Navigation Links
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 advers e 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."

About Ganite

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.

About Genta

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.

Safe Harbor

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.

     CONTACT:

     For Genta Incorporated

     Tara Spiess/Andrea Romstad

     TS Communications Group, LLC

     (908) 286-3980

     

info@genta.com

CONTACT: Tara Spiess or Andrea Romstad, both of TS Communications Group,LLC, +1-908-286-3980, , for Genta Incorporated info@genta.com

Web site: http://www.genta.com/http://www.idispharma.com/http://www.genta.com//

Ticker Symbol: (NASDAQ-NMS:GNTA)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... AAIPharma Services Corp./Cambridge Major Laboratories, Inc. ... development services for the pharmaceutical and biotechnology industries, ... in its Charleston, SC ... recent investments. Charleston ... with small-scale lyophilization. The site has invested in ...
(Date:2/11/2016)... ANKENY, Iowa , 11 de fevereiro de ... a inauguração de sua fábrica de soroalbumina bovina ... Nova Zelândia. A fábrica fica na Ilha Norte ... Loop "), desenvolvido e estabelecido na fábrica da ... Iowa . O projeto e instalação dos ...
(Date:2/11/2016)... Breast Cancer Therapeutics in Asia-Pacific Markets to 2021 ... (APAC) breast cancer market will experience considerable expansion from $1.9 ... Compound Annual Growth Rate (CAGR) of 8.5%. --> ... states that the Asia-Pacific (APAC) breast ... 2014 to $3.4 billion by 2021, at a Compound Annual ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Donor Network West, the organ procurement ... announced a partnership with San Ramon Regional Medical Center. Under the collaboration, the first ... a way to accommodate a more certain time frame for donor families for the ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... “Revolutionizing Cancer Care.” , The print component of “Revolutionizing Cancer Care” ... Pittsburgh/Cleveland, New York, Washington DC/Baltimore, and Seattle, with a circulation of approximately 250,000 ...
(Date:2/12/2016)... ... 12, 2016 , ... US Sport Camps is pleased to announce the addition ... Norwalk, serves as the host site and directing the camps is PGA Professional and ... successful camps in recent years around Des Moines and are fortunate to have such ...
(Date:2/12/2016)... , ... February 12, 2016 , ... ... explosive growth in the field of long term care. With that, says Patrick ... well-trained healthcare professionals in administrative roles in long term care environments. His company, ...
(Date:2/12/2016)... ... 2016 , ... With the exception of restorative dentistry, to date there has been no other ... approval by the FDA, there is a now a new protocol in stopping cavity progression; ... simple and quick to apply. The application is as simple as drying the tooth ...
Breaking Medicine News(10 mins):