Origin applies to China regulatory agency for clinical pathway classification
PRINCETON, New Jersey, Oct. 28, 2019 (GLOBE NEWSWIRE) -- Origin, Inc., a Phase III clinical-stage biotechnology company, today announced that it had applied to NMPA (formerly CFDA) for classification of its plasma-generated nitric oxide device for the purposes of conducting clinical trials in Hong Kong and mainland China, and that NMPA had accepted its submission. A determination is expected within sixty business days.
Origin is in preliminary discussions with clinical trial sites in Hong Kong and China in relation to clinical trials of its Ionojet™ technology for the treatment of diabetic foot ulcers (DFU). It is anticipated that, if the discussions proceed to fruition, the trials would form part of the dataset required to progress the technology towards a potential future regulatory approval. The application for classification to NMPA, is a key first step in designing the DFU trials, which would be financed by investment from Hong Kong. In due course, Origin will look to conduct trials not just in DFU but also in other clinical indications.
Michael Preston, Chairman and CEO of Origin said “With the dramatic expansion of the diabetes epidemic in China, the incidence of DFU is growing proportionately, at great human cost to patients and financial burden to the Chinese healthcare system. With its ease of delivery, promising signal of efficacy from earlier trials in the US, and pricing flexibility, we believe that Ionojet™ can potentially play a valuable role in combatting the devastating impact of DFU in China.”
Origin, Inc. is a Phase III clinical-stage biotechnology company that applies its proprietary technology to generate and deliver nitric oxide (NO) from a defined high-energy plasma stream. It has recently completed a Phase IIb dose-ranging trial for the treatment of chronic diabetic foot ulcers. Origin’s unique plasma stream delivers therapeutic concentrations of NO directly to the targeted area and stimulates NO activity below the skin. NO is a biologically active agent, shown to modify disease pathways through anti-microbial, anti-inflammatory, tissue-regenerative and vasodilatory activities. Origin's technology is currently being studied in several highly unmet medical conditions, including the treatment of wounds, ulcers, and acute and chronic infections. Planned expansion of the clinical pipeline includes potential indications in dermatology, dentistry, and pain and inflammation. Origin, Inc. was founded in 2010 and is based in Princeton, New Jersey.
For more information, please visit www.originww.com.
CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.
Cautionary Note Regarding Forward Looking Statements
This press release and any statements of representatives and partners of Origin, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements.” Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Readers are cautioned that actual results (including, without limitation, the actual timing for, or actual results of, the Company’s clinical development and funding activities in China as described herein) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
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