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Histamine dihydrochloride (subcutaneous) Maxim.

Carlos M Galmarini¹

¹Université Claude Bernard Lyon 1, 8 Avenue Rockefeller, 69373 Lyon, France. fgalma@rockefeller.univ-lyon1.fr

Current Opinion in Investigational Drugs (London, England : 2000)

|January 15, 2005

Summary

Maxim is developing a subcutaneous formulation of histamine dihydrochloride (Ceplene) as an adjuvant therapy for cancers and infections. Phase III trials for metastatic melanoma were ongoing in 2002.

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Area of Science:

Oncology
Immunotherapy
Pharmacology

Background:

Histamine dihydrochloride (Ceplene) is being developed as an adjuvant therapy.
It is intended for use in combination with interleukin-2 (IL-2).
Potential applications include metastatic melanoma, hepatitis C, acute myelogenous leukemia, and renal cell carcinoma.

Purpose of the Study:

To evaluate the efficacy and safety of subcutaneous histamine dihydrochloride (Ceplene) as an adjuvant to IL-2 therapy.
To investigate its potential in treating various cancers and viral infections.

Main Methods:

Phase III clinical trials were conducted for metastatic melanoma.
The formulation is subcutaneous.
Combination therapy with IL-2 was employed.

Main Results:

The compound was in Phase III trials for metastatic melanoma across multiple regions by October 2002.
A Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) in November 2003 for malignant melanoma in combination with IL-2.

Conclusions:

Histamine dihydrochloride (Ceplene) shows promise as an adjuvant therapy in combination with IL-2.
Further development and regulatory review are underway for specific indications like malignant melanoma.

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