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.

ASHP honors First DataBank pharmacist with the title of Fellow for excellence in pharmacy practice

First DataBank, a leading provider of drug databases that help drive patient safety, today announced that the American Association of Health-System Pharmacists will honor First DataBank pharmacist Joan Kapusnik-Uner, Pharm.D, with the title of "Fellow" in recognition of the excellence she has achieved in pharmacy practice. The 2010 Fellows will be honored on Tuesday, June 8, 2010, during the ASHP Summer Meeting in Tampa, FL.

7 Jun 2010

Array BioPharma presents positive Phase 1 clinical data of ARRY-520 KSP inhibitor for multiple myeloma

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

7 Jun 2010

Incyte presents additional results from INCB7839 Phase I/II trial for HER2-positive metastatic breast cancer

Incyte Corporation announced today additional positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 66 patients with HER2-positive metastatic breast cancer during a poster session at the American Society of Clinical Oncology (ASCO) meeting in Chicago, IL, June 4 to June 8, 2010.

7 Jun 2010

Positive results from Phase 2, open-label ENCORE 303 trial to be presented at ASCO 2010

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, reported final results from the Phase 2, open-label ENCORE 303 trial in post-menopausal women with advanced, estrogen receptor positive breast cancer who were progressing on aromatase inhibitor therapy.

5 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

Morria Biopharmaceuticals to present Phase II study results of MRX-4 at EAACI Congress

Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on novel, anti-inflammatory drugs, announced today that it will be presenting the results from its ICH compliant Phase II study of MRX-4>th EAACI Congress in London on June 7th. The results will be presented by the study's principal investigator Prof. Eric Bateman.

4 Jun 2010

Onyx Pharmaceuticals commences Phase 1 study of ONX 0912 oral proteasome inhibitor for cancer

Onyx Pharmaceuticals, Inc. today announced the initiation of a Phase 1 study of ONX 0912, an oral proteasome inhibitor, in patients with advanced refractory or recurrent solid tumors.

2 Jun 2010

Enrollment and dosing in NeuroDerm's Phase I clinical trial of ND0611 completed

NeuroDerm, Ltd. announced today the successful enrollment and dosing in its Phase I clinical trial of ND0611. ND0611, a proprietary drug formula administered via a dermal patch, is designed to maintain continuous therapeutic levodopa concentrations for improving the treatment of Parkinson's disease.

1 Jun 2010

PBI awarded contract to provide essential laboratory data for Phase I cardiovascular trial

Pacific Biomarkers, Inc. has been awarded a contract by a leading multinational pharmaceutical company to provide essential laboratory data for an adaptive Phase I cardiovascular trial. This study is part of a major drug-development program to evaluate an innovative new treatment to reduce recurrent cardiovascular events associated with acute coronary syndrome.

27 May 2010

Cytochroma reports positive Phase 1/2 results for CTAP101 Capsules in non-dialysis CKD patients

Cytochroma today announced positive Phase 1/2 results for CTAP101 Capsules, a product being developed to treat secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency in non-dialysis chronic kidney disease (CKD) patients. The study demonstrated that a single dose of CTAP101 Capsules was safe, effective and well tolerated.

25 May 2010

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology, to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.

25 May 2010

Phase 1 clinical trial of OXY111A initiated

NormOxys Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body's ability to deliver oxygen to diseased tissues, today announced that it has initiated a Phase 1 clinical trial of OXY111A, a novel allosteric modulator of affinity of oxygen to hemoglobin. NormOxys plans to initially develop this compound as a treatment for chronic heart failure and cancer indications.

24 May 2010

KaloBios Pharmaceuticals' KB001 promising in prevention of serious lung infection

The data from the initial clinical studies with KB001, a novel antibody fragment against PcrV on Pseudomonas aeruginosa (Pa) bioengineered by KaloBios Pharmaceuticals, Inc. and partnered with sanofi pasteur, demonstrated promising therapeutic activity in the prevention of serious lung infection in mechanically ventilated patients colonized with the bacterium and in limiting potentially damaging inflammation in patients with cystic fibrosis, where Pa plays an important role in the disease.

18 May 2010

Cerenis' CER-001 Phase 1 study data supports continued clinical development for acute coronary syndromes

Cerenis Therapeutics, a biopharmaceutical company focused on discovering and developing novel HDL therapies, today announced the completion of a Phase 1 study of the Company's CER-001 investigational product candidate to treat patients with acute coronary syndromes. Results of the completed study provide evidence that the investigational therapy was safe and well-tolerated at all dose levels evaluated, including those intended for future clinical development.

18 May 2010

MorphoSys AG (DE) - AbD Serotec enters new growth area

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its research and diagnostic antibody unit AbD Serotec is active in a new growth area.

18 May 2010

Emisphere Technologies first-quarter net loss increases to $18.5 million

Emisphere Technologies, Inc. today announced its financial results for the first quarter 2010.

17 May 2010

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Emergent BioSolutions Inc. announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.

17 May 2010

Inhibitex reports net loss of $4.8M for first-quarter 2010

Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.

14 May 2010

Chimerix commences first-in-human study of CMX157 for HIV

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced the commencement of a first-in-human study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV). CMX157 has the potential to increase efficacy and decrease toxicity as compared to tenofovir, and may enable the creation of new 'one pill, once-a-day', fixed-dose combination regimens for the treatment of HIV infection.

14 May 2010

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Repligen Corporation announced today that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for a Phase 1 study of RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor. This is a double-blind, single ascending dose, Phase 1 study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects.

13 May 2010

Pharmacokinetics News and Research

Further Reading

ASHP honors First DataBank pharmacist with the title of Fellow for excellence in pharmacy practice

Array BioPharma presents positive Phase 1 clinical data of ARRY-520 KSP inhibitor for multiple myeloma

Incyte presents additional results from INCB7839 Phase I/II trial for HER2-positive metastatic breast cancer

Positive results from Phase 2, open-label ENCORE 303 trial to be presented at ASCO 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Morria Biopharmaceuticals to present Phase II study results of MRX-4 at EAACI Congress

Onyx Pharmaceuticals commences Phase 1 study of ONX 0912 oral proteasome inhibitor for cancer

Enrollment and dosing in NeuroDerm's Phase I clinical trial of ND0611 completed

PBI awarded contract to provide essential laboratory data for Phase I cardiovascular trial

Cytochroma reports positive Phase 1/2 results for CTAP101 Capsules in non-dialysis CKD patients

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

Phase 1 clinical trial of OXY111A initiated

KaloBios Pharmaceuticals' KB001 promising in prevention of serious lung infection

Cerenis' CER-001 Phase 1 study data supports continued clinical development for acute coronary syndromes

MorphoSys AG (DE) - AbD Serotec enters new growth area

Emisphere Technologies first-quarter net loss increases to $18.5 million

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Inhibitex reports net loss of $4.8M for first-quarter 2010

Chimerix commences first-in-human study of CMX157 for HIV

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

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