Healthcare Industry News: gallium nitrate injection
News Release - March 2, 2006
Randomized Trial Shows Ganite(R) Effective When Compared with a Leading Bisphosphonate in Patients with Cancer-Related HypercalcemiaBERKELEY HEIGHTS, N.J., March 2 (HSMN NewsFeed) -- Genta Incorporated (Nasdaq: GNTA ) announced publication of a randomized, double- blind, Phase 2 trial that showed GaniteŽ (gallium nitrate injection) was highly effective when compared with ArediaŽ (pamidronate disodium; Novartis, Inc.) in hospitalized patients with cancer-related hypercalcemia. This condition, in which blood calcium levels may rise to immediately life- threatening levels, is the most common metabolic complication in patients with advanced cancer. Ganite is approved for marketing in the U.S. for symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. Results of the trial were published in the current issue of The Cancer Journal and were communicated by the principal investigator, Dr. Frederique Cvitkovic from the Centre Rene Huguenin in St. Cloud, France, on behalf of a combined French and American study group.
In this trial, 64 patients who had been hospitalized with hypercalcemia were randomly assigned to receive Ganite (200 mg/m2/day for 5 days) or one of two doses of Aredia (60 mg, or 90 mg if the blood calcium level was extremely elevated) plus placebo for 4 days. 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 difference was not statistically significant.) Patients with severe hypercalcemia did not respond better to 90 mg of pamidronate (3 of 6 patients; 50%) than to 60 mg of pamidronate (7 of 13; 54%), or compared with the response to Ganite in patients with severe hypercalcemia (15 of 21 patients; 71%). The response to pamidronate was lower in patients with epidermoid (squamous) cancers (33%) compared with 68% for Ganite. Both drugs were relatively well-tolerated. 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 represents the most extreme form of bone loss, in which the rate of calcium loss from bone overwhelms the kidney's ability to excrete it, leading to an acutely life-threatening condition," noted Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "Highly potent agents are an essential aspect of current therapy. While bisphosphonates such as Aredia and ZometaŽ (zoledronate; Novartis, Inc.) 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. 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."
About Cancer-Related Hypercalcemia
Cancer-related hypercalcemia is a life-threatening elevation of blood calcium that can occur in up to 50% of patients with advanced cancer. The disorder is usually caused by the release of factors from tumor cells that markedly accelerate the loss of calcium from bone. Hypercalcemia is particularly common in patients with cancers of the lung, breast, kidney, head and neck, and multiple myeloma.
Ganite was originally developed by the U.S. National Cancer Institute as a cancer chemotherapy drug. A separate series of studies showed that the drug markedly reduced the loss of calcium from bone - an observation that suggested the drug may be useful in hypercalcemia, as well as other conditions associated with loss of bone mass. Ganite has proved safe and effective in normalizing high levels of blood calcium by inhibiting calcium resorption from bone. In a double-blind clinical trial that compared Ganite with calcitonin (a commonly used anti-hypercalcemia drug), 50 patients were randomized to receive either Ganite at a dosage of 200 mg/m2/day for 5 days, or calcitonin at a dosage of 8 IU/kg four times per day for 5 days. Normalization of calcium (normocalcemia) was achieved in 75% of patients who received Ganite, compared with 27% of patients treated with calcitonin (P = 0.0016). Ganite appeared to be useful in treating hypercalcemia associated with many different types of cancer, irrespective of the initial severity of the disorder.
Important Safety Information about GaniteŽ (gallium nitrate injection)
Ganite is contraindicated in patients with severe renal impairment (serum creatinine > 2.5 mg/dL). While Ganite was generally well tolerated by patients who received the drug in clinical trials, concurrent use of Ganite with other potentially nephrotoxic drugs like aminoglycosides and amphotericin B may increase the risk for developing severe renal insufficiency in patients with cancer-relapsed hypercalcemia. If use of a potentially nephrotoxic drug is indicated during Ganite therapy, Ganite should be discontinued and hydration for several days is recommended. Please see accompanying full Prescribing Information in the Package Insert or on the Ganite website at http://www.ganite.com.
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. GenasenseŽ (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is GaniteŽ (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: http://www.genta.com.
This press release contains forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report/Form 10-K for 2004.
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