Claritas Pharmaceuticals Inc V.CLAS.H

NEWS TODAY --- CANINE TOXICOLOGY POSITIVE 🦠 humans next?

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Data from Canine Toxicology Studies are Strongly Positive The canine studies at Covance evaluated four dose levels of R-107: 60, 75, 90, and 150 milligrams per kilogram of body weight given daily as a singular intramuscular injection, the same route of administration that is planned for the initial clinical studies in humans. In addition, R-107 was also administered as a repeat daily injection for 7 consecutive days, a length of time consistent with the anticipated duration of therapy in the clinical setting of COVID-19 infection. At all dose levels tested, R-107 was well tolerated by the animals. Given that the intended therapeutic dose of R-107 in humans is only 10-15 milligrams per kilogram of body weight, the results of these completed toxicology studies are expected to provide at least a 5-fold safety margin for human use. This level of safety margin substantially exceeds the standard requirement of regulatory agencies, such as the FDA. In addition, the canine studies successfully measured the plasma levels of R-107 and its metabolites, including the therapeutically active payload metabolite, R-100. The plasma levels of both R-107 and R-100 were found to be linearly related to the dose level of R-107, a correlation that will simplify the selection of the optimal dosing regimen when the drug reaches the stage of clinical testing. R-107 is a Nitric Oxide-Releasing Molecule R-107 is a liquid, nitric oxide-releasing molecular prodrug that can be administered by injection, in contrast to nitric oxide gas therapy which requires a special type of delivery device and complex administration by trained respiratory therapists. When administered by injection, R-107 is slowly hydrolyzed by the blood, thereby releasing its active payload, R-100, which in turn steadily and slowly releases nitric oxide. This depot-like action of R-107 results in a sustained delivery of nitric oxide to tissues throughout the body, allowing for a smooth delivery of the active drug over 24 hours following a single dose of R-107. Professor Salvatore Cuzzocrea, President of the University of Messina and former President of the European Shock Society is working with Salzman Group and Claritas, and has read and approved of the scientific disclosure in this news release. Professor Cuzzocrea has deep expertise regarding the medical use of nitric oxide and nitric oxide donors, and has published more than 600 papers on nitric oxide. He has conducted research and experiments with nitric oxide and nitric oxide donors since 1994, and worked closely as an advisor with the Salzman Group team that designed and invented R-107.

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"Prior to initiation of Phase 1 clinical studies in humans, the FDA requires a number of GLP studies to be performed in animals. The positive results in the canine toxicology studies that we are announcing today, together with the positive results in the rodent toxicology studies that we announced last week satisfy the FDA requirements for safety toxicology studies in both species that are a

[noeIstrlfe]

"Prior to initiation of Phase 1 clinical studies in humans, the FDA requires a number of GLP studies to be performed in animals. The positive results in the canine toxicology studies that we are announcing today, together with the positive results in the rodent toxicology studies that we announced last week satisfy the FDA requirements for safety toxicology studies in both species that are a

[noeIstrlfe]

"Prior to initiation of Phase 1 clinical studies in humans, the FDA requires a number of GLP studies to be performed in animals. The positive results in the canine toxicology studies that we are announcing today, together with the positive results in the rodent toxicology studies that we announced last week satisfy the FDA requirements for safety toxicology studies in both species that are a

[noeIstrlfe]

"Prior to initiation of Phase 1 clinical studies in humans, the FDA requires a number of GLP studies to be performed in animals. The positive results in the canine toxicology studies that we are announcing today, together with the positive results in the rodent toxicology studies that we announced last week satisfy the FDA requirements for safety toxicology studies in both species that are a

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