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August 2016 CÚRAMs First Co-Funded Clinical Trial Successfully Completed with Arch Therapeutics
Arch Therapeutics, Inc. in collaboration with CÚRAM, Science Foundation Ireland Centre for Research in Medical Devices and the Clinical Research Facility at NUI Galway have successfully met the objectives of a recently completed single-center, randomized, single-blind prospective clinical study of the AC5 Topical Hemostatic DeviceTM in skin lesion patients with bleeding wounds. This was the first study assessing the safety and performance of AC5 in humans and was conducted at University College Hospital, Galway, Ireland.
The objectives of the study were to evaluate the safety and performance of AC5 in patients scheduled to undergo excision of skin lesions on their trunk or upper limbs. The primary endpoint was safety throughout the surgical procedure and until the end of a 30-day follow-up period post procedure. Safety of the clinical investigation device was determined by monitoring for treatment related adverse events. The primary objective was met, as the safety outcomes of both the AC5 treatment group and the control group were similar. No serious adverse events were reported.
A secondary endpoint was performance as assessed by time to hemostasis. The median time to hemostasis of wounds in the AC5 treatment group was 41% faster than for those in the control group. This result was statistically significant (p<0.001, Wilcoxon signed rank test).
An additional secondary endpoint of healing of treated wounds was assessed as measured by the ASEPSIS wound score at Days 7 and 30. There was no evidence, at either follow-up day, of an adverse effect of AC5 treatment on the wound ASEPSIS score. The ASEPSIS score did not appear to be compromised, as the majority of patients had an ASEPSIS score of 0 in both wounds at Days 7 and 30. All AC5-treated wounds healed satisfactorily as per wound healing scoring criteria.
Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, "These top-line data support that AC5 was safe and performed as expected in the patients enrolled in this study. These successful results mark a significant milestone in the development of AC5 and we are grateful to the support we have received from our colleagues at CÚRAM and CRFG, as well as others involved in the process. We look forward to further advancing our self-assembling peptide technology platform for this and other applications."
The clinical study enrolled 46 patients, including 10 who were taking antiplatelet monotherapy. Each patient had bleeding wounds created as a result of the excision of at least two skin lesions under local anesthetic in the same setting. On a randomized basis, one lesion received AC5 and the other(s) received a control treatment consisting of standard therapy plus a sham. Each subject was followed-up for safety assessment both on Day 7 and again on Day 30, which marked the end of the subject's participation in the clinical study.
"These results demonstrate significant improvement in efficacy without compromising patient safety. We believe that AC5 represents a unique technology that will provide both rapid and sustained hemostasis and important differentiable clinical benefits," concluded Norchi.
Arch's clinical advisory committee has deemed the study results to be clinically significant and have recommended submitting a manuscript to a peer-reviewed medical journal for publication. The Company expects to submit further study details and data, including subgroup analysis, to a peer-reviewed journal for publication. The Company also plans to include data from this trial in a CE mark application for AC5, which is currently anticipated to be filed at the earliest by the end of this year. Arch is currently planning its next clinical-regulatory steps for both the EU and the US.
Professor Abhay Pandit, Director of CÚRAM, said: “Clinical trials are an essential component in creating medical devices that realise their full potential and ensuring the safety value of each new development. Without these trials, research cannot be translated into economic, health or societal benefits. Our collaboration with Arch Therapeutics is very exciting. Leaders within CÚRAM have a successful history working with Arch, and we are delighted to support their drive to commercialization for what should be very important products for the healthcare industry.”