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Stories from the dialysis comunity across the globe.
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Adjusting Starting Dose of Lenalidomide for Renal Function May Not ... - Cancer Therapy Advisor |
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March 26, 2015
Adjusting the starting dose of lenalidomide according to renal function did not compromise the efficacy or safety of lenalidomide.
According to a recent study published online early in the International Journal of Hematology, researchers have found that adjusting the starting dose of lenalidomide according to renal function did not compromise the efficacy or safety of lenalidomide plus low-dose dexamethasone in Chinese patients with advanced relapsed and/or refractory multiple myeloma and renal impairment.
For the study, researchers conducted a subgroup analysis of the MM-021 trial to assess the efficacy and safety of lenalidomide plus low-dose dexamethasone in Chinese patients with advanced relapsed or refractory multiple myeloma and renal impairment.
Researchers classified patients as having either no/mild renal impairment (CrCl ?60mL/min), moderate impairment (CrCl ?30 to <60 mL/min), or severe renal impairment (CrCl <30 mL/min).
RELATED: Carfilzomib Superior to Bortezomib for Relapsed Multiple Myeloma
Patients received lenalidomide at a starting dose of 25 mg/day on days 1-21, which was adjusted for baseline renal function. Patients received the regimen until disease progression or discontinuation.
Results showed response rates for mild, moderate, and severe impairment were 50%, 42%, and 42%, respectively. Patients with no/mild renal impairment experience a longer median progression-free survival and overall survival compared with those with moderate or severe renal impairment.
In regard to safety, grade 3-4 anemia, neutropenia, and thrombocytopenia were more common in patients with severe renal impairment.
Reference
- Zhou B-b, Yu L, Du X, et al. Lenalidomide plus low-dose dexamethasone in Chinese patients with relpased or refractory multiple myeloma and renal impairment. Int J Hematol. 2015. [Epub ahead of print]. doi: 10.1007/s12185-015-1771-7.
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Tax relief for kidney ailment medicines - NYOOOZ |
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MUMBAI: The Maharashtra government will waive taxes on medicines for dialysis and kidney-related treatment. It will also come up with a special law to curb malpractices in paramedical services, like pathology laboratories, and regulate their fees and overall functioning. Finance minister Sudhir Mungantiwar, while replying to a debate on his budget in the state assembly, had earlier announced a waiver for medicines required for cancer and heart patients.
Mungantiwar, in his budget speech, had promised to list out cancer medicines which will be notified for tax waiver soon. Sources said even machinery and surgical equipment required for dialysis and kidney treatment may get some waivers, taking into consideration the high cost of such treatment in private hospitals. Officials said advanced machinery for dialysis was available only at private hospitals.
The tax on `guide wire`, required for medical treatment of heart patients, has also been reduced from 12.5% to 5%, which will ultimately reduce the cost of heart treatment and operations from the beginning of the new fiscal. Replying to a calling attention motion over the alleged bogus operation of pathology labs and exorbitant fees charged by them from poor patients in the state, education minister Vinod Tawde said the Maharashtra Paramedical Council Bill (2011) would have to be redrafted t...
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3 Division of Cardiovascular Medicine, Brigham Women's Hospital, Boston, MA ... - Nature.com |
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Nature.com
Adjustments for all end points except ESRD were age, gender, race (black/white), insulin treatment, urinary protein-to-creatinine ratio, s-albumin, blood urea nitrogen, C-reactive protein, hemoglobin level, reticulocytes, arrhythmia, cerebrovascular
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Transition Therapeutics (TTHI) Issues Encouraging Update on ELND005 Phase 1 - StreetInsider.com |
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Transition Therapeutics (Nasdaq: TTHI) announced results from two phase 1 clinical studies of neuropsychiatric drug candidate ELND005. These studies, an absorption-metabolism-excretion ("AME") study and a renal clearance study, are specialized clinical pharmacology trials that are required by the United States Food and Drug Administration ("FDA") for the approval of most drugs in development.
The AME study enrolled 8 subjects and the renal clearance study enrolled 42 subjects. In both studies, ELND005 showed good safety and tolerability. The key result of the AME study was that ELND005 showed good oral bioavailability as there was nearly 100% absorption. ELND005 showed no evidence of hepatic or intermediary metabolism and the study demonstrated that the main excretion route of ELND005 is via the kidney. These AME properties of good oral bioavailability, low protein binding, and lack of CYP metabolism are usually associated with consistent plasma levels and with a reduced risk of drug-drug interactions. The AME profile of ELND005 is well suited for an Alzheimer's disease patient population that is commonly administered multiple concomitant medications, many of which are metabolized by the liver.
The renal clearance study evaluated the pharmacokinetic profile of ELND005 in subjects with various degrees of renal impairment. In this study, ELND005 showed minimal protein binding in plasma regardless of renal function. Across the 5 study arms, subjects with worse renal function had increased plasma drug exposure compared to those with normal renal function. The study provided important guidance for the minimum creatinine clearance needed to allow patient participation in studies with a fixed dose regimen of ELND005. This minimum creatinine clearance is consistent with the threshold used as exclusion criterion in the ongoing study of ELND005 in Agitation and Aggression of AD (ELND005-AG201, the HarmonyAD Study).
"The informative results from these studies together with the thorough QT study results reported last November, showing no QTc prolongation, are supportive of the suitability of ELND005 in the elderly AD population. These studies are part of a comprehensive package of data being complied by our wholly owned subsidiary, Transition Therapeutics Ireland Limited, to advance ELND005 toward regulatory approval," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition.
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Transition Therapeutics Announces Results from Phase 1 AME Renal ... - PR Newswire (press release) |
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TORONTO, March 26, 2015 /PRNewswire/ - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX:TTH) today announced results from two phase 1 clinical studies of neuropsychiatric drug candidate ELND005. These studies, an absorption-metabolism-excretion ("AME") study and a renal clearance study, are specialized clinical pharmacology trials that are required by the United States Food and Drug Administration ("FDA") for the approval of most drugs in development. The AME study enrolled 8 subjects and the renal clearance study enrolled 42 subjects. In both studies, ELND005 showed good safety and tolerability. The key result of the AME study was that ELND005 showed good oral bioavailability as there was nearly 100% absorption. ELND005 showed no evidence of hepatic or intermediary metabolism and the study demonstrated that the main excretion route of ELND005 is via the kidney. These AME properties of good oral bioavailability, low protein binding, and lack of CYP metabolism are usually associated with consistent plasma levels and with a reduced risk of drug-drug interactions. The AME profile of ELND005 is well suited for an Alzheimer's disease patient population that is commonly administered multiple concomitant medications, many of which are metabolized by the liver. The renal clearance study evaluated the pharmacokinetic profile of ELND005 in subjects with various degrees of renal impairment. In this study, ELND005 showed minimal protein binding in plasma regardless of renal function. Across the 5 study arms, subjects with worse renal function had increased plasma drug exposure compared to those with normal renal function. The study provided important guidance for the minimum creatinine clearance needed to allow patient participation in studies with a fixed dose regimen of ELND005. This minimum creatinine clearance is consistent with the threshold used as exclusion criterion in the ongoing study of ELND005 in Agitation and Aggression of AD (ELND005-AG201, the HarmonyAD Study). "The informative results from these studies together with the thorough QT study results reported last November, showing no QTc prolongation, are supportive of the suitability of ELND005 in the elderly AD population. These studies are part of a comprehensive package of data being complied by our wholly owned subsidiary, Transition Therapeutics Ireland Limited, to advance ELND005 toward regulatory approval," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition. About the ELND005 AME and Renal Clearance Studies AME Study Design This study was designed to assess the absorption, metabolism, and excretion of a radio labeled ELND005 molecule ("14C-ELND005") following a single oral administration in healthy male subjects. All subjects received a single oral dose of 1000 mg (approximately 100 µCi) 14C-ELND005. All subjects were enrolled and evaluated concurrently. Renal Clearance Study Design This study was designed to evaluate the pharmacokinetics, safety, and pharmacodynamic profiles of ELND005 following a single 1000 mg dose to healthy matched control subjects and subjects with varying degrees of renal impairment (mild to severe) and following 2 single 1000 mg doses in end stage renal disease ("ESRD") subjects. About ELND005 ELND005 is an orally bioavailable small molecule that is being investigated for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes ?-amyloid anti-aggregation and regulation of brain myo-inositol levels. An extensive clinical program of Phase 1 and Phase 2 studies has been completed with ELND005 to support clinical development. ELND005 is being studied as a potential treatment of agitation and aggression in Alzheimer's disease and as a therapy for those with Down syndrome. ELND005 has received fast track designation from the psychiatry division of the United States Food and Drug Administration for its potential as a treatment of Neuropsychiatric Symptoms (including Agitation and Aggression) in AD. About Transition Transition is a biopharmaceutical development company, advancing novel therapeutics for CNS and metabolic disease indications. The Company's wholly-owned subsidiary, Transition Therapeutics Ireland Limited is developing CNS drug candidate ELND005 for the treatment of Alzheimer's disease and Down syndrome. Transition's lead metabolic drug candidate is TT401 (LY2944876) for the treatment of type 2 diabetes and accompanying obesity. The Company's shares are listed on the NASDAQ under the symbol "TTHI" and the Toronto Stock Exchange under the symbol "TTH". For additional information about the Company, please visitwww.transitiontherapeutics.com.
Notice to Readers: Information contained in our press releases should be considered accurate only as of the date of the release and may be superseded by more recent information we have disclosed in later press releases, filings with the OSC, SEC or otherwise. Except for historical information, this press release may contain forward-looking statements, relating to expectations, plans or prospects for Transition, including conducting clinical trials and potential efficacy of its products. These statements are based upon the current expectations and beliefs of Transition's management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include factors beyond Transition's control and the risk factors and other cautionary statements discussed in Transition's quarterly and annual filings with the Canadian commissions.
SOURCE Transition Therapeutics Inc.
RELATED LINKS
http://www.transitiontherapeutics.com
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