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Business Wire
29-05-2025
- Health
- Business Wire
UCI Health Partner with Sierra Donor Services to Expand Kidney Transplant Opportunities Utilizing Paragonix KidneyVault Preservation Technology
WALTHAM, Mass.--(BUSINESS WIRE)-- Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today a groundbreaking initiative with Sierra Donor Services and UCI Health to place high-risk donor kidneys, expanding transplant opportunities for patients in need. , a nonprofit organ procurement organization (OPO) serving more than 2.8 million people across 13 counties in Northern California and Nevada, is leveraging this collaboration to successfully place kidneys that were previously deemed high risk due to donor complications, geographic limitations, and other logistical considerations. Utilizing Paragonix's latest innovation—the KidneyVault Portable Renal Perfusion System —Sierra Donor Services has facilitated the transplantation of complex donor kidneys that had initially been declined due to factors such as donor age, cause of death, and underlying medical conditions. Through this technology, UCI Health has been able to transplant these organs successfully, demonstrating the transformative potential of advanced organ preservation in expanding the donor pool. The cutting-edge preservation system aims to combat key transplantation challenges by ensuring superior organ protection during transport and providing real-time monitoring of organ conditions and location. UCI Health, one of California's largest academic health systems, is the clinical enterprise of the University of California, Irvine and one of the fastest growing kidney transplant centers on the west coast. UCI Health is at the forefront of transplant innovation, seeking new opportunities and technologies to both improve access to donor organs and post-transplant outcomes. The lifesaving initiative is playing a critical role in addressing California's organ shortage by enabling the safe and effective utilization of kidneys that may have otherwise been potentially discarded. 'Currently, nearly 20,000 Californians are on the waiting list for a transplant, with 85% of them in need of a kidney. Last year over 9,000 kidneys recovered for transplant were ultimately unable to be used for a life saving transplant,' said Donna Smith, Chief Clinical Officer at Sierra Donor Services. 'The portable renal perfusion technology provided by KidneyVault gives us greater flexibility to place these much-needed organs, offering a second chance at life to patients who might not have otherwise received one.' Dr. Robert R. Redfield, Chief of Transplantation at UCI Health, emphasized the importance of this innovative preservation system in expanding transplant opportunities. 'UCI Health is proud to have the oldest and largest kidney transplant program in Orange County, with survival outcomes exceeding the national average,' said Dr. Redfield. 'This technological improvement allows transplant centers like ours to consider more complex organs, as donations that must travel greater distances can now be perfused throughout the entire transplant journey.' President of Paragonix Technologies, Dr. Lisa Anderson, PhD, echoed this sentiment, highlighting the company's commitment to honoring the gift of organ donation. 'Every organ donation is an incredible gift, and we believe it should be treated as such every single time,' said Dr. Anderson. 'With the KidneyVault Portable Renal Perfusion System, OPOs and transplant centers can confidently offer this life-saving gift to more patients by utilizing organs that previously would have gone unused.' For more information about Paragonix Technologies, please visit About Sierra Donor Services Sierra Donor Services (SDS) serves nearly three million people in Northern California and Northern Nevada. We are an exceptional team of professionals dedicated to saving and improving lives by connecting organ and tissue donation to the patients who need them. We strive to extend the reach of each generous donor's gift to those who are always profoundly grateful for them. For more information, visit About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ('AOP') devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit
Yahoo
27-05-2025
- Business
- Yahoo
Traws Pharma Announces Receipt of FDA Guidance on Tivoxavir Marboxil and Reports Plans for Pursuing Stockpiling for Pandemic Preparedness
NEWTOWN, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA, the Agency). The FDA provided feedback on development paths for potential approval of tivoxavir marboxil (TXM) for bird flu and seasonal flu, including on the use of the Animal Rule. The Animal Rule is intended to provide a path to approval in situations when human clinical studies would be unethical or impractical. 'The FDA has provided detailed feedback on the development paths for approval, including a combined clinical study enrolling seasonal flu and bird flu-infected subjects, as such infections occur. We are requesting a Type D meeting with the FDA to specify next steps and look forward to working closely with the Agency to develop TXM for bird flu and seasonal flu,' said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. 'The consistent finding of therapeutic effects of TXM in three animal models of bird flu increases our confidence that this compound should be rapidly progressed for stockpiling and pandemic readiness by government agencies,' said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). 'To that end, we have initiated a dialog with the Biomedical Advanced Research and Development Authority (BARDA), the responsible agency for stockpiling for pandemic preparedness in the United States, and we plan to engage with respective international regulatory agencies for the same purpose. With the known history that previous H5N1 virus outbreaks in human populations are associated with death rates of up to 50%1, we believe that these actions should be pursued with great urgency.' 'This initial interaction with the FDA has helped guide the development of TXM as a broad therapeutic against pandemic and seasonal influenza,' commented Iain Dukes, MA DPhil, Interim CEO of Traws Pharma. 'We are committed to progressing the process for stockpiling TXM to prevent any pandemic outbreaks associated with bird flu.' About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders2,3, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird flu and seasonal flu. Source information: Per link Per link TRAW data on file About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, our ability to take advantage of expedited regulatory pathways for tivoxavir marboxil, our ability to obtain regulatory approval of tivoxavir marboxil, the expectations of our interactions with regulatory authorities, including both the FDA and BARDA and international regulatory agencies, market conditions, regulatory requirements, changes in government regulation, the extent of the spread and threat of the bird flu, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Nora BrennanTraws Pharma, Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@
Yahoo
25-03-2025
- Business
- Yahoo
Traws Pharma's COVID-19 Candidate, Ratutrelvir, Presented at ICAR
Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimen Preparations are underway for FDA interactions and initiation of Phase 2 studies Data presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced that positive data supporting the potential for ratutrelvir, a main protease inhibitor, as a treatment for COVID-19, were presented on March 20, 2025 in a poster at the International Conference for Antiviral Research (ICAR 2025), held in Las Vegas, Nevada. Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC), commented, 'Traws designed ratutrelvir to overcome the limitations of current COVID treatments. COVID continues to be a significant cause of mortality for older adults with underlying medical conditions and people who are immunocompromised1. Requirement to use the boosting agent ritonavir with widely used treatment2 increases drug-drug interaction risk for patients with complex medical conditions and may limit patient eligibility for therapy3. Data presented at ICAR provide support that ratutrelvir treatment does not require co-administration of a metabolism inhibitor such as ritonavir, significantly simplifying ease of use, a key potential differentiator.' C. David Pauza, PhD, Chief Science Officer for Traws Pharma, added: 'Recent publications cite a relationship between the probability of slow viral clearance being associated with higher risk for long COVID4. Ratutrelvir suppressed replication of 18 different strains of SARS-CoV-2 in laboratory tests, maintained human blood levels within the predicted therapeutic window (>EC90), and did not require coadministration of ritonavir. Data presented at ICAR 2025 shows that ratutrelvir is highly active against native virus and nirmatrelvir-resistant strains and omicron variants. Additionally, we know that the patterns of drug resistance mutations selected in vitro using ratutrelvir are largely distinct from the emerging clinical data on drug resistance to nirmatrelvir (protease inhibitor in Paxlovid™)4 and ensitrelvir5. Ratutrelvir is differentiated from these drugs in terms of in vitro potency, human pharmacokinetics, and drug resistance patterns.' 'We believe ratutrelvir has the potential to be a highly differentiated, broadly active treatment for COVID. Preparations are underway to meet with the FDA to align on a path forward and initiate Phase 2 studies,' noted Werner Cautreels, PhD, Chief Executive Officer for Traws Pharma. 'We plan to host an Investor Event on Monday, March 31, 2025 at 10:00 AM ET to present an overview of preclinical and human data on ratutrelvir and outline potential next steps towards approval.' To register for the virtual Investor Event, click here. Ratutrelvir poster: Poster Title: Phase I Clinical Study of Ratutrelvir, a Potent Inhibitor of the SARS-CoV-2 Main Protease (Mpro/3CL): Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Poster Date: March 20, 2025 Data in the poster suggest that ratutrelvir could be used for COVID-19 therapy without ritonavir. Phase 1 results helped Traws define a target Phase 2 dose and treatment regimen and demonstrated excellent overall safety and tolerability: Potent Preclinical Suppression of Resistant Virus: Laboratory studies show that ratutrelvir is a highly active suppressor of COVID-19 replication of original and Omicron variants Pharmacokinetic (PK) Results Do Not Require a Metabolism Inhibitor: Drug exposure studies show that ratutrelvir metabolism is not induced by ten days of treatment at 600 mg/day and trough blood plasma levels of drug are maintained at four times the EC90. These data provide support that ratutrelvir treatment does not require coadministration of a metabolism inhibitor such as ritonavir, significantly simplifying ease of use, a key differentiator Phase 1 data also show potential safety and attractive PK for a 10-day regimen: Data from single- and multiple ascending dose (SAD, MAD) studies demonstrated excellent safety/tolerability at all doses tests At the selected Phase 2 dose and regimen of 600 mg/day for 10 days, ratutrelvir established and maintained 24-hour trough blood levels of approximately 13-times the EC50 and drug levels remained above the EC90 for 2 days after treatments cessation. The 10-day dosing regimen is intended to achieve optimal viral suppression and reduce the rates for clinical rebound About RatutrelvirRatutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19, to be used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir's pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for long COVID.4 Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity7,8. Source information: Carly Herbert et al. (2025) Clinical Infectious Diseases. Tamura, T.J, et al., 2024, JAMA Network Open :e2435431-e2435431 Uehara, T., al., (2025). "Ensitrelvir treatment–emergent amino acid substitutions in SARS-CoV-2 3CLpro detected in the SCORPIO-SR phase 3 trial." Antiviral Research : 106097 10K report 2024, Feb 27, 2025 ; Merck.& Co 10K, Feb 25 2025 Paxlovid is a registered trademark of Pfizer Inc. About Traws Pharma, Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable. The Company's two antiviral programs are investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a COVID treatment, targeting the Main protease (Mpro or 3CL protease), without the need for co-administration of ritonavir. For more information, please visit and follow us on LinkedIn. Forward-Looking StatementsSome of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, Traws' interactions with and guidance from the FDA, collaborations, market conditions, regulatory requirements and pathways for approval, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for long COVID, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Nora BrennanTraws Pharma, Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@ in to access your portfolio
