Cynata Therapeutics announces positive trial results

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Australian stem cell and regenerative medicine company Cynata Therapeutics (ASX:CYP) has announced 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.

CYP-001 is the company’s lead Cymerus mesenchymal stem cell (MSC) product candidate in steroid-resistant acute graft-versus-host disease (GvHD).

In a statement, the company said overall survival in Cohort A remains at seven out of eight patients (87.5 percent) with no treatment-related serious adverse events (SAEs) or safety concerns.

According to Dr Kilian Kelly, Cynata’s vice president of product development, “There is a clear unmet need for improved treatment options in steroid-resistant GvHD, where the prognosis for patients remains poor and there are very high mortality rates.

"We are delighted to report that all patients evaluated in Cohort A continue to do well six months after treatment with CYP-001, and that no safety concerns have arisen. We look forward to reporting further follow-up data from these patients late this year, and to the first data readout from our higher-dose Cohort B in the coming weeks.”

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. 

"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," said the company.