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Metabolite in Medical Technology

NKTR-102 (PEG-Irinotecan) Demonstrates Significant Tumor Growth Inhibition In Multiple Preclinical Tumor Models

... Exposure of Tumor Tissue to the Active metabolite of Irinotecan SAN FRANCISCO, Oct. 25 ... the effective half-life of irinotecan's active metabolite in tumor tissues. In a colorectal cancer model, ... NKTR-102 administration, exposure to the active metabolite of irinotecan in colorectal and lung tumor tissue ...

Cardax Pharmaceuticals Nominates Clinical Candidate Heptax for Liver Disease; Heptax Ameliorates Inflammation and Oxidative Stress Related to Liver Disease and Metabolic Syndrome

... Preclinical animal studies with the Company's compounds or its active metabolite have demonstrated reductions in blood pressure, triglycerides, cholesterol ... required for clinical study and it is converted to the natural active metabolite in the gastrointestinal tract. It effectively combines the properties of ...

Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies

... radiochemical and chemical analysis services to obtain definitive metabolite disposition data in humans. Covance offers 24-hour turnaround of ... parent compound; total radioactivity; pharmacokinetic interpretation; and metabolite profiling and identification. Covance's clinical development ...

Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594

... elevated levels of uric acid in the blood stream. RDEA594 is a major metabolite in both humans and animals of RDEA806, the Company's lead ... has potential for treating gout patients with hyperuricemia. RDEA594 is a metabolite of RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI) in ...

Additive Anti-Tumor Activity of NKTR-102 in Combination With Bevacizumab Highlighted in Positive Preclinical Data Presented at AACR Meeting

... and a 4-fold lower peak plasma concentration (Cmax) of SN38, the active metabolite of irinotecan, as compared to the equivalent dosing of irinotecan. The ... in a markedly improved time-concentration profile for SN38, the active metabolite of irinotecan, as compared to treatment with irinotecan. Nektar ...

Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference

... in a significantly improved pharmacokinetic profile for the active metabolite of irinotecan as compared to treatment with irinotecan. "The studies for ... data focused on the pharmacokinetics and pharmacodynamics of the active metabolite of irinotecan following administration of NKTR-102 in mouse xenograft ...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

... to the editor About Sodium Oxybate Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. ...

Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

... accordingly. About Sodium Oxybate Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. ...

Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders

... The most common adverse reactions associated with BUPHENYL were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these ...

Corgenix AspirinWorks(R) Test Recognized in POLYCAP Study at ACC.09

... only FDA-cleared test that measures urinary 11dhTxB2 to accurately determine the effect of aspirin in apparently healthy individuals. 11dhTxB2 is a metabolite of thromboxane A2, the target of aspirin therapy. The AspirinWorks Test was launched in the U.S. in June 2007 following FDA 510(k) clearance, ...

Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)

... has demonstrated in vitro anti-HCV activity with EC(50) values of 90 +/- 60 nM, which is approximately 15- to 20-fold more potent than the active metabolite of Pharmasset's first generation nucleoside polymerase inhibitor, R7128. In vitro studies of PSI-7851 have not shown evidence of any mitochondrial ...

Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders

... The most common adverse reactions associated with BUPHENYL(R) were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these ...

Researchers Discover Metabolite Linked to Aggressive Prostate Cancer

... of the cells and the biochemistry that occurs during cancer development," says Chinnaiyan, a Howard Hughes Medical Institute investigator. One metabolite in particular, sarcosine, appeared to be one of the strongest indicators of advanced disease. Levels of sarcosine, an amino acid, were elevated in 79 ...

Immunomedics Announces Preclinical Therapy Results of SN-38 Immunoconjugate for Colorectal Cancer

... antibody-drug conjugate, selectively delivers SN-38 to human colon carcinoma in animal models as an effective new therapy. SN-38 is the active metabolite of irinotecan, a chemotherapeutic agent approved by the FDA for the treatment of colorectal, lung, and other cancers. Due to its toxicity and poor ...

Jazz Pharmaceuticals, Inc. Completes Enrollment in Second of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia

... America. About Sodium Oxybate Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. ...

Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fibromyalgia

... 46982308. About Sodium Oxybate Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. ...

Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate

... 3 clinical testing. The paper describes in vitro metabolism of Liquiritigenin which is almost exclusively metabolized by cytochrome P450 3A4. The metabolite that was identified is three times more potent than the parent compound towards selective activation of the estrogen receptor beta. Enzyme ...

Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial

... associated with gout in the past 40 years About RDEA594 RDEA594, our lead product candidate for the treatment of gout, is a major metabolite of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in clinical development for the treatment of HIV. RDEA594 does not have ...

Pharmasset Receives Notice of Allowance

... composition of matter of a family of molecules invented at Pharmasset for the treatment of hepatitis C virus (HCV), including PSI-6130 and the active metabolite of PSI-7851. R7128, a prodrug of PSI-6130, a nucleoside analogue polymerase inhibitor of HCV, is being developed through Pharmasset's collaboration ...

Nektar Announces Expanded Phase 2 Clinical Development Plan For NKTR-102 (PEG-irinotecan)

... and lung cancer. Administration of NKTR-102 in an animal model also results in a markedly improved time-concentration profile for SN38, the active metabolite of irinotecan, as compared to treatment with irinotecan. Nektar PEGylation technology can enhance the properties of therapeutic agents by ...

New Data Show TORISEL Improves Progression-Free Survival for Patients With Relapsed/Refractory Mantle Cell Lymphoma

... dexamethasone, rifampin) and strong inhibitors of CYP3A4 (e.g., ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended. St. John's Wort may decrease TORISEL ...

New Analyses Presented at ASCO Reaffirmed Efficacy and Safety of TORISEL in Patients With Advanced Kidney Cancer

... dexamethasone, rifampin) and strong inhibitors of CYP3A4 (e.g., ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended. St. John's Wort may decrease TORISEL ...

Wyeth Initiates INTORACT -- A New Clinical Trial to Examine TORISEL Plus Avastin for First-Line Treatment of Advanced Kidney Cancer

... dexamethasone, rifampin) and strong inhibitors of CYP3A4 (e.g., ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended. St. John's Wort may decrease TORISEL plasma ...

Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage 4 Melanoma

... these initial data are very promising," said Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "Temozolomide is the active metabolite of dacarbazine (DTIC), which is the chemotherapy drug used in our ongoing Phase 3 AGENDA trial in patients with melanoma and low-normal LDH. We also ...

Significant Anti-Tumor Activity of NKTR-102 in Patients With Refractory Solid Tumors; Interim Data Published in ASCO 2008 Proceedings

... was up to six-fold higher than the exposure previously reported with irinotecan at equivalent doses. SN38, a topoisomerase I inhibitor, is the active metabolite of irinotecan. The ASCO abstract reports interim data on 27 of 32 patients in the first of three dose schedules from the Phase 1 trial.(1) Results ...

NKTR-118 Shows Substantial Oral Bioavailability and Extended Half-Life in Phase 1 Clinical Data Presented at American Pain Society Meeting

... A total of 32 subjects enrolled in the trial. The secondary objective of the trial was to evaluate the pharmacokinetics of oral NKTR-118 and its metabolite (NKTR-118 glucuronide) following twice-daily oral administration for seven days. Escalating doses up to 250 mg twice daily were studied. Subjects ...

Michael J. Fox Foundation Announces $5.6-Million Award for Phase 2 Clinical Trial Studying Neuroprotective Potential of Inosine

... the Edmond J. Safra Foundation, one of the most steadfast supporters of The Michael J. Fox Foundation since its inception. Urate is a natural metabolite and major antioxidant in humans. Previous studies found that healthy people with higher urate levels in the blood had a reduced risk of developing ....

ANX-201 Demonstrates a Unique Resistance Profile in Preclinical Tests

... reverse transcriptase inhibitor (RTI) that is being developed to provide benefits for treatment-resistant HIV-infected patients. Foscarnet, the main metabolite of ANX-201, is approved by the FDA for use in immunocompromised patients with CMV retinitis and mucocutaneous acyclovir-resistant HSV infections. ...

Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs

... program for NCX 4016 in type 2 diabetes was put on hold in 2007, due to unexpected in vitro test results observed for NCX 4015, a potential, specific metabolite of NCX 4016. NicOx has not received any further results suggesting a potential concern with NCX 4015. Following an in-depth internal evaluation of ...

Nektar Commences Phase 2 Clinical Development Program for NKTR-102 (PEG-Irinotecan) in Colorectal Cancer

... tumor model. Administration of NKTR-102 in an animal model results in a significantly improved time-concentration profile for the active metabolite of irinotecan as compared to treatment with standard irinotecan. About Nektar Nektar Therapeutics is a biopharmaceutical company that develops ...

Wyeth's TORISEL Receives European Commission Approval for the Treatment of Advanced Kidney Cancer

... (eg, dexamethasone, rifampin) and strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended. St. John's Wort may decrease TORISEL ...

Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers

... in vital signs, electrocardiograms, hematologic, renal or other laboratory parameters. The plasma exposure to PSI-6130 and PSI-6206, the uridine metabolite of PSI-6130, increased with increasing doses of R7128. Food increased the exposure of PSI- 6130 by approximately 20%. Please see ...

Furamidine Found to Inhibit a Key Enzyme Involved in Cancer Cell DNA Repair Mechanisms

... Cancer Institute on the ability of furamidine to inhibit a key enzyme involved in the DNA repair process (see Note below). Furamidine is the active metabolite (DB75) of Immtech's proprietary, orally bioavailable prodrug, pafuramidine. Of interest is furamidine's potential to inhibit DNA repair in cancerous ...

Anadys Reports Preclinical Data Showing ANA773 Promotes Anti-Tumor Activity of Natural Killer Cells

... from an in vitro study showing that the active metabolite of ANA773 promotes natural killer ... a.m. EDT). The study found that the active metabolite of ANA773, an oral Toll-like receptor 7 (TLR7) ... in vitro. Human PBMC stimulated with the active metabolite of ANA773 increased NK cell cytotoxicity and ...

Antares Pharma Announces Positive Results from Application Site Study for Anturol

... the ratio of plasma levels of R- to S- enantiomers of the active metabolite was lower following gel application (in comparison to higher a ratio of R- ... overall plasma levels of combined R- and S- enantiomers of the active metabolite were also lower in Anturol(R) in comparison to levels known in oral ...

CeNeS Pharmaceuticals plc: Update on Successful Phase III results announced on Lead Product M6G

... PONV is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life. The active potent metabolite of morphine, morphine-6-glucuronide (M6G), may offer therapeutic advantages over morphine in having an equivalent analgesic effect, but with a ...

CeNeS Pharmaceuticals Plc Announces Preliminary Results for The Year Ending 31 December 2006

... ('PONV') is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life. The active potent metabolite of morphine, morphine-6-glucuronide (M6G), offers therapeutic advantages over morphine in having an equivalent analgesic effect, but with a reduced ...

ACADIA Pharmaceuticals' Schizophrenia Programs to Be Presented at the 2007 International Congress on Schizophrenia Research

... ACADIA is developing ACP-103 for the treatment of sleep maintenance insomnia. About ACP-104 ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine, and is in Phase II-stage development by ACADIA as a novel stand-alone therapy for schizophrenia. ACP-104 offers an atypical ...

NeoPharm Provides Update on LE-SN38 Program

... findings from a Phase 2 clinical trial in second-line metastatic colorectal cancer patients with its drug product candidate LE-SN38, the active metabolite of irinotecan (Camptosar(R)). While the interim analysis of data following the completion of treatment of the first 21 patients demonstrated disease ...
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