Cynata to go Ahead with their Phase 2 Clinical Trial Post Favourable Advice from MHRA

Cynata Therapeutics (ASX: CYP) is an Australian biotechnology company which is in the business of researching and manufacturing regenerative medicine targeted towards the development of therapies based on a proprietary therapeutic stem cell platform called Cymerus. It is designed to use induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) which helps in overcoming the challenges of other production methods to economically manufacture cell therapy products, including mesenchymal stem cells (MSCs) at a commercial scale without the limitation of multiple donors.

On 12th March 2019, the company announced that in order to go ahead with its planned Phase 2 clinical trial of CYP-002 (Cymerus MSCs), it had received favourable advice from United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

Critical limb ischemia (CLI) is a medical condition in which the blood flow and oxygen supply to the specific parts of the body become insufficient. The primary cause of restricted blood flow and oxygen is the narrowing of arteries in the limbs. The CLI often results in amputation of the affected limb and is also highly risky for cardiovascular events.

MHRA apart from favourable advice has also confirmed the following:

  • The proposed 90-patient Phase 2 clinical trial design is generally acceptable
  • The completed preclinical proof of concept study in a model of CLI is acceptable.
  • The CYP-002 manufacturing process and quality control testing is acceptable
  • Cynata’s proposed preclinical biodistribution study is acceptable, and no other preclinical safety studies are required to support the clinical trial.

The clinical trials are expected to be commenced during the second half of 2019, and the company anticipates the trials to be conducted at a number of centres in the UK and Australia.

The company’s Vice President of product development, Dr. Kilian Kelly stated that they have built a strong relationship with one of the most respected regulatory authorities worldwide (MHRA) in this highly successful meeting and are pleased with the outcome. This successful meeting also confirms the safety data from the completed Phase 1 trial supports the direct progression to Phase 2 trials.

Yesterday on 11th March 2019, the company announced that it had received funding for the study investigating advanced materials for the manufacturing and delivery of highly potent mesenchymal stem cells (MSCs). This study is being conducted jointly with the University of Melbourne. A cash award made to the University of Melbourne by Victorian Medical Research Accelerator Fund and Cynata will contribute Cymerus MSCs for the study.

Dr. Kilian Kelly stated This project would lead to the development of materials that would hold great potential for improving both the delivery of cells for therapeutic purposes and their manufacturing. This could prove to be a highly impactful technology in terms of clinical and economical use which will lead the company to explore potential commercial use.

On 7th January 2019, the company had received notice of acceptance from IP Australia for Cymerus patent application

On the technical front, the stock is trading 0.62% up on the ASX at A$1.61 as of 12th March 2019 compared to the previous closing of A$1.60. The stock has delivered a return of more than 63% in the last three months.


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