Pneumonia, Ventilator-Associated

LEXINGTON, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced participation in the NIH-funded Antibacterial Resistance Leadership Group (ARLG) pilot study for pneumonia patients. The Pneumonia Direct Pilot study is a prospective, observational, diagnostic, feasibility study to determine the accuracy of multiple pathogen- and host-directed tests for the diagnosis of ventilator-associated pneumonia (VAP). Under the direction of Kimberly Hanson, M.D., University of Utah, the study seeks to explore new approaches for diagnosing VAP along with more comprehensive detection of antibiotic-resistant infections. The feasibility design is intended to inform future interventional studies that will investigate the clinical impact of combined pathogen and host-directed testing approaches. “I am elated that the innovative research leaders of Antibacterial Resistance Leadership Group are collaborating with T2 Biosystems to evaluate direct-from-blood diagnostic technology for the management of patients with pneumonia. This study will explore whether the combined diagnostic testing can successfully provide more targeted antimicrobial therapy, strengthen stewardship, and improve outcomes,” said Dr. Thomas J. Walsh, Director of the Center for Innovative Therapeutics and Diagnostics (citdx.org) and member of the T2 Biosystems Scientific Advisory Board. In the pilot study, the FDA-cleared T2Bacteria® Panel and the T2Resistance® Panel, included as one of the pathogen directed platforms, will be evaluated for the ability to rapidly detect infections in the blood currently missed by conventional methods. The T2 sample testing for the multi-center study will be performed at Johns Hopkins Medicine laboratories. The extremely low level of detection by T2 Biosystems’ technology (“T2MR”) in whole blood (1 – 11 CFU/mL) has been effective in detecting secondary infections. Most recently, a 2022 publication1 in the journal Microbiology Spectrum evaluated the use of T2 Biosystems’ sepsis tests in COVID-19 patients and found “without the additional use of T2MR, 13.3% of candidemia and 10% of bacterial superinfections would have been missed.” About Ventilator-associated pneumonia (VAP)Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections complicating critical care medicine. Recent studies have reported that VAP affects between 5-40% of patients intubated for more than 2 days, with significant variation by county, intensive care unit (ICU), and criteria used to define the disease2. Patients who develop VAP have prolonged durations of mechanical ventilation, increased lengths of ICU stay, and higher hospital costs3. Poor outcomes are due, at least in part, to difficulties in making a diagnosis of VAP, which in turn delays the initiation of appropriate antibiotic therapy4. The clinical criteria suggestive of VAP are non-specific and standard microbiologic testing does not definitively separate airway colonizers from invasive pathogens. The resultant diagnostic uncertainty is a major driver of unnecessary antibiotic use and potentially antimicrobial resistance in the ICU5,6. Furthermore, selecting effective empiric therapy for VAP is also complicated because multidrug-resistant pathogens may be isolated in early-onset VAP (i.e., within the first 4 days of hospitalization) as well as in late-onset cases7. About T2 BiosystemsT2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements about the ability of the Company’s product to provide more targeted antimicrobial therapy, strengthen stewardship, and improve outcomes, as well as statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release. Research discussed in this publication is supported in part by the ARLG Grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. For more information about this trial, visit ClinicalTrials.gov and search identifiers NCT NCT06181669. References: 1 Seitz T, Holbik J, Hind J, Gibas G, Karolyi M, Pawelka E, Traugott M, Wenisch C, Zoufaly A. Rapid Detection of Bacterial and Fungal Pathogens Using the T2MR versus Blood Culture in Patients with Severe COVID-19. Microbiol Spectr. 2022 Jun 29;10(3):e0014022. doi: 10.1128/spectrum.00140-22. Epub 2022 Jun 13. PMID: 35695564; PMCID: PMC9241933. 2 Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med. May 2020;46(5):888-906. doi:10.1007/s00134-020-05980-0 3 Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. Oct 2005;33(10):2184-93. doi:10.1097/01.ccm.0000181731.53912.d9 4 Kuti EL, Patel AA, Coleman CI. Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: a meta-analysis. Journal of critical care. Mar 2008;23(1):91-100. doi:10.1016/j.jcrc.2007.08.007 5 Nussenblatt V, Avdic E, Berenholtz S, et al. Ventilator-Associated Pneumonia: Overdiagnosis and Treatment Are Common in Medical and Surgical Intensive Care Units. Infection Control & Hospital Epidemiology. 2014;35(3):278-284. doi:10.1086/675279 6 Klompas M. Does this patient have ventilator-associated pneumonia? Jama. Apr 11 2007;297(14):1583-93. doi:10.1001/jama.297.14.1583 7 Khan S, Liu J, Xue M. Transmission of SARS-CoV-2, Required Developments in Research and Associated Public Health Concerns. Front Med (Lausanne). 2020;7:310. doi:10.3389/fmed.2020.00310 Investor Contact: Philip Trip Taylor, Gilmartin Group ir@T2Biosystems.com 415-937-5406

LOS GATOS, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (OTC QB: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that its 2023 Annual Meeting of Stockholders ("Annual Meeting"), scheduled for Friday, December 15, 2023, was convened and adjourned, without any business being conducted, due to lack of the requisite quorum. The Annual Meeting has been adjourned to 9:00 AM local time on January 12, 2024 at the Company’s offices located at 983 University Avenue, Bldg. B, Los Gatos, CA 95032, to allow additional time for stockholders to vote on the proposals set forth in Aridis’s definitive proxy statement on Schedule 14A, filed with the Securities and Exchange Commission on November 3, 3023. The record date for the Annual Meeting remains November 2, 2023. Stockholders who have previously submitted their proxy or otherwise voted and who do not want to change their vote need not take any action. Company stockholders as of the November 2, 2023 record date can vote, even if they have subsequently sold their shares. The Company’s board of directors and management respectfully request all such holders as of the record date to please vote your proxies as soon as possible. No changes have been made in the proposals to be voted on by stockholders at the Annual Meeting. The Company strongly advises all of its stockholders to read the proxy statement and other proxy materials relating to the Annual Meeting because they contain important information. Such proxy materials are available at no charge on the Securities and Exchange Commission's website at www.sec.gov. In addition, copies of the Proxy Statement and other documents may be obtained free of charge by accessing http://annualgeneralmeetings.com/ards2023 or by contacting the Company’s Corporate Secretary at 408-385-1742 or by mail to Corporate Secretary, Aridis Pharmaceuticals, Inc., 983 University Avenue, Bldg. B, Los Gatos, CA 95032. About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as first-line treatments to combat antimicrobial resistance (AMR) and viral pandemics. The Company is utilizing its proprietary ʎPEX TM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized by the natural human immune system for high potency. Hence, they are already fit-for-purpose and do not require further engineering optimization to achieve full functionality. The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antibacterial and antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care, which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below: Aridis' Pipeline AR-301 (VAP). AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in VAP patients. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in a Phase 2a clinical study in CF patients. AR-320 (VAP). AR-320 is a fully human mAb targeting S. aureus alpha-toxin for prevention of VAP. Statistically significant Phase 2 data in the target population of those ≤ 65 years of age was published in the September 2021 Lancet Infectious Diseases journal. AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that target multiple sites on the spike proteins of the SARS-CoV-2 virus. AR-101 (HAP). AR-101 is a fully human IgM mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide. This program is licensed to the Serum Institute of India and Shenzhen Arimab. AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb directed against the F-protein of diverse clinical isolates of respiratory syncytial virus (RSV). This program is licensed exclusively to the Serum Institute of India. AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii. For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/. Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2022, and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Contact: Investor RelationsDave Gentry, CEORedChip CompaniesARDS@redchip.com SOURCE Aridis Pharmaceuticals, Inc.

VANCOUVER, Canada--( BUSINESS WIRE )--Following its successful fundraising of C$4.91 million (US$3.62), Canadian life sciences company Ondine Biomedical Inc. will continue accelerating commercialisation of its proven nasal photodisinfection technology. This cutting-edge technology replaces topical antibiotics for the prevention of healthcare-associated infections (HAIs) and kills all types of pathogens – bacteria, viruses and fungi – without causing antimicrobial resistance. The company has confirmed that it has more than doubled the number of Steriwave ® deployments in 2023 and is in discussions with more than 75 hospitals in the UK, Mexico, Spain, and Canada. The growing global focus on preventing HAIs post-surgery, coupled with the escalating challenge of antimicrobial resistance, has spurred heightened interest in Ondine’s photodisinfection technology. The deployments are in areas of major surgery, including spinal, orthopedic, and cardiovascular. The antibiotic mupirocin has been used for nasal decolonization for the prevention of HAIs since the 1980s. However, mupirocin has resistance rates of up to 81%, 2 and very poor compliance. 3 Carolyn Cross, CEO of Ondine, commented, "We have put great efforts into improving our commercial activity sales process, which has increased the speed of the average sales cycle from contact to deployment by 50%. We have appointed distributors in the UK, Spain, and Mexico and are gaining real momentum. What is particularly encouraging is that many hospitals are recommending Steriwave to other hospitals. We believe this momentum will continue to increase, and commercial sales will become more significant in 2024.” The five-minute Steriwave nasal decolonization procedure is easy to incorporate into the pre surgery procedures. It is painless and very well received by patients who are often intrigued by the process. There have been no reports of serious side effects as a result of Steriwave usage. Steriwave has been used by more than 150,000 patients, including at Vancouver General Hospital where its use has been associated with a significant reduction in HAIs across major surgeries. 4,5 As well as growing its commercial activities, the company continues to work closely with HCA – the largest hospital group in the United States – to prepare for the Phase 3 trial in circa 14 HCA hospitals as part of its Ondine’s submission to the FDA for approval. The company already has approval for Steriwave in Canada, the UK, the EU, and Mexico. Implementing nasal decolonization prior to major surgery to reduce HAIs is recommended by leading medical bodies, including the World Health Organization, 6 the Society for Healthcare Epidemiology of America (SHEA), 7 and NICE. 8 The nose is the major reservoir of pathogens and the majority of surgical site infections (SSIs) and bloodstream infections have been traced back to bacteria in the patient’s nose. 9 A patient with a surgical site infection (SSI) will, on average, spend 7 to 11 days longer in the hospital, significantly increasing costs and lengthening patients' recovery. 10 While currently focusing on nasal decolonization, Ondine’s patented photodisinfection technology will be developed to prevent and treat a wide variety of topical infections. About Ondine Biomedical Inc. Ondine Biomedical Inc. is a Canadian life science company pioneering the field of photodisinfection therapies. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications. 1 Stone PW. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009 Oct;9(5):417-22. doi: 10.1586/erp.09.53. PMID: 19817525; PMCID: PMC2827870. 2 Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother . 2015;70(10):2681-2692. doi:10.1093/jac/dkv169 3 Hansen D, Patzke PI, Werfel U, Benner D, Brauksiepe A, Popp W. Success of MRSA eradication in hospital routine: depends on compliance. Infection. 2007 Jun;35(4):260-4. doi: 10.1007/s15010-007-6273-y. Epub 2007 Jul 23. PMID: 17646910. 4 Bryce E, Wong T, Forrester L, Masri B, Jeske D, Barr K, Errico S, Roscoe D. Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis. J Hosp Infect. 2014 Oct;88(2):89-95. doi: 10.1016/j.jhin.2014.06.017. Epub 2014 Aug 1. Erratum in: J Hosp Infect. 2015 Sep;91(1):93. PMID: 25171975. 5 Moskven E, Banaszek D, Sayre E, Gara A, Bryce E, Wong T, Ailon T, Charest-Morin R, Dea N., Dvorak M, Fisher C, Kwon B, Paquette S, Street J. Effectiveness of prophylactic intranasal photodynamic disinfection therapy and chlorhexidine gluconate body wipes for surgical site infection prophylaxis in adult spine surgery. Can J Surg. 2023 Nov;66(6), E550–E560. https://doi-org.libproxy1.nus.edu.sg/10.1503/cjs.016922 6 World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. World Health Organization; 2016. Available at: https://www-who-int.libproxy1.nus.edu.sg/publications/i/item/9789241550475 . Accessed December 12, 2023. 7 Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to prevent surgical site infections in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2023;44(5):695-720. doi:10.1017/ice.2023.67 8 National Institute for Health and Care Excellence (NICE). NICE Surgical Site Infections: Prevention and Treatment. NICE; 2019. Available at: https://www.nice.org.uk/guidance/ng125 . Accessed December 12, 2023. 9 von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001 Jan 4;344(1):11-6. doi: 10.1056/NEJM200101043440102. PMID: 11136954. 10 Seidelman JL, Mantyh CR, Anderson DJ. Surgical Site Infection Prevention: A Review. JAMA. 2023;329(3):244–252. doi:10.1001/jama.2022.24075