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.

Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Omeros Corporation today announced that it has submitted to the U.S. Food and Drug Administration (FDA) an investigational new drug (IND) application to initiate the Phase 2 clinical program for OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin‑associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.

4 Mar 2014

LFB SA initiates Phase 3 program for human Factor VIIa in patients with congenital hemophilia

LFB SA, through its rEVO Biologics subsidiary, announced today initiation of the global Phase 3 program for LR769, a novel recombinant form of human Factor VIIa, in patients with congenital hemophilia A or B with inhibitors.

4 Mar 2014

Intra-Cellular Therapies initiates Phase I/II clinical trial to evaluate pharmacokinetics in patients with dementia

Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the initiation of ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects and in patients with dementia, including Alzheimer's disease.

4 Mar 2014

Exposure to very low concentrations of BPA by pregnant females can cause fetal abnormalities in primates

Bisphenol A (BPA) is a chemical that is used in a wide variety of consumer products, such as resins used to line metal food and beverage containers, thermal paper store receipts, and dental composites.

28 Feb 2014

Omeros doses first patient in second Phase 2 clinical trial of OMS824

Omeros Corporation today announced dosing of the first patient in a second Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor being developed for the treatment of schizophrenia, Huntington's disease (HD) and other cognitive disorders. The Phase 2 trial will evaluate the tolerability, safety, pharmacokinetics and performance on a battery of tests in patients with symptomatic HD.

19 Feb 2014

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

Viamet Pharmaceuticals Inc. today reported positive interim results from an ongoing Phase 2 study of VT-1161, the Company's novel oral antifungal compound, in patients with moderate to severe acute vulvovaginal candidiasis (AVVC). This study is intended as a precursor to a Phase 2b study in patients with recurrent vulvovaginal candidiasis (RVVC).

18 Feb 2014

FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration granted accelerated approval of NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH.

18 Feb 2014

Ario Pharma begins XEN-0501 Phase IIa study for treatment persistent cough in COPD patients

Ario Pharma Ltd, the Cambridge biopharmaceutical company developing innovative new approaches to treat respiratory disease, announced today that it has commenced a Phase IIa study of its TRPV1 antagonist, XEN-0501, for the treatment and prevention of cough in patients with chronic obstructive pulmonary disease (COPD). Persistent cough in COPD and other respiratory conditions present as a huge unmet medical need, with novel therapies urgently needed to improve the quality of life of patients.

11 Feb 2014

Sarepta Therapeutics reports positive safety results from AVI-7288 Phase I study

Sarepta Therapeutics, Inc., a developer of innovative RNA-based therapeutics, today announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers.

10 Feb 2014

e-Therapeutics initiates Phase I clinical trial with oral formulation of ETS2101 anti-cancer compound

e-Therapeutics plc (AIM:ETX) announced today that it has dosed the first healthy volunteer in a newly initiated Phase I clinical trial with an oral formulation of its anti-cancer compound, ETS2101.

10 Feb 2014

Spinifex announces results of Phase 2 clinical trial of EMA401 in postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that The Lancet has published the results of its Phase 2 clinical trial of its lead candidate, EMA401, in postherpetic neuralgia (PHN).

5 Feb 2014

Addressing antibiotic resistance: an interview with Professor Otto Cars, Uppsala University, Sweden

Antibiotic resistance is a consequence of antibiotic use. Bacteria adapt to the threat of antibiotics using mechanisms to overcome the drug. These bacteria, which we call resistant bacteria, then survive.

3 Feb 2014

Omeros announces positive results from Phase 2a trial of OMS824 in patients with schizophrenia

Omeros Corporation today announced positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.

29 Jan 2014

CytRx initiates aldoxorubicin Phase 2 trial in HIV-infected patients with Kaposi's sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a Phase 2 clinical trial to determine preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi's sarcoma.

23 Jan 2014

CytRx receives FDA approval to continue dosing aldoxorubicin for patients with soft tissue sarcomas

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas.

22 Jan 2014

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

Kolltan Pharmaceuticals, a privately held biopharmaceutical company, today announced treatment of the first cancer patient with Kolltan's lead drug candidate, KTN3379, as part of a Phase 1 clinical study evaluating safety, preliminary evidence of antitumor activity, and pharmacokinetics. KTN3379 is a human monoclonal antibody that blocks the activity of ErbB3, a member of the ErbB family of receptor tyrosine kinases.

21 Jan 2014

European Commission approves ViiV Healthcare's Tivicay for treatment of HIV infected adults

ViiV Healthcare today announced that the European Commission has approved Tivicay (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.

21 Jan 2014

Daiichi Sankyo submits Marketing Authorization Application for edoxaban to EMA

Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency.

7 Jan 2014

e-Therapeutics announces continuation of ETS2101 phase I trial in brain cancer

e-Therapeutics plc today announces that the investigator-led phase I trial of ETS2101 in brain cancer will continue into 2014. Five dose escalation steps have been completed without any drug-related serious adverse events and the investigator therefore intends to enrol further patients at higher dose levels.

7 Jan 2014

ANP reports positive interim results from ATL1103 Phase II clinical trial for acromegaly

Antisense Therapeutics Limited is pleased to advise that positive results have been achieved from the interim analysis of a subset of available data from its Phase II clinical trial of ATL1103 in patients with the growth disorder, acromegaly.

23 Dec 2013

Pharmacokinetics News and Research

Further Reading

Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

LFB SA initiates Phase 3 program for human Factor VIIa in patients with congenital hemophilia

Intra-Cellular Therapies initiates Phase I/II clinical trial to evaluate pharmacokinetics in patients with dementia

Exposure to very low concentrations of BPA by pregnant females can cause fetal abnormalities in primates

Omeros doses first patient in second Phase 2 clinical trial of OMS824

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

Ario Pharma begins XEN-0501 Phase IIa study for treatment persistent cough in COPD patients

Sarepta Therapeutics reports positive safety results from AVI-7288 Phase I study

e-Therapeutics initiates Phase I clinical trial with oral formulation of ETS2101 anti-cancer compound

Spinifex announces results of Phase 2 clinical trial of EMA401 in postherpetic neuralgia

Addressing antibiotic resistance: an interview with Professor Otto Cars, Uppsala University, Sweden

Omeros announces positive results from Phase 2a trial of OMS824 in patients with schizophrenia

CytRx initiates aldoxorubicin Phase 2 trial in HIV-infected patients with Kaposi's sarcoma

CytRx receives FDA approval to continue dosing aldoxorubicin for patients with soft tissue sarcomas

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

European Commission approves ViiV Healthcare's Tivicay for treatment of HIV infected adults

Daiichi Sankyo submits Marketing Authorization Application for edoxaban to EMA

e-Therapeutics announces continuation of ETS2101 phase I trial in brain cancer

ANP reports positive interim results from ATL1103 Phase II clinical trial for acromegaly

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