Origin(TM) Announces Positive Interim Results from Phase IIb Dose-Ranging Study for Diabetic Foot Ulcers
(Thomson Reuters ONE) -
* Interim results demonstrate strong evidence of healing and favorable safety
profile
* Highest-performing arm (4X per week, 12 minutes):
· 95% mean wound-size reduction in 12 weeks
· 71% of wounds achieved complete healing in 12 weeks
* Goals of dose-ranging study on track to be fully met
* All arms outperformed standard of care industry average for complete wound
closure
* Full results expected to serve as the basis for the pivotal trial study
design
PRINCETON, N.J., Oct. 26, 2017 (GLOBE NEWSWIRE) -- Origin, Inc. (formerly
Advanced Plasma Therapies, Inc.), a Princeton, NJ based clinical-stage
biotechnology company, today announced positive interim results from its
"GENESIS" dose-ranging (Phase IIb) trial of plasma-generated nitric oxide in
patients with chronic diabetic foot ulcers (DFUs). In addition to meeting its
primary outcome measure of safety, interim results from the "GENESIS" trial
demonstrated strong evidence of healing. Origin has developed a proprietary
technology which, for the first time, generates and delivers therapeutic
quantities of plasma-generated nitric oxide (NO) into the tissue, potentially
addressing a wide range of unmet medical needs.
Key interim results from GENESIS include 95% average wound-size reduction at 12
weeks with 71% of wounds achieving complete closure (12-minute dose of NO
treated 4 times per week, along with SOC).
"These are excellent early results. They suggest that our NO therapy compares
favorably to the average 55% closure rate of a number of other approved advanced
wound products,(1-9)" said Michael Preston, Chairman and CEO of Origin. "A
comparison of our results with data available from other studies suggests that
our strongest performing arm healed chronic DFUs better than almost all
currently available or well-publicized products.(1-9)"
Dr. Patrick Briggs of Texas Gulf Coast Medical Group, and a GENESIS
investigator, said the innovative therapy was far different from any other
therapy for foot and ankle wounds.
"I am excited about this therapy because it's new, different, and outside
anything else I've seen. We have nothing today to deal with the microvascular
issues that are associated with diabetic foot wounds. I'm really looking at that
vasodilatory effect that you can get with nitric oxide," Dr. Briggs commented.
Origin's technology enables the physician to generate and deliver a high-quality
therapeutic dose of plasma-streamed NO at the point of care. This unique system
ensures that each patient consistently receives the intended treatment directly
into the affected wound tissue.
Mr. Preston added: "With our novel therapy, we expect to address a critical
unmet need for the approximately two million people in the U.S. currently
suffering from chronic DFUs(11-12). The development of a safe and effective
wound-closure treatment for chronic DFUs, which frequently lead to limb
amputation, represents an increasing medical need and significant market
opportunity. The full study results are expected to serve as the basis for the
pivotal trial study design."
In GENESIS, patients are treated for up to 12 weeks and then monitored with
regular follow-up visits for another 12 weeks post treatment. This planned
interim analysis includes patients who either healed within 12 weeks or
completed the treatment phase of the trial. An additional 11 subjects remain in
the treatment phase and will be included in ongoing analysis of the data. A
total of 18 patients dropped out of the trial, with no device-related adverse
events reported at this time.
Study Design
GENESIS is a 27-week study recruiting up to 100 patients across 15 clinical
sites in the U.S. designed to demonstrate safety and healing, and determine the
optimal treatment regimen for chronic diabetic DFUs. After a two-week run-in
period, patients are randomized into one of four different dosing regimens or a
SOC-only treatment arm. Wound sizes range from 1.0 - 9.9 cm(2).
* 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.
"DFUs affect as many as 15%(13) of the 30 million diabetic patients(11) in the
U.S. and are responsible for more hospitalizations than any other diabetic
complication, thereby representing a significant cost to the healthcare system,"
said Dr. David Dantzker, Vice Chairman and CMO of Origin, and former Chairman of
the American Board of Internal Medicine. "We believe that NO has the potential
to change not only the trajectory of wound healing, but also the underlying
biology by which wounds heal. Furthermore, our therapy has the potential to
address additional sizeable markets, including unmet needs in other areas of
wound care, dermatology, dental, skin infection, and inflammation and pain."
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 30 million people in
U.S. have diabetes(11) and it is estimated that at least 15%(13) will develop a
DFU resulting in $11,000-16,000 annual incremental cost per
patient(14) (excluding amputation). Approximately 60% of these wounds are not
healed after initial treatment with standard of care and are then considered
chronic(15). An estimated 85% of all diabetic lower-extremity amputations are
preceded by a chronic, non-healing foot ulcer(16) and approximately 15% of
diabetic patients will have an amputation during their lifetime(17). The five-
year mortality rate for DFU patients with an amputation is estimated up to 74%,
higher than that for several types of cancer including breast, colon, prostate
and Hodgkin's disease(18).
About Origin
Origin, Inc. (formerly Advanced Plasma Therapies, Inc.) is a clinical-stage
biotechnology company that applies its proprietary technology to generate and
deliver Nitric Oxide (NO) from a defined high-energy plasma stream. This
targeted, plasma-generated NO stream penetrates the tissue to achieve its
therapeutic effect. NO is a biologically active agent, shown to modify disease
pathways through anti-microbial, anti-inflammatory, tissue-regenerative and
vasodilatory activities. Origin's technology will be initially studied in
several highly unmet conditions, including the treatment of wounds, ulcers, and
acute and chronic infections. Origin's first planned product is a therapy for
use in treating diabetic foot ulcers (DFU), a condition that results in an
estimated $9-$13 billion of US annual healthcare costs(14). Further studies are
planned outside of the US to address this global epidemic. Origin, Inc. was
founded in 2010 and is based in Princeton, New
Jersey.
For more information, please visit www.originww.com.
(1 )BioDrugs. 2002;16(6):439-55.;( 2 )Diabetes Care 2003 Jun; 26(6): 1701-
1705.; (3 )Ostomy Wound Manage. 2006 Jun;52(6):68-70, 72, 74 passim.; (4 )Int
Wound J. 2013 Oct; 10(5): 502-507.; (5 )Int Wound J. 2009 Jun;6(3):196-
208.; (6 )https://www.prnewswire.com/news-releases/new-study-shows-diabetic-
foot-ulcers-treated-with-oasis-ultra-tri-layer-matrix-demonstrated-
significantly-better-and-more-rapid-wound-closure-compared-to-standard-care-
300074793.html; (7 )Ostomy Wound Manage. 2005 Aug;51(8):24-39.; (8 )WOUNDS.
2013;25(12):340-344.; (9 )Wound Repair Regen. 2015 Nov-Dec;23(6):891-
900.; (10) The International Journal of Lower Extremity Wounds Vol 10, Issue 4,
pp. 218 - 223.; (11)https://www.healio.com/endocrinology/diabetes/news/in-the-
journals/%7B476de9eb-1079-49bc-a35a-57fa20086cfa%7D/cdc-100-million-americans-
have-diabetes-or-prediabetes-accessed 07/19/17; (12)Margolis D, Malay DS,
Hoffstad OJ, et al. Incidence of diabetic foot ulcer and lower extremity
amputation among Medicare beneficiaries, 2006 to 2008 [article online],
2011.; (13) Singh N., Armstrong D. G., Lipsky B. A. Preventing foot ulcers in
patients with diabetes. The Journal of the American Medical
Association. 2005;293(2):217-228. doi: 10.1001/jama.293.2.217.; (14) Rice et al.
Burden of Diabetic Foot Ulcers for Medicare and Private Insurance. Diabetes
Care. 2013.; (15 )Frykberg RG, Banks J. Challenges in the Treatment of Chronic
Wounds. Advances in Wound Care. 2015;4(9):560-582.
doi:10.1089/wound.2015.0635; (16) Deshpande et al. Epidemiology of Diabetes and
Diabetes-Related Complications. Physical Therapy. 2008;88(11):1254-1264.
doi:10.2522/ptj.20080020.; (17 )Jonasson et al. Risks of Nontraumatic Lower-
Extremity Amputations in Patients with Type 1 Diabetes. Diabetes Care 2008 Aug;
31(8): 1536-1540; (18) Robbins JM, et al. Journal of the American Podiatric
Medicine. 2008; vol. 98, issue 6
Contacts
Origin
Mike Preston
Chairman and CEO
mpreston(at)originww.com
+1 845 494 5049
Betsy Hanna
COO and President, Human Health
bhanna(at)originww.com
+1 609 250 6004
MBS Value Partners
Katja Buhrer/Betsy Brod
katja.buhrer(at)mbsvalue.com
betsy.brod(at)mbsvalue.com
+1 212 661 7004
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: 26.10.2017 - 14:30 Uhr
Sprache: Deutsch
News-ID 565462
Anzahl Zeichen: 10801
contact information:
Town:
Princeton
Kategorie:
Business News
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