Cytheris to start two phase I/IIa clinical trials of CYT107, its new recombinant Interleukin-7, in Hepatitis C and oncology
- Category: Proteins and Peptides
- Published on Friday, 01 June 2007 04:00
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PARIS, France | May 31, 2007 | Cytheris, a product-oriented biopharmaceuticalcompany focused on the research and development of new and critic alagents for immune modulation, today announced it will start two phaseI/IIa clinical trials of its CYT107 recombinant interleukin in Hepatitis C and oncology. These follow the successful completion of four phase I studies. The company expects these new trials to confirm IL-7's potential in building immune system response.
The Hepatitis C trial (CYT107-05) will concern HCV infected patientsthat are non-responders to the reference treatment (12 weeks ofPEG-Interferon + Ribavirin). This multicentric dose escalation study(France, Switzerland) will include 12-18 patients. They will receiveCYT107 (rh-IL-7) injected weekly over 4 weeks in addition to their reference treatment. More than one third of the patients do not respond to the reference treatment because they are unable to mountan efficient immune response against the virus. Cytheris expects theaddition of CYT107 treatment to restore appropriate T cell function and help these patients cope better with the virus.
The oncology trial (CYT107-04) targets patients with metastatic melanoma or advanced renal cell carcinoma. It will include 18 to 30patients, both lymphopenic and non-lymphopenic in a dose escalationmode. It will be conducted at NCI (Bethesda, MD USA) in collaborationwith Prof. Steve Rosenberg. Most recent clinical data demonstrate howcritical the immunological status of cancer patients is for theirclinical outcome. CYT107 is expected to boost patients' immuneresponses against their tumor. This will be important in thetreatment of post-chemotherapy residual diseases and/or to supportefficacy of various cancer vaccine approaches.
"These two new trials should help confirm the strong potential ofIL-7 in reconstituting the immune system and enhancing the specificimmune response against various fatal infectious or malignantdiseases," said Michel Morre, CEO of Cytheris. "These two studiesform part of Cytheris's ambitious phase I/II program. Four phase onestudies of recombinant human IL-7 have already been completed inoncology and HIV in both France and the US. As of today, more than 60patients have been treated, with encouraging results which we havepresented in many international meetings such as AACR and ASCO US2006, ASH 2006 and CROI 2007.
"Although the primary objectives of these trials consist inestablishing the safety and pharmacokinetic profiles of CYT107,biologically active doses will be sought based on the measures of afull set of immunological surrogate markers together with the controlof the viral load in the HCV study and tumor growth and extension inthe oncology study.
Main results for both studies should be available in the secondquarter of 2008, opening the door to larger phase II studies.
Cytheris, Paris, is a product-oriented biopharmaceutical companyfocused on the research and development of new and critical agentsfor immune modulation. These drugs aim at reconstituting andenhancing the immune system of patients suffering from cancer,chronic viral or bacterial infections (such as HIV and HCV) orlympho-depleting treatments (e.g. post-chemo,-BMT and -HCT).The company's lead compound, recombinant Interleukin-7 (rIL-7) is acritical growth factor for immune T Cell recovery and enhancement.Clinical trials conducted on more than 60 patients in France and USAhave already demonstrated the impressive ability of rIL-7 to expandand protect CD4+ and CD8+ T cells.A second family of products is based on highly potent NKT/dendriticcell ligands, in-licensed from several New York universities. Theproduct family strengthens innate and adaptive immunity connectionsand will provide new immuno-therapeutic adjuvants for cancer andchronic infectious diseases.
The company, founded in 1999, operates from Issy les Moulineaux,Paris and its US subsidiary in Rockville (MD). It has a network ofstrong and active collaborations with world-leading academic andclinical teams. Today Cytheris employs 22 experienced people inEurope and USA. Its investors include AXA Private Equity, BioamGestion, Credit Agricole Private Equity and CDC Innovation (Paris), T2C2 Bio2000 and CDPQ (Montreal), Forbion Capital Partners(Amsterdam). Website: www.cytheris.com.