Cynata Therapeutics ($0.20) has made strong progress with its Phase I clinical trial of CYP-006TK for diabetic foot ulcers (DFUs), meeting its primary endpoints of safety and tolerability, as well as showing good signs of efficacy. The data released follows on from earlier data in February this year from the first 16 patients and remains consistent.
Health burden of diabetes
DFUs are a common and serious complication of diabetes, with about 20% of DFUs leading to amputation. Around 38 million Americans have diabetes. Stem cells are believed to enhance wound healing due to multiple mechanisms. These include differ- entiation of stem cells into skin cells, but also provide a source of cytokines (to control inflammation) and growth factors that pro- mote wound healing.
Novel wound dressing
The study used a novel mesenchymal stem cell (MSC)-based topi- cal wound dressing. In the trial, 30 participants were randomised to receive CYP-006TK for four weeks and then standard-of-care (SoC), or entirely SoC, with researchers measuring wound size over time.
Reduction in wound size
At 12 weeks, the CYP-006TK group decreased their wound sizes by 65%, while the SoC group achieved a mean decline of 22%.
By the 24-week mark, patients on CYP-006TK had undergone an 84% decrease in wound size, while the SoC group decreased their mean wound size by 48%.
There was a more pronounced improvement in the larger wounds treated with Cynata's stem cell therapy. This is evident from the mean changes in wound area measured expressed as mm2 rather than percentage change (see table below). At 12 weeks (including all patients), the active arm achieved a mean 181mm2 reduction in wound size, compared to a 355mm2 increase in mean wound area,
Phase I Trial Results in Mean Wound Sizes
indicating some of the larger wounds were deteriorating in the first 12 weeks in the control. After 24 weeks, the active arm achieved a mean 261mm2 decrease in wound area compared to a mean 62mm2 increase in the control arm.
While the trial wasn't powered to detect statistical significance, CEO Kilian Kelly said "We believe there is a clear signal indicating improved wound healing."
He added: "Finally, today's results further exemplify the commer- cial attractiveness of the broader Cymerus platform, with the Com- pany now having two distinct product candidates that have gen- erated positive clinical data."
Cymerus platform technology
The MSCs were generated using Cynata's proprietary Cymerus platform. Unlike conventional MSC manufacturing, Cymerus' MSCs are derived from a single donor, with enormous scalability and potency.
"If subsequent trials confirm similar effects then we might be on the path to a therapy," said CMO Dr. Jolanta Airey.
Cynata raised A$8 million through an institutional placement after the result at $0.18 per share. Cynata is capitalised at $52 million.
Bioshares recommendation: Speculative Buy Class A
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