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.

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

Pharnext receives French approval for Pleodrug Phase II clinical trial in Charcot-Marie Tooth disease type 1A

Pharnext SAS, a biopharmaceutical company specializing in the development of innovative treatments for severe neurological diseases and other major unmet medical needs, today announced that the French Agency for Healthcare Product Safety (AFSSAPS) has authorized a Phase II clinical trial with the first drug (a Pleodrug™) generated by the company's Pleotherapy™ technology platform in patients suffering from Charcot-Marie Tooth disease type 1A (CMT1A.

4 Dec 2010

SuperGen to present SGI-110 data for MDS, AML at ASH annual meeting

SuperGen, Inc. today announced that a summary of preclinical efficacy, safety, and pharmacokinetics data of SGI-110 will be presented at the American Society of Hematology in Orlando on Saturday, December 4, 2010 at 5:30 pm ET.

3 Dec 2010

FDA accepts IND application to initiate human clinical trial to evaluate BNC

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).

3 Dec 2010

SAGE launches two new journals in Drug Safety, Hematology

SAGE Expands Therapeutic Advances series by launching two new journals in Drug Safety and Hematology. SAGE has extended its suite of Therapeutic Advances journals with the launch of a further two titles: Therapeutic Advances in Drug Safety, and Therapeutic Advances in Hematology.

3 Dec 2010

Geron commences enrollment in imetelstat Phase 2 clinical trial for metastatic breast cancer

Geron Corporation today announced enrollment of the first patient in a randomized Phase 2 clinical trial of its telomerase inhibitor drug, imetelstat (GRN163L), in combination with paclitaxel (with or without bevacizumab) in patients with locally recurrent or metastatic breast cancer.

3 Dec 2010

Advinus collaborates with Corning to bring Epic technology to India

Advinus Therapeutics, the research-based pharmaceutical company promoted by the TATA Group, and Corning Incorporated today announced a collaboration to bring Corning Epic label-free detection technology to India.

2 Dec 2010

CytRx commences tamibarotene Phase 2b clinical trial in NSCLC

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that it is initiating a multicenter Phase 2b clinical trial with its oncology drug candidate tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC).

2 Dec 2010

Pfizer to present data on hematology portfolio at ASH Annual Meeting

Pfizer said today that new data on investigational compounds in its hematology portfolio will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, December 4-7.

1 Dec 2010

Pharmacokinetics News and Research

Further Reading

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

Pharnext receives French approval for Pleodrug Phase II clinical trial in Charcot-Marie Tooth disease type 1A

SuperGen to present SGI-110 data for MDS, AML at ASH annual meeting

FDA accepts IND application to initiate human clinical trial to evaluate BNC

SAGE launches two new journals in Drug Safety, Hematology

Geron commences enrollment in imetelstat Phase 2 clinical trial for metastatic breast cancer

Advinus collaborates with Corning to bring Epic technology to India

CytRx commences tamibarotene Phase 2b clinical trial in NSCLC

Pfizer to present data on hematology portfolio at ASH Annual Meeting

Industry Focus - Biopharma eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

Latest News