SciFluor Life Sciences Announces First Patients Dosed in Retinal Program with Investigational New Drug Application for SF0166...
October 17 2016 - 2:00AM
Business Wire
Company’s first two clinical trials of SF0166
Topical Ophthalmic Solution have commenced patient dosing
SciFluor 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), 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.
About SF0166SciFluor is developing SF0166, a potent and
selective small molecule inhibitor of integrin αvβ3 with an optimum
balance of physiochemical properties to allow it to distribute to
the retina in high concentrations after topical administration to
the eye. It has been tested in an extensive set of pre-clinical
assays and shown to be effective in a validated in vivo model of
wet-AMD. The non-fluorinated compound on which it is based does not
distribute appreciably to the back of the eye after topical
administration.
About DMEDiabetic Macular Edema (DME) is the swelling of
the retina in diabetics due to the leakage of fluid from blood
vessels within the macula. The macula is important for the sharp,
straight-ahead vision that is used for reading, recognizing faces,
and driving. As macular edema develops, blurring occurs in the
middle or just to the side of the central visual field. Visual loss
from diabetic macular edema can progress over a period of months
and make it impossible to focus clearly. Treatment options for
patients with DME traditionally include anti-VEGF drugs,
corticosteroid drugs, and laser surgery. The anti-VEGF drugs are
administered by frequent intravitreal injections into the back of
the eye performed in a doctor’s office. Corticosteroid use
increases the risk of cataracts and glaucoma. Therefore, improved
treatment options could benefit patients.
About wet-AMDAge-related Macular Degeneration (AMD) is
the most common cause of severe vision loss in older Americans. It
affects central vision and may interfere with daily tasks such as
reading and driving. Macular degeneration affects the retina in two
forms – dry and wet AMD, also called neovascular AMD. Wet AMD is
frequently accompanied by a relatively sudden loss of vision. This
is caused by the growth of abnormal blood vessels underneath the
retina that leak fluid or blood. Recent advances in the treatment
of wet AMD can now prevent further loss of vision, or even restore
vision in some cases, if treatment is given promptly. Primary
treatment is the use of anti-VEGF drugs administered by frequent
intravitreal injection. Generally, the effectiveness of these
treatments decreases with time, therefore improved treatments are
actively being sought after. A topically administered drug that is
safe and effective could potentially be a major advance in the
treatment of retinal disorders.
About SciFluor Life Sciences LLCSciFluor Life Sciences is
a drug discovery company developing a best-in-class portfolio of
partnership-ready therapeutic drugs strategically capitalizing on
the transformational power of fluorine. The company creates new
chemical entities (NCEs) directed towards precedented biological
targets. SciFluor strategically incorporates fluorine or
fluorine-containing groups to design drugs with improved
pharmacological profiles that provide important benefits over
existing therapies such as improved safety, efficacy, tissue
penetration, more convenient dosing and better patient compliance.
This capital-efficient and de-risked drug discovery approach has
resulted in the generation of a proprietary pipeline of novel and
differentiated small molecule drugs across a range of therapeutic
categories and disease areas including retinal disease, CNS
disorders, and inflammatory disease and pain.
About Allied MindsAllied Minds (LSE: ALM) is a
diversified holding company focused on venture creation within the
life science and technology sectors. With unparalleled access to
hundreds of university and federal labs across the U.S., Allied
Minds forms, funds, and operates a portfolio of companies to
generate long-term value for its investors and stakeholders. Based
in Boston, with nationwide presence in Los Angeles and New York,
Allied Minds supports its businesses with capital, central
management, and shared services. For more information, please visit
www.alliedminds.com.
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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Media Contact:fama PR for SciFluorTed Weismann,
617-986-5009alliedminds@famapr.com
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