Phase 2 Clinical Results of Ganite Plus Standard Therapy in Patients with Relapsed/Refractory Lymphoma Presented at ASCO
BERKELEY HEIGHTS, N.J., June 04, 2007 /PRNewswire-FirstCall/ -- Genta Incorporated announced the presentation of results from a Phase 2 clinical trial of its marketed product, Ganite(R) (gallium nitrate injection), plus rituximab (Rituxan(R); Genentech/IDEC) and dexamethasone in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). The data were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.
Previously published studies have indicated that high doses of gallium nitrate used alone or in combination with chemotherapy showed preliminary evidence of clinical activity in patients with Hodgkin's disease and non- Hodgkin's lymphoma. Based on these data, investigators at Loyola University Medical Center sought to incorporate gallium nitrate into a minimally myelosuppressive "salvage" regimen (called "GaRD") that was designed to treat patients who had failed multiple types of standard therapy.
In the GaRD trial, gallium nitrate was administered in combination with rituximab and dexamethasone. Twenty-two patients with NHL were entered into this study, most of whom had been refractory to multiple salvage therapies. All patients had failed prior treatment with rituximab, including 18 of 22 who received rituximab in their last regimen. Overall, 41% of patients achieved a major objective response, including 8 (36%) with complete or unconfirmed complete responses and 1 (5%) with a partial response. Two of the major responders had previously failed a stem cell transplant; both patients remain in sustained remission 14+ and 18+ months after their last relapse. Six other patients achieved stable disease. Five patients subsequently underwent a stem cell transplant. Of all 22 patients treated with the GaRD regimen, 46% are alive at a median followup of 17+ months, and 7 are currently without evidence of disease.
No non-hematologic Grade 4 adverse events were reported. Grade 4 lymphopenia, neutropenia and thrombocytopenia were observed in 1, 2 and 2 patients, respectively. Grade 1-3 anemia, nausea/vomiting and hypocalcemia were observed in 18, 1, and 3 patients, respectively.
"Myelosuppression, particularly neutropenia, is a substantial clinical problem in patients with relapsed NHL," said Dr. Scott E. Smith, MD, PhD, Assistant Professor of Medicine at Loyola, who was the principal investigator of this trial. "Based on these favorable results, we have organized a followup trial of GaRD used in combination with another standard regimen that we expect to initiate in a Chicago-based clinical collaboration."
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 is approved in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration.
Important Safety Information about Ganite(R) (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. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The leading drug in Genta's small molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. Genta is partnered with IDIS (http://www.idispharma.com) on a program whereby both Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: http://www.genta.com.
This press release may contain 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. Forward- looking statements include, without limitation, statements about:
-- the Company's ability to obtain necessary regulatory approval for Genasense(R) from the U.S. Food and Drug Administration ("FDA") or European Medicines Agency ("EMEA"); -- the safety and efficacy of the Company's products or product candidates; -- the Company's assessment of its clinical trials; -- the commencement and completion of clinical trials; -- the Company's ability to develop, manufacture, license and sell its products or product candidates; -- the Company's ability to enter into and successfully execute license and collaborative agreements, if any; -- the adequacy of the Company's capital resources and cash flow projections, and the Company's ability to obtain sufficient financing to maintain the Company's planned operations; -- the adequacy of the Company's patents and proprietary rights; -- the impact of litigation that has been brought against the Company and its officers and directors and any proposed settlement of such litigation; -- the Company's ability to regain compliance with the NASDAQ's listing qualifications, or its ability to successfully appeal the NASDAQ delisting; and -- the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
The Company does not undertake to update any forward-looking statements. 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 on Form 10-K for 2006 and its most recent quarterly report on Form 10-Q.
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Posted: June 2007