No Treatment-Related Safety Concerns Reported
- No safety issues related to the investigational treatment reported at 30 days post treatment of the first patient following single dose NKG2D CAR T-cell infusion; triggers enrollment of other two patients in the first cohort.
- The trial is a dose escalation study evaluating safety and feasibility of a CAR T-cell therapy in patients with acute myeloid leukemia or multiple myeloma.
MONT-SAINT-GUIBERT, Belgium, June 10, 2015 (GLOBE NEWSWIRE) -- Celyad SA (Euronext Brussels and Paris: CYAD), today announced the completion of the 30-day safety follow-up of the first patient enrolled in the Company's Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).
The first patient suffers from AML. This Phase I trial is a dose escalating study. Following the infusion of the first dose of NKG2D CAR T-cell, no safety issues were reported with the treatment over the follow-up period of 30 days. This marks an important step in demonstrating the safety of NKG2D CAR-T cell infusion at that dose and triggers the enrollment of the next two patients in the first dose cohort.
Dr. Christian Homsy, CEO of Celyad, commented, "At 30 days post NKG2D CAR-T cell infusion for this first patient, no safety issues were reported. This is a great milestone in validating our new CAR T-cell platform. We look forward to recruiting of the remaining patients in this first dose cohort."
The full data readout from the Phase I trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-cell as primary endpoints, with secondary endpoints including clinical efficacy.
The NKG2D CAR T-cell is an autologous chimeric antigen receptor T lymphocyte (CAR T-cell) therapy constructed using the native sequence of natural killer cell (NK cell) receptors which, unlike traditional CAR technologies such as those targeting the CD19 antigen, has the potential to target a broad range of solid tumors and blood cancers by targeting ligands present on numerous types of cancer cells. The research underlying this technology was originally conducted at Dartmouth College by Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology, Cancer Research and Blood.
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Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy treatments with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure®, for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in April 2015.
Celyad's shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CYAD.
To learn more about Celyad, please visit www.celyad.com
Forward looking statements
In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of clinical trials, including Phase III clinical trials for C-Cure® and Phase I clinical trial for NKG2D CAR T-cell additional clinical results validating the use of adult autologous stem cells to treat heart failure and CAR T-cell autologous therapy to treat cancer; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; obtaining, maintaining and protecting intellectual property, our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties, competition from others developing products for similar uses, our ability to manage operating expenses, and our ability to obtain additional funding to support our business activities and establish and maintain strategic business alliances and business initiatives. Any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
C3BS-CQR-1, C-Cure, NKG2D CAR T-cell, C-Cathez, OnCyte, Celyad, Cardio3 BioSciences and the Cardio3 BioSciences, Celyad, C-Cathez, CHART-1, CHART-2 and OnCyte logos are signs internationally protected under applicable Intellectual Property Laws. Mayo Clinic holds equity in Celyad as a result of intellectual property licensed to the Company.