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.

Clinical Pharmacokinetics Research Laboratory deploys AB SCIEX mass spectrometry technology

AB SCIEX, a global leader in life science analytical technologies, today announced that the Clinical Pharmacokinetics Research Laboratory at the University of Rhode Island's College of Pharmacy is using AB SCIEX mass spectrometry technology to develop a novel test that would enable clinical researchers to use saliva to monitor immunosuppressant drugs commonly administered to make organ transplants successful.

28 Jul 2010

Pharmasset announces data from PSI-352938 single ascending dose study

Pharmasset, Inc. announced today that safety and pharmacokinetic data from the PSI-352938 single ascending dose study support progression to a multiple ascending dose trial with PSI-938, which has initiated dosing. PSI-938 is a guanine nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus infection.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Compound Management & Integrity conference to address challenges in improvement methodologies

An efficient and versatile compound management operation is essential for the success of all downstream processes in high throughput screening (HTS) and small molecule development. The 6th Compound Management & Integrity conference taking place September 20 - 22, 2010 will address issues concerned with improving both strategic and tactical aspects of compound management.

27 Jul 2010

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Merrimack Pharmaceuticals, Inc. and sanofi-aventis announced today that the first patient has received an initial dose in a Phase 2 randomized double blind clinical study combining MM-121 with exemestane (Aromasin®) in breast cancer patients.

22 Jul 2010

AMRI initiates enrollment for Phase I study of ALB-127158 for obesity

AMRI has commenced enrollment for a Phase I study of ALB-127158(a), a novel MCH1 receptor antagonist offering a potential new approach for the treatment of obesity. The announcement was made yesterday during a presentation by AMRI's Dr. Peter Guzzo, director, discovery research and development, at the 6th Obesity and Diabetes Drug Development Summit in Arlington, VA. Preclinical data were also reported.

21 Jul 2010

PROLOR Biotech initiates Phase II clinical trial of biobetter version of human growth hormone

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced initiation of a Phase II clinical trial of hGH-CTP, the company's proprietary biobetter version of human growth hormone (hGH).

21 Jul 2010

Seattle Genetics, Agensys commence ASG-5ME ADC phase I clinical trial for metastatic pancreatic cancer

Seattle Genetics, Inc. and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.

20 Jul 2010

Geron commences enrollment in imetelstat Phase 2 clinical trial for NSCLC

Geron Corporation today announced enrollment of the first patient in a randomized Phase 2 clinical trial of its telomerase inhibitor drug, imetelstat (GRN163L), as maintenance therapy following platinum-based induction therapy for patients with non-small cell lung cancer (NSCLC).

19 Jul 2010

ArmaGen uses BBB molecular Trojan horse platform technology to create brain penetrating form of human EPO

Human erythropoietin (EPO) is a potent neuroprotective agent for multiple brain disorders, including stroke, brain and spinal cord injury, and Parkinson's disease. However, EPO drug development for the brain is limited, because EPO does not cross the blood-brain barrier (BBB). In acute stroke or brain injury, the BBB is intact in the early hours after the insult when neuroprotection is still possible. Therefore, large molecule biopharmaceuticals such as EPO must be re-engineered to enable BBB transport.

17 Jul 2010

Simulations Plus third-quarter consolidated revenues increase 14.9% to record $3.1 million

Simulations Plus, Inc., a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its third quarter of fiscal year 2010 ended May 31, 2010 (3QFY10).

17 Jul 2010

QR Pharma to present positive clinical data from mechanism of action study in MCI at ICAD 2010

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), is presenting a poster today on positive clinical data from its recent mechanism of action study in mild cognitive impaired (MCI) patients at the International Congress on Alzheimer's Disease (ICAD 2010).

15 Jul 2010

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

BioInvent reached an important milestone when the results of a phase II trial of TB-402 following orthopaedic surgery, were reported in May. The data showed that TB-402 is statistically better at preventing thrombosis than enoxaparin, the current standard treatment. Supported by these good results, BioInvent and the company's partner, ThromboGenics, will now prioritise securing a development partner for the programme to ensure that the necessary resources is in place to take the product candidate to the market.

14 Jul 2010

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber model of allergic rhinitis caused by natural exposure to seasonal allergens.

14 Jul 2010

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Florbetaben PET tracer data to be presented at Alzheimer's Association ICAD 2010

Bayer HealthCare Pharmaceuticals, Inc. today announced that data on the company's investigational PET amyloid imaging tracer Florbetaben (BAY 94-9172) will be presented at the Alzheimer's Association International Conference on Alzheimer's Disease 2010 in Honolulu July 10 – 15.

9 Jul 2010

Data shows potential health benefits of S-equol in relieving menopausal symptoms

The findings of a scientific conference examining the growing body of research and potential health benefits of S-equol were published this month in the Journal of Nutrition. Manuscripts based on presentations made at the conference, which was organized by the Life Sciences Research Office, reveal data that S-equol is a safe, natural and effective solution to providing relief of menopausal symptoms such as hot flashes and muscle discomfort.

9 Jul 2010

Pharmacokinetics News and Research

Further Reading

Clinical Pharmacokinetics Research Laboratory deploys AB SCIEX mass spectrometry technology

Pharmasset announces data from PSI-352938 single ascending dose study

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Compound Management & Integrity conference to address challenges in improvement methodologies

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

AMRI initiates enrollment for Phase I study of ALB-127158 for obesity

PROLOR Biotech initiates Phase II clinical trial of biobetter version of human growth hormone

Seattle Genetics, Agensys commence ASG-5ME ADC phase I clinical trial for metastatic pancreatic cancer

Geron commences enrollment in imetelstat Phase 2 clinical trial for NSCLC

ArmaGen uses BBB molecular Trojan horse platform technology to create brain penetrating form of human EPO

Simulations Plus third-quarter consolidated revenues increase 14.9% to record $3.1 million

QR Pharma to present positive clinical data from mechanism of action study in MCI at ICAD 2010

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Florbetaben PET tracer data to be presented at Alzheimer's Association ICAD 2010

Data shows potential health benefits of S-equol in relieving menopausal symptoms

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