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.

Paloma Pharmaceuticals receives FDA approval to enter Phase I studies with P529

Paloma Pharmaceuticals, Inc. announced today that it has received acceptance of its IND to enter Phase I studies with Palomid 529 (P529) in patients with age-related macular degeneration (AMD).

5 Feb 2010

"Knowledge deficit" about methadone responsible for resulting deaths

In a unique and comprehensive literature review of poisoning deaths involving opioids from 1999 -- 2009, the deaths involving methadone were found to be disproportionately high. Methadone represented less than five percent of all opioid prescriptions but is responsible for a third of the deaths. After four years of investigation, the major underlying cause was found to be fundamental misunderstandings about the properties of the medicine -- a "knowledge deficit" -- especially when converting patients from other opioids.

4 Feb 2010

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Seattle Genetics, Inc. and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma.

4 Feb 2010

Study: Generic nifedipine product not bioequivalent to Adalat XL

An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.

4 Feb 2010

Positive results from Phosphagenics' TPM Phase 1B clinical study for transdermal delivery of oxycodone

Phosphagenics Limited today announced positive results from a Phase 1B clinical study using the Company’s patented TPM™ (Targeted Penetration Matrix) for the transdermal delivery of oxycodone. The results of the successful trial demonstrate that daily application of a TPM™ patch delivers therapeutic levels of oxycodone into the blood stream in a reproducible, consistent and sustained manner.

2 Feb 2010

TOPICA's IND for onychomycosis antifungal agent accepted by FDA

TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for the use of luliconazole, its lead product candidate, in patients with onychomycosis (nail and nail bed fungal infections).

1 Feb 2010

Lanzoprazole and astemizole hold promise for early detection of AD

Investigators from the International Center for Biomedicine and the University of Chile, in collaboration with the Center for Bioinformatics of the Universidad de Talca, have discovered that two drugs, the benzimidazole derivatives lanzoprazole and astemizole, may be suitable for use as PET (positron emission tomography) radiotracers and enable imaging for the early detection of Alzheimer's Disease. The study is published in the current issue of the Journal of Alzheimer's Disease.

30 Jan 2010

GenSpera commences treatment in G-202 Phase I trial for solid tumors

GenSpera, Inc. announced that the first patient was treated in the Phase I clinical study of its cancer chemotherapeutic agent, G-202, at the University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. The trial is also being conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.

27 Jan 2010

USAN approves generic name "ulimorelin" for Tranzyme Pharma's TZP-101

Tranzyme Pharma today announced that the United States Adopted Name Council (USAN) has approved the generic name “ulimorelin” for Tranzyme’s novel, late-stage, prokinetic agent TZP-101. Ulimorelin, if approved, is expected to be a first-in-class drug for the treatment of gastrointestinal (GI) dysmotility indications in acute care (hospital-based) settings.

27 Jan 2010

Eating green leafy vegetables could reverse the effects of aflatoxin poisoning

Not only are the vitamins and minerals good for you, but eating greens could also save your life, according to a recent study led by the National Nuclear Security Administration's Lawrence Livermore National Laboratory scientists.

27 Jan 2010

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies’ long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

25 Jan 2010

Dosing in First-in-Man Phase I study of 4SC AG's 4SC-203 commenced

4SC AG, a drug discovery and development company, today announced the start of dosing in a First-in-Man Phase I study in healthy volunteers evaluating 4SC-203, a novel multi-target kinase inhibitor, with particular specificity against selected kinases, including FMS-like tyrosine kinase 3 (FLT3), FLT3 mutants and vascular endothelial growth factor receptors (VEGF-R).

21 Jan 2010

PROLOR Biotech's hGH-CTP Phase I study data to be presented at the BIO CEO & Investor Conference

PROLOR Biotech, Inc., today announced that final data from a randomized, dose-escalating Phase I clinical study of its longer-acting version of human growth hormone (hGH-CTP) will be featured in an oral presentation by PROLOR management at the 12th Annual BIO CEO & Investor Conference to be held at the Waldorf-Astoria Hotel in New York City on February 8-9, 2010.

20 Jan 2010

PTC Therapeutics initiates additional clinical trial of ataluren in boys and young men with nmDBMD

PTC Therapeutics, Inc. (PTC) today announced the initiation of an additional clinical trial of ataluren (PTC124®) in boys and young men with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD) who have permanently lost the ability to walk independently.

20 Jan 2010

Fc engineering enhances antibody half-life

A Nature Biotechnology article published online January 17 reveals that Xencor Inc.’s proprietary Fc engineering extends the half-life of antibodies while maintaining their potency and extending duration of action. These results, published in an article entitled, “Enhanced antibody half-life improves in vivo activity” demonstrate the potential of Fc engineering to impact the flexibility of route, schedule and dose for nearly any antibody.

20 Jan 2010

DURECT commences dosing in its POSIDUR Phase III clinical trial

DURECT Corporation announced today that it has begun dosing patients in its U.S. pivotal Phase III clinical trial to evaluate POSIDUR™ (SABER™-Bupivacaine), an investigational drug, for the treatment of post-surgical pain. The pivotal trial, referred to as BESST (Bupivacaine Effectiveness and Safety in SABER Trial), is an international, multi-center, randomized, double-blind, controlled trial evaluating the safety, efficacy, effectiveness, and pharmacokinetics of POSIDUR in patients undergoing general surgical procedures.

19 Jan 2010

PCI Biotech AS completes second dose group in phase I/II study of Amphinex

PCI Biotech AS ( PCIB.OL) reported today that it has completed the successful treatment of the second dose group in the phase I/II study of its proprietary photosensitiser Amphinex® used in combination with the cytotoxic agent bleomycin in cancer patients.

19 Jan 2010

New clinical study: CeNeRx BioPharma's CXB722 has potential as novel anxiolytic

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today reported that a new clinical study shows that its investigational compound CXB722 has potential as a novel anxiolytic, demonstrating a significant effect on both endocrine and cardiovascular biomarkers associated with stress.

13 Jan 2010

Cytheris commences enrollment in its recombinant human Interleukin-7 INSPIRE 2 program for HIV

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in INSPIRE 2, a Phase IIa clinical program evaluating the company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non Responders (INR) after at least 12 months of highly active anti-retroviral therapy (HAART).

12 Jan 2010

Idenix Pharmaceuticals announces significant progress in HCV development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced significant progress in three HCV programs

12 Jan 2010