Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Cytheris Publication in Blood Demonstrates CYT107 Reverses Lymphopenia

Published: Tuesday, February 05, 2013
Last Updated: Monday, February 04, 2013
Bookmark and Share
Data strongly supports development of CYT107 for treatment of PML in lymphopenic patients.

Cytheris SA has announced the publication of a paper demonstrating that Cytheris' CYT107, glycosylated recombinant human interleukin-7 (glycosylated r-h-IL7) can enhance immune T cell recovery after a T cell-depleted (TCD) allogeneic hematopoietic stem cell transplantation (allo-HSCT).

The study detailed in the paper demonstrated an increase in functional T cells, including viral-specific T cells that recognize CMV, and enhanced T cell receptor diversity. Additionally, there was no significant GVHD or other serious toxicity.

The paper by Drs. Perales and van den Brink has been pre-published in the on-line version of the journal Blood (http://www.ncbi.nlm.nih.gov/pubmed/23012326).

It details the phase I study performed in 12 patients undergoing TCD allo-HSCT. The paper is titled "Recombinant Human Interleukin-7 (CYT107) Promotes T Cell Recovery Following Allogeneic Stem Cell Transplantation."

"Lymphopenia post-HSCT is a serious problem leading to mortality and morbidity, notably from potentially life-threatening infections and relapse. Several of these infections are resistant to standard treatments or have no treatment at all," said Dr Miguel Perales, MD, Director, Adult Bone Marrow Transplantation Fellowship, Memorial Sloan-Kettering Cancer Center, New York.

Dr Perales continued, "CYT107 is the first agent to demonstrate the ability to reverse post-transplant lymphopenia without increasing risks. It may offer the possibility to restore the T-cell immune system to fight these serious and often fatal infections, and improve survival."

"These data confirm the potential seen in other studies for CYT107 to treat lymphopenia and lymphopenia driven diseases. PML, Cytheris lead indication for CY107, is a rare and devastating disease with one year mortality of 40-50 per cent that is caused by reactivation of latent JC virus in lymphopenic patients," said Therese Croughs, chief medical officer at Cytheris.

Croughs continued, "We have already gathered clinical data supporting the efficacy and safety of CYT107 in PML through several compassionate use treatments. These new data in TCD allo-HSCT patients are particularly interesting in the context of PML due to the virus-specific immune responses. They also open the future possibility of use of CYT107 to treat resistant viral infections, such as CMV, in post-transplant and other lymphopenic populations."

The study was a phase I trial of r-hIL-7 (CYT107) in recipients of TCD allo-HSCTs. Twelve patients were treated with escalating doses of CYT107 administered weekly for 3 weeks. At baseline, patients were profoundly lymphopenic.

CYT107 induced a doubling in CD4+ and CD8+ T cells. The main effect of IL-7 was an expansion of effector memory T cells, the predominant subset identified in Cytheris patients. There was no significant effect on CD4+CD25+FoxP3+ T cells, NK or B cells.

Importantly, there were not only quantitative increases in T cells after a short course of IL-7, but an increase in functional T cells, including viral-specific T cells that recognize CMV. Enhanced TCR diversity was also observed after treatment.

The study drug was well tolerated with only one patient developing acute skin GVHD. The results indicate that r-hIL-7 can enhance immune recovery after a TCD allo-HSCT without causing significant GVHD or other serious toxicity.

"The results announced today strongly support the Cytheris strategy to conduct a pivotal registration study of CYT017 in PML," said Damian Marron, chief executive officer at Cytheris. "PML affects around 4,000 people in the US and EU alone. Bringing a treatment to this population would not only save and change patients' lives but would also respond to the pharmaceutical industry's desire to develop breakthrough drugs for targeted indications."

PML is a severe demyelinating disease of the central nervous system caused by the JC virus. It occurs in many conditions leading to severe lymphopenia such as HIV infection, some cancers and organ transplantation treated with immunosuppressive therapies.

PML is a very rare disease, affecting around four out of a million individuals. There is currently no marketed drug for the treatment of this devastating condition.

Cytheris has obtained scientific advice for a pivotal phase IIb study protocol with CYT107 in HIV-related PML. Cytheris reached an agreement with the EMA on the key study endpoints. Cytheris will start this phase IIb study, intended to be the pivotal registration study, in early 2013.

Additionally, The European Commission has granted an orphan designation for Cytheris' CYT017, glycosylated recombinant human interleukin-7 (glycosylated r-h-IL7), for the treatment of Progressive Multifocal Leukoencephalopathy (PML).


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Cytheris Announces Interim Results from ECLIPSE II Hepatitis C Multicenter Study
Data to be presented at The Liver Meeting®, the 62nd annual meeting of the AASLD in San Francisco, November 4-8, 2011.
Wednesday, November 16, 2011
Initiation of ORVACS-Sponsored Phase II Clinical Study into Attack of the Viral Reservoir of HIV Patients
By combining an integrase inhibitor and a CCR5 inhibitor with IL-7 to target or induce activation of latently infected cells this study aims to investigate whether exhausting the HIV reservoir and ultimately obtaining virus eradication is feasible.
Wednesday, November 03, 2010
Scientific News
Improving Natural Killer Cancer Therapy
Vanderbilt University researchers discover transcription factor critical for NK cell expansion. Findings could lead to increased therapeutic efficacy.
Molecular Mechanism For Generating Specific Antibody Responses Discovered
Study could spur more ways to treat autoimmune disease, develop accurate vaccines.
Gut Microbiomes Of Infants Have An Impact On Autoimmunity
Exposure to pathogens early in life is beneficial to the education and development of the human immune system.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
COPD Linked to Increased Bacterial Invasion
Persistent inflammation in COPD may result from a defect in the immune system that allows airway bacteria to invade deeper into the lung.
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
Vaccinations Are More Effective When Administered In The Morning
Research from the University of Birmingham shows that influenza vaccinations have more protective responses when administered in the morning.
Secrets of a Deadly Virus Family Revealed
Scripps Research scientists uncover the glycoprotein structure of LCMV. The findings could guide development of treatments for Lassa fever.
Cytokine Triggers Immune Response at Expense of Blood Renewal
Research highlights promise of Anti-IL-1 drugs to treat chronic inflammatory disease.
Reduced Immune Response Causes Flu Deaths in Older Adults
Yale study suggests that immune response to flu causes death in older people, not the virus.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!