Viralgen

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Viralgen

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Viralgen

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San Sebastian, Basque Country, Spain

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Position on the value chain

With the ultimate aim to create a European alliance for bioproduction in Europe, organisations have joined forces with COBIOE. Discover who are our associates.

Bio-resources and biobanking
  • Cells, tissues and humanized xeno-organs
  • Biosamples
  • Viral, phage or bacterial specimen
Identification of biotherapies
  • Target identification
  • Target validation
  • Screening
Drug design
  • Drug assessment
  • Drug engineering
  • In vitro preclinical studies
Clinical validation
  • Clinical trials
  • In vivo preclinical validation
  • Pre-industrial scale production
Production
  • Upstream processes
  • Downstream processes
  • Quality control
Market access
  • CE mark / market authorisation
  • Payment / Reimbursement
  • Care pathways

Viralgen last news

12/01/2024

Bayer and AskBio begin Phase II congestive heart failure treatment trial

Bayer and AskBio have commenced the Phase II GenePHIT clinical trial for AB-1002 to treat congestive heart failure (CHF). The post Bayer and AskBio begin Phase II congestive heart failure treatment trial appeared first on Clinical Trials Arena .

11/01/2024

One-time gene therapy for heart failure moves to Phase II trial

Gene therapy company Asklepios BioPharmaceutical (AskBio, a subsidiary of Bayer) has announced plans to initiate a Phase II trial of gene therapy AB-1002 for the treatment of congestive heart failure (CHF). GenePHIT (Gene PHosphatase Inhibition Therapy) will evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischaemic cardiomyopathy classified [...] The post One-time gene therapy for heart failure moves to Phase II trial appeared first on Drug Discovery World (DDW) .

05/01/2024

AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure (CHF)

Research Triangle Park, N.C.‚Äď January 5, 2024¬†‚ÄstAsklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as¬†NAN-101) for the treatment of congestive heart failure¬†(CHF). GenePHIT is an adaptive, double-blind, placebo-controlled, randomized, multicenter trial to evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischemic cardiomyopathy classified as New York Heart Association (NYHA) Class III Heart Failure who have¬†been medically stable for at least 4 weeks.1¬†The advancement of AB-1002 into Phase 2 marks a significant milestone for this novel gene therapy for¬†CHF¬†and, if successful, could bring this important investigational therapy one step closer to treating patients with high unmet medical need.¬† GenePHIT will include between 90 and 150 adults with left ventricle ejection fraction between 15 and 35%,¬†who continue to suffer from¬†heart failure symptoms despite guideline recommended therapy. The primary¬†efficacy¬†endpoint at 52 weeks is a modified win ratio¬†of several clinically meaningful assessments.1 "AskBio is excited to initiate GenePHIT under the leadership of Roger Hajjar, MD, Scientific Chair CHF, and Lothar Roessig, MD, Integrated Product Team Lead CHF," said¬†Jude Samulski, PhD, Co-Founder and Chief Scientific Officer, AskBio.¬†"We believe this trial will help determine the potential of AB-1002 as a treatment for one of the world's most devastating diseases, and we look forward to learning more about this important investigational¬†cardiac¬†gene therapy. Our hope is that one day AB-1002 will potentially help patients suffering from congestive heart failure." The GenePHIT trial, which includes 52-week safety and primary efficacy and four-year long-term follow-up periods, is currently recruiting. AskBio plans to¬†conduct the trial in the U.S. and multiple countries in Europe.1¬†For more information, please¬†visit clinicaltrials.gov (NCT#05598333) or visit askbio.com. AB-1002 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. AB-1002 is manufactured by Viralgen Vector Core, a wholly owned and independently operated subsidiary of AskBio. About Congestive Heart Failure Heart failure occurs when the heart cannot pump blood efficiently enough to meet the body's needs, including providing sufficient oxygen to the organs.2¬†Congestive heart failure results in the slowing of the blood flow out of the heart, which causes the blood returning to the heart through the veins to back up.3¬†This causes congestion in the body's tissues. Symptoms include swelling in the legs and ankles. Sometimes, fluid collects in the lungs and interferes with breathing. Approximately 26 million people worldwide are living with congestive heart failure.4 About AskBio Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for congestive heart failure, Huntington's disease, limb-girdle muscular dystrophy, multiple system The post AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure (CHF)¬† appeared first on AskBio .