Welcome, Guest
Username: Password: Remember me
Adult Stem Cell News and Developments other than Cytori
  • Page:
  • 1

TOPIC: Capricors Allogeneic Cardiac Clinic Fails- Lay-offs

Capricors Allogeneic Cardiac Clinic Fails- Lay-offs 12 May 2017 09:45 #9325

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3255
  • Thank you received: 1108
Capricor to Cut Jobs as Cardiac Cell Therapy Falters in Heart Attack Study

Capricor Therapeutics said it would have to cut jobs and the scope of its operations after interim data from a Phase II study evaluating its lead allogeneic cardiosphere-derived cell therapy CAP-1002 in heart attack patients showed that the trial was unlikely to meet its primary 12-month efficacy endpoint. The firm said it would now focus its resources on its Duchenne muscular dystrophy (DMD) program for CAP-1002.

The 142-patient ALLSTAR trial was evaluating CAP-1002 in adults who have experienced a large heart attack with residual cardiac dysfunction. The prespecified interim analysis on 6 months of follow-up data indicated that the study wasn’t going to demonstrate a statistically significant difference in the efficacy endpoint of percent change from baseline infarct size as a percentage of left ventricular mass, measured by cardiac magnetic resonance imaging (MRI).

"The lack of a clear difference in the change in scar size from baseline to 6 months between the active and control groups in the interim observations from ALLSTAR was unexpected,” admitted Linda Marbán, Ph.D., president and CEO of Capricor. “These results diverge from the consistent and extensive record of activity observed with our cell technology in the setting of cardiac fibrosis as demonstrated by both preclinical and clinical studies, and we hope to gain an understanding of the factors that led to these observations through the conduct of further analyses.”

Raj Makkar, M.D., co-principal investigator of the ALLSTAR Trial, and associate director for interventional technologies in the Heart Institute at Cedars-Sinai Medical Center, added, "We believe it is important to note that the observed improvements in scar size in the placebo group are markedly inconsistent with the well-established natural history of this disease process. It is certainly possible that, for a variety of reasons, the greater number of sites involved in the conduct of ALLSTAR contributed to an increase in variability seen in the scar measurements as determined by MRI."

Carpricor said it would continue to analyze cumulative ALLSTAR data, which showed no notable differences between treatment groups in ejection fraction, but did show near statistically significant reductions in mean end-diastolic volume and trends toward reduction in mean end-systolic volume associated with CAP-1002 therapy.

The firm hasn’t disclosed how many jobs will have to go, but said it would now concentrate on developing CAP-1002 for the DMD indication, including the ongoing Phase I/II HOPE trial evaluating skeletal muscle performance and cardiac biomarkers in boys and young men with DMD treated using CAP-1002. Positive 6-month data from the single-dose HOPE study were reported last month.

Full article : HERE

Please Log in or Create an account to join the conversation.

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:

Capricors Allogeneic Cardiac Clinic Fails- Lay-offs 12 May 2017 10:57 #9326

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3255
  • Thank you received: 1108
And while we are at it...

MesoBlast passed their "Futility Test" on the first 270 patients of the in total 600 patients CHF clinic.

Means the safety is OK and this review did NOT indicate that the primary endpoint is NOT achievable...they simply do not know and will continue.

Melbourne, Australia; and New York, USA; April 10, 2017: Mesoblast Limited (ASX: MSB;
Nasdaq: MESO) today announced that the Phase 3 trial of its allogeneic mesenchymal precursor cell
(MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure
(CHF) was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial's
first 270 patients. It is expected that the trial will enroll in total approximately 600 patients. After
notifying the Company of the interim analysis results, the trial’s Independent Data Monitoring
Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and
formally recommended that the trial should continue as planned.


File Attachment:

File Name: MESO-SuccessfulInterimAnalysisinPhase3HeartFailureTrial.pdf
File Size: 370 KB
Attachments:

Please Log in or Create an account to join the conversation.

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:
  • Page:
  • 1
Time to create page: 0.137 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites