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TOPIC: Celyad-formerly Cardio³- reported CHF PIII results

Celyad-formerly Cardio³- reported CHF PIII results 09 Jul 2016 07:58 #7397

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A statistically-significant difference on the primary endpoint was not reached; however, a positive trend was seen across all treatment groups, and the primary endpoint was met (p=0.015) for a subset representing 60% of the population of the CHART-1 study (baseline End Diastolic Volume (EDV) segmentation).
Based on the positive subgroup analysis, Celyad will contact the European Medicines Agency concerning a marketing authorization application.
Prof. Jozef Bartunek will present the full 39 weeks' data at the "Hot Line Heart Failure and Innovative Approaches" Late Breaking Clinical Trial Session at ESC on Sunday, August 28, 2016.
Celyad will seek a partner to accelerate further development and commercialization of C-Cure®.
MONT-SAINT-GUIBERT, Belgium, June 28, 2016 (GLOBE NEWSWIRE) -- Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular diseases and immuno-oncology, today announced headline results for CHART-1, its European Phase III clinical trial for its lead cardiovascular disease product candidate.

Across the complete trial population, a positive trend was clearly identifiable. However, a statistically-significant difference between treatment and control (sham procedure) was not reached.

For patients representing 60% of the overall study population and categorized by their End Diastolic Volume (EDV) at inclusion, significance was met for the primary endpoint (p = 0.015). Most importantly, in this subgroup, a strong trend or a statistical significant positive difference was seen in all individual elements of the composite primary endpoint (Mortality, Worsening Heart Failure Events, Quality of Life, 6 minutes Walking Test, End Systolic Volume and Ejection Fraction).

The study procedure was well tolerated with no safety concerns.

The CHART-1 trial has been selected by the European Society of Cardiology to be presented at the "Hot Line Heart Failure and Innovative Approaches" Late Breaking Clinical Trial session of the ESC congress in Rome on Sunday, August 28, 2016, at 11:54 am CEST. The European Society of Cardiology has organized a press conference scheduled at 8 am CEST on the same day.

Based on the positive results seen in this highly clinically relevant group of patients for whom treatment options are currently limited, Celyad will contact the European Medicine Agency concerning a marketing authorization application.

The Company will use the CHART-1 results as a foundation to optimize the design of the pivotal CHART-2 US trial. In line with this, Celyad confirms it is seeking partnerships to accelerate further development and commercialization of C-Cure®.

Dr. Christian Homsy, CEO of Celyad, commented: "For the first time in a randomized, double-blind, controlled, Phase III cell therapy study, a positive effect, consistent across all parameters tested, was observed for a substantial, clearly definable, group of heart failure patients.

CHART-1 has allowed us to better define the patient population that would benefit from C-Cure®. We are excited by the prospects for C-Cure® as a new potential treatment option for a highly relevant heart failure population. We are confident that the results will generate interest from potential partners that could accelerate the development and commercialization of C-Cure®."

Prof. Jozef Bartunek, CHART-1 principal co-investigator, said: "This pioneering study has contributed greatly to our understanding of heart failure disease and the place of regenerative medicine in its management. The results seen for a large clinically relevant number of the patients are ground breaking. We look forward to completing the full analysis and making the data available to the medical community at ESC.

On behalf of the CHART 1 steering committee we wish to thank the patients and families who were enrolled in the study as well as all the physicians and medical teams that made this study possible." Prof. Gerasimos Filippatos, Immediate Past-President of the Heart Failure Association of the European Society of Cardiology, member of the CHART-1 dissemination committee, said, "The CHART-1 results have identified a well-defined group of patients with symptomatic heart failure despite optimal therapy. Those patients are a large subset of the heart failure population and present specific therapeutic challenges. The outcome of CHART-1 indicate those patients could benefit from this therapy".


The above news caused the PPS to drop from 40+$ to roughly 25$ which is still a market cap of 250 Mio. Anyway- its probably not C-Cure which brings the fantasy to Celyad, but its CAR-T technology, which is described as follows:
In addition, the Company is developing a next generation 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, NKR-2 (NKG2D CAR T-cell), entered a Phase I clinical trial in April 2015.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Celyad-formerly Cardio³- reported CHF PIII results 09 Jul 2016 08:14 #7398

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So now we will have (I believe for the first time) the results of a CHF trial for Cell therapy where the number of patients treated - 271 - were probably of sufficient number to draw substantiated conclusions.

For those that do not know of C-Cure on the clinic-

About C-Cure®
C-Cure® is Celyad's product candidate based on its cardiopoiesis platform being evaluated for heart failure. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Doctor Atta Behfar, and has been published in numerous peer-reviewed publications. C-Cure® consists of a patient's own cells harvested from bone marrow, treated with a combination of cytokines and growth factors and then re-injected into the heart. It is designed to enhance reparative capabilities in the failing heart.

About CHART-1
The CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial is a Phase III clinical trial to evaluate C-Cure® for the treatment of heart failure. CHART-1 is a prospective, controlled multi-center, randomized, double-blinded Phase III clinical trial comparing treatment with C-Cure® to a sham treatment. The trial recruited 271 evaluable patients with chronic advanced symptomatic heart failure in 12 countries in Europe and Israel. The trial is designed to assess the safety and efficacy of C-Cure®. The primary endpoint of the trial was a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine-month post-procedure.


Of course when the numbers are available in late August, I will intend to spend some quality time on it. The other trial for AMI is already very old- the REPAIR-AMI clinic in Germany of which the 5 years results are out and which I know by "heart" :grin: . That clinic from Zeiher/Dimmeler did 201 patients and was the inspiration for BAMI (despite all the negative NIH clinics in the US) which is simply whole marrow- uncultured- from the patient.

BAMI is supposed to treat 3000 patients and is ongoing since 2013 to my knowledge- mainly in Germany, but that is logical, since I believe the Zeiher/Dimmeler tech (which cannot be patented) is used in the trial. See Clinicaltrials.gov record : HERE

All the above were AUTO clinics.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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