Origin, Inc. Announces First 50 Patients Randomized, And Full Site Activation In Phase IIb Dose-Ranging Study For Diabetic Foot Ulcers
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@originww.com +1 845 494 5049 Betsy Hanna bhanna@originww.com +1 609 250 6004 MBS Value Partners Lisa Sher/Betsy Brod lisa.sher@mbsvalue.com betsy.brod@mbsvalue.com +1 212 750 5800 The Life Sciences Division Ali Minhas/Dr Navid Malik ali@thelifesciencesdivision.com navid@thelifesciencesdivision.com +44 203 457 1073