Author Archives: Admin, Oxidien

A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study Using a Proprietary Orally Administered Oxalate Decarboxylase (OxDC)

GAINESVILLE, FLA, USA, September 10, 2020 /EINPresswire.com/ — Oxidien Pharmaceuticals, a clinical-stage biopharmaceutical company mitigating kidney stone disease by treating secondary hyperoxaluria, announced today the publication of data from a clinical study on the effectiveness of its highly potent and acid stable Oxalate Decarboxylase (OxDC) to reduce urinary oxalate in subjects on a high oxalate diet. The study was published in Kidney360, a new addition to the American Society of Nephrology portfolio of journals.

This was an inpatient study where treatment with OxDC at relatively low doses of 1,000 units (umol/min/mg) with meals 3 times per day resulted in removal of over half of the oral bio-load of oxalate (56%) resulting in a significant reduction in urinary oxalate levels. The baseline corrected within-subject mean reduction in 24-hour urinary excretion was 12.5 mg or 29% with 94% of participants responding to the treatment. The net effect as compared to placebo was 24% reduction in urinary oxalate. All pre-determined endpoints were met. The study provides additional support for Synechococcus elongatus OxDC effectiveness in hyperoxaluria. The next planned trial will evaluate increased doses in a dose-finding study.

OxDC was well tolerated with no serious adverse events reported. In addition, there were no product related adverse events and any adverse events experienced were classified as mild or moderate in severity. All adverse events were resolved by the end of study and all subjects completed study.

“We are excited to see these data peer-reviewed and published as we continue to advance our secondary hyperoxaluria program in the clinic”, said Helena Cowley, President and Chief Executive Officer of Oxidien. “We would like to thank the investigators, staff, and volunteers for their participation and for contributing to our understanding of this Synechococcus elongatus OxDC as we work to address a significant unmet need in hyperoxaluria.”

The paper titled “A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study Using an Orally Administered Oxalate decarboxylase (OxDC)” is available online today by clicking here .

About Oxidien Pharmaceuticals, LLC
Oxidien Pharmaceuticals is a clinical stage biopharmaceutical company addressing a large unmet need in kidney disease. The company is focused on treating secondary hyperoxaluria using novel oral enzymatic approaches. The company is currently inviting new investors to participate in the financing of its Phase 2 clinical trial. Oxidien has a strong intellectual property position with issued and pending patents in all major markets. The leadership team has a proven track record of successful product development and regulatory approval, and is experienced in operating, growing and providing returns to its investors. Oxidien Pharmaceuticals is affiliated with UF Innovate | The Hub – a world-recognized leader in business incubation affiliated with one of the national leading research institutions, the University of Florida. Oxidien Pharmaceuticals is also a proud industry partner of the Oxalosis and Hyperoxaluria Foundation (OHF), a member of the Kidney Health Initiative (KHI), and a member of the Mayo Clinic Innovation Exchange (the Exchange). For more information on OHF, KHI, or the Exchange please visit www.ohf.org and www.khi.asn-online.org and https://innovationexchange.mayoclinic.org/, respectively. For additional information on Oxidien please visit www.oxidien.com.
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Helena Cowley
Oxidien Pharmaceuticals, LLC
+1 352-672-5320
email us here
Visit us on social media:
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A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study Using a Proprietary Orally Administered Oxalate Decarboxylase (OxDC)

GAINESVILLE, FLA, USA, September 10, 2020 /EINPresswire.com/ — Oxidien Pharmaceuticals, a clinical-stage biopharmaceutical company mitigating kidney stone disease by treating secondary hyperoxaluria, announced today the publication of data from a clinical study on the effectiveness of its highly potent and acid stable Oxalate Decarboxylase (OxDC) to reduce urinary oxalate in subjects on a high oxalate diet. The study was published in Kidney360, a new addition to the American Society of Nephrology portfolio of journals.

This was an inpatient study where treatment with OxDC at relatively low doses of 1,000 units (umol/min/mg) with meals 3 times per day resulted in removal of over half of the oral bio-load of oxalate (56%) resulting in a significant reduction in urinary oxalate levels. The baseline corrected within-subject mean reduction in 24-hour urinary excretion was 12.5 mg or 29% with 94% of participants responding to the treatment. The net effect as compared to placebo was 24% reduction in urinary oxalate. All pre-determined endpoints were met. The study provides additional support for Synechococcus elongatus OxDC effectiveness in hyperoxaluria. The next planned trial will evaluate increased doses in a dose-finding study.

OxDC was well tolerated with no serious adverse events reported. In addition, there were no product related adverse events and any adverse events experienced were classified as mild or moderate in severity. All adverse events were resolved by the end of study and all subjects completed study.

“We are excited to see these data peer-reviewed and published as we continue to advance our secondary hyperoxaluria program in the clinic”, said Helena Cowley, President and Chief Executive Officer of Oxidien. “We would like to thank the investigators, staff, and volunteers for their participation and for contributing to our understanding of this Synechococcus elongatus OxDC as we work to address a significant unmet need in hyperoxaluria.”

The paper titled “A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study Using an Orally Administered Oxalate decarboxylase (OxDC)” is available online today by clicking here .

About Oxidien Pharmaceuticals, LLC
Oxidien Pharmaceuticals is a clinical stage biopharmaceutical company addressing a large unmet need in kidney disease. The company is focused on treating secondary hyperoxaluria using novel oral enzymatic approaches. The company is currently inviting new investors to participate in the financing of its Phase 2 clinical trial. Oxidien has a strong intellectual property position with issued and pending patents in all major markets. The leadership team has a proven track record of successful product development and regulatory approval, and is experienced in operating, growing and providing returns to its investors. Oxidien Pharmaceuticals is affiliated with UF Innovate | The Hub – a world-recognized leader in business incubation affiliated with one of the national leading research institutions, the University of Florida. Oxidien Pharmaceuticals is also a proud industry partner of the Oxalosis and Hyperoxaluria Foundation (OHF), a member of the Kidney Health Initiative (KHI), and a member of the Mayo Clinic Innovation Exchange (the Exchange). For more information on OHF, KHI, or the Exchange please visit www.ohf.org and www.khi.asn-online.org and https://innovationexchange.mayoclinic.org/, respectively. For additional information on Oxidien please visit www.oxidien.com.
###

Helena Cowley
Oxidien Pharmaceuticals, LLC
+1 352-672-5320
email us here
Visit us on social media:
Twitter
LinkedIn

GAINESVILLE, FL, USA, July 9, 2020 /EINPresswire.com/ — Oxidien Pharmaceuticals, a clinical-stage biopharmaceutical company developing a best-in-class enzyme therapeutic for an underserved kidney disease indication, today announced three additions to its Scientific and Medical Advisory Board (SMAB) to provide external advice on its development activities and clinical program in secondary hyperoxaluria.

Helena Cowley, Chief Executive Officer of Oxidien, said: “The strengthening of our Scientific and Medical Advisory Board is very significant at this stage in our development and will provide for additional expertise in strategic development decisions. Each board member brings a wealth of knowledge, experience and a complementary external perspective. We look forward to working with them.”

The new additions to Oxidien’s SMAB are:

John C. Lieske, M.D.
Dr. Lieske is a nephrologist at Mayo Clinic in Rochester, Minnesota, and a Professor of Medicine at Mayo Clinic College of Medicine. Dr. Lieske has a long-standing interest in urinary stone disease and urinary proteomics and has over the last decade completed multiple clinical trials evaluating various potential treatment strategies for urinary stone patients including those with primary and enteric hyperoxaluria. Dr. Lieske earned his MD from the University of Chicago, and then completed his Internal Medicine residency at Emory University followed by a clinical and research nephrology fellowship at the University of Chicago. In addition to his active kidney stone practice Dr. Lieske is medical director of the Renal Testing laboratory at Mayo Clinic that coordinates all kidney related testing, including those related to the diagnosis and treatment of kidney stone patients. Currently Dr. Lieske serves as director for the Rare Kidney Stone Consortium and site PI for the Unites States Urinary Stone Disease Network recruiting site at Mayo Clinic.

Kristina L. Penniston, PhD, RDN
Dr. Penniston is a Senior Scientist in the Department of Urology at the University of Wisconsin School of Medicine and Public Health and has been the Registered Dietitian Nutritionist for the UW Health University Hospital Metabolic Stone Clinic since 1999. Her research focuses on the role of nutrition in kidney stones with a specific interest medical nutrition therapy and health-related quality of life. Dr. Penniston currently serves as the Secretary-Treasurer of the Research on Calculus Kinetics (ROCK) Society and the Interactions Core Director for the NIH/NIDDK O’Brien Centers Cooperative Research Program in Benign Urology.

Kyle Wood, M.D.
Dr. Wood is a fellowship trained endourologist and Assistant Professor at the University of Alabama at Birmingham (UAB). He is affiliated with one of the only multidisciplinary metabolic kidney stone clinics in the Southeast. Dr. Wood was an AUA research scholar and now is an NIH funded K08 grant scholar conducting kidney stone research with a special interest in the role of obesity in oxalate metabolism and kidney stone disease. Dr. Wood graduated from Brown University with honors, attended medical school at the University of Massachusetts, did his residency at Wake Forest University, and his fellowship at UAB.

ABOUT OXIDIEN PHARMACEUTICALS, LLC
Oxidien Pharmaceuticals is a clinical stage biopharmaceutical company addressing a large unmet need in kidney disease. The company is focused on treating secondary hyperoxaluria using novel oral enzymatic approaches. The company is currently seeking investors for its Phase 2 clinical trial. Oxidien has a strong intellectual property position with issued and pending patents in all major markets. The leadership team has a proven track record of successful product development and regulatory approval, and is experienced in operating, growing and providing returns to its investors. Oxidien Pharmaceuticals is a proud industry partner of the Oxalosis and Hyperoxaluria Foundation (OHF), a member of the Kidney Health Initiative (KHI), and a member of Mayo Clinic Innovation Exchange (MCIE). For more information on OHF, KHI, or MCIE please visit www.ohf.org and https://khi.asn-online.org/ and https://innovationexchange.mayoclinic.org/, respectively. For additional information on Oxidien please visit www.oxidien.com.
###

Helena Cowley
Oxidien Pharmaceuticals, LLC
+1 352-672-5320
email us here
Visit us on social media:
TwitterLinkedIn

Proceeds with Development of Lead Candidate to Address Unmet Need in Kidney Disease

GAINESVILLE, FL, US, December 19, 2019 /EINPresswire.com/ — Oxidien Pharmaceuticals, a clinical-stage biopharmaceutical company developing a best-in-class enzyme therapeutic for secondary hyperoxaluria, announced today that it has received encouraging responses from U.S. Food and Drug Administration (FDA) regarding their proposed Phase 1/2 trial in secondary hyperoxaluria patients and other development plans for its lead drug candidate.

The FDA reviewed Oxidien’s IND enabling pre-clinical data, and results from a prospective, randomized, double-blind, placebo-controlled healthy volunteer study evaluating both safety and efficacy. The official record of the meeting detailed the FDA’s requirements around the development plan (nonclinical and Phase 1/2) and confirmed that the proposed clinical end-points as well as the general trial design were reasonable.

“We are very pleased with the outcome of this interaction and appreciate the guidance from the agency,” said Helena Cowley, Chief Executive Officer of Oxidien Pharmaceuticals.

Earlier this year, Oxidien Pharmaceuticals, LLC, spun out the hyperoxaluria research division from Captozyme Inc., a microbiome contract development and manufacturing organization. Having raised a total of $5.7 million to support the development of novel oxalate-reducing enzymes, Captozyme established a solid foundation of data enabling a well-informed clinical program. Helena Cowley, former CEO of Captozyme, brings intimate understanding for the unmet need in hyperoxaluria from close to a decade of active participation in this area of disease.

“During the coming months we will work to secure the additional funds required to initiate and complete our Phase 1/2 trial. There is significant value and opportunity in the assets spun out. We are committed to realizing this value for our shareholders while making a big difference in patients’ lives,” Helena Cowley concluded.

About Hyperoxaluria
Approximately 2 million people in the U.S. are affected by hyperoxaluria, a condition for which there is currently no effective treatment option. Hyperoxaluria is a metabolic disorder presenting as elevated levels of oxalate in urine caused by either a defect in the handling of dietary oxalate (secondary hyperoxaluria) or a genetic condition causing increased liver production of oxalate (primary hyperoxaluria). Secondary hyperoxaluria increases the risk of recurrent stone disease, which can lead to progressive chronic kidney disease and end-stage renal failure.

About Oxidien Pharmaceuticals, LLC
Oxidien Pharmaceuticals is a clinical stage biopharmaceutical company addressing a large unmet need in kidney disease. The company is focused on treating secondary hyperoxaluria using novel oral enzymatic approaches. Oxidien has a strong intellectual property position with patents pending world-wide. The leadership team has a proven track record of successful product development, regulatory approval, and with operating, growing and exiting healthcare businesses. Oxidien Pharmaceuticals is located in Gainesville, FL, in UF Innovate the Hub – a world-recognized leader in biotechnology business incubation affiliated with one of the national leading research institutions, the University of Florida. For additional information on UF Innovate the Hub please visit http://innovate.research.ufl.edu/. For additional information on Oxidien please visit www.oxidien.com.

Helena Cowley
Oxidien Pharmaceuticals, LLC
+1 352-672-5320
email us here