Acute respiratory distress syndrome

Trevena Announces Completion of Phase 1 Study for TRV045, Novel S1P Receptor Modulator

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Wednesday, November 9, 2022
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CHESTERBROOK, Pa., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced positive clinical data for TRV045, its selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator. The 3-part randomized, double-blind, placebo-controlled Phase 1 study evaluated safety, tolerability and PK in healthy volunteers. TRV045 is being developed as a potential treatment for diabetic neuropathic pain (DNP). Through a collaboration with the National Institutes of Health, the Company is also exploring TRV045 as a potential treatment for epilepsy.

Key Points: 
  • Were pleased to report positive Phase 1 data on our novel S1P1 receptor modulator, TRV045, which are consistent with its distinct mechanism of action, said Carrie Bourdow, President and CEO of Trevena.
  • This study was a three-part study design, examining the PK profile, safety and tolerability of orally administered TRV045 in healthy volunteers.
  • Part 1 Single Ascending Dose: This study phase investigated the PK profile, safety and tolerability of single ascending doses of TRV045 or placebo.
  • Part 2 Food Effect: This study phase investigated the PK profile, safety and tolerability of TRV045 administered with a high-fat meal in 3 study cohorts.

EQS-News: invIOs GmbH: APEIRON Respiratory Therapies announces positive results from Phase I trial of inhaled APN01

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Monday, November 7, 2022
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In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.

Key Points: 
  • In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.
  • With the current trial of inhaled APN01 and our previous Phase 2 trial using intravenous administration in COVID-19, we have shown that APN01 is a safe and well tolerated potential treatment approach for a number of respiratory diseases.
  • More information on the demerger of AResT and invIOs from APEIRON Biologics AG can be found on the invIOs website here .
  • The first EPiC-based candidate, APN401, is currently being evaluated in a clinical Phase 1b trial in patients with advanced solid tumors.

APEIRON Respiratory Therapies announces positive results from Phase I trial of inhaled APN01

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Thursday, November 3, 2022
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In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.

Key Points: 
  • In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19.
  • With the current trial of inhaled APN01 and our previous Phase 2 trial using intravenous administration in COVID-19, we have shown that APN01 is a safe and well tolerated potential treatment approach for a number of respiratory diseases.
  • The double-blind, placebo-controlled, dose-escalation study was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled APN01.
  • The first EPiC-based candidate, APN401, is currently being evaluated in a clinical Phase 1b trial in patients with advanced solid tumors.

LUMC to Fund New Clinical Trial of Cynata's Cymerus™ MSCs in Kidney Transplantation

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Friday, November 4, 2022
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MELBOURNE, Australia, Nov. 4, 2022 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: "CYP" or "Cynata"), a clinical-stage biotechnology company specialising in cell therapeutics, is delighted to announce that the LUMC is funding an important clinical trial to investigate Cynata's Cymerus™ MSCs as a treatment for renal graft rejection and to potentially reduce the requirement for anti-rejection drugs.

Key Points: 
  • Kidney transplantation is life-saving in patients with chronic renal failure and frees the patient from the need for dialysis.
  • The clinical trial, entitled the "Safety and Efficacy of iPSC-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients - the Nereid Study", will be led by Prof.
  • "This exciting new collaboration follows very promising clinical trial data with MSCs published by Professor Rabelink[1] and our own published pre-clinical data[2] in organ transplant rejection.
  • The consistency and potency of Cynata's unique iPSC-derived Cymerus MSCs make them an ideal candidate for this clinical trial."

AcelRx to Host Third Quarter 2022 Financial Results Call and Webcast on November 14, 2022

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Thursday, November 3, 2022
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HAYWARD, Calif., Nov. 3, 2022 /PRNewswire/ --AcelRx Pharmaceuticals, Inc.(Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company, today announced that it will release third quarter financial results after market close onMonday, November 14, 2022.

Key Points: 
  • HAYWARD, Calif., Nov. 3, 2022 /PRNewswire/ --AcelRx Pharmaceuticals, Inc.(Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company, today announced that it will release third quarter financial results after market close onMonday, November 14, 2022.
  • Thereafter, AcelRx management will host a live webcast and conference call at4:30 p.m. Eastern Daylight Time/1:30 p.m. Pacific Daylight Time onNovember 14, 2022,to discuss the financial results and provide an update on the Company's business.
  • The webcast can be accessed by visiting the "Investors" section of the Company's website at www.acelrx.com and clicking on the webcast link within the News & Events/Upcoming Events section.
  • The webcast will include a slide presentation and a replay will be available on the AcelRx website for 90 days following the event.

Blu Biotech Inc. Announces a Patent License Agreement with University of Michigan

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Wednesday, November 2, 2022
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Under the terms of the agreement, Blu Biotech will produce and commercialize the device for use in diagnostic testing.

Key Points: 
  • Under the terms of the agreement, Blu Biotech will produce and commercialize the device for use in diagnostic testing.
  • Blu Biotech has the right to exclusively utilize the technology for breath analysis products in the United States and Canada, Europe, and non-exclusively in other parts of the world.
  • The commercial device will combine high-performance breath analysis with point-of-care utilization for the diagnosis and monitoring of multiple diseases.
  • "We are incredibly excited to have the opportunity to work with the University of Michigan, one of the world's leading research institutions.

SeaStar Medical (NASDAQ: ICU) Commences Trading on Nasdaq Capital Market and Outlines Corporate Strategy and Near-Term Catalysts

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Monday, October 31, 2022
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Denver, Colorado, Oct. 31, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced the commencement of trading on the Nasdaq Capital Market under the ticker symbol “ICU” having successfully completed its previously announced definitive agreement for a business combination transaction with LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special purpose acquisition company. The Company also provided a business outlook and outlined key upcoming milestones.

Key Points: 
  • SeaStar Medical has continued to deliver on its promises with operational excellence.
  • In addition to the progress weve made on the corporate front, we continue to advance our innovative SCD therapy platform.
  • I am excited for what is to come and look forward to providing updates as we execute on the milestones ahead.
  • Denver-based SeaStar Medical (Nasdaq: ICU) is a medical technology company that is focusing on redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs.

AcelRx Pharmaceuticals Announces Presentation of a Large Cohort of Complex Plastic Surgery Procedures Performed with DSUVIA at Plastic Surgery The Meeting 2022

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Monday, October 31, 2022
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HAYWARD, Calif., Oct. 31, 2022 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that an abstract, entitled, "Experience in Complex Outpatient Plastic Surgery Procedures Using Sufentanil Sublingual Tablets" was presented on Friday, October 28th by Jeffrey DeWeese, M.D., FACS, at Plastic Surgery The Meeting 2022, held October 27-30, in Boston, MA. The study, conducted in 324 patients undergoing complex plastic surgery procedures, found many positive benefits of using sufentanil sublingual tablets (SST), 30 mcg (brand name DSUVIA®), including the ability to perform complex, extensive cosmetic procedures without general anesthesia, allowing a rapid discharge time.

Key Points: 
  • This "awake" surgery analysis was a prospective, single-group cohort that were 95% female and ranged in age from 15 to 81 years.
  • Procedures included liposuction, breast augmentation, breast reduction, brachioplasty, facelift, rhinoplasty, and blepharoplasty, and most significantly, abdominoplasty, which is usually only performed under general anesthesia.
  • A sufentanil sublingual tablet (SST) 30 mcg (DSUVIA) was administered sublingually, followed by injection of local and/or tumescent anesthesia.
  • DSUVIA allows an option for patients not wanting to undergo general anesthesia for both short and lengthy plastic surgery procedures."

AcelRx Pharmaceuticals Announces the European Launch of DZUVEO by its Partner, Aguettant

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Thursday, October 27, 2022
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HAYWARD, Calif., Oct. 27, 2022 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that its commercial partner, Laboratorie Aguettant ("Aguettant"), has launched DZUVEO® (sufentanil sublingual tablet, 30 mcg), which is branded as DSUVIA® in the U.S., across Europe.

Key Points: 
  • "We remain impressed with, and are confident in the expertise of the Aguettant commercial team, and believe that the recent DSUVIA growth seen over the last five quarters here in the U.S. will support the Aguettant European launch."
  • "Partnering with AcelRx and leveraging the knowledge they've gained while commercializing DSUVIA in the U.S. has been extremely useful while we prepared for our launch across Europe," said Eric Rougemond, CEO of Aguettant.
  • DZUVEO has been approved by the European Medicines Agency and AcelRx's European commercialization partner, Aguettant, will market the drug in Europe.
  • Please refer to the Summary of Product Characteristics (SmPC) of DZUVEO in the European countries concerned by the marketing of this specialty product.

Veru Announces Late-Breaker Oral Presentation of Sabizabulin Treatment for Hospitalized Adults with COVID-19 on Supplemental Oxygen at Infectious Disease Week 2022

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Monday, October 24, 2022
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Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients, said Paula Skarda, M.D.

Key Points: 
  • Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients, said Paula Skarda, M.D.
  • Internal Medicine/Pediatrics Regions Hospital, St. Paul, Minnesota, a lead investigator in Verus Phase 2 and Phase 3 clinical trials of sabizabulin.
  • Patients were randomized (2:1) to sabizabulin 9 mg or placebo oral daily dose (up to 21 days or discharge from hospital).
  • Randomization was stratified by oxygen requirement at baseline (WHO 4 = supplemental oxygen, WHO 5 = NIV/forced oxygen, WHO 6 = mechanical ventilation).