ATRA-IV liposomal retinoic acid

An investigational product

What is ATRA-IV?

ATRA-IV (formerly known as ATRAGEN^®) is a liposome-encapsulated, intravenous form of all-trans-retinoic acid (ATRA), a derivative of vitamin A. An oral formulation (Vesanoid^®, tretinoin, Hoffmann-La Roche) is commercially available in the United States for treatment of acute promyelocytic leukemia.

ATRA-IV has received orphan drug designations from the US Food and Drug Administration for T-cell non-Hodgkin's lymphoma, and acute and chronic leukemia.

How is ATRA-IV different from the oral formulation?

ATRA-IV is encapsulated in liposomes and is designed to be administered intravenously. It has been developed to overcome certain deficiencies associated with the original oral formulation.

Although the oral form has been demonstrated to be effective against a range of cancers in clinical trials, the duration of its efficacy has been transient. Recent evidence indicates that the reason for the waning efficacy of the oral formulation may be a result of falling plasma concentrations that occur during prolonged treatment.

Early clinical results with Antigenics’ liposome-encapsulated formulation show that treatment with ATRA-IV results in increased plasma concentrations of the medication compared with the oral form. By raising levels of the medication in the blood, the bioavailability of the treatment may be expanded.

In what kind of cancers is ATRA-IV being tested?

To date, numerous clinical trials with ATRA-IV have been conducted in various indications, and more than 250 patients with a wide range of cancers have received ATRA-IV. Antigenics has filed an investigational new drug (IND) application to evaluate ATRA-IV in combination treatment with Oncophage cancer vaccine for metastatic kidney cancer or melanoma.

Is Antigenics enrolling patients for a clinical trial of ATRA-IV?

No, Antigenics is not currently enrolling patients for a clinical trial of ATRA-IV. However, the company has filed an IND application to evaluate ATRA-IV in combination with Oncophage in metastatic kidney cancer or melanoma.

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ATRA-IV references