Genta says cancer-related hypercalcemia drug Ganite shows promise

By Elaine Rigoli

Tampa, Fla., March 2 - Genta, Inc. said results from a randomized, double-blind, phase 2 trial showed that Ganite (gallium nitrate injection) was highly effective when compared with Aredia (pamidronate disodium) in hospitalized patients with cancer-related hypercalcemia.

In this trial, 64 patients who had been hospitalized with hypercalcemia were randomly assigned to receive Ganite (200 mg/m2/day for five days) or one of two doses of Aredia (60 mg, or 90 mg if the blood-calcium level was extremely elevated) plus a placebo for four days, according to a company news release.

The primary endpoint of the study was to describe the proportion of patients who subsequently achieved a normal blood calcium level (normocalcemia).

In this critically ill population, 22 of 32 patients (69%) treated with Ganite achieved normocalcemia compared with 18 of 32 patients (56%) treated with Aredia. The company noted that the difference was not statistically significant.

Patients with severe hypercalcemia did not respond better to 90 mg of pamidronate (three of six patients; 50%) than to 60 mg of pamidronate (seven of 13; 54%), or compared with the response to Ganite in patients with severe hypercalcemia (15 of 21 patients; 71%), the release said.

The response to pamidronate was lower in patients with epidermoid (squamous) cancers (33%) compared with 68% for Ganite.

Clinically significant kidney toxicity, which has been associated with both drugs, was not observed in either treatment group. Hypophosphatemia - a low blood level of phosphorus - was observed in more than 80% of patients in both treatment groups.

Hypercalcemia, in which blood calcium levels may rise to life-threatening levels, is the most common metabolic complication in patients with advanced cancer, the release said.

Ganite is approved for marketing in the United States for symptomatic patients with cancer-related hypercalcemia that is resistant to hydration.

"Highly potent agents are an essential aspect of current therapy. While bisphosphonates such as Aredia and Zometa (zoledronate) are the most widely prescribed drugs for cancer-related bone loss, this trial suggests that Ganite is highly potent and may be at least as effective as one of the leading bisphosphonates," said Raymond P. Warrell Jr., Genta's chairman and chief executive officer, in a company statement.

"Going forward, we want to take advantage of this high potency to develop better treatments for skeletal dysfunction that afflict so many patients with advanced cancer."

Genta, located in Berkeley Heights, N.J., is a biopharmaceutical company that develops products for the treatment of patients with cancer.

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