The effectiveness of many anticancer drugs varies greatly from patient to patient and personalized dosages are required to avoid adverse side effects. The invention provides for the first time an electrochemical method to measure the concentration of the drug Irinotecan in patient’s plasma and then to establish the optimal dose, with an on-site test readable in real time.

Patent Status

SUBMITTED

Priority Number

102019000008841

Priority Date

13/06/2019

License

INTERNATIONAL

Market

The Imatinib Drug Market is expected to register a CAGR (Compound Annual Growth Rate) of 3% during the period 2020-2025. Several factors are propelling the growth of this market such as increasing prevalence of cancer, increasing demand of target drug therapy and the patent expiry of imatinib drug. (Source: “IMATINIB DRUG MARKET - GROWTH, TRENDS, AND FORECAST (2020 - 2025)” – Mordor Intelligence). Imatinib is an anticancer drug used in particular for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
North America is expected to hold a majority of the market share; in fact, according to the National Cancer Institute, in 2018around 1,735,350 new cases of cancer were diagnosed in the US whereas around 600,000 died of cancer. Furthermore, leukemia is one of the most common cancers in the US (Source: “Imatinib Drug Market Size, Share & Trends Analysis Report, by Drug Form (Tablet and Capsules), by Application (Blood Cancer (Leukemia and Other Blood Cancers), Gastrointestinal Stromal Tumors (GIST), Skin Tumors (Dermatofibrosarcoma Protuberans), and Other Tumors) and Forecast Period, 2020-2026” - Orion Market Research).

Problem

Imatinib is an anti-leukemic drug used primarily for the first-line treatment of certain forms of cancers, including the acute lymphoblastic leukemia, certain types of gastrointestinal stromal tumors and, in particular, the Philadelphia chromosome positive chronic myeloid leukemia. However, the pharmacological treatment with this drug is not free of critical issues because of its narrow therapeutic window, which means that the concentrations within which pharmacotherapy is effective or toxic are quite close.
In this regard, therapeutic drug monitoring (TDM) which is the measurement of the concentration levels of Imatinib or its metabolites in the patient’s blood at fixed times after administration of the drug, has become essential to be able to define a customized treatment for the specific patient.

Current Technology Limits

The methods and instrumentations currently used for the precise determination of the concentration of the metabolites of Imatinib in biological samples (High Performance Liquid Chromatography, HPLC coupled to mass spectrometry) are poorly suitable for use in a TDM methodology due above all to the poor portability of the instruments, the relatively long analysis times, and the need for centralised analysis laboratories and qualified personnel. An effective use of the TDM methodology requires instead simple and fast analytical protocols for the detection and control of the concentration of the drug in the patient’s blood.

Killer Application

Starting from this method it will be possible to develop a portable device for carrying out therapeutic monitoring of Imatinib drug. This will make the test results readily and easily accessible at the patient’s bed (point-of-care), avoiding long times required by specialized analysis.

Our Technology and Solutions

Imatinib is an anticancer drug used in particular for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia. The therapeutic drug monitoring (TDM) greatly improves the effectiveness of the cancer treatment and helps to personalize the doses and to limit side effects. Quick procedures are therefore essential. The patented electrochemical method provides a simple, fast and cost-effective protocol for the measurement of Imatinib concentration through plasma collection. Said method is suitable for the manufacturing of a device, that will make the test results readily and easily accessible at the patient’s bed (point-of-care), avoiding long times required by specialized analysis. The method involves the selective extraction of the drug on a liquid-liquid extraction column and a following measurement of its concentration using an electrochemical technique, in particular adsorptive stripping voltammetry.

Advantages

• Simple protocol to be performed also by non-specialized personnel;
• Rapid and accurate diagnosis on site;
• Minimum amount of plasma required;
• Real-time results;
• Determination of drug concentration and therefore of treatment effectiveness for a timely adjustment of individual dosage.

Roadmap

The research group is currently looking for partners (pharmaceutical companies, medical devices companies, etc.) to produce and commercialize the device currently under development.

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