Cytorex Biosciences Inc, (Cytorex), a South Florida biotechnology company with research and development facilities in Texas, announced today that the results of a compassionate and humanitarian clinical study conducted in the city of Merida-Venezuela, evaluating the efficacy of a topical therapeutic agent developed with its Cytoreg® therapeutic technology in patients diagnosed with diabetic foot, have been successfully presented at the 81st Scientific Session of the American Diabetes Association held June 25-29, 2021.
Cytorex Biosciences Inc.'s novel proposal for the treatment of diabetic foot is a highly effective therapeutic solution with no side effects that facilitates the topical treatment of ulcers and infections in the extremities of patients with diabetes 2 and could have an impact on the reduction of amputations.
A team of Venezuelan researchers from different specialties carried out this clinical study. Aware of the complications of diabetic foot wounds, including bacterial infections, ulcerations and gangrene, they knew that they are one of the main causes of hospitalization and account for 85% of diabetic amputations.
Katiuska Villasana, who initially led the laboratory research team in the development of an experimental animal model, had been able to measure how the therapeutic agent under investigation Cytoreg®, increased arterial oxygen levels in a Wistar rat model, administered orally. It is important to highlight that this therapy in its development has complied with a series of toxicological and pharmacological safety tests required for approval by the US FDA and its development route for other pathologies, such as brain tumors.
With the evidence of increased oxygenation, a clinical team headed by Dr. Dario Carrillo, diabetic foot specialist, and Ms. Villasana, together with another group of specialists, under a compassionate and humanitarian use protocol, tested Cytoreg® orally and diluted topically in patients with diabetic foot ulcers in a 30-day study in the city of Merida, Venezuela. The total study population was ten patients under informed and written consent. On average, all ten (10) patients received oral Cytoreg® daily for 30 days. Five (5) patients received both oral Cytoreg® plus one topical wound cleansing per week with Cytoreg® diluted in isotonic saline. In addition to standard clinical observations, wound healing was monitored using the St. Elian's checklist system. Four of the five patients in the oral plus topical treatment group had complete wound closure after thirty days. Two of the patients in the oral-only group had complete wound closure. There were no significant changes in oxygen saturation in the affected tissues, insulin and glycemia levels. However, significant increases in arterial hemoglobin and arterial oxygen-pO2- were observed. Significant decreases in glycosylated hemoglobin (HbA1c), aspartate aminotransferase, glutamic-pyruvic transaminase, creatinine and urea levels were also observed. The overall results are encouraging and given its relevant therapeutic success, this work was distinguished with an invitation to present its results at this scientific meeting of the American Diabetes Association.
Dario Carrillo, M.D., a diabetic foot specialist, says, "It has been a surprising and pleasant experience to appreciate the efficacy of using this novel topical solution on the lesions. It allowed us to replace the use of antibiotics on the lesions and to obtain greater efficacy in terms of tissue response".
Cytoreg® Technology is a broad and novel technological proposal from which therapeutic agents are obtained to treat different pathologies. This technology platform provides an ionic transport complex (electrons) in high concentrations that is used in each agent to be designed for the treatment of different diseases. In the case of the topical agent used in these compassionate and humanitarian clinical trials of diabetic foot, there are no irritation or caustic effects on the skin.
"The details of the results of this clinical research work will be widely appreciated in the publication that will be announced in the coming weeks once it has been reviewed by the referee committee of the scientific journal that is now evaluating it for approval and publication," said William "Bill" Bauta PhD, consultant to the president of Cytorex Biosciences Inc.
"The Adult Population living with diabetes, according to D-Foot International between 2017 and 2045 is estimated to grow by 47% from 425 Million in 2017 to 628 Million in 2045. Diabetic foot and lower extremity complications are severe, chronic and can affect between 40 and 60 million people with diabetes worldwide. As a Research and Development Corporation, we make another contribution from our technology platform now for the treatment of Diabetic Feet. We want the world to see that we are a corporation with innovative and emerging therapeutic technologies." .... says William Jimenez C, CEO -President of Cytorex Biosciences Inc.
About Cytorex Biosciences, Inc.
Cytorex Biosciences, Inc. is a small innovative biotechnology company based in South Florida with a research and development coordination center in Kingwood, Texas focused on the development and research of ionic therapeutic agents, based on the Cytoreg® therapeutic technology, for the development of therapeutic agents for the treatment of pathologies such as cancer, autoimmune diseases, neurodegenerative diseases, kidney stones, pathologies derived from bacteria, viruses such as Ebola and COVID among other pathologies. Cytorex has worldwide intellectual property rights on its technologies, as well as other new patents pending and others in development. Cytorex is currently in pre-clinical stage development for a therapeutic agent for the treatment of Glioblastoma Multiforme brain tumors.
For more information about Cytorex Biosciences, Inc. please visit the company's website at http://www.cytorex.com
William Jimenez C. - President - CEO
Eduardo Gonzalez - Project Manager
Telephone: 281-348-5577 - 832-995-8326
Email: [email protected]