R&D / Pipeline
Our pipeline of product candidates represents an important opportunity to improve the treatment of patients undergoing cancer treatment.
The company is reformulating generic medicines that are well characterized and have a long and robust medical history. This allows for a shortened development timeline and significantly reduced financial investment and risk by leveraging the 505(b)2 regulatory pathway.
Highly Emetogenic Chemotherapy Delayed Chemotherapy Induced Nausea and Vomiting (HEC D-CINV)
Of the 1.6M chemotherapy patients per year in the United States, 35% treated with Highly Emetogenic Chemo (HEC) for average of 6 cycles per year
There is a significant unmet medical need in Highly Emetogenic Delayed CINV (HEC D-CINV); an estimated 50% of patients treated with standard of care continue to vomit in the delayed stage (aggregated from product monographs). There are no 5-HT3 receptor antagonists approved for the treatment of HEC D-CINV.
CMIO-ONDAN is designed to be the first 5-HT3 receptor antagonist with an on-label indication for HEC D-CINV. Our proprietary patch technology is designed to protect from nausea and vomiting by providing a quick onset as well as sustained 5-day efficacy. In the delayed stage, CMIO-Ondan is designed to avoid periods of unprotection due to ondansetron’s short 4-hour half-life
Animal studies have 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.
Pediatric Chemotherapy Induced Nausea and Vomiting (CINV) in hematopoietic stem cell transplantation (HSCT)
Complete control of CINV in hematopoietic stem cell transplantation is low; 76-78% of children continue to vomit and 88-93% experience nausea. The standard of care is burdensome and involves multiple IV infusions and stomach tubing. A transdermal patch offers an improved quality of life and outcomes for children, a significant convenience and compliance improvement, and cost-savings to hospitals by eliminating multiple IV administrations, reduced infusion chair time, and avoidance of stomach tubing.
PARP Inhibitor induces nausea and vomiting (PIINV)
PARP Inhibitors are novel DNA-repair for solid tumors, but side effects are a key issue in abandoning PARP-Inhibitor treatment, Key side effects include nausea (68.6% of patients) and vomiting (36.2% (Liu 2018)). Existing antiemetics are contraindicated for use with PARP inhibitors or are not suited for long-term use. CMIO-OLANZ is designed to improve quality of life and outcomes by controlling PIINV without significant side effects.
Brain Cancer, cerebral edema
Steroids, including dexamethasone, cause significant adverse effects including steroid-induced diabetes, muscle waste, insomnia and agitation. Dexamethasone is the standard of care in brain cancer; majority of glioblastoma patients are treated with dexamethasone to reduce swelling and edema. CMIO-Dex leverages the ChemioCare transdermal platform technology for a reduced drug exposure, which is expected to reduce and/or delay serious side effects, improving quality of life and potentially extending lifespan.
Emphasis on focus. The company is using a lean development approach in a single lead indication to maximize value creation opportunities. There is an exciting opportunity to expand into additional therapeutic areas after accelerating the CINV products to market.