Cynata Reports Positive Six-Month Data from Cohort A in Phase 1 Trial of CYP-001 in GvHD

Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce positive safety and sustained overall survival rates from a six month follow-up assessment of patients enrolled in Cohort A of its Phase 1 clinical trial of CYP-001, the company’s lead Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD).

As quoted in the press release:

In the Phase 1 trial, eight patients with steroid-resistant acute GvHD were enrolled in Cohort A, and received two infusions of CYP‑001 administered one week apart. Each dose was 1 million cells per kilogram of body weight (cells/kg), up to a maximum dose of 100 million cells.

The primary evaluation period involved assessment of safety and efficacy (response to treatment) up to day 100. In accordance with the trial protocol, patients then entered the long term follow-up phase of the trial, primarily to monitor safety, with assessments at approximately six, 12, 18 and 24 months after the first dose of CYP-001.

As reported in February 2018, overall survival in Cohort A at day 100 was 87.5 percent, while the Overall and Complete Response rates by day 100 were 100 percent and 50 percent, respectively.¹ As previously reported, one patient in Cohort A died after developing pneumonia, which is common in recipients of bone marrow transplants and similar procedures. This death was not considered to be treatment related.

Click here to read the full press release.