Dallas Liver Meeting; 50th AASLD

Report 8 from Dallas - Maxamine for HCV 
Jules Levin, NATAP

In Dallas I spoke with officials from Maxim and I spoke with researchers about the Maxim therapy for HCV. It was during the AASLD Meeting in Dallas that Maxim Pharma released the press release excerpted below. The 12 week study they refer to is ongoing in Europe. They have been holding discussions with the US FDA but a US study was placed on hold. Although discussions are ongoing and a US study is expected but possibly later in 2000. They may want to await 6 months data from ongoing study before starting US study. Maxamine is a histamine. One concern about a histamine is the possiblity for causing anaphylactic reaction. However, I have heard that so far in about 1000 patients receiving Maximine they have not seen a case. Maxima is being studied in several cancers by Maxim. In one study for malignant melanoma its being used with IL-2 and IFN-alpha. Another study in the US and Europe is looking at it with IL-2 for acute myelogenous leukemia (AML). Several additional cancer studies are ongoing. Maxim is a small company and as you know developing a drug can be expensive.

In Dallas Maxim distributed this explanation of how Maximine may work. 

" Phagocyte cells located within and surrounding tumors may actually help the tumor defend itself against attack by the body's immune system. Phagocyte cells inhibit or destroy the natural tumor-killing activity of NK cells and t-cells by releasing reactive oxygen metabolites (ROMs). Administration of cytokines, regardless of the dose, cannot reverse this immunosuppression and apoptosis.

It was then also discovered that the addition of an H2 receptor agonist such as Maximine could inhibit the production and release of ROMs. This blocking capability protects the NK cells and t-cells and facilitates their enhanced activation by cytokines, resulting in improved anti-tumor activity".

The data and information on Maxamine is preliminary. The utility and safety of Maxamine is also unknown. The data at 12 weeks is preliminary but worth being aware of it. If the efficacy and safety holds up further studies will occur. Administration of the drug is also something to consider. Currently, its being explored with subcutaneous injection 3, 5, 6 or 10 mg a week. The ongoing 12 week study has an option to continue for 48 weeks with a 6-month follow-up post-treatment. 

Maxim Reports Preliminary Phase II Results of Maxamine in the Treatment of Hepatitis C

SAN DIEGO--(BW HealthWire)--Nov. 8, 1999--Maxim Pharmaceuticals (AMEX:MMP)(SSE:MAXM) announced today preliminary 12-week results from a phase II dose-ranging study of Maxamine(R) in combination with interferon in the treatment of previously untreated hepatitis C-infected patients.

The ongoing study is designed to evaluate the safety and activity of four different dose regimens of Maxamine in combination with the standard dose of interferon. After 12 weeks of therapy, the combination of Maxamine and interferon achieved a complete biochemical and viral response in 72 percent of all patients, compared to the 25 to 40 percent response that is commonly observed in patients with similar profiles treated with interferon alone. A complete biochemical response is defined as normalization of liver enzyme levels; a complete viral response is defined by virus levels that are below the limit of detection using a validated PCR-RNA technique.