R&D / Pipeline
Our pipeline of product candidates represents an important opportunity to improve the treatment of patients experiencing CINV. We use proprietary transdermal technology with products that build on the current treatment guidelines.
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.
Transdermal technology uses adhesive patches to deliver medicines through the skin. The delivery is a controlled, sustained release over 3-5 days.
Transdermal patches have many key benefits: the first is elimination of peak blood levels. Lower peak blood levels provide the same level of efficacy but avoids or eliminates side effects associated with oral or IV delivery. An additional benefit is that by going through the skin, transdermal patches bypass first pass metabolism. This allows for lower overall exposure to a drug and again, reduced side effects.
ChemioCare is transforming the four active ingredients below using proprietary formulations and advanced transdermal technology. Transdermal delivery is expected to transform the incidence of adverse events by exposing the patient to significantly lower amounts of the active ingredient, avoiding blood peak levels, and avoiding first-pass metabolism.
There is a significant unmet medical need in Highly Emetogenic Delayed CINV (HEC D-CINV); an estimated 65% of patients treated with standard of care achieve complete response (Rapoport 2015). There are no 5-HT3 receptor antagonists approved for the treatment of HEC D-CINV. CMIO-ONDAN is designed to be the first of its class, 5-HT3 receptor antagonists, with an on-label indication for HEC D-CINV.
Ondansetron has a 5.7-hour half life, CMIO-ONDAN has a 5-day sustained transdermal delivery to provide adequate therapeutic blood levels during delayed CINV.
Olanzapine was added to the international guidelines for the treatment of CINV in 2017. It is an atypical antipsychotic that has been found to improve patient outcomes when added to the previous triple-regimen standard of care. Somnolence, constipation, and dry mouth are common side effects associated with current dose forms – affecting between 17.5 and 34% of patients. These are side effects that can be transformed via lower exposure and transdermal delivery.
A genericized steroid recommended by the guidelines for use in both Acute and Delayed CINV Dexamethasone is a first-line standard of care agent, used in nearly every patient. Its use includes control of emesis as well as the control of other effects of Cancer and the Chemotherapy agents - including pain and inflammation. When used at the recommended dose levels, Dexamethasone triggers significant medical side effect challenges for patients including: elevation of blood sugar, a reduction in white blood cells, insomnia, and GI problems.
Dronabinol, delta-9-tetrahydrocannabinol (Δ-9-THC), is a synthetic cannabinoid. Dronabinol is indicated in the guidelines for patients that do not respond to standard of care antiemetics. Oral dronabinol is limited by a lack of efficacy and consistency of efficacy in the treatment of CINV. CMIO-DRONAB is designed to deliver consistent, adequate blood levels of dronabinol, a product with a unique mechanism of action compared to the standard of care.
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.