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Aroplatin™ liposomal platinum agentAn investigational productWhat is Aroplatin?Aroplatin™ is an investigational liposomal formulation of a third-generation, DACH platinum chemotherapeutic that is currently being evaluated in clinical trials. It is a new chemical entity that is structurally similar to Eloxatin® (oxaliplatin, Sanofi-Aventis), an approved treatment for colorectal cancer. How is Aroplatin different from other platinum treatments? Although platinum-based therapies (such as carboplatin and cisplatin) exhibit activity against solid tumors, some tumors are either resistant to these agents or become resistant during treatment. More importantly, these compounds can have toxic side effects on the nervous system and kidneys that can be so severe as to limit treatment. Similarly, oxaliplatin has been associated with dose-limiting neurotoxicity. Laboratory studies in animals indicate that as an analog of platinum compounds, Aroplatin demonstrates measurable antitumor activity. These findings suggest that Aroplatin may be useful in cancers that are already resistant to platinum agents. In addition, liposome encapsulation has been shown to increase a drug’s bioavailability, which can extend the treatment’s effect. In some cases, liposomal drugs have been shown to accumulate at the site of a tumor, delivering higher concentrations of the drug to a disease target. The liposomal delivery system can also help to reduce the damaging effects of some drugs on healthy tissues, which can markedly improve a treatment’s safety profile. What are the side effects of treatment with Aroplatin? The most common side effects reported in clinical studies with Aroplatin can be divided into those related to the liposomal component, and those related to the platinum agent contained within the liposome. Side effects related to the liposomal component, usually seen during and within 24 hours after IV infusion, include dyspnea (shortness of breath), back or chest pain, general pain, pyrexia (fever) and leukocytosis (increase in white blood cells in the blood). Side effects related to the platinum component of Aroplatin include fatigue, constipation, diarrhea, dehydration, neutropenia (decrease in body’s white blood cells, which may make fighting infection more difficult) and thrombocytopenia (reduced platelets in the blood, which makes blood clotting more difficult). In what kind of cancers are you testing Aroplatin? To date, nine clinical studies in 213 patients have been conducted to test the safety and efficacy of Aroplatin in a wide range of cancers, including colorectal and kidney cancers. Initial results suggest that Aroplatin treatment appears to be associated with tumor response and may be a promising approach to therapy for a range of different cancers. Preliminary data from a Phase 2 study of Aroplatin in advanced colorectal cancer showed that of the 18 patients who received at least two courses of Aroplatin, one had a partial response, and three patients experienced disease stabilization that lasted for at least three months. Antigenics recently reformulated Aroplatin to enhance its pharmacological activity. The new version of Aroplatin is currently being evaluated in a Phase 1 clinical trial involving up to 28 patients with advanced solid tumors or B-cell lymphoma. The dose-ranging study will evaluate the safety and pharmacokinetic profile of Aroplatin, as well as assess its clinical activity. Is Antigenics enrolling patients for a clinical trial of Aroplatin? Yes, Antigenics is currently enrolling patients for a multicenter, Phase 1 research study of Aroplatin as a treatment for advanced solid tumors or B-cell lymphoma. The primary objectives of the study are to establish the maximum tolerated dose for Aroplatin, and to determine the product’s pharmacokinetics and overall safety profile.
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