Pharmacokinetics News and Research

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The term pharmacokinetics is derived from the ancient Greek words “pharmakon” and “kinetikos”, meaning “drug” and “putting in motion” respectively. It is one of the main branches of pharmacology, and refers to the way that the body reacts on and affects a pharmaceutical substance in the body.

Genmab announces Phase II ofatumumab study results in RRMS patients

Genmab A/S announced today encouraging results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS).

13 Sep 2010

FerroKin BioSciences initiates international Phase 2 study of FBS0701

FerroKin BioSciences today announced the initiation of an international Phase 2 study of FBS0701, a novel once-daily iron chelator in development for the treatment of transfusional iron overload. The Phase 2 study will assess the safety, tolerability, and pharmacodynamics of FBS0701.

10 Sep 2010

Tetraphase announces 13 data presentations on TP-434 broad spectrum antibiotic at ICAAC 2010

Tetraphase Pharmaceuticals, Inc., today announced that 12 poster presentations and an oral summary presentation on preclinical and clinical data for its lead drug candidate, TP-434, will be presented at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, MA, being held September 12 -15 at the Boston Convention and Exhibition Center.

9 Sep 2010

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals, Inc. today announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX.

8 Sep 2010

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

YM BioSciences Inc., today announced the publication of Phase I results demonstrating that CYT997, a novel vascular disrupting agent (VDA), was well tolerated at doses that were associated with pharmacodynamic evidence of vascular disruption in tumors. The article entitled "Phase I trial of CYT997, a novel cytotoxic and vascular-disrupting agent," was published in the premier cancer journal, the British Journal of Cancer.

8 Sep 2010

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Emergent BioSolutions Inc. announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

8 Sep 2010

Trius Therapeutics announces presentations from drug development programs at 50th ICAAC

Trius Therapeutics, Inc. announced today that the results of multiple studies from its drug development programs, including its lead antibiotic drug candidate torezolid phosphate (TR-701), will be presented in poster presentations at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Boston September 12-15.

8 Sep 2010

NIH awards St. Jude $8.6M to focus on anticancer agent research in children

With its new expansion of the Pharmacogenomics Research Network (PGRN), the National Institutes of Health (NIH) awarded St. Jude Children's Research Hospital a prestigious grant to focus on anticancer agent research in children.

8 Sep 2010

VirtualScopics enters molecular imaging collaboration with ABX-CRO

VirtualScopics, Inc., a leading provider of quantitative imaging for clinical trials, today announced it has entered into a scientific collaboration, specific to molecular imaging, with ABX-CRO, a Dresden, Germany based full-service contract research organization. The collaboration joins two of the scientific pioneers in the use of advanced imaging for the clinical study of drugs and medical devices.

7 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

Axelar AB publishes first AXL1717 data on phase I/II cancer study

Axelar AB today announces that the first submitted medical article on the ongoing phase I/II cancer study with AXL1717 has been published in Acta Oncologica.

7 Sep 2010

Inhibitex completes INX-189 Phase1a trial for HCV

Inhibitex, Inc., announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting.

2 Sep 2010

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

2 Sep 2010

Trius commences oral torezolid phosphate Phase 3 clinical study for ABSSSI

Trius Therapeutics, Inc. announced that the first patient has been dosed in its Phase 3 clinical study of the oral dosage form of torezolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The double-blind, active control, pivotal study is designed to compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate for six days of treatment with the efficacy and safety of twice-daily oral administration of 600 milligrams of linezolid (Zyvox®) for 10 days of treatment.

30 Aug 2010

KemPharm broadens protection for LAT prodrug technology platform for ADHD with second patent

KemPharm, Inc. announced today that it has received a Notice of Issuance from the United States Patent and Trademark Office (USPTO) for its patent application entitled "Non-Standard Amino Acid Conjugates of Amphetamine and Processes for Making and Using the Same", U.S. Patent No. 7,776,917 B2. This patent, combined with KemPharm's recently issued U.S. Patent No. 7,772,222, provides broad protection of the Company's Ligand Activated Therapy (LAT) prodrug technology platform and its application to the treatment of Attention Deficit – Hyperactivity Disorder.

27 Aug 2010

Alexza Pharmaceuticals licenses Staccato nicotine technology to Cypress Bioscience

Alexza Pharmaceuticals, Inc. announced today that it has licensed its Staccato nicotine technology to Cypress Bioscience, Inc. The Staccato nicotine technology is a novel electronic multidose delivery system designed to help people stop smoking. The Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation, mimicking the nicotine effects of smoking without the harmful side effects associated with cigarettes.

26 Aug 2010

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent.

26 Aug 2010

Researchers develop microneedles to deliver quantum dots for skin cancer treatment

Researchers from North Carolina State University have developed extremely small microneedles that can be used to deliver medically-relevant nanoscale dyes called quantum dots into skin - an advance that opens the door to new techniques for diagnosing and treating a variety of medical conditions, including skin cancer.

26 Aug 2010

Simulations Plus launches Version 7.0 of GastroPlus software for pharmaceutical industry

Simulations Plus, Inc.,a leading provider of simulation and modeling software for pharmaceutical discovery and development, has announced the launch of Version 7.0 of GastroPlus, the industry's gold standard software for the simulation of drug absorption, pharmacokinetics, and pharmacodynamics.

25 Aug 2010

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the first patient has been treated in its clinical trial of STA-9090 in combination with docetaxel for the treatment of advanced solid tumor malignancies.

24 Aug 2010

Pharmacokinetics News and Research

Further Reading

Genmab announces Phase II ofatumumab study results in RRMS patients

FerroKin BioSciences initiates international Phase 2 study of FBS0701

Tetraphase announces 13 data presentations on TP-434 broad spectrum antibiotic at ICAAC 2010

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Trius Therapeutics announces presentations from drug development programs at 50th ICAAC

NIH awards St. Jude $8.6M to focus on anticancer agent research in children

VirtualScopics enters molecular imaging collaboration with ABX-CRO

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Axelar AB publishes first AXL1717 data on phase I/II cancer study

Inhibitex completes INX-189 Phase1a trial for HCV

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Trius commences oral torezolid phosphate Phase 3 clinical study for ABSSSI

KemPharm broadens protection for LAT prodrug technology platform for ADHD with second patent

Alexza Pharmaceuticals licenses Staccato nicotine technology to Cypress Bioscience

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Researchers develop microneedles to deliver quantum dots for skin cancer treatment

Simulations Plus launches Version 7.0 of GastroPlus software for pharmaceutical industry

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

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