Neovii: Long-term Outcomes After Standard Graft-Versus-Host Disease (GvHD) Prophylaxis in Hemopoietic Cell Transplantation From Matched Unrelated Donors Strongly Support the Use of Grafalon(R) (Anti-Human-T-Lymphocyte Immunoglobulin) as Standard Therapy

Food and Healthcare Press Releases Monday June 26, 2017 12:45
RAPPERSWIL, Switzerland--26 Jun--PRNewswire/InfoQuest
  • The 8-year follow-up results of a randomized phase 3 multicenter trial in adult patients with hematologic malignancies clearly showed more favorable results in the Grafalon(R) group
  • Severe GvHD-free and relapse-free survival was 34% in the Grafalon(R) group versus 13% in non-Grafalon(R) group
  • The probability of being alive and free of immunosuppressive therapy was 47% in Grafalon(R) group versus 11% in non-Grafalon(R) group
  • Relapse mortality was not increased by Grafalon(R), supporting the long-term safety of Grafalon(R)

Neovii is pleased to announce the publication of the long-term outcomes of a multicenter parallel-group randomized trial conducted in Europe and Israel. The study looked at patients after standard GvHD prophylaxis with cyclosporine A and methotrexate with or without Grafalon(R) (anti-human-T-lymphocyte immunoglobulin- ATLG) (60 mg/kg total dose) in adult patients receiving myeloablative conditioning prior to hematopoietic stem cell transplantation from matched unrelated donors. Published in the June edition of The Lancet Haematology, the results showed the probability of being alive and free of immunosuppressive therapy at 8 years was 47% in the ATLG group and 11% in the non-ATLG[1] group.

(Logo: http://mma.prnewswire.com/media/527086/Neovii_Pharmaceuticals_Logo.jpg )

"The significantly improved composite endpoint 'Severe GvHD free and relapse free survival' clearly indicates the impact of ATLG in the cure of patients without ongoing morbidity, which is the main aim of allogeneic stem cell transplantation. This is supported by the fact that the vast majority of patients alive after ATLG-containing GvHD prophylaxis are free of immunosuppressive therapy," said Professor Jurgen Finke, the principal investigator of the study and Deputy Head of the Department of Hematology and Oncology at the Faculty of Medicine and Medical Center at the University of Freiburg, Germany. Professor Finke is also Chairman of the German Stem Cell Transplant Working Group (DAG-KBT). He added, "The results clearly demonstrate the importance of ATLG administration in matched unrelated stem cell transplantation and will certainly influence decision-making and patient counselling in the long run."

Alexandre Sudarskis, CEO of Neovii, commented, "These ground-breaking results undoubtedly prove the long-term efficacy of Grafalon(R) administration as part of a myeloablative conditioning regimen." He added, "Neovii strives to better meet the needs of our patients and to improve their quality-of-life with our effective antibody therapies, allowing physicians to apply a safe and robust therapy." Neovii supports research and development activities in the fields of stem cell transplantation, solid organ transplantation, and immune and hemato-oncological disorders.

About the study

Prospective, multicenter, open-label, randomized, phase 3 study of Grafalon(R) comparing standard ciclosporin A and methotrexate containing GvHD prophylaxis. Patients were randomized to either receive or not receive Grafalon(R). The study was conducted in 9 European countries and Israel in 31 study centers, enrolling 202 patients. Patients had acute leukemia or myelodysplastic syndrome or myeloproliferative disease in an early (n=107) or advanced disease status (n=94). After myeloablative conditioning, patients received transplantation of blood stem cells (n=164) or bone marrow grafts (n=37). Study results were published in 2009[2] and 2011[3].

About GvHD

Graft versus host disease (GvHD) is a serious, life threatening complication after allogeneic stem cell transplantation. It develops when the new immune system, which arises from the transplanted stem cells (graft), attacks tissues and organs of the recipient (host). It can be classified as acute or chronic, depending on the time of occurrence and/or the pathology.

About Grafalon(R)

Grafalon(R) (formerly commercialized as ATG Fresenius), is a rabbit anti-human T-lymphocyte immunoglobulin, used as part of immunosuppressive regimens for the prevention of graft versus host disease in stem cell transplantation, prevention and treatment of rejection in solid organ transplantation or as immunosuppressive in the treatment of aplastic anemia (according to country-specific approved indications). With more than 200,000 treated patients to date in more than 50 countries, Grafalon(R) enjoys worldwide recognition among solid organ and stem cell transplant teams and has transformed the way transplant teams manage the care of their patients around the world.

About Neovii

Neovii is an independent, dynamic and rapidly-growing global biopharmaceutical company with a patient-focused mission to develop and market novel life-transforming therapies. Neovii has been dedicated for over three decades to improving outcomes in transplantation medicine, hemato-oncological and immune disorders.

Neovii Pharmaceuticals AG global headquarters is in Rapperswil, Switzerland, with offices in Massachusetts, USA. Its biologics manufacturing facility is in Grafelfing, Germany.
Neovii has a global reach with products sold in over 50 countries worldwide.
References

[1] Finke, Jurgen et al. Long-term outcomes after standard graft-versus-host disease prophylaxis with or without anti-human-T-lymphocyte immunoglobulin in haemopoietic cell transplantation from matched unrelated donors: final results of a randomised controlled trial. The Lancet Haematology, June 2017; 4(6):e293-e301.

[2] Finke, Jurgen et al. Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial. Lancet Oncology, September 2009; 10(9):855-64.

[3] Socie, Gerard et al. Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti-T-cell globulin ATG-Fresenius. Blood, June 2011; 117(23):6375-82.

For further information
Contact info@neovii.com or call us at +41 55 210 05 00. For details on the full publication, visit http://www.thelancet.com .
Source: Neovii Pharmaceuticals AG

Latest Press Release

Covaris Introduces the 96 oneTUBE-10 AFA Plate for Improved NGS Workflows

Today, Covaris Inc. announced the release of the 96 oneTUBE-10 AFA Plate, which enables scalable and simplified workflows by leveraging Covaris' gold standard focused-acoustic technology to meet rapidly increasing Next-Generation Sequencing (NGS) demands...

2018 Empire State Building Run-Up Lottery Registration Opens on November 14, 2017

Runners must enter by December 10 for a chance to participate in the 41st Annual Run-Up on Wednesday, February 7, 2018, at 8:00 p.m. Empire State Realty Trust, Inc. (NYSE: ESRT) today announced that lottery registration for the 2018 Empire State...

Alpinion Medical Systems Launches E-CUBE 8, the New Ultrasound Diagnostic System

One of South Korea's global medical device manufacturers, Alpinion Medical Systems introduced its new E-CUBE 8, the latest and last addition to the E-CUBE lineup. The E-CUBE 8 is a smart, reliable product that ensures high performance with outstanding...

Photo Release: The Royal Danish Embassy and Novo Nordisk Pharma (Thailand) Co., Ltd launch the Blueprint for Change address Diabetes challenge , aligned with national NCD targets

On the 5th November 2017, right after the WDD event at the Vachirabenjatas Park (Suan Rot Fai Park) . Mr.Uffe Wolffhechel, the ambassador of the Royal Danish Embassy, Thailand (right) together with Mr.Mihai Irimescu, General Manager of Novo Nordisk...

Stryker announces publication of the DAWN(TM) Trial results in the New England Journal of Medicine

The New England Journal of Medicine published the results of the DAWN Trial, the first to provide compelling evidence in treating late window and wake-up stroke patients with mechanical thrombectomy. Currently, less than one in 10 patients suffering from...

Related Topics