Source: Arch Therapeutics, Inc.
Treatment Effect of AC5-Significantly Shortening of Time To Hemostasis vs Control- Was Consistent Whether Patients Were Taking Antiplatelet Therapy or Not
Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of devices for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, reports additional positive data in its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device™ ("AC5™") in skin lesion patients with bleeding wounds. On August 15, 2016, the Company reported top-line data from the clinical study that indicated that AC5 was safe and that it reduced time to hemostasis in wounds versus controls. Today, the Company released the results of additional analysis of the subgroup of 10 patients who were taking a prescribed antiplatelet medication, commonly known as a blood thinner, such as aspirin, which indicated that AC5 had similar effects for the subgroup of patients taking an antiplatelet agent.
In
particular, in this newly reported analysis of the primary and
secondary outcomes for wounds among patients treated with an
antiplatelet agent, the primary objective of safety throughout the
surgical procedure and until the end of a 30-day follow-up period post
procedure was met and AC5 was well tolerated. Moreover, AC5 shortened
time to hemostasis ("TTH") versus a control whether or not patients were
taking antiplatelet therapy, suggesting that AC5 performance is not
affected by antiplatelet therapy. The reduced median TTH of the AC5
treated wounds versus the control wounds was statistically significant
for both the overall group of 46 patients (p<0.001) and for the
subgroup of 10 patients on antiplatelet therapy (p=0.005). Further, the
median TTH for wounds treated with AC5 was less than 30 seconds for both
the overall study group and for the subset of patients taking
antiplatelet therapy.
Terrence
W. Norchi, MD, President and CEO of Arch Therapeutics, said, "We have
eagerly awaited initial data to support the hypothesis that the
mechanism of action of AC5 is independent of a patient's underlying
bleeding or coagulation status. These results are an important first
step in highlighting an important differentiating feature of AC5 and our
self-assembling peptide technology platform."
Jack
Kelly, MD, Principal Investigator of the study, and a plastic,
reconstructive and aesthetic surgeon and Professor of Surgery at Galway
University Hospital, Galway, Ireland, said, "We have been impressed with
how patients in this study responded to treatment and how easy AC5 was
to use. The favorable safety and efficacy profile of AC5 in the overall
study was supported when looking at the subset of patients taking
antiplatelet therapy, which is particularly noteworthy. Many patients
have perturbed hemostasis pathways, whether from natural disease or the
use of prescribed or over the counter blood thinners, therefore we
always have a concern about more bleeding in these patients. AC5 may
provide their care providers a valuable tool to address those
challenges."
As
previously reported, this first study assessing the safety and
performance of AC5 in humans served to evaluate the safety and
performance of AC5 in patients scheduled to undergo excision of skin
lesions on their trunk or upper limbs. Of the 46 patients enrolled in
the human study, 10 patients were taking an antiplatelet agent and 36
were not. Each patient had two wounds, of which one was treated with AC5
and the other received standard care plus a sham treatment according to
a randomization process. Consequently, each patient served as her/his
own control.
The
study's overall primary objective of safety throughout the surgical
procedure and until the end of a 30-day follow-up period post procedure
was met and AC5 was well tolerated. 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. The
majority of patients had an ASEPSIS score of 0 in both wounds on both
days, and all AC5-treated wounds healed satisfactorily as per wound
healing scoring criteria.
Previously,
Arch's clinical advisory committee deemed the study results to be
clinically significant and have recommended submitting a manuscript to a
peer-reviewed medical journal for publication. In light of this new
data, the committee added, "This first human study assessing the safety
and performance of AC5 has revealed an impressive and statistically
significant result in patients on an antiplatelet agent, indicating that
it may have broad potential scope in different applications."
The
advisors include Arthur Rosenthal, PhD, Professor of Practice,
Emeritus, Department of Biomedical Engineering, Boston University, and a
former member of Arch's Board of Directors; Steven Schwaitzberg, MD,
Professor and Chairman of the Department of Surgery at the University of
Buffalo's Jacobs School of Medicine and Biomedical Sciences and past
President of the Society of American Gastrointestinal Endoscopic
Surgeons; Paresh Shah, MD, Vice Chair of Surgery, Director of General
Surgery and Professor of Surgery at New York University Langone Medical
Center, New York University Langone School of Medicine; and William
Denman, MD, anesthesiologist at Massachusetts General Hospital, past
Chief Medical Officer of GE Healthcare and past Chief Medical Officer of
Covidien.
The
Company expects to submit further study details and data to a
peer-reviewed journal for publication. The Company also plans to include
data from this trial in its regulatory filings, including 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.
The
study, conducted at University College Hospital, Galway, Ireland, was
carried out in collaboration with CÚRAM, Science Foundation Ireland
Centre for Research in Medical Devices and the HRB Clinical Research
Facility based at National University of Ireland Galway.
About Arch Therapeutics, Inc.
Arch
Therapeutics, Inc. is a medical device company developing a novel
approach to stop bleeding (hemostasis) and control leaking (sealant)
during surgery and trauma care. Arch is developing products based on an
innovative self-assembling peptide technology platform to make surgery
and interventional care faster and safer for patients. Arch's flagship
development stage product candidate, known as the AC5 Surgical
Hemostatic Device™, is being designed to achieve hemostasis in surgical
procedures.
About HRB Clinical Research Facility, Galway, Ireland
The
HRB Clinical Research Facility, Galway (CRFG) is a joint venture
between Galway University Hospitals (GUH), Saolta, and National
University of Ireland, Galway (NUIG) and has been in operation since
March 2008. The HRB-CRFG provides the infrastructure, physical space,
facilities, expertise and culture needed to optimally support clinical
research. It focuses on studies aimed at understanding a range of
diseases and speedily translating the knowledge obtained through this
research work into advances in patient care.
About CÚRAM
CÚRAM
is the Science Foundation Ireland Centre for Research in Medical
Devices, based at NUI Galway. Supported by Science Foundation Ireland
(SFI) and industry partners, CÚRAM enhances Ireland's standing as a
major hub for the global medical devices industry. Its goal is to
radically improve quality of life for patients with chronic illness by
developing the next generation of smart, implantable medical devices.
CÚRAM's innovative approach incorporates biomaterials, drug delivery,
cell based technologies, glycosciences and device design to enhance,
develop and validate both traditional and new combinational medical
devices, from molecular design stage to implant manufacturing. CÚRAM's
devices are being developed with strong clinical collaborations to
enable rapid translation of research findings to clinical application.
Key to the approach is the establishment of unique networks of national
and international collaborations, integrating world class clinical,
academic and industrial partners
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