A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)

The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM.
Funding Source - FDA Office of Orphan Products Development (OOPD)

Start Date17 Jun 2021

Sponsor / Collaborator

Seattle Children's Hospital

[+1]

NCT02354859 / CompletedPhase 2IIT

A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)

The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.
Funding Source - FDA OOPD

Start Date01 Mar 2016

Sponsor / Collaborator

University of Washington

[+1]

NCT01093521 / CompletedPhase 1IIT

A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients

The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sputum.
Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD)

Start Date01 Apr 2010

Sponsor / Collaborator

University of Washington

[+1]

100 Clinical Results associated with Gallium nitrate

100 Translational Medicine associated with Gallium nitrate

100 Patents (Medical) associated with Gallium nitrate

2,021

Literatures (Medical) associated with Gallium nitrate

31 Dec 2024·Journal of the International Society of Sports Nutrition

Acute effects of various doses of nitrate-rich beetroot juice on high-intensity interval exercise responses in women: a randomized, double-blinded, placebo-controlled, crossover trial

Article

Author: Jiaqi, Zhang ; Chen, Zheng ; Zihan, Dai ; Tsz-Chun Poon, Eric ; Heung-Sang Wong, Stephen

BACKGROUND:

This study investigated the acute effects of various doses of nitrate-rich beetroot juice on the responses to high-intensity interval exercise in women.

METHODS:

A double-blinded, randomized, placebo-controlled, crossover trial was conducted with 13 recreationally active young women (age = 23 ± 2 years). All participants performed interval exercise (8 × 1-min bouts of cycling at 85% of peak power output [PPO] interspersed with 1-min active recovery at 20% of PPO) 2.5 h after consumption of the randomly assigned beetroot juice containing 0 mmol (placebo), 6.45 mmol (single-dose), or 12.9 mmol (double-dose) __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__NO3-. The heart rate (HR), blood pressure, blood lactate, blood glucose, oxygen saturation, rating of perceived exertion (RPE), and emotional arousal were assessed.

RESULTS:

Nitrate supplementation significantly altered the HR and RPE responses across the three trials. The mean HR was lower in the single- and double-dose groups than in the placebo control group during both work intervals and recovery periods, as well as across the overall protocol (all p < .05). The mean RPE was lower in the single- and double-dose groups than in the control group during recovery periods and across the overall protocol (all p < .001). However, there was no significant difference in either HR or RPE between the single- and double-dose groups at any time point.

CONCLUSIONS:

Acute nitrate ingestion led to significant decreases in the mean HR and RPE during high-intensity interval exercise, but no additional benefit was observed with higher nitrate content. These findings may assist practitioners in implementing more effective nitrate supplementation strategies during high-intensity interval exercise.

31 Dec 2024·Journal of oral microbiology

The effects of nitrate on the oral microbiome: a systematic review investigating prebiotic potential

Review

Author: Rosier, Bob T. ; Burleigh, Mia C. ; Moran, Siobhan P. ; Henriquez, Fiona L.

Background:

Nitrate (NO₃^-) has been suggested as a prebiotic for oral health. Evidence indicates dietary nitrate and nitrate supplements can increase the proportion of bacterial genera associated with positive oral health whilst reducing bacteria implicated in oral disease(s). In contrast, chlorhexidine-containing mouthwashes, which are commonly used to treat oral infections, promote dysbiosis of the natural microflora and may induce antimicrobial resistance.

Methods:

A systematic review of the literature was undertaken, surrounding the effects of nitrate on the oral microbiota.

Results:

Overall, n = 12 in vivo and in vitro studies found acute and chronic nitrate exposure increased (representatives of) health-associated Neisseria and Rothia (67% and 58% of studies, respectively) whilst reducing periodontal disease-associated Prevotella (33%). Additionally, caries-associated Veillonella and Streptococcus decreased (25% for both genera). Nitrate also altered oral microbiome metabolism, causing an increase in pH levels (n = 5), which is beneficial to limit caries development. Secondary findings highlighted the benefits of nitrate for systemic health (n = 5).

Conclusions:

More clinical trials are required to confirm the impact of nitrate on oral communities. However, these findings support the hypothesis that nitrate could be used as an oral health prebiotic. Future studies should investigate whether chlorhexidine-containing mouthwashes could be replaced or complemented by a nitrate-rich diet or nitrate supplementation.

01 Dec 2024·Redox Biology

Bariatric surgery blunts nitrate-mediated improvements in cardiovascular function of overweight women by interfering with gastric S-nitrosothiol formation

Article

Author: Kemp, Rafael ; Conde-Tella, Sandra Oliveira ; Júnior, Wilson Salgado ; Cássia-Barros, Alessandra ; Salgado Júnior, Wilson ; Lacchini, Riccardo ; Coelho, Eduardo Barbosa ; Feelisch, Martin ; Sanches-Lopes, Jéssica Maria ; Tanus-Santos, Jose Eduardo

Inorganic nitrate (NO₃^-) and nitrate-rich foods have been shown to exert antioxidative effects and lower blood pressure in experimental animal models and human clinical studies. The specific handling of nitrate, including its enterosalivary recirculation, secretion into saliva, oral microbial reduction to nitrite (NO₂^-), and the pH-dependent nitrosative capacity in the stomach have all been recognized as being important for nitrate's beneficial effects. Obesity is of major health concern worldwide and associated with increased cardiovascular risk; whether nitrate lowers blood pressure and improves endothelial function in this setting has not been investigated. We here tested the hypotheses that i) nitrate elicits cardiovascular benefits in overweight women; and ii) these beneficial effects would be diminished in women who underwent bariatric Roux-en-Y gastric bypass (RYGB) surgery. Our controlled clinical trial included 15 women with prior RYGB surgery and 15 overweight female controls. All participants received a single dose of 0.1 mmol/kg/day nitrate in the form of a beetroot extract for 14 days. Blood collection, 24-h ambulatory blood pressure measurements and endothelial function tests were performed before and after nitrate treatment. Plasma nitrite, nitrate, and S-nitrosothiol (RSNO) concentrations were determined by ozone-based reductive chemiluminescence while thiobarbituric acid reactive substances (TBARS) and total antioxidant capacity (TAC) were measured using plate-reader based assays. Nitrate reduced blood pressure and improved endothelial function in controls, but not in women with prior bariatric surgery. Nitrate also increased circulating nitrate/nitrite and RSNO levels in controls, but the latter was blunted following RYGB surgery despite even larger increases in nitrite concentrations. Similarly, nitrate increased antioxidant responses in controls but not in women with prior bariatric surgery. This is the first study to show that nitrate exerts beneficial cardiovascular effects in obesity and that the morphological/functional modifications elicited by RYGB surgery abrogates nitrate's effectiveness by preventing gastric RSNO formation.

News (Medical) associated with Gallium nitrate

02 Dec 2009

·www.biospace.com

Genta Incorporated to Support Initiation of New Clinical Trial using Ganite(R) as Treatment for Life-Threatening Infections in Patients with Cystic Fibrosis

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA) announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

25 May 2007

·www.biospace.com

Genta Incorporated to Present Multiple Abstracts at the Annual Meeting of the American Society of Clinical Oncology

BERKELEY HEIGHTS, N.J., May 25 /PRNewswire-FirstCall/ -- Genta Incorporated announced that several abstracts featuring its oncology products, Genasense(R) (oblimersen sodium) Injection, and Ganite(R) (gallium nitrate injection), will be presented at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 1-5, 2007. The abstracts include the following: -- LDH is a Prognostic Factor in Stage IV Melanoma Patients but is a Predictive Factor only for Bcl-2 Antisense Treatment Efficacy: Re- analysis of GM301 and EORTC18951 Randomized Trials. Abstract #8552; Sunday, June 3, 2007. -- A Phase III Randomized Trial of Intensive Induction and Consolidation Chemotherapy +/- Oblimersen (Genasense; G3139), a Pro-Apoptotic Bcl-2 Antisense Oligonucleotide, in Untreated Acute Myeloid Leukemia Patients greater than or equal to 60 Years Old: Cancer and Leukemia Group B (CALGB) Study 10201. Abstract #7012; Saturday, June 2, 2007. -- GaRD Study: Gallium, Rituximab, and Dexamethasone for Relapsed NHL. Poster #Y1, Abstract #8079; Saturday, June 2, 2007. -- Oblimersen (Genasense(R)) Can Be Administered by Subcutaneous and Brief Intravenous Infusion: Clinical Pharmacokinetics and Pharmacodynamics in Patients with Advanced Cancer. (Publication) -- Long-term Administration of Oblimersen plus Chemotherapy: An Analysis of Safety in Patients with Solid Tumors and Hematologic Cancers. (Publication) 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 lead 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 ( ) 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: . 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: Tara Spiess/Andrea Romstad TS Communications Group, LLC (908) 286-3980 info@genta.com Genta Incorporated CONTACT: Tara Spiess or Andrea Romstad of TS Communications Group, LLC,+1-908-286-3980, or info@genta.com, for Genta Incorporated Web site:

OligonucleotideSmall molecular drugASCOCollaborate

02 Feb 2007

·www.biospace.com

Genta Incorporated Completes Response To EMEA List Of Outstanding Issues For Genasense(R) Marketing Authorization Application In Melanoma

BERKELEY HEIGHTS, N.J., Feb. 2 /PRNewswire-FirstCall/ -- Genta Incorporated today announced that the Company has completed its response to the 180-day List of Outstanding Issues from the European Medicines Agency (EMEA) regarding its Marketing Authorization Application (MAA) for Genasense(R) (oblimersen sodium), its lead anticancer product, for treatment of patients with advanced melanoma. The Company currently anticipates that EMEA's Committee on Human Medicinal Products (CHMP) will complete its review and issue its opinion regarding approval within the next 90 days. Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. A summary of data from the final analysis of the pivotal Phase 3 trial of Genasense appears below. Efficacy The MAA is based on long-term data derived from the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In this trial, which was conducted at 139 sites in 9 countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The submission includes data compiled after 24-months of minimum follow-up on all patients. Unless otherwise noted, these results were based on an intent-to-treat analysis: Endpoint Genasense/DTIC DTIC P Overall response 13.5 % 7.5 % 0.007 Complete response 2.8 % 0.8 % 0.03 Durable response 7.3 % 3.6 % 0.03 Progression-free survival, 2.6 mos. 1.6 mos. 0.0007 median Overall survival, median 9.0 mos. 7.8 mos. 0.077 Prior to randomization, patients were prospectively stratified according to certain risk factors, including elevated blood levels of an enzyme known as LDH -- a factor that previous studies have shown is strongly associated with poor outcome. The final analysis has shown that LDH was the sole stratification factor significantly associated with a treatment interaction. When this treatment effect was evaluated, the efficacy of Genasense was significantly superior for all major efficacy outcomes in patients who had normal LDH at baseline, a group that comprised approximately two-thirds of patients in the trial (N=508). In this group, the following efficacy results were observed: Endpoint Genasense/DTIC DTIC P Overall response 17.2 % 9.3 % 0.009 Complete response 3.4 % 0.8 % 0.04 Durable response 9.6 % 4.0 % 0.014 Progression-free survival, 3.1 mos. 1.6 mos. 0.0007 median Overall survival, median 11.4 mos. 9.7 mos. 0.018 Safety In the randomized trial, the most frequent serious adverse events that occurred in greater than or equal to 5% of patients were fever and disease progression (6.2% vs. 2.8%, and 5.1% vs. 4.7%, respectively, for Genasense/DTIC compared with DTIC alone). The most frequent Grade 3 or 4 adverse events that occurred in greater than or equal to 5% of patients were neutropenia (21.3% vs. 12.5%), thrombocytopenia (15.9% vs. 6.4%), leukopenia (7.5% vs. 3.9%), anemia (7.3% vs. 4.7%), and nausea (6.7% vs. 2.5%). Although there was an increase in discontinuations due to adverse events in the Genasense arm (19% vs. 11%), there was no difference in the number of fatal, treatment-emergent adverse events (i.e., events that lead to a death on study or within 30 days from last study treatment). Data from this trial were recently published in the Journal of Clinical Oncology and can be accessed at: . About Malignant Melanoma Malignant melanoma is the most deadly form of skin cancer. Melanoma is responsible for more than 90% of all skin cancer deaths. The European Network of Cancer Registries estimates that more than 60,000 cases of melanoma are diagnosed each year. The incidence of this disease is increasing by approximately 4 percent annually in the U.S., where it is the number one cause of cancer deaths for women aged 25 to 29. Additional information about melanoma can be accessed at: . About Genasense Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer. 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. Genta has completed a pending 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 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. For more information about Genta, please visit our website at: . 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; -- the Company's ability to regain compliance with the NASDAQ's listing qualifications; 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 2005 and its most recent quarterly report on Form 10-Q. CONTACT: Tara Spiess/Andrea Romstad TS Communications Group, LLC info@genta.com (908) 286-3980 Genta Incorporated CONTACT: Tara Spiess, or Andrea Romstad, both of TS Communications Group,LLC, +1-908-286-3980, info@genta.com, for Genta Incorporated Web site:

OligonucleotideSmall molecular drug

100 Deals associated with Gallium nitrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00940	Gallium nitrate	-	DB05260

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Humoral Hypercalcemia of Malignancy	US	Genta, Inc.	17 Jan 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 2	US	Genta, Inc.	01 Jun 2002
Non-Hodgkin's lymphoma refractory	Phase 2	US	Genta, Inc.	01 Jun 2002
Refractory Lymphoma	Phase 2	US	Genta, Inc.	01 Jun 2002
Non-Hodgkin Lymphoma	Phase 2	-	Astellas Pharma, Inc.	-
Non-Hodgkin Lymphoma	Phase 2	-	Memorial Sloan Kettering Cancer Center	-
Infectious Diseases	Phase 1	US	-	-
Infectious Diseases	Phase 1	-	Genta, Inc.	-
Infectious Diseases	Phase 1	-	Astellas Pharma, Inc.	-
Infectious Diseases	Phase 1	-	Memorial Sloan Kettering Cancer Center	-
Bone Cancer	Preclinical	US	-	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02354859 (CTgov)	Phase 2	Cystic Fibrosis	119	placebo+Gallium nitrate (Gallium)	yskeicdyor(czeogmbvuu) = mupjluhkvn tuviqcttry (nprypcjqiv, njzgtphblw - pwqdfxqmgl) View more	-	21 Mar 2019
				placebo+gallium nitrate (Placebo)	yskeicdyor(czeogmbvuu) = fynufirtfj tuviqcttry (nprypcjqiv, xxuqwltybh - benaqkekyl) View more
NCT01093521 (CTgov)	Phase 1	Cystic Fibrosis	20	Gallium+Ganite (IV Gallium (Ganite®) Infusion 100 mg/m2/Day)	apckalngwy(wazwfpdwjd) = lvjdljwxkn cwrljlreft (nriwmalqba, oidepriepx - jzyozfyjtp)	-	12 Jan 2016
				Gallium+Ganite (IV Gallium (Ganite®) Infusion 200 mg/m2/Day)	apckalngwy(wazwfpdwjd) = nmzrroxupx cwrljlreft (nriwmalqba, fucduqxfvx - xoaznsknpp)
ASCO2006	Phase 2	Diffuse Large B-Cell Lymphoma	22	Gallium nitrate, rituximab, and dexamethasone (GaRD)	btnegxprgy(oidlloziiv) = ncfkectydt outvrhlmkh (butyyjcklh ) View more	Positive	20 Jun 2006

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