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SciFluor Life Sciences Announces First Patients Dosed in Retinal Program with Investigational New Drug Application for SF0166 Topical Ophthalmic SolutionSciFluor Life Sciences, Inc., a clinical stage biopharmaceutical company that strives to create innovative best-in-class therapeutics for patients in multiple disease categories including ophthalmologic and neurologic disease, announced today that the first patients have been dosed in both Phase I/II trials of SF0166 Topical Ophthalmic Solution. This represents an important step forward in the clinical investigation of SF0166 Topical Ophthalmic Solution as a potential new treatment for diabetic macular edema (DME) and age-related macular degeneration (wet-AMD (News - Alert)), which are disease states that represent a combined estimated $8 billion current market value. Clinical Study SF0166-C-001 is designed to be a multi-center, randomized Phase I/II trial being conducted in the United States to evaluate the safety and preliminary efficacy of SF0166 for the treatment for patients with DME. A separate multi-center, randomized, Phase I/II trial of SF0166 has been initiated in patients with wet-AMD. Each trial has two dose groups of up to 20 patients with an aim to collect safety and tolerability data as well as to record changes in retinal thickness and visual acuity. Details of these trials can be found at www.ClinicalTrials.gov. In preclinical models, SF0166 has been shown to distribute to the back of the eye in therapeutically-effective amounts. The development of topically administered treatments for retinal diseases has long been considered an enormous challenge by the scientific and medical communities. This is largely because clinically relevant amounts of any given drug need to reach the retina and be retained for an appropriate period of time to exert a therapeutic effect. To date, no topically administered drug has been approved for the treatment of either DME or wet-AMD. "We are pleased to have initiated clinical studies of SF0166 for the treatment of DME and wet-AMD and look forward to generating the clinical data required to advance this potential new therapy," said D. Scott Edwards, Ph.D., Vice President and General Manager at SciFluor. "The two on-going Phase I/II studies will provide initial assessments of the safety, tolerability and preliminary efficacy of SF0166 in patients to guide further clinical development." Omar Amirana, MD, SciFluor's Chief Executive Officer and Senior Vice President at Allied Minds, said, "SciFluor is on the path towards executing its mission of advancing drug candidates in billion dollar markets which may be capable of significantly improving patients' lives. This terrific achievement marks yet another clinical stage advance in the Allied Minds life sciences portfolio." SciFluor is a subsidiary of Allied Minds (LSE: ALM, a diversified holding company focused on venture creation within the life science and technology sectors.
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About SciFluor Life Sciences LLC
About Allied Minds Allied Minds Forward-Looking Statement This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risk and uncertainties described in the risk factors included in the company's regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law, regulatory requirement, the Prospectus Rules, the Listing Rules and the Disclosure and Transparency Rules, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
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