ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company based on proprietary transdermal delivery, today announced the minipig safety and pharmacokinetic study results of CMIO-Ondan, a 5-day transdermal formulation of ondansetron for the treatment of chemotherapy induced nausea and vomiting (CINV). In summary, the animal study demonstrated that CMIO-Ondan can deliver sustained blood levels of ondansetron above that equivalent to the minimum effective dose in humans over five days. The preclinical safety and irritation results demonstrate that the formulation appears to be non-irritating.
This primary objective of the current study was to measure ondansetron plasma concentrations following the application of a single transdermal patch over the clinical dosing interval in minipigs. The current data shows that it is possible to prepare an adhesive matrix patch of commercially feasible size capable of delivering therapeutic quantities of ondansetron through the skin.
The patch site was visually inspected before and after patch application and removal and assessed for skin irritation using the Draize skin irritation scale. The average total score was 0.6 on the first day and was virtually zero after 2 days. This indicates only very mild transient irritation. Additionally, the maximum blood concentration or Cmax observed was well below the level that is established to trigger QT prolongation.
Pedro Lichtinger, Chairman and CEO added, "The safety and pharmacokinetic data support continued development of ChemioCare’s ondansetron matrix patch. We are proceeding to finalize and manufacture an improved formulation which we intend to advance into GLP/GMP studies."
CMIO-Ondan is scheduled to enter a Human Proof of Concept (POC) clinical study later this year. The main objectives of the POC clinical study will be to assess the optimal dose, safety, tolerability and pharmacokinetic profile of CMIO-Ondan in healthy human subjects.
"The results of this preclinical study demonstrate that CMIO-Ondan can provide sufficient blood levels to achieve efficacy in the delayed stage of CINV," said Jamie Oliver, Chief Medical Officer. "No currently available 5-HT3 receptor antagonist has been successful in providing additional protection to patients from vomiting for a full 5 days following Highly Emetogenic Chemotherapy. CMIO-Ondan is designed to provide protection from nausea and vomiting in both acute and delayed stage CINV symptoms by providing a quick onset as well as sustained efficacy – avoiding the periods of unprotection due to ondansetron’s short 4-hour half-life."
Highlights of the Results and Next Steps
CMIO-Ondan successfully delivers sustained plasma concentrations of ondansetron in vivo through a minipig animal model
Using standard skin sensitization and irritation scales, no major skin irritation issues were observed
The patch sized used is within commercially feasible limits
GLP/GMP manufacture will now proceed to provide clinical supplies for further studies including a GLP skin sensitization study
A clinical proof of concept (POC) study will be conducted in healthy subjects using a dose-escalation design. The study is expected to be conducted in mid-2019.
Following human proof of concept, CMIO-Ondan is anticipated to enter directly into a pivotal Phase 3 clinical trial. Regulatory feedback towards the design of this trial will be provided at a pre-IND meeting with FDA to be requested in March with an FDA response by the end of May 2019.
A biotech company focused on improving the profiles of generic medicines through its proprietary transdermal delivery technology. The platform technology uniquely combines high flux and sustained release into a matrix drug in adhesive patch. ChemioCare has 3 patches in development for cancer and cancer supportive care, its lead two programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is establishing improved efficacy and reduced or eliminated side effects from originator products.
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