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.

Phase I study of Affinium Pharmaceuticals' AFN-1252 for MRSA initiated

Affinium Pharmaceuticals announced today the commencement of a Phase I study in the United States for its novel molecular entity, AFN-1252, a first in class antibiotic candidate focused on the oral and IV treatment of susceptible and highly resistant strains of Staphylococcus aureus.

12 Apr 2010

Cempra to make poster presentations on CEM-101 and CEM-102 at ECCMID 2010

Cempra Pharmaceuticals today announced poster presentations on its novel antibiotic CEM-101, a next-generation macrolide, and CEM-102, the company's proprietary front-loading oral dosing regimen of sodium fusidate, at the 20th European Congress of Clinical Microbiology and Infectious Disease, April 10 to 13, 2010, in Vienna Austria.

12 Apr 2010

AED Vimpat to be the subject of numerous studies and analyses at AAN meeting

The antiepileptic drug Vimpat- (lacosamide) (C-V) will be the subject of numerous studies and analyses-both UCB-sponsored and independent-at the 62nd annual American Academy of Neurology meeting, taking place at the Metro Toronto Convention Centre in Toronto from April 10-17.

9 Apr 2010

Cempra Pharmaceuticals announces schedule of poster presentations at ECCMID 2010

Cempra Pharmaceuticals today announced its schedule of poster presentations at the 20th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna, Austria, on April 10-13, 2010.

8 Apr 2010

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

MAP Pharmaceuticals, Inc. today announced that the Company initiated a pharmacodynamics (PD) trial to compare the acute effect of LEVADEX™ orally inhaled migraine therapy to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure as measured by echocardiography.

8 Apr 2010

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Genta Incorporated today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

7 Apr 2010

Request for lift of full clinical hold on Proellex program

Repros Therapeutics Inc. today announced that the Company has requested a lift of the full clinical hold on its oral drug Proellex® being developed for the treatment of uterine fibroids and endometriosis. On August 4, 2009, the FDA noted that further testing of Proellex® was placed on full clinical hold due to findings of serious adverse events associated with liver toxicity.

5 Apr 2010

Cellvax moves to new laboratory facility in ENVA

Cellvax is a French service company which provides complete in vitro & in vivo preclinical innovating services allowing to accelerate the drug development process for unmet needs related with severe human diseases, mainly in oncology field.

3 Apr 2010

BELLUS Health initiates Phase I clinical study for NRM8499

BELLUS Health Inc. announced today that, on March 30, 2010, the Company initiated a Phase I clinical study for NRM8499, a prodrug of tramiprosate. NRM8499 is intended for the treatment of Alzheimer's disease.

1 Apr 2010

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

Genta Incorporated today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company's newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development.

31 Mar 2010

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

PolyMedix, Inc., an emerging bio-technology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B clinical study with its novel defensin-mimetic antibiotic, PMX-30063. The data from the study demonstrate that administration of multiple doses of PMX-30063 are safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the study.

31 Mar 2010

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

QRxPharma announced today initiation of the Company's first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo®CR. MoxDuo®CR contains a fixed 3:2 morphine:oxycodone combination and is intended to be dosed twice daily in patients experiencing chronic pain, an approximately US$7 billion dollar market worldwide.

31 Mar 2010

Research challenges current thinking about TB bacterium

Two new tuberculosis studies by UT Southwestern Medical Center researchers provide good news and bad news about the bacterium that infects nearly a third of the world's population and a disease that kills nearly 2 million people each year.

30 Mar 2010

Enobia Pharma unveils findings from first HPP self-reported patient survey at ACMG 2010

Enobia Pharma Inc. unveiled findings from the first hypophosphatasia self-reported patient survey intended to evaluate the burden of illness associated with HPP at the 2010 American College of Medical Genetics Annual Clinical Genetics Meeting.

30 Mar 2010

Trius Therapeutics' Phase 1 trial establishes safety and tolerability of IV torezolid phosphate for MRSA

Trius Therapeutics, Inc. today announced results from its Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of the intravenous (IV) dosage form of torezolid phosphate, an IV and orally administered second generation oxazolidinone for the treatment of serious gram positive infections, including methicillin-resistant Staphylococcus aureus (MRSA).

30 Mar 2010

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Ligand Pharmaceuticals Incorporated today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers.

29 Mar 2010

Positive results from Pearl Therapeutics' Phase 1 study of inhaled combination bronchodilator for COPD

Pearl Therapeutics Inc., a company developing clinically differentiated combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from a Phase 1 safety and pharmacokinetics study of PT003, its lead combination therapeutic for the treatment of chronic obstructive pulmonary disease (COPD). Based on these results, and previously announced positive results from Phase 2a studies of PT003's individual components, the company has advanced PT003 into a Phase 2b trial.

29 Mar 2010

Genta reports net loss of $11.7M for fourth-quarter 2009

Genta Incorporated today reported results for the quarter and year ended December 31, 2009. The Company also provided an overview of recent corporate highlights and anticipated milestones.

29 Mar 2010

DARA BioSciences announces the initiation of Phase I clinical study for DB959

DARA BioSciences, Inc. announced that it has initiated a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

Pharmacokinetics News and Research

Further Reading

Phase I study of Affinium Pharmaceuticals' AFN-1252 for MRSA initiated

Cempra to make poster presentations on CEM-101 and CEM-102 at ECCMID 2010

AED Vimpat to be the subject of numerous studies and analyses at AAN meeting

Cempra Pharmaceuticals announces schedule of poster presentations at ECCMID 2010

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Request for lift of full clinical hold on Proellex program

Cellvax moves to new laboratory facility in ENVA

BELLUS Health initiates Phase I clinical study for NRM8499

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

Research challenges current thinking about TB bacterium

Enobia Pharma unveils findings from first HPP self-reported patient survey at ACMG 2010

Trius Therapeutics' Phase 1 trial establishes safety and tolerability of IV torezolid phosphate for MRSA

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Positive results from Pearl Therapeutics' Phase 1 study of inhaled combination bronchodilator for COPD

Genta reports net loss of $11.7M for fourth-quarter 2009

DARA BioSciences announces the initiation of Phase I clinical study for DB959

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

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Expanding research and clinical options for children with cancer

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