ChemioCare USA Inc, a private biotech company focusing on cancer care, is adapting and tailoring its five-day adhesive transdermal patch, CMIO-ONDAN, which delivers ondansetron and is a 5HT3 receptor antagonist, which treats chemotherapy-induced nausea and vomiting in adults towards pediatric Chemotherapy Induced Nausea and Vomiting (CINV).
Children above the age of five are more prone to vomiting than adults when receiving chemotherapy. CINV manifests itself in two phases: acute (day 1) and delayed (days 2-5). Pediatric CINV does not have any approved treatments for the delayed phase of CINV in Highly Emetogenic Chemotherapy (HEC).
Current guidelines recommend three IV infusions of a 5HT-3 receptor antagonist every four hours following chemotherapy; this treatment regimen provides protection only in the acute phase.
“A pediatric CINV transdermal patch will address a significant unmet medical need and improve the quality of life and outcomes for children and teenagers that have to go through chemotherapy,” ChemioCare CEO Pedro Lichtinger said in a statement on Friday.
“With approximately nineteen thousand children and young adults ages 0-19 diagnosed each year, the indication will be classified as a pediatric orphan. The pediatric development program can be expected to employ the time, cost, and data protection benefits provided to orphan disease development programs,” added Lichtinger.
The CEO said he expected “broad endorsement” for CMIO-ONDAN in pediatrics and “increased formulary adoption in the adult population.”
A pediatric transdermal patch leverages the breakthrough development by ChemioCare for their Ondansetron five-day transdermal patch under development for adult CINV. These potential benefits include offering fast CINV protection when applied up to one hour prior to chemotherapy as well as sustained protection for five days.
The pediatric transdermal patch will be the first and only protection for the Highly Emetogenic Chemotherapy (HEC) delayed stage. Therefore, the patch will “provide cost savings” by substituting “multiple IV applications, reduced infusion chair time, avoidance of stomach tubing, and avoidance of noncompliance and expulsion of medicine,” said the company.
ChemioCare, based in New York, specializes in neutralizing chemotherapy-induced nausea and vomiting through its own transdermal patch technology. Its management is looking to take the company public in in the fall of this year.
Its other transdermal patches include its Olanzapine and Dexamethasone patches, CMIO-OLANZ and CMIO-DEX. CMIO-OLANZ, which relies on a seven-day transdermal delivery system, is the first product in development for PARP inhibitor-induced nausea and vomiting. CMIO-DEX, which also relies on a seven-day delivery, is used to control swelling and edema in brain cancer and brain surgery. Dexamethasone is highly-effective, but can, unfortunately, cause severe side effects.
Both the five-day CMIO-ONDAN patch and CMIO-OLANZ are set to enter Phase 3 clinical programs next year.
Contact Uttara Choudhury at [email protected]