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Using novel enzyme compounds Oxidien develops superior treatments for

secondary hyperoxaluria to ultimately mitigate kidney stone disease.

See Oxidien’s 90 second presentation that came in top three at innovation challenge by life science nation.

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2° Hyperoxaluria

Secondary hyperoxaluria is a disease with significant unmet medical need. Patients demonstrate wide ranging severity, from manageable symptoms to severe and chronic complications.

There are two types of Secondary (2°) Hyperoxaluria : Idiopathic Hyperoxaluria (IH) and Enteric Hyperoxaluria (EH) 1, 2, 3 .

IH is the most common type, and mostly observed in individuals with calcium oxalate kidney stones1, 4, 5.

EH is partly caused by an underlying gastrointestinal complication associated with a malabsorption of oxalate. In these patients, oxalate becomes more available for absorption 2 , which can cause severe kidney damage and can lead to end-stage renal failure.

Products

OX-1

OX-1 is a novel oxalate decarboxylase (OxDC) enzyme developed with the support of multiple National Institute of Health (NIH) Small Business Innovation Research (SBIR) Grants. OX-1 demonstrates stability in a wide pH range including very acidic environments; thus, can effectively degrade oxalate in the gastrointestinal tract, in particular the stomach.

A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study Utilizing Orally Administered Oxalate Decarboxylase (OxDC) To Reduce Urinary Oxalate.

(Pending Peer-Review)

In Vitro And In Vivo Safety Evaluation of Ox-1

AA-1

AA-1(also known as A0) is an oxalate decarboxylase (OxDC) enzyme originating from a fungal source. AA-1 has the potential to degrade oxalate throughout the complete gastrointestinal tract due to its extremely wide pH activity profile with activity in neutral and basic pH range.

Urinary Oxalate by Enzymatic Reduction of Dietary and Endogenous Oxalate, an abstract and poster featuring research partner, Captozyme, and their A0 research.

“By leveraging a 10-year development history in a prior successful venture, Oxidien is able to expeditiously move the needle in Secondary Hyperoxaluria for the benefit of patients world-wide. Oxidien has built a world-class team of advisors and staff that includes pioneers in hyperoxaluria.” 

Team

 Helena Cowley

Helena Cowley

MS, MBA

Chief Executive Officer

Helena Cowley has over 10 years of experience in roles of increasing responsibility in biotech. Prior to Oxidien, Helena was CEO of Captozyme, Inc., a contract manufacturing organization she built, alongside the two scientific co-founders, and spearheaded the exit of to Arranta Bio in 2019. Over Helena’s tenure Captozyme tripled revenues and was named among the top 50 fastest-growing University of Florida alumni-led businesses in the 2019 Gator100 and a “Florida Company to Watch” in 2017. Helena is a co-inventor on two patents and received the Florida Governor’s Entrepreneur Award in 2015.

Loren Miller

Loren Miller

PhD

Regulatory Affairs

Dr. Loren Miller has extensive knowledge of US and global regulatory standards in drug development. Dr. Millers experience in the pharmaceutical industry is diverse and spans from emerging companies to large pharma, Contract Research Organizations (CRO), and academic institutions. His therapeutic area of expertise includes Central Nervous System disorders, GI disease, Inflammatory disease, Oncology, Dermatology, Pulmonary/Respiratory disease. He also provided management oversight and technical expertise to 23 NDAs/NDA clinical supplements of which 20 received regulatory approval.

Paul Hassie

Paul Hassie

CPA

Financial Consultant

Mr. Paul Hassie provides financial, accounting and management services to small and mid-market companies in various industries. These services include strategic planning, interim CFO assistance, SEC and financial reporting, budgeting, valuation and financial projection modeling, due diligence, equity and debt financing, staff recruitment and evaluation, and compensation planning. Previously, Mr. Hassie served as Chief Financial Officer of publicly-held biotechnology companies raising over $45 million through initial public offerings and privately-held biotechnology companies raising over $125 million through venture capital and private placement financings. Mr. Hassie was a Senior Manager in the Boston office of Ernst & Young LLP, providing audit and financial consulting services to emerging mid-market companies. Mr. Hassie is a Certified Public Accountant and holds a Bachelor of Science degree in Accounting from Bryant University, as well as an MBA in Management and a Master of Science in Taxation from Bryant University.

New Team Member Coming Soon

New Team Member Coming Soon

 Ira W. Klimberg

Ira W. Klimberg

MD

Medical Advisor

Dr. Ira W. Klimberg served as Assistant Professor and Director of Resident Education at the division of Urology at the University of Florida. He pioneered outpatient prostate surgery, and founded the Society of Ambulatory Urologic Surgeons. Dr. Klimberg has been principal investigator on over 250 clinical trials, and was Medical Director of the Urology Center of Florida, the largest outpatient urologic trial site in the southeast. He has been a scientific and marketing consultant to major pharmaceutical and device companies.

Mark Mugerditchian

Mark Mugerditchian

BS, MA

CMC Consultant

Mr. Mark Mugerditchian has over 40 years of experience in the pharmaceutical industry including large multi-national companies, and Small Cap and Venture backed life science companies. He has had extensive successful experience in manufacturing as a product development leader with a broad technical background in pharmaceutical and biotech manufacturing and development including a variety of formats of drug substance (small molecule synthesis and biotechnology) and drug products, (SVP, LVP, Solid Oral Dose, inhalation, transdermal, diagnostic and medical device).

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Oxidien Pharmaceuticals, LLC

747 SW 2nd Avenue, IMB 57
Gainesville, FL 32601

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