Methylene blue

Two research groups design a plasma (an ionized gas) reactor maintained by microwaves that makes it possible to decontaminate waters with high concentrations of dye. Plasma is an ionized gas -- that is, a gas containing electrons, ions, atoms, molecules, radicals, and photons. It is often called the fourth state of matter and, surprisingly, it permeates everything. Plasmas, which are artificially generated by transmitting energy to a gas, are found in the fluorescent tubes that light kitchens, but they have also allowed mobiles to become smaller and smaller. Plasma has been a veritable revolution in the world of technology. Before, to engrave the circuits on the silicon plates used in electronic devices like mobile phones, it was necessary to use polluting chemical products. Now, the use of plasma has made it possible to do this more cleanly and precisely, it being possible to make the slits smaller and smaller, and, with them, the devices. But plasma has other applications too, such as water treatment. The FQM-136 Physics of Plasmas and FQM-346 Organic Catalysis and Nanostructured Materials groups at the University of Cordoba collaborated on a research study whose purpose was the elimination of contaminants present in water by applying plasma to promote chemical processes. With the aim of tackling the problem of the increasing presence of organic pollutants in waters, such as dyes and other compounds from agricultural and industrial activity in waters that destabilize ecosystems, these researchers opted for the application of plasma. In 2017 they demonstrated, for the first time, that the argon plasmas induced by microwaves open to the air, when acting on water, generated in it reactive species containing oxygen and nitrogen (such as hydroxyl radicals, hydronous peroxide, nitrogen radicals) capable of decontaminating it. Now the researchers Juan Amaro Gahete, Francisco J. Romero Salguero and María C. García have managed to design a reactor of this type of plasma and to significantly increase the amounts of these active species generated in water, thus making possible the destruction of high concentrations of dyes (in this case, methylene blue) in just minutes. This was achieved by altering the design of the surfatron, the metal device that mixes the energy from a microwave generator with the plasma to maintain it. "What we've done is to place a small piece of silicon in the quartz discharge tube, allowing a different plasma to be generated, one that is not filamentary and is more efficient at creating active species when interacting with water," explained Professor María C. García. The aforementioned plasma components, when interacting with water, generate oxidizing species capable of degrading organic compounds and killing microorganisms, which allows this plasma reactor to be used in applications related to water remediation. This new configuration, therefore, expands the applicability of this type of plasmas. "The design completely changes the configuration of the electromagnetic field generated by the surfatron to create the plasma, resulting in plasma with different and more efficient properties, also eliminating the problem of filamentation (the division of the plasma column into many filaments), which destabilizes it," explained Professor García. And then...decontamination. "Those oxidizing species generated due to the action of plasma are very reactive and make it possible to destroy the organic matter inside the water," continued Professor Francisco J. Romero. For this to happen, the plasma is not introduced into the water. Rather it is made to act remotely, so that between the water and the plasma there is a zone of air where numerous reactions occur due to collisions between the excited species and the molecules of oxygen, nitrogen and water vapor, and "reactive species that diffuse into the liquid and end up with the contaminants" are generated. The decontaminating potential of this type of plasma, generated with this new design "has been tested to reduce high concentrations of methylene blue dye in water, with very efficient results in terms of energy, achieving the complete elimination of the dye at reduced treatment times," said researcher Juan Amaro. Thus, with this work progress is made on one of the applications of plasma, that "fourth state of matter" created by providing a stable gas with energy and converting it into an ionized gas, with this being applicable to almost everything: manufacturing microchips, disinfecting surfaces, healing wounds, depositing anti-reflective coatings on glasses, improving seed germination, recovering waste, activating the surface of plastics to achieve better paint adhesion, and countless other applications.

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE: TAK) today announced that the Phase 3 ADMIRE-CD II study, assessing the efficacy and safety of Alofisel® (darvadstrocel) for the treatment of complex Crohn’s Perianal Fistulas (CPF), did not meet its primary endpoint of combined remission at 24 weeks, based on topline data. The safety pro darvadstrocel was consistent with prior studies and there were no new safety signals identified. “While we are disappointed with this outcome, we recognize that medical research for difficult-to-treat conditions such as complex CPF remains challenging," said Chinwe Ukomadu, head of the GI & Inflammation Therapeutic Area Unit at Takeda. "We believe there are valuable lessons to learn from ADMIRE-CD II and are grateful to the patients and investigators who made this important research possible.” Full results of the study will be presented at a future medical meeting or published in a peer-reviewed journal. Alofisel is approved in the European Union, Israel, Switzerland, Serbia, United Kingdom and Japan based on positive data from the previously completed ADMIRE-CD study.1-6 The approval in Japan is also based on positive data from the Japanese study, Darvadstrocel-3002.7 In addition, approximately 800 patients have been enrolled in INSPIRE, an ongoing, observational study of the real-world effectiveness and safety of Alofisel in patients with complex CPF.8 Takeda is continuing to assess the financial impacts of the study results, including impairment loss for intangible assets, on the fiscal quarter ended September 30, 2023. Any revisions to the consolidated forecast for the fiscal year ending March 31, 2024 (FY2023) will be announced during Takeda’s second quarter earnings call, scheduled for October 26, 2023. About Alofisel® Alofisel® (darvadstrocel) is a dispersion of expanded allogeneic (or donor-derived), adipose-derived mesenchymal stem cells (eASC) for the treatment of complex CPF in adult patients with non-active or mildly active luminal Crohn’s disease (CD).1 It is the first allogeneic stem cell therapy to receive centralized marketing authorization approval in the European Union, and the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy to be approved in Japan.9,10 Alofisel was previously investigated in a study called ADMIRE-CD - a randomized, double-blind, controlled, Phase 3 trial investigating the efficacy and safety of Alofisel for the treatment of complex perianal fistulas in 212 adult patients with non-active/mildly active luminal CD.11,12 The study showed that a significantly greater proportion of patients in the Alofisel group, compared to the control group, achieved the primary endpoint of combined remission at a 24 week follow-up (51.5% vs 35.6%; a difference of 15.8 percentage points; 97.5% CI 0.5-31.2; P =0.021), and this was maintained over 52 weeks (56.3% vs 38.6%; a difference of 17.7 percentage points; 95% CI 4.2-31.2; P =0.01).11 Alofisel treatment had a similar safety pro to the control group and was well-tolerated over 52 weeks.11 Therapeutic Indications Alofisel is approved in the European Union, Israel, Switzerland, Serbia and the United Kingdom for the treatment in adult patients with complex CPF with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.1-5 Alofisel should be used only after conditioning of the fistulas.1 In Japan, Alofisel is indicated for the treatment of complex CPF in patients with non-active or mildly active luminal Crohn’s disease.6 This product is indicated for the treatment of patients who have shown an inadequate response to at least one existing medicinal treatment.6 Important Safety Information1 Contraindications Hypersensitivity to the active substance, bovine serum or to any of the excipients. Special warnings and special precautions for use Alofisel may contain trace amounts of either gentamicin or benzylpenicillin and streptomycin. This should be considered in patients with known hypersensitivity to these classes of antibiotics. Local anesthesia is not recommended due to the unknown effect of local anesthetics on the injected cells. The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g., hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) through the fistula tracts is not allowed before, during, or after the injection of darvadstrocel as this may compromise cell viability. Alofisel is indicated for injection in the fistula tract tissue only. Alofisel must not be administered using a needle thinner than 22G. Thinner gauge needles can cause cell disruption during injection and may compromise cell viability. As Alofisel is a living stem cell therapy, it cannot be sterilized, and therefore could contain potentially infected biological material, although the risk is considered to be low and controlled in the manufacturing process. Patients should be followed up for potential signs of infection after administration. Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which darvadstrocel is indicated. Patients treated with Alofisel must not donate blood, organs, tissues and cells for transplantation. The traceability requirements of cell-based therapy medicinal products must apply. Fertility, Pregnancy & Lactation No data is available from the use of Alofisel in pregnant women. Alofisel is not recommended during pregnancy and in women of childbearing potential who are not using contraception. As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding. Adverse reactions include: Common (≥1/100 to <1/10): anal abscess, proctalgia, anal fistula and procedural pain. Conditioning of fistulas has been associated with proctalgia and procedural pain. For EU audiences, please see the Summary of Product Characteristics (SmPC) for Alofisel® Please consult with your local regulatory agency for approved labeling in your country. Takeda in Gastroenterology We believe that gastrointestinal (GI) and liver diseases are not just life-disrupting conditions, but also diseases that can impact a patient’s quality of life.13,14 Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. 13,14 With nearly 30 years of experience in gastroenterology, Takeda has made significant strides in addressing GI patient needs with treatments for inflammatory bowel disease (IBD), acid-related diseases, short bowel syndrome (SBS) and motility disorders. We are making significant strides toward closing the gap on new areas of unmet needs for patients who have celiac disease, alpha-1 antitrypsin-associated liver disease and Crohn’s disease, among others. Together with researchers, patient groups and others, we are working to advance scientific research and clinical medicine in GI. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. 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These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. References 1. Alofisel Summary of Product Characteristics. Available at: . Last accessed October 2023. 2. Alofisel Summary of Product Characteristics. Available at: . Last accessed October 2023. 3. Swissmedic. Alofisel®, Suspension zur Injektion (Darvadstrocelum). Available at: . Last accessed October 2023. 4. Details of drug: Alofisel. Available at: . Last accessed October 2023. 5. Orphan Register. Available at: . Last accessed October 2023. 6. Japan Pharmaceuticals and Medical Devices Agency. Products Approved in FY 2021: Regenerative Medical Products. Available at: . Last accessed October 2023. 7. Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease. Available at: . Last accessed October 2023. 8. An observational post-marketing registry on the effectiveness and safety of darvadstrocel in patients with Crohn's disease and complex perianal fistulas (INSPIRE). European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP). Available at: . Last accessed October 2023. 9. Takeda Pharmaceutical Company Ltd. TiGenix and Takeda announce Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn’s disease in Europe. Available at: . Last accessed October 2023. 10. Takeda Pharmaceutical Company Ltd. Takeda Receives Approval to Manufacture and Market Alofisel®▼ (darvadstrocel) in Japan for Treatment of Complex Perianal Fistulas in Patients with Non-active or Mildly Active Luminal Crohn’s Disease. Available at: (darvadstrocel)%2C%20developed,or%20mildly%20active%20Crohn's%20disease. Last accessed October 2023. 11. Panés J, García-Olmo D, Van Assche G et al. ADMIRE CD Study Group Collaborators. Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn's disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. 12. Panés J, García-Olmo D, Van Assche G, et al. ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016;24;388(10051):1281-90. 13. Center for Drug Evaluation and Research (CDER) & the FDA. The Voice of the patient/functional gastrointestinal disorder. 2016. Available at: . Last accessed October 2023. 14. Jones R, Hunt C, Stevens R, et al. Management of common gastrointestinal disorders: quality criteria based on patients’ views and practice guidelines. Br J Gen Pract. 2009;59:e199-208.