Origin(TM) Announces First 50 Patients Randomized, and Full Site Activation in Phase IIb Dose-Ranging Study for Diabetic Foot Ulcers
(Thomson Reuters ONE) -
PRINCETON, N.J., June 01, 2017 (GLOBE NEWSWIRE) -- Origin, Inc. (formerly
Advanced Plasma Therapies, Inc), a Princeton, NJ based clinical-stage wound care
company focused on treatment of Diabetic Foot Ulcers (DFUs) today announced
that the first 52 patients have been randomized in the "GENESIS" trial, marking
the passing of the halfway enrollment point for the study. The first patient in
the study was randomized on March 21, 2017. These patients are being treated in
its U.S. dose-ranging Phase IIb "GENESIS" trial. Additionally, all the sites
designated for the study have been activated. Origin has developed a proprietary
technology to generate and deliver therapeutic quantities of plasma-
generated Nitric Oxide (NO) for a wide range of potential human health benefits.
The GENESIS trial is designed to demonstrate healing and optimize the treatment
regimen for chronic Diabetic Foot Ulcers (DFUs).
"We are excited about the pace of enrollment for the GENESIS trial and the full
activation of all our sites, both of which are ahead of schedule. The rate of
enrollment is ahead of what we had envisaged and, if maintained, points to an
earlier look than anticipated at data from our first controlled US trial," said
Michael Preston, Chairman and CEO of Origin. "The enrollment rate for the
GENESIS trial is a clear indication that DFUs represent a critical unmet need
for patients with diabetes, a disease that is growing far too rapidly and
affecting more than 49 million people in the US and EU alone. Plasma-generated
Nitric Oxide has the potential to offer a safe and effective wound closure
treatment, particularly for patients with Diabetic Foot Ulcers, where limb
amputation is often the outcome. Because DFUs affect as many as 7 million people
in the US and EU with diabetes (as high as 15% of the diabetic patient
population), we believe that Origin's first targeted indication represents a
large market opportunity."
Study design
GENESIS is a single-blinded 27-week study which will recruit up to 100 patients
across 15 clinical sites in the U.S. After a three-week qualification period,
patients will be randomized into one of four different dosing regimens or a
standard of care (SOC) treatment arm to assess efficacy and safety. Patients
will be treated over 12 weeks and monitored for 12 weeks post-treatment.
* Arm 1: SOC alone, including dressing changes, wound cleansing, pressure
relief (off-loading) and wound debridement
* Arm 2: 6 minute dose of plasma-generated nitric oxide, 2 times per week,
along with SOC
* Arm 3: 6 minute dose of plasma-generated nitric oxide, 4 times per week,
along with SOC
* Arm 4: 12 minute dose of plasma-generated nitric oxide, 2 times per week,
along with SOC
* Arm 5: 12 minute dose of plasma-generated nitric oxide, 4 times per week,
along with SOC
Efficacy will be measured by wound closure rate (in cm2 of epithelium coverage
per week) and wound closure percentage (efficacy measures for the study analyzed
through a maximum of 12 weeks of treatment). Safety will be measured by wound-
related adverse events, including adverse events of all causes that affect the
wound.
"Diabetes and consequential diabetic foot ulcers are a growing healthcare burden
impacting millions of people," concluded Michael Preston, Chairman and CEO of
Origin. "Reaching these two key milestones in the GENESIS trial, full site
activation and more than 50% of patients enrolled and randomized, further
advances our goal; to become the therapy of choice for the treatment of DFUs,
and potentially, severe wounds of all types. We look forward to providing an
update and readout of the interim results as early as the third quarter of
2017."
About DFUs
Diabetic foot ulcers are chronic, non-healing, penetrating wounds of the foot
in patients with type 1 and type 2 diabetes mellitus. Over 49 million people in
US and EU have diabetes1 and as many as 15% can develop DFUs at $11,000-16,000
annual incremental cost per patient2 (excluding amputation). 60% of patients are
not healed after initial treatment with standard of care1. There is clear need
for new and effective therapies.
About Origin
Origin, Inc. (formerly Advanced Plasma Therapies, Inc) is a clinical-stage
company that incorporates its proprietary technology to generate and deliver
Nitric Oxide (NO) from a defined high-energy plasma stream to address
therapeutic needs. NO is a biologically active agent, with the ability to modify
disease pathways through proven anti-microbial, anti-inflammatory, tissue-
regenerative and vasodilatory activities. Origin's technology will be initially
applied to several highly unmet conditions, including the treatment of wounds,
ulcers, and acute and chronic infections. Origin's first potential product is a
device focused on diabetic foot ulcers (DFU) a market estimated to be $13
billion2. Origin, Inc. was founded in 2010 and is based in Princeton, New
Jersey.
For more information, please visit www.originww.com.
1 Worldwide Wound Management, Forecast to 2024: Established and Emerging
Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and
Rest of World. MedMarket Diligence, LLC. Published December 2015. 2 Rice et al.
Burden of Diabetic Foot Ulcers for Medicare and Private Insurance. Diabetes
Care. 2013.
Contacts
Origin
Mike Preston
mpreston(at)originww.com
+1 845 494 5049
Betsy Hanna
bhanna(at)originww.com
+1 609 250 6004
MBS Value Partners
Lisa Sher/Betsy Brod
lisa.sher(at)mbsvalue.com
betsy.brod(at)mbsvalue.com
+1 212 750 5800
The Life Sciences Division
Ali Minhas/Dr Navid Malik
ali(at)thelifesciencesdivision.com
navid(at)thelifesciencesdivision.com
+44 203 457 1073
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Origin via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 01.06.2017 - 14:30 Uhr
Sprache: Deutsch
News-ID 545837
Anzahl Zeichen: 6794
contact information:
Town:
Princeton
Kategorie:
Business News
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