Pharmacokinetics News and Research

RSS

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.

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Clinical Data, Inc., today announced that Santen Pharmaceutical Co., Ltd., has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data's highly selective adenosine A2A agonist, ATL313, for the indication of primary open angle glaucoma and ocular hypertension.

From Santen Pharmaceutical Co., Ltd. 23 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Anavex Life Sciences Corp. announced today that it has filed the regulatory submission for ANAVEX 2-73 with the German Health Authority, BfArM, and the local Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.

21 Dec 2010

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Ambit Biosciences, today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.

20 Dec 2010

VistaGen reports successful completion of AV-101 Phase 1 safety study for neuropathic pain

VistaGen Therapeutics, Inc., a stem cell technology company focused on drug discovery and development, today announced the successful completion of its initial Phase 1 safety study of AV-101, the Company's novel orally available prodrug candidate for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S.

20 Dec 2010

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

Icagen, Inc. today provided an update on its sodium channel program for pain and related disorders, which is being conducted in collaboration with Pfizer. As previously reported, the companies recently selected a candidate compound to advance into further clinical studies. Dosing of this candidate compound has now been initiated in a Phase I study in healthy volunteers.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

Alnylam Pharmaceuticals progress in delivery and translation of RNAi therapeutics

Alnylam Pharmaceuticals, a leading RNAi therapeutics company, presented new data at the 2010 International Chemical Congress of Pacific Basin Societies, being held in Honolulu, Hawaii, December 15-20.

17 Dec 2010

Ocera completes two studies of OCR-002 in patients with hyperammonemia, hepatic encephalopathy

Ocera Therapeutics, Inc. announced today that it has completed two studies evaluating the safety and pharmacokinetics of OCR-002 (ornithine phenylacetate) which includes healthy volunteers and patients with liver cirrhosis. OCR-002 recently received Orphan Drug status and Fast Track designation by the United States Food and Drug Administration for the treatment of hyperammonemia (excessive ammonia levels) and resultant Hepatic encephalopathy.

16 Dec 2010

Abbott initiates ABT-806 Phase 1 trial in EGFR expressing tumors

Life Science Pharmaceuticals (LSP) announced today a milestone related to monoclonal-antibody (mAb) 806 licensed to Abbott. A Phase 1 trial with ABT-806, a humanized version of mAb 806 that selectively targets the epidermal growth factor receptor (EGFR), has been initiated by Abbott in the U.S. The trial will assess the safety and pharmacokinetics of ABT-806 in patients with advanced solid tumors likely or known to express EGFR.

15 Dec 2010

Tolerx commences TRX518 Phase 1 trial in malignant melanoma

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of TRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells.

14 Dec 2010

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced first-in-human Phase 1 clinical trial results for CMX157 demonstrating a favorable safety, tolerability and drug distribution profile.

14 Dec 2010

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

Arena Pharmaceuticals, Inc. announced today the initiation of dosing in a Phase 1 clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH.

10 Dec 2010

Positive data from Celator's CPX-351 Phase 2 study in newly-diagnosed AML presented at 52nd ASH

Celator Pharmaceuticals today announced positive clinical data in elderly patients with newly-diagnosed acute myeloid leukemia (AML) treated with CPX-351 (Cytarabine:Daunorubicin) Liposome Injection. Data were presented from the podium at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

8 Dec 2010

GlycoMimetics highlights clinical, preclinical progress of GMI-1070 in sickle cell crisis at ASH 2010

GlycoMimetics, Inc., a clinical-stage biotechnology company developing a new class of glycobiology-based therapies for a broad range of indications, today announced that two oral presentations and two abstracts were delivered at the 52nd Annual Meeting of the American Society of Hematology in Orlando, Florida. The presentations and abstracts highlighted clinical and preclinical progress with GlycoMimetics's lead compound GMI-1070, now in Phase 2 clinical trials in sickle cell crisis.

8 Dec 2010

Global phase III study to provide novel extended release of topiramate

Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers.

7 Dec 2010

rVWF safe in patients with type 3 and severe type 1 von Willebrand disease, suggests interim study data

Recombinant von Willebrand factor (rVWF) may be safe and well tolerated in patients with type 3 and severe type 1 von Willebrand disease, according to interim data from a Phase 1 multicenter, international clinical study presented today at the 52nd Annual Meeting of the American Society of Hematology.

From Baxter International Inc. 7 Dec 2010

Phase 1 clinical data: ARRY-520 shows positive preliminary results in treating multiple myeloma

Array BioPharma Inc. today announced the presentation of positive Phase 1 clinical data for its novel kinesin spindle protein inhibitor, ARRY-520. The data, which were presented at the 2010 Annual Meeting of the American Society of Hematology in Orlando, Florida, indicate that ARRY-520 was well tolerated and has shown encouraging preliminary results in the treatment of multiple myeloma.

6 Dec 2010

First patient dosed with rFVIIIFc in A-LONG trial

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient has been dosed with the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.

6 Dec 2010

Alexion Pharmaceuticals reports interim results from phase 1 trial on samalizumab antibody

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced the presentation of interim results from the first Phase I/II trial of samalizumab, the company's investigational, first-in-class humanized monoclonal antibody.

6 Dec 2010

Pharmacokinetics News and Research

Further Reading

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

VistaGen reports successful completion of AV-101 Phase 1 safety study for neuropathic pain

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

Alnylam Pharmaceuticals progress in delivery and translation of RNAi therapeutics

Ocera completes two studies of OCR-002 in patients with hyperammonemia, hepatic encephalopathy

Abbott initiates ABT-806 Phase 1 trial in EGFR expressing tumors

Tolerx commences TRX518 Phase 1 trial in malignant melanoma

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

Positive data from Celator's CPX-351 Phase 2 study in newly-diagnosed AML presented at 52nd ASH

GlycoMimetics highlights clinical, preclinical progress of GMI-1070 in sickle cell crisis at ASH 2010

Global phase III study to provide novel extended release of topiramate

rVWF safe in patients with type 3 and severe type 1 von Willebrand disease, suggests interim study data

Phase 1 clinical data: ARRY-520 shows positive preliminary results in treating multiple myeloma

First patient dosed with rFVIIIFc in A-LONG trial

Alexion Pharmaceuticals reports interim results from phase 1 trial on samalizumab antibody

Industry Focus - Biopharma eBook

How can microdialysis benefit drug development

Global and Local Efforts to Take Action Against Hepatitis

Addressing Important Cardiac Biology Questions with Shotgun Top-Down Proteomics

Latest News