activities, proliferative M & A activities, and lucrative IPOs are majorly responsible for the growth of the Global CAR-T Cell Therapy Market in the next five years.
Consistent researches on cancer and its treatment along with the advancement in the therapeutics are further substantiating the growth of the Global CAR-T Cell Therapy Market in the future five years. Increasing demand for the effective cancer treatment for the growing number of people suffering from cancer along with the flourishing pharmaceutical industry producing products and therapies for the cancer are also responsible for the growth of the Global CAR-T Cell Therapy Market in the forecast years through 2027.
Although side-effects of the CAR-T cells therapy and high cost of treatment making it unaffordable to the financially challenged population may restrain the growth of the market. Government schemes, tax incentives, along with insurance policies for the treatment and increasing number of NGOs working for providing in-expensive treatment to the patients lacking financial support may aid the growth of the Global CAR-T Cell Therapy Market in the forecast period.
The Global CAR-T Cell Therapy Market is segmented by product type, tumor type, indication, treatment type, targeted antigen, end-user, regional distribution, and competition landscape. Based on treatment type, the market is further segmented into single treatment and combination treatment.
Single treatment is anticipated to hold the largest revenue shares of the market and dominate the market segment in the upcoming five years on grounds of increasing cases of cancer among the population. Increasing awareness about the cancer diagnostics and early recognition of the tests are responsible for the patients opting for single treatment.
Cancer in early stages can be treated with single treatments. The combination treatments are recent developments where multiple therapies are involved together to stop the cancer tumor development, to remove the lumps, and even alter the genetic information.
Objective of the Study:
Report Scope:
Years considered for this report:
CAR-T Cell Therapy, By Product Type:
CAR-T Cell Therapy Market, By Tumor Type:
CAR-T Cell Therapy Market, By Indication:
CAR-T Cell Therapy Market, By Treatment Type:
CAR-T Cell Therapy Market, By Targeted Antigen
CAR-T Cell Therapy Market, By End-User:
CAR-T Cell Therapy Market, By Region:
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global CAR-T Cell Therapy Market.
For more information about this report visit https://www.researchandmarkets.com/r/bg6oxl
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Global $33+ Billion CAR-T Cell Therapy Markets, 2017-2021 & 2022-2027: Focus on Yescarta, Kymriah, Tecartus, Breyanzi, Abecma - GlobeNewswire
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Neurona Therapeutics Presents Preclinical Data at the American Academy of Neurology (AAN) Annual Meeting from Lead Cell Therapy Candidate, NRTX-1001,…
Posted: April 6, 2022 at 2:00 am
Neurona Therapeutics
SAN FRANCISCO, April 01, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced the presentation of preclinical data from its lead inhibitory neuron cell therapy candidate, NRTX-1001. NRTX-1001 is being evaluated in a Phase 1/2 clinical trial in people with drug-resistant mesial temporal lobe epilepsy. The data are being presented at the annual meeting of the American Academy of Neurology (AAN) held April 2-7, 2022 in Seattle, WA.
These studies were part of an important body of work that supported the design of our first-in-human clinical trial and provided important insight into potential biomarkers using magnetic resonance spectroscopy (MRS) to correlate neurometabolic changes with seizure reduction following NRTX-1001 administration, said Cory R. Nicholas, Ph.D., Neuronas president and chief executive officer. We are excited to have begun recruiting for the clinical trial and to evaluate the safety and efficacy of NRTX-1001, which has the potential to improve quality of life for people living with drug-resistant focal epilepsy.
The data, generated from a single targeted administration in a preclinical model of chronic mesial temporal lobe epilepsy, demonstrate that the NRTX-1001 inhibitory neurons persisted in the epileptic hippocampus for the duration of the 7-month study, were well-tolerated, and resulted in significant seizure suppression. The activity of NRTX-1001 was not perturbed by co-administration of the common anti-seizure drugs levetiracetam or diazepam. Moreover, the NRTX-1001-treated group exhibited significantly less mortality and reduced hippocampal sclerotic pathology compared to controls. Of translational relevance as a potential biomarker of seizure reduction, non-invasive 1H MRS analysis revealed a metabolic signature of the epileptic hippocampus that was corrected to normal, non-epileptic levels following NRTX-1001 administration.
About Neuronas Clinical Trial of NRTX-1001 for MTLENeuronas multi-center, Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant mesial temporal lobe epilepsy (MTLE). The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE. The second stage will consist of a randomized, blinded investigation of NRTX-1001 compared to a control group to determine safety and efficacy in up to 30 people with MTLE. Patient recruitment is underway at epilepsy centers across the United States. For more information, please visit http://www.clinicaltrials.gov (NCT05135091).
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About NRTX-1001NRTX-1001 is a regenerative neural cell therapy derived from human pluripotent stem cells. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Delivered as a one-time dose, the human interneurons are intended to integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyperexcitable neural networks that underlie epilepsy, as well as other disorders of the nervous system.
About Mesial Temporal Lobe Epilepsy (MTLE)MTLE primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. MTLE is the most common type of focal epilepsy. For some people with seizures that are resistant to drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or ablated by laser, can be an option. However, the current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects.
About NeuronaNeuronas regenerative neural cell therapies have single-dose curative potential. Based on a novel neural cell lineage developed by the companys scientific founders, Neurona has built a robust regenerative platform and is developing off-the-shelf, allogeneic neuronal, glial, and gene-edited cell therapy candidates that provide long-term integration and repair of dysfunctional neural networks for multiple neurological disorders. For more information about Neurona, visit http://www.neuronatherapeutics.com
Neurona TherapeuticsInvestor and Media Contacts:
Sylvia WheelerWheelhouse LSAswheeler@wheelhouselsa.com
Elizabeth Wolffe, Ph.D.Wheelhouse LSAlwolffe@wheelhouselsa.com
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Neurona Therapeutics Presents Preclinical Data at the American Academy of Neurology (AAN) Annual Meeting from Lead Cell Therapy Candidate, NRTX-1001,...
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Syncona : Resolution Therapeutics and panCELLa Inc announce a Research Evaluation & Option Agreement to develop iPSC-derived macrophage cell…
Posted: April 6, 2022 at 2:00 am
Granting Resolution an Option to a Commercial License to panCELLa's FailSafe and iACT StealthCells Technology
London and Toronto, 5 April, 2022 - Resolution Therapeutics Limited ("Resolution"), a biopharmaceutical company developing macrophage cell therapy to treat advanced liver disease, and panCELLa Inc, ("panCELLa") a private biotechnology company which makes cell lines incorporating therapeutic cell-focused Platform Technologies that are widely available for the treatment of degenerative, infectious and malignant diseases, today announced a research collaboration to develop iPSC-derived macrophage cell therapies. Under the agreement, panCELLa is providing its hypo-immunogenic engineered iPSC technology to Resolution. Resolution is using its proprietary macrophage engineering and manufacturing technology to develop "off-the-shelf" macrophage cell therapies. As part of this agreement Resolution has an option to obtain commercial rights to use the panCELLa technology in the field of macrophage biology.
panCELLa, a specialist in developing cell-based therapies for a broad range of diseases, provides safe therapeutic cell products. Under the terms of the collaboration, Resolution will have access to two of panCELLa's platforms, FailSafeTM and induced Allogeneic Cell Tolerance (iACT Stealth CellsTM), which paves the way for Resolution to progress the development of its allogeneic macrophage programme, expanding the Company's pipeline with iPSC-derived macrophages. This technology has the potential to guarantee long term engraftment of cells, which, in turn, could enable an unprecedented level of safety. Specifically, the iACT Stealth CellsTM protect the implanted cells from the patient's immune system offering long-term allogeneic-tolerance without the need for immune suppression. FailSafeTM is a superior safety switch. Unlike others, it will not be lost or silenced as it is precisely linked to cell division. Any time that cells deregulate or "go rogue" they can be eliminated while still allowing the therapeutic non-dividing cells to continue to do their work.
"We are thrilled to partner with panCELLA, a pioneer in the development of safe iPSC-derived cell therapies," said Edward Hodgkin, Chairman and CEO of Resolution. "We believe panCELLa's technology has the potential to overcome the dual challenge of preventing host immune rejection of allogeneic cell therapy, while adding to their safety, which will be key to delivering durable patient benefit."
"Resolution technology and innovation are impressive and we believe in their plan for the development of macrophage cell therapy for advanced liver disease," said Mahendra Rao, Chairman of panCELLa." Resolution is well-positioned to develop off-the-shelf products that maintain optimal macrophage function with prevention of immune rejection, which are critical for persistent engraftment of cells and clinical benefit."
Resolution is developing macrophage cell therapies to repair inflammatory organ damage, with a focus on treatment of end-stage chronic liver disease. Macrophages are cells of the innate immune system which orchestrate the body's defence against infection and injury; the company is built upon more than a decade of work in the Founders' laboratories characterising the role of macrophages in organ repair, including the liver, both in the pre-clinical and clinical settings.
panCELLa aims to make its therapeutics cell focused Platform Technologies widely available for the treatment of degenerative, infectious and malignant diseases. panCELLa continues its internal R&D efforts to develop additional novel uses of its platform technologies in areas such as bio-production, cancer vaccination and tolerization.
The terms of the collaboration have not been disclosed.
- Ends -
Further information:
JW Communications
Julia Wilson
+44 (0)7818 430877
Notes for Editors:
About Resolution
Resolution Therapeutics is a biotechnology company developing macrophage cell therapies to treat advanced liver disease. The Company is built upon more than a decade of work in the Founders' laboratories characterising the role of macrophages in organ repair, including the liver, both in the pre-clinical and clinical settings. Resolution will discover, develop, and take to market macrophage cell therapies based on its proprietary platform of macrophage biology, cell engineering and manufacturing processes. http://www.resolution-tx.com
About panCELLa
Founded in 2015, panCELLa is a privately-held early-stage biotechnology firm based on the innovative technology developed in Dr. Andras Nagy's lab at the Sinai Health System (SHS). panCELLa has created platforms that allow for the development of safe, universal, "off-the-shelf" cell lines. To learn more, visit https://pancella.com
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Syncona : Resolution Therapeutics and panCELLa Inc announce a Research Evaluation & Option Agreement to develop iPSC-derived macrophage cell...
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First Patient With Lymphoma Receives Novel Cell Therapy in Large-Scale Trial – Curetoday.com
Posted: April 6, 2022 at 1:56 am
The first patient with lymphoma received treatment with AB-205 in the phase 3 E-CELERATE trial assessing the novel cell therapy with high-dose chemotherapy and blood stem cell transplantation, according to a press release from Angiocrine Bioscience, the manufacturer of the therapy.
AB-205 is a genetically engineered cell therapy that is administered intravenously and consists of allogeneic engineered human endothelial cells. It is currently being assessed in the E-CELERATE trial, in which researchers will evaluate the efficacy and safety of this cell therapy for the treatment of damaged organ vascular stem cell niches from high-dose chemotherapy. Researchers will also see whether the cell therapy can prevent the progression of severe multiorgan complications, which can potentially prolong hospitalization and can be life threatening, according to the release.
According to the trials ClinicalTrials.gov listing, researchers estimate to enroll 148 patients aged 40 years and older with lymphoma. Patients who will be assigned treatment with AB-205 or placebo, and both groups will be treated with standard-of-care preventive and supportive therapies. All patients enrolled in the trial will be candidates for high-dose chemotherapy and autologous hematopoietic cell transplantation.
We are excited to initiate this pivotal phase 3 study, said Dr. Paul Finnegan, chief executive officer of Angiocrine Bioscience, in the release. We look forward to continuing to work with many of the leading cancer centers in the United States as we advance into the final clinical stages of this exciting program.
Patients with lymphoma are often treated with high-dose chemotherapy followed by blood stem cell transplantation with the intention to cure, according to the trials ClinicalTrials.gov listing. Despite this approach, high-dose chemotherapy may cause damage to health tissues resulting in complications related to the immune system, blood, gastrointestinal systems and other organs.
The estimated study completion date for the E-CELERATE trial is January 2023, according to ClinicalTrials.gov.
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Approval Sought for Ibrutinib Combination in Patients With Mantle Cell Lymphoma – Targeted Oncology
Posted: April 6, 2022 at 1:56 am
An application seeking the approval of a new indication for the combination of ibrutinib, bendamustine, and rituximab in adult patients with previously untreated mantle cell lymphoma has been submitted.
A Type II variation application seeking the approval of a new indication for the combination of ibrutinib (Imbruvica), bendamustine, and rituximab (Rituxan) in adult patients with previously untreated mantle cell lymphoma (MCL) who are not candidates for autologous stem cell transplant (ASCT) has been submitted to the European Medicines Agency (EMA).1
Findings from the phase 3 SHINE trial (NCT01776840), which examined the combination in patients with newly diagnosed MCL aged 65 years or older, is the basis of the application. Results showed that the combination demonstrated a significant improvement in progression-free survival (PFS) compared to rituximab alone.
MCL can be a difficult blood cancer to treat, and despite progress in this area of the last few years, an unmet need remains for new treatment approaches, Edmond Chan, MBChB, MD (Res), EMEA therapeutic area lead hematology, at Janssen-Cilag Limited, stated in a press release. This submission to the EMA is a testament to our commitment to deepening the impact ibrutinib can have for patients and represents an important step toward providing patients and health care professionals with the addition of targeted therapy to standard therapy.
The trial included 523 participants with MCL who had clinical stage II, III, or IV disease by Ann Arbor classification.2Eligibility for participation was open to patients with at least 1 measurable site of disease, and an ECOG performance status of 0 or 1. Additionally, patients could not have received prior therapies for their disease.
Patients were randomized 1:1 to receive either ibrutinib or placebo, both in combination with an open-label bendamustine plus rituximab background treatment for a maximum of 6 cycles. Of the participants who achieved a complete (CR) or partial response (PR), open-label background therapy with rituximab maintenance was continued every second cycle for up to 12 additional doses. Patients then received ibrutinib or placebo in addition to this background treatment.
In the experimental treatment arm, bendamustine was given intravenously (IV) at a dose of 90 mg/m2 on days 1 and 2 of cycles 1 through 6, and IV rituximab was delivered at a dose of 375 mg/m2on day 1 of cycles 1 through 6. If either CR or PR was achieved at this time, patients were administered rituximab at the same dose on day 1 of every second cycle for up to 12 additional doses. Additionally, ibrutinib was given orally, once a day at a dose of 560 mg, continually starting on day 1 of cycle 1. Either combination was given until progressive disease, intolerable toxicity, or study completion.
If stable disease following initial chemoimmunotherapy was achieved, patients continued to receive ibrutinib or placebo until progressive disease, intolerable disease, or study end. Patients who experienced disease progression needed to discontinue study treatment.
The primary end point of the trial was PFS, with secondary end points including overall survival, overall response rate, minimal residual disease negativity rate, duration of response, time to next treatment, number of participants affected by adverse events, toxicity, and other various pharmacokinetic measures.
The trial, which met its primary end point, will have its data shared at an upcoming medical conference, according to a press release issued by the Janssen Pharmaceutical Companies of Johnson & Johnson.
As the first approved BTK inhibitor, ibrutinib has now been used to treat more than 250,000 patients globally. It is also the first BTK inhibitor to be studied as a frontline treatment option for patients with MCL. We are committed to the continued development of ibrutinib in B-cell malignancies where unmet needs remain in our efforts to make meaningful differences and change outcomes for patients, Craig Tendler, MD, global head of late development, Diagnostic & Medical Affairs, Hematology & Oncology, at Janssen Research & Development, LLC, added in the press release.
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Approval Sought for Ibrutinib Combination in Patients With Mantle Cell Lymphoma - Targeted Oncology
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Bayer reloads Leaps with 1.3 billion to step up investments in biotech innovation – MedCity News
Posted: April 6, 2022 at 1:56 am
Over the past seven years, Bayers investment arm has infused 50-plus companies with more than 1.3 billion. Leaps by Bayer is accelerating its dealmaking pace and Bayer is committing another 1.3 billion, which the multinational corporation estimates will fuel its investment vehicle for two more years.
Bayer announced the capital commitment on Friday during the companys Breakthrough Innovation Forum, an event that covered the corporations plans in healthcare and agriculture. Those two fields were the core focus areas when Bayer formed Leaps in 2015, aiming to invest in companies developing breakthrough solutions to big challenges facing humanity, challenges that the corporation termed leaps. At the start, Bayer identified 10 leaps. The healthcare leaps span genetic diseases; organ and tissue replacement; cancer; neurological disorders; autoimmune diseases and inflammation; and the application of data to health.
Leaps has not tipped its hand on its plans for future investments. But if Bayers dealmaking in recent years is any indication, cell and gene therapies are likely bets. In 2019, Bayer fully acquired BlueRock Therapeutics, a cell therapy developer it had formed three years earlier as a joint venture with venture capital firm Versant Ventures. A BlueRock cell therapy in development for Parkinsons disease began clinical testing last year. BlueRock develops off-the-shelf therapies from induced pluripotent stem cells. The experimental cell therapy DA01 is comprised of neurons that produce dopamine that Parkinsons patients lack. These cells are surgically transplanted in the brain, where its hoped they will produce dopamine and potentially offer a superior alternative to the older dopamine substitutes that are part of the current standard of care.
Bayers gene therapy investment includes the commitment of up to $4 billion to acquire AskBio, a gene therapy biotech whose pipeline most advanced programs are for Parkinsons and the neuromuscular disorder Pompe disease. And earlier this year, Bayer struck up a partnership that enables it to use Mammoth Biosciences CRISPR to develop new in vivo gene editing therapies. The initial focus of the Mammoth alliance is liver diseases. Bayer hasnt abandoned traditional small molecule drugs, but its toolbox for discovering them. Last August, Bayer paid $1.5 billion up front to acquire Vividion Therapeutics, a biotech whose technology finds binding pockets on proteins that had been considered undruggable.
In an interview during the J.P Morgan Health Care Conference in January, Christian Rommel, the head of research and development of Bayers pharmaceuticals division, told MedCity News that Bayers investments are part of a broader strategic transformation oriented around innovative new medicines, some of them in new modalities. Rommel said Bayer will look for additional acquisitions or partnerships that fit this strategy.
Its now in our DNA, he said. We will continue to look for things that enhance our capabilities and success of our pipeline.
Cell therapy investments by Leaps include Indapta, a biotech that is researching therapies employing natural killer immune cells. The most recent Leaps cell therapy investment is Affini-T Therapeutics. In late March, Leaps co-led a $175 million investment the startup, which is based on cell therapy research from the Fred Hutchinson Cancer Research Center.
Leaps has also deployed its cash toward artificial intelligence. It was among the investors in AI-based biotech company Recursion, which went public last year. Other companies whose AI drug discovery work has financial backing from Leaps include Dewpoint Therapeutics, which employs AI to develop biomolecular condensate drugs. Leaps has also shown interest in new approaches to developing protein drugs, co-leading the investment rounds of GRObio and Gandeeva Therapeutics.
The interest of Bayers investment arm in AI extends to healthcare software. Last summer, Leaps led a $90 million investment in Ada, a German startup that is developing AI-based software for checking symptoms. Leaps is also an investor in Transcarent, a healthcare navigation formed started by Livongo Health founder Glen Tullman.
Photo by Flicker user Bex Walton via a Creative Commons license
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Support for blood cancer patients is thin. This needs to change – TimesLIVE
Posted: April 6, 2022 at 1:56 am
While South Africans recently observed Human Rights Day, the notion of basic human rights continues to be a global topic of contention, particularly as the World Health Organisation (WHO) asserts that health is a fundamental human right.
The organisations director-general, Dr Tedros Adhanom Ghebreyesus, expands on this notion well, explaining that enjoying the highest attainable standard of health is a fundamental right of every person.
In SA, the publics right to health is protected by Section 27a of the constitution, which declares that everyone has the right to access to healthcare services. While this is embedded in our rights as citizens, it is often our misinterpretations and the failures of providers that lead to the collapse of such rights.
The right to adequate healthcare is particularly relevant when addressing dread diseases such as cancer, where specialised medical interventions can prolong or save a life. Most notable is the need for interventions to address more pressing cancers, such as hematologic malignancies, or blood cancers. These are orphan diseases and are not nearly as common as the more predominant types, such as breast and prostate cancer.
All cancers require immediate intervention, but once blood cancer is detected in a patient, the clock starts ticking to seek appropriate treatment. While conventional intensive treatments such as chemotherapy have proven useful, they can only drive the disease into remission and patients have a high likelihood of relapse.
Treatments such as blood stem cell therapy have a high probability of eradicating the disease. However, there have been challenges to the procedure in SA.
The department of health promulgated the Medical Schemes Act 131 in 1998, which featured an annexure that defines what stem cell transplantation is and how patients would qualify. It also noted that the act would be reviewed and updated every two years. However, this has not happened.
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Support for blood cancer patients is thin. This needs to change - TimesLIVE
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Addition of Lenalidomide to SOC Shows Feasibility, Safety in MDS, AML and CMML – Targeted Oncology
Posted: April 6, 2022 at 1:56 am
AZALENA trial shows encouraging response rates, duration of response and survival including patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, and acute myeloid leukemia with MDS-related changes.
Following allogenic stem cell transplant (allo-SCT), lenalidomide (Revlimid) at a dose of 5 mg a day can be added safely to the standard of care combination of azacitidine (Vidaza) and donor lymphocyte infusions (DLI) as salvage therapy for patients with relapse of myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) with MDS-related changes, results from the phase 2 AZALENA study (NCT02472691) show.1
The open-label, single-arm, multicenter study investigated the safety and feasibility of lenalidomide in addition to the standard therapy of azacitidine and DLI as first salvage therapy for this patient population.
We have seen encouraging response rates, duration of response and survival including patients with early and/or hematologic relapse in AZALENA. Azacitidine, lenalidomide and DLI favorable modulated the balance between GvHD and [graft-versus-leukemia; GvL] and is an efficient treatment option for patients with myeloid neoplasms relapsing after allogeneic stem cell transplantation which should be further investigated in randomized trials, stated Thomas Schroeder, MD, assistant professor, section head, Department of Internal Medicine, Division of Hematology/Oncology, medical director of Radiation Oncology, University of New Mexico, during an presentation of the data at the 48th Annual EBMT Meeting.
AZALENA enrolled 50 participants aged 18-99 with first relapse of de novo or therapy-related MDS, CMML or AML in various participating centers across Germany.2 Other requirements for inclusion in the study included possibility of DLI, no previous therapy for relapse after allo-SCT, an ECOG status of 0-2, and no uncontrolled infection at the time of enrolment.
Of the patients enrolled in the trial, the median age was 63 years. Forty-six percent of the patients with AML (n = 23), 48% with MDS (n = 24) and 6% with CMML (n = 3). A majority of patients (72%) were not in remission at the time of transplantation but received standard-dose conditioning (68%).
Patients included in the study received a median of 275 treatment cycles and were given azacitidine as a standard of care at 75 mg for 7 days every 28 days for up to 8 cycles. DLIs were then administered after cycle 4, 6 and 8 at a dose of 5-10x105CD3+/kg (1st DLI), 1-5x106CD3/kg (2nd DLI) and 5-15x106CD3/kg (3rd DLI).
The investigational drug, lenalidomide, was also started on day 1 for 21 days every 28 days for 8 cycles at most. A starting dose of 2.5 mg of lenalidomide per day was given to the first 10 patients. If no dose limiting toxicity was observed at the time of a first interim analysis, the next 10 patients were to be treated with 5 mg per day. In case of no DLT after a second interim analysis, the remaining 30 patients were treated with 5 mg per day.
The primary end point of the study was to evaluate safety including the number, types, and severity of adverse events (AEs), graft versus host disease (GvHD) and hospitalization. The secondary end point of the study examined safety in regard to response, duration of response, and overall survival.
Findings revealed there to be an overall response rate of 56% (n = 28). The time to complete response was 113 days seen in the 50% of patients with a median of 4 cycles. A total of 20 patients with CR had received DLI. Of the patients included, 6% showed a partial response. The median OS for all patients was 21 months and the 1-year OS rate was 65%. Patients who achieved remission had a superior survival versus 9.7 months.
In regard to toxicity, almost a third of the patients had either grade 3 or 4 neutropenia (30%) or thrombopenia (38%) at the time of study entry. Of the 275 treatment cycles, 246 included 89% of patients receiving the combination therapy, and in 29 cycles, lenalidomide was omitted in 5 patients (11%).
Lenalidomide-related AEs which were grade 3 or higher were seen in some patients including 38% of patients (n = 19) having to be hospitalized at some point in the duration of the trial. Grade 3 AEs seen in patients included infections (20%), febrile neutropenia (10%), gastrointestinal disorders (6%), and nervous system disorders (6%). Grade 4 AEs consisted of infections (4%) and febrile neutropenia (2%).
Looking at GvHD, 30% of the patients suffered from acute GvHD and 38% chronic GvHD. Time to GvHD onset was approximately 112 days the majority of patients with GvHD (77%, n = 20) had received DLI.
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Addition of Lenalidomide to SOC Shows Feasibility, Safety in MDS, AML and CMML - Targeted Oncology
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Facebook and radicalisation: how can we regulate the internet to prevent harm? – Stuff
Posted: April 6, 2022 at 1:55 am
Oh, hi! Long time no see! My name is Robbie and Im another white man behind a desk, and things are pretty bad, huh?
In case you never go outside and have these videos sent to your door on a USB delivered by a carrier pigeon, you might have missed a wee bit of a scuffle outside New Zealand Parliament. It turns out there were some folks there with some really interesting opinions! Would you like to meet them? I bet you wouldnt!
Its time to play Meet That Protestor!
[Spanish Flea starts playing. Robbie pulls out a thin old-school microphone.]
Bachelorette number one is Chantelle Baker! With nearly 100,000 Facebook followers, Chantelle well outnumbers her dad, former leader of the New Conservatives, who only has 52,000 Facebook followers. Embarrassing! Chantelle enjoys sharing live streams of peace and love that include other protestors saying, Were not leaving till we hang them. Baker disavows those protestors in the strongest possible terms by joining them and supporting their protest.
READ MORE:* The outing of an Internet troll showed women can win* The internet is no safer three years on from the Christchurch terror attack * We have failed to rein in social media's misinformation
Bachelor number two! Its the Freedom and Rights Coalition with 44,000 followers on Facebook. No wonder people love them! After all, they stand for Freedom and Rights. This might be Brian Tamakis group, but unfortunately, he cant make it because of all that breaking the law business. But dont worry! He could be your pen pal! The man writes beautiful letters warning New Zealanders that were heading down the path of UN ideology of socialism. After a walk down the path of socialism, why not go for a romantic walk down the beach with the Freedom and Rights Coalition!
Supplied/WhiteManBehindADesk
Satirist Robbie Nicol AKA White Man Behind A Desk details Facebook and radicalisation.
Bachelor number three is Counterspin Media NZ! Why not form a thruple with Kelvyn Alp and Hannah Spierer? Together you can fight the Deep State and the transhumanist agenda, and youre bound to win, because those things dont exist! Alp has lots to teach you about the moon landings, and hed love to buy you dinner with the money he makes selling weight loss pills and fraudulent vaccine passports. Maybe hell even tell you about the violent coup hes got planned. Shhh! Its a secret, but hell probably yell it to you in a livestreamed video being watched by police.
Congratulations! Youve made it to the protest! Now that youre here, why not get to know someone new? Introducing Bachelor number four, far-right white supremacist group Action Zealandia! Parliament changed security arrangements after video appeared to show these folks gaining access to a construction site in Bowen House. When theyre not helping protestors become Nazis, Action Zealandia enjoys organising terror cells, fighting hate speech laws, and grooming teenagers to join their white supremacist organisation! Action Zealandia isnt allowed to have a Facebook page any more, and Ill give you 10 guesses why.
What a friendly bunch.
Obviously, thats just a sample - theres also Billy Te Kahika, NZ Doctors Speaking Out with Science, or, more accurately, speaking without science, and a bunch of people exhausted and angry with Covid and the world in general who didnt know what else to do.
But! Were not going to be talking about police decisions in response to the protest or Speaker of the House Trevor Mallard playing games with the sound-system. Instead, were going to talk about how the protestors got there, because while there are a number of different factors that led people there, theres one thing that stands out above all else: Facebook.
Founder, CEO, and controlling shareholder of Facebook Mark Zuckerberg was determined to get people vaccinated. He and his wife, Priscilla Chan, have invested a lot of time and money into vaccination programmes, which makes it even sadder that his wee side-hustle, Facebook, turned so many people against them. Its like if Ronald McDonald became obsessed with encouraging healthy eating, but refused to give up his day job.
Facebook makes money in a similar way to a newspaper: users write content, Facebook publishes that content, they editorialise that content with an algorithm, and then they sell ad space around that content. For context, these ad sales accounted for nearly all of Facebooks $86 billion USD revenue in 2020.
Unlike a newspaper, Facebook doesnt pay its writers, fact-check its content, or spend much money on editorial oversight. The good part of this system is that you get to hear from people that newspapers wouldnt normally publish. The bad part is that you get to hear from people that newspapers wouldnt normally publish.
For example, last month was the three-year anniversary of the Christchurch shooting, which was streamed live on Facebook and seen by thousands of people.
In response to the shooting, Facebook re-established the GIFCT as an independent organisation with their frenemies Microsoft, YouTube, and Twitter. The GIFCT is focused on removing TVEC. Acronyms are fun! Unless they stand for Global Internet Forum to Counter Terrorism or Terrorist and Violent Extremist Content. Then theyre no fun at all.
The operating board of the GIFCT is made up of Facebook, Microsoft, Twitter, and YouTube (owned by Google). Its sort of like a cigarette company setting up a council to help us deal with all the lung cancer. Thanks, corporations! Where would we be without you helping us deal with the problem you cause for profit?
When one of these companies identifies a piece of content as TVEC through vague and unknowable means, they give it a hash, pop it on the database of hashes, and it goes out to the Hash Sharing Consortium. Now, the Hash Sharing Consortium might sound like a nerdy group of stoners, but it isnt. Its different.
Basically, tech companies give TVEC a digital fingerprint, so all the other major online service providers can be like, Oop, someones trying to upload a terrorist video. And they stop them from uploading the content.
People can then slightly edit that content and reupload it and then someone has to report the new content, get that new content uploaded to the hash database, and the whole process starts again. Its kind of like whack-a-mole, only instead of a mole, its the worst thing youve ever seen in your life.
The way these OSPs or Online Service Providers decide what counts as terrorist content is haphazard at best. When New Zealands Chief Censor, David Shanks, decides what content should be illegal, its an extremely delicate process. He has to decide whether sharing extremist imagery is an important part of exposing New Zealanders to the horrors of the world, or whether it may cause further harm. According to the Guardian, Youve got to protect freedom of expression, he says.
Youve got to protect this vital ability to have opinions, to spread them, to access information of any kind.
Dawid Sokoowski/Unsplash
In response to the shooting, Facebook re-established the GIFCT as an independent organisation with their frenemies Microsoft, YouTube, and Twitter, writes Robbie Nicol.
The only reason to diverge from that principle, ever, he says, is to prevent harm something he consults groups ranging from medical experts to high school students about.
Facebook has a different approach.
As of 2019, Facebook was paying people US$15 an hour to look at up to 400 posts a day of the worst stuff imaginable: beheadings, animal abuse, hate speech, and pictures of you with the flash on.
It was then up to these underpaid, traumatised workers to decide the cultural and political context of each post from countries all over the world, sometimes in languages they didnt understand. This led to genuine Nazi content being left up and people getting blocked for sharing photos of Taika Waititi from Jojo Rabbit. Thats not a joke, by the way, that actually happened.
This work is supplemented by machine learning that works perfectly. According to the Wall Street Journal, in leaked documents scientists pointed out the companys ability to detect the content in comments was bad in English, and basically non-existent elsewhere. So, as I said, perfect.
This work is also supplemented by a list of dangerous individuals and organisations, the terrorist section of which seems to be heavily copy-and-pasted from the US governments list of terrorists. This is good because the US government is totally unbiased and completely trusted by every country in the world.
And while these companies often leave up content they claim to have banned, theyre also taking down content that they shouldnt. In June 2017, YouTube announced a plan to combat terrorist content online, and it worked well. In fact, you could argue it worked too well.
To quote Wired: The quick flagging and removal of content appears successful. Unfortunately, we know this because of devastating false-positives: the removal of content used or uploaded by journalists, investigators, and organisations curating materials from conflict zones and human rights crises for use in reporting, potential future legal proceedings, and the historical record.
The thing is, censorship is hard. Its complicated and political and has enormous ramifications for democracy. Facebook isnt doing it properly, and theyre not being nearly transparent enough about how they do it.
But even worse than Facebooks inability to effectively remove harmful content is how they editorialise all the stuff thats left.
To understand why Facebook is such a great platform for radicalisation it helps to look at the changes they made to their algorithm in 2018. When I say the Facebook algorithm, I mean the code they use to decide what pieces of content they promote.
In the same way that a newspaper uses an editor to decide what goes on the front page, Facebook uses an algorithm to decide what goes at the top of your newsfeed.
Whats fun about the changes they made in 2018 is that Facebook pretended they were making these changes for the greater good. Unfortunately, internal documents suggest that instead of making these changes for the good of humankind, they were actually making the changes to increase profit, which was shocking to everyone involved.
In 2018, Facebook was worried about declining engagement". To quote the Wall Street Journal, the fear was that eventually, users might stop using Facebook altogether. A terrifying thought.
[Insert Lionel Hutz shuddering at the idea of a world without lawyers.]
So, Facebook switched things up. Now, an angry reaction was worth five times a like; a long passionate comment was worth twice a short comment saying, Good job!; an angry rant sharing the original content was worth 30 times a like and so on.
Glen Carrie/unsplash
Facebook uses an algorithm to decide what content appears at the top of your newsfeed.
In a public letter to Facebook, BuzzFeed CEO Jonah Peretti, the elder brother of Chelsea Peretti (FUN FACT!) complained that the change to the algorithm was forcing them to post increasingly controversial content to generate arguments in the comments.
In an internal report investigating the effects of the new algorithm on the politics of Poland, Facebook researchers wrote, One partys social media management team estimates that they have shifted the proportion of their posts from 50/50 positive/negative to 80 per cent negative, explicitly as a function of the change to the algorithm.
Staff at Facebook tried to come up with solutions, but again, quoting the Wall Street Journal, Mr Zuckerberg said he didnt want to pursue it if it reduced user engagement, according to the documents. What a piece of s....
The worlds most popular newspaper, Facebook, is a lawless hellscape that chooses its top stories based on how many complaints they get, and it turns out that has some negative consequences for the planet earth and the people who live there.
A landmark study in Germany looked at thousands of anti-refugee hate crimes and compared them to variables that might be relevant. These included wealth, demographics, support for far-right politics, newspaper sales, the number of refugees, history of hate crime and the number of protests. One variable stood out: Towns where Facebook use was higher than average reliably experienced more attacks on refugees.
Sometimes Facebooks ability to fuel hate crimes is even more extreme. Facebook was forced to admit that it played a role in inciting violence during the militarys genocidal campaign against the Rohingya in Myanmar. Just for some context here, inciting violence in a genocide is bad.
Similarly, in Ethiopia, an investigation by Vice said violence had been supercharged by the almost-instant and widespread sharing of hate speech and incitement to violence on Facebook, which whipped up peoples anger.
And then theres Covid-19. Again, Facebook wanted to stop the spread of misinformationthey gave free ads to the World Health Organisation and added links to accurate information on posts about the pandemic, but it wasnt enough to counteract the fundamental business model of Facebook. Publish content without editorial oversight and promote anything that drives engagement.
So, cool. Great. Facebook, the worlds most popular newspaper, might eventually stop publishing neo-Nazis like the folks at Action Zealandia, but they will actively promote anti-vaxxers because of all the people arguing in the comments, and once youre at the rally, Im sure there are some friendly dudes in brown shirts ready to say hi.
The problem is big, but, surprisingly, governments seem willing to tackle it anyway.
Law-makers in the EU proposed a law that would require online service providers to remove illegal content within one hour. It turned out to be pretty controversial, but as with most controversial actsthe French did it anyway. And this law doesnt just cover TVEC!
The BBC writes: Failure to remove content could attract a fine of up to 1.25m (1.1m). France's regulator, the Superior Council of the Audiovisual (CSA), will have the power to impose heftier fines of up to 4 per cent of global turnover for continuous and repeated violations.
For context, 4 per cent of Facebooks revenue in 2021 was nearly $5 billion USD. Thats quite a big fine.
The UK has put forward a white paper on statutory duty of care, arguing the platform that should be regulated not the content, including the design of the platform and the operation of the business. Secondly, the duty of care implies a risk assessment so that reasonably foreseeable harms are avoided where possible or mitigated.
Its written like that because the British are, unfortunately, British.
Here in New Zealand, were undergoing a review of content regulation and working on hate speech reform.
The Department of Internal Affairs has been put in charge of removing TVEC - forcing them to draw the line between radical politics and terrorism and the line between important journalism on the topic of terrorism and media used to promote terrorist acts.
Maybe thats something our Chief Censor and the Classification Office should decide, but there you go. Apparently, weve decided to give it to the Department of Internal Affairs, the department of government work that nobody else wanted to do.
Ultimately, we know that the GIFCT is insufficient, because social media companies are not going to voluntarily invest enough money to monitor what they share. We know that the Facebook algorithm is a worse editor than Rupert Murdoch, willing to throw anything on the front page that riles people up. And we know that this problem is not limited to Facebook, this s...show runs across multiple platforms that all basically run the same way.
But it took us a long time to figure out how to regulate television and radio and newspapers. And its going to take us a long time to figure out how to regulate the internet. These are enormous questions of democracy, and free speech, and protecting people from harm.
Everyone needs to be a part of this discussion.
So, if you wouldnt mind, maybe start a long pointless argument in the comments. Do all the different kinds of reactions you can think of. Reshare this video with a long speech youve copy-and-pasted from the internet.
Maybe that way we can get an important story on the front page.
White Man Behind A Desk is the work of satirist Robbie Nicol and playwright Finnius Teppett. See more at Patreon.com/WhiteManBehindADesk.
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Facebook and radicalisation: how can we regulate the internet to prevent harm? - Stuff
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The Power of Pain | Peter J. Leithart – First Things
Posted: April 6, 2022 at 1:55 am
Korean-born philosopher Byung-Chul Han completed his dissertation on Heideggers concept of Stimmung (mood) in 1994, and his early books were meditations on death and dying. Since the 2010 publication of Mdigkeitsgesellschaft (English title, The Burnout Society), now translated into a dozen languages, hes produced a steady stream of slender, poetic works of cultural commentary that track the transformations of human experience weve suffered as we adjust to the digital age. My task as a philosopher, he says, is to explain what kind of society we live in. Philosophy is truth-speaking.
In Burnout Society, Han contrasted the immunological paradigm of the twentieth century with the neuronal culture of the twenty-first. In a politics of immunology, everything foreign is simply combated. . . . even if it has no hostile intentions, even if it poses no danger, it is eliminated on the basis of its Otherness. Weve outgrown all that, we in our twenty-first-century adulthood. More and more, Han claimed, we live in a society where otherness and foreignness have disappeared. Foreign has morphed into exotic, and weve become tourists of difference. Along the way, weve outgrown barriers. The old world was marked by borders, transitions, thresholds, fences, ditches, and walls that prevent universal change and exchange. The twenty-first century began a decade early with the removal of a wallin Berlinand globalized hybridization has since displaced the regime of immunization. We now live in a world without walls.
Hans reflections havent aged well. Walls are back in style, partly in reaction to a real pandemic. But his claim that our neuronal age will be plagued by pathologies deriving from an excess of positivity is more plausible. In place of threats from the Other, we face too-much-of-the-Same, surplus positivity. Han has in mind both the homogenization of culture and the surfeit of goods, the overproduction, overachievement, and overcommunication enjoyed by globalizations winners. Excess hasnt made us happy, or even free. Were no longer subjects of a Foucauldian disciplinary society; rather, hedonism has itself become a principle of domination, represented for Han by that omnipresent data-collector, the smartphone. A new form of human existence has emerged, the self-projecting, even self-optimizing subject, driven not by external compulsion but by the internal pressure to achieve and to display achievement. Always on, we suffer from exhaustion, fatigue, and suffocationin a word, Mdigkeit or burnout.
This overstressed achievement self in the neuronal age is in the background of Hans 2021 The Palliative Society, an elegant Jeremiad against algophobia, the fear of pain that now occupies our souls. Humans have always avoided painful conditions, but today our instinct to recoil has been institutionalized. Pain has no meaning; it lies entirely outside the symbolic system. Playgrounds are cushioned or cordoned for safety. Entertainment and social media keep us in a continuous state of anesthesia. We avoid the disturbances of art, reducing beauty to the likeable. Conflict and controversial thinkers are muted. Transhumanist philosopher David Pearce hopes well eventually eliminate the soul-destroying cruelties of traditional modes of love.
Algophobia detaches us from the Other, who is inevitably a source of discomfort. Our technologies train our seeing and regulate our reactions to what we see. Film permits an exceptional degree of cold cruelty, crueler than the ancient arena because more abstract and distant. We comfortably watch real and fake violence, becoming purveyors and consumers of violence porn that has the effect of an analgesic. Insensitive to the pain of others, we adopt the passivity and indifference of the silent spectator. Images overwhelm us, but instead of shocking us to action, they erode our capacity for shock: Our attention is so fragmented that such shock is impossible. Our souls form calluses.
Overshadowing our flight from pain is a universal imperative to Be Happy. We still experience pain, but pain isnt allowed to speak; its never given room to become eloquent, to rise to heights of protest or passion. Pain is depoliticized. It retreats to soothing screens or visits the doctors office for relief. The palliative society thus brings the end of revolution. Palliation transforms the exercise of power. Once upon a time, rulers ruled by inflicting bodily pain. According to Foucault, modern disciplinary power formed human beings into cogs in the industrial machine. The genius of palliative power is that it doesnt seem to be power at all; it feels like liberation. In the quest for self-realization, the achievement selves of the palliative society cheerily exploit themselves. Power decouples from pain and repression: Smart power operates in seductive and permissive ways. We live in a smart panopticon: We are constantly asked to communicate our needs, wishes and preferences. . . . Total communication, total surveillance, pornographic exposure and panoptic surveillance coincide. Freedom and surveillance become indistinguishable.
It cant work. Happiness must be fractured to be genuine. Without pain, happiness becomes reified into a boring repetition of the same. Pain bears happiness. . . . Any intensity is painful. Passion binds pain and happiness together. As Nietzsche knew, we cant think or discover truth without pain. Algophobia keeps us from scraping against the sharp edges of reality. We know it cant work, so we seek outlets from the numbing pressure of painless happiness. Girls cut themselves. Young men seek out fight clubs and gyms. Nietzsches anesthetized last men might suddenly turn into barbaric first men, recovering the ancient joys of pain-suffering and pain-inflicting heroism.
Hans books have been described as a form of philosophical haiku, and he illuminates by offering flashes in the darkness. Often enough, what Han exposes is recognizable. I came away from The Palliative Society thinking William Jamesian thoughts, with an ecclesial twist. James hoped to end war, yet, knowing that war alone arouses passions, virtues, and strengths that cannot be achieved in any other human endeavor, he searched for a moral equivalent of war. Heres one of the many ways the church can shore up and rebuild: Remember we cant be disciples of the crucified without carrying a cross of our own. Call Christians, especially young Christians, to strenuous, grueling, and, yes, painful service to the kingdom.
Peter J. Leithart is President ofTheopolis Institute.
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The Power of Pain | Peter J. Leithart - First Things
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