Clinical-stage Biotechnology company, Cynata Therapeutics Limited (ASX: CYP) unveils its clinical study report on the first-ever clinical trial utilizing induced pluripotent stem cell (iPSC)-derived therapy.
In the announcement dated 21 March 2019, Cynata told that it has completed the clinical study report (CSR) on the Phase 1 trial of its leading Cymerus™ mesenchymal stem cell, CYP-001, aimed at the treatment of steroid-resistant acute graft versus host disease (GvHD).
As per the company’s information, the copy of the report has already been sent to its partner Fujifilm who now has 90 days to exercise the license option. Fujifilm further continues to conduct product development campaigns together with Cynata for CYP-001 so as to start the Phase 2 clinical program in 2019.
Chief Executive Officer of Cynata, Dr Ross Macdonald stated that completion of clinical study report marks a significant milestone for the company as it underscores the success of Phase 1 clinical trial of CYP-001 while achieving all efficacy and safety endpoints.
Cynata reported some key highlights of the final results which include the overall response rate of 87%, a complete response rate of 53% and overall survival rate of at least 87% by Day 100 of the primary evaluation period. Moreover, the trial has also been safe throughout as the company did not identify any safety concerns or the occurrence of an adverse event relating to the treatment.
The UK Chief Investigator for the trial, Dr Adrian Bloor stated that it has been an extremely crucial trial and it's encouraging to have favourable results with significant Overall Response and Complete Response rates. Dr Bloor added that they are looking forward to evaluating CYP-001 further in the next phase of clinical trial.
In a separate announcement to the Australian Securities Exchange, Cynata also announced that the term of Fujifilm Corporation’s license option in graft-versus-host disease (GvHD) has been extended to 19 September 2019.
Dr Macdonald stated “The purpose of this extension is to enable the parties to seek to accommodate certain requests made by Fujifilm in relation to structural aspects of the GvHD license agreement. Cynata notes that Fujifilm has not raised any material issues in respect of the financial, clinical or technical aspects of CYP-001 or Cynata’s core Cymerus™ technology generally.”
Going forward, the company aims to accelerate the development of Phase-2 program for CYP-001 while seeking Fujifilm’s decision in relation to the exercise of the license option.
Following the release of duo-announcements, the trading halt on Cynata securities got lifted today. But as the stock joined backed the trading trail, the investors pressed the sell button and the stock declined as much as 29.379% to last trade at $1.250 on 21 March 2019.
The historical performance of CYP has been in an uptrend as the stock price increased 41.60% over the past 12 months including an attractive 70.19% returns reported in the last three months.
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