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.

First patient treated in Phase Ib expansion study of CUDC-101

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers.

3 Aug 2010

FDA approves N30 Pharma's NDA for N6022 GSNOR

N30 Pharmaceuticals, LLC today announced the approval of its Investigational New Drug Application for N6022 by the U.S. Food and Drug Administration. N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR), has the potential to be an important new treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD).

3 Aug 2010

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin Pharmaceutical Inc. announced today an update in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Data reported in this announcement reflect preliminary results as of July 23, 2010. Complete top-line results are expected in the fourth quarter of 2010.

3 Aug 2010

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.

2 Aug 2010

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Bio-Path Holdings, Inc.,, a biotechnology company with drug development operations in Houston, Texas, announced today that the first patient has been dosed in a Phase I study of its cancer drug candidate, Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), in patients with Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL) or Myelodysplastic Syndrome (MDS).

30 Jul 2010

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

29 Jul 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010.

29 Jul 2010

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

Pharmacokinetics News and Research

Further Reading

First patient treated in Phase Ib expansion study of CUDC-101

FDA approves N30 Pharma's NDA for N6022 GSNOR

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

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

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