DEA Registration granted: expands capability to develop controlled substances via transdermal patches
NEW YORK, Oct. 18, 2018 — ChemioCare USA Inc. (“ChemioCare” or the “Company”), a biotech company focused on transforming patient outcomes in cancer supportive care, today announces a successful Drug Enforcement Administration (DEA) registration: ChemioCare’s exclusive formulation development partner, Transdermal Research Pharm Laboratories LLC (TRPL), has obtained a new registration with the DEA as a Manufacturer authorized to handle Schedule 1 controlled substances.
This successful DEA registration allows TRPL to initiate formulation development of a dronabinol transdermal patch, CMIO-DRONAB, the fourth program in parallel development in the ChemioCare supportive care platform. Pedro Lichtinger, ChemioCare Chairman and CEO explains, “Advancing our dronabinol program is another development milestone for our Company. We have made significant progress establishing unique profiles for each patch, all are driven by on-label superiority. The profiles have expanded beyond our initial focus on CINV, establishing ChemioCare as a platform supportive care company.” The DEA registration also establishes an opportunity to research additional indications for dronabinol by leveraging its activity at cannabinoid receptors.
The Company has identified significant unmet medical needs that its Olanzapine and Dexamethasone patches, CMIO-OLANZ and CMIO-DEX, are uniquely positioned to address:
- CMIO-OLANZ, olanzapine 7-day transdermal delivery system (TDS), is the first product in development for PARP inhibitor induced nausea and vomiting. CMIO-OLANZ formulation development is expected to complete its Proof Of Concept in animals before the end of the year.
- CMIO-DEX, dexamethasone 7-day TDS, dexamethasone is used extensively in the control of swelling and edema in Brain Cancer and Brain Surgery. Dexamethasone is highly effective in this setting but unfortunately causes severe side effects. We believe that the use of transdermal technology can maintain efficacy while significantly reducing side effects by bypassing the first metabolism pass and CMax characteristics of the current oral use. Our Laboratory has shown flux and is working on improving steady state delivery.
CMIO-ONDAN, ondansetron 5-day transdermal patch, has completed a POC study in animals and is also expected to complete its human POC study mid 2019. CMIO-ONDAN is in development to be the first 5HT3 Receptor Antagonist to obtain an indication for delayed CINV in the Highly Emetogenic Chemotherapy (HEC) patient segment. This product’s Phase 3 clinical program has been validated by our Scientific Advisory Board and is in the process of being included in our request for a pre-IND meeting with the FDA.
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By leveraging its Transdermal Platform and the 505(b)2 regulatory path, both CMIO-ONDAN and CMIO-OLANZ are expected to be ready to enter their phase 3 clinical programs next year.
A biotech company focused on transforming patient outcomes in cancer supportive care. ChemioCare has a platform of transdermal patches in development using proprietary, proven technology. The company is targeting the 505(b)2 regulatory path and establishing on-label superiority that addresses a major unmet medical need for patients, establishing improved efficacy and reduced or eliminated side effects from reference products.
To learn more, visit www.chemio.care.
This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as “may,” “should,” “plan,” “intend,” “potential,” “continue,” “believe,” “expect,” “predict,” “anticipate” and “estimate,” the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company’s control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the company’s beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.
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