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.

Pharmasset reports positive data from PSI-7977 and PSI-938 HCV clinical programs

Pharmasset, Inc., announced today positive data from interim analyses of two of its clinical programs: the HCV genotype 2 or 3 (GT2/3) arm of the PSI-7977 Phase 2b trial and the 14 day PSI-938 monotherapy cohort of the dual nucleotide study.

7 Jan 2011

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Anavex Life Sciences Corp. announced today that ANAVEX 2-73 has been named 2010's "most promising trial drug" by the editorial staff at Alzheimer's Weekly. The publication selected the ANAVEX 2-73 trial from a field of over 100 trials that treat dementias such as Alzheimer's and following the review of more than 10,000 articles.

7 Jan 2011

Nippon Kayaku begins apaziquone Phase 1 bladder cancer study in Japan

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the first patient has been dosed in Japan in a Nippon Kayaku sponsored Phase 1 study of apaziquone in bladder cancer.

7 Jan 2011

MacroGenics commences MGAH22 Phase I trail for patients with HER2-positive cancer

MacroGenics, a privately held biotechnology company that develops immunotherapeutics to treat autoimmune disorders, cancer and infectious diseases, today announced that it had administered drug to the first cohort of patients in a Phase I clinical trial of MGAH22.

6 Jan 2011

Positive topline results from ZGN-433 Phase 1b study in obesity patients

Zafgen, a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced positive topline results from its Phase 1b study of ZGN-433, a methionine aminopeptidase 2 inhibitor, for the treatment of severe obesity.

6 Jan 2011

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced that patient enrollment was recently completed in the company's Phase 1/2 clinical trial of ISV-303, a novel compound being developed to reduce the pain and inflammation associated with ocular surgery.

6 Jan 2011

SuperGen initiates enrollment in first human trial of SGI-110 in MDS and AML

SuperGen, Inc. today announced that it has enrolled the first patient in its first in human study of SGI-110, a second-generation hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML).

5 Jan 2011

Alnylam presents ALN-VSP Phase I trial results for liver cancer

Alnylam Pharmaceuticals, a leading RNAi therapeutics company, today presented new clinical data from its ALN-VSP Phase I liver cancer trial in a presentation at the Dana-Farber Cancer Institute in Boston. Results from molecular analysis of human biopsy samples showed achievement of pharmacologically relevant siRNA drug levels in tissues.

5 Jan 2011

Vaccinex receives FDA clearance to initiate VX15/2503 Phase 1 clinical trial in advanced solid tumors

Vaccinex, Inc. announced today that it has received clearance from FDA and will initiate a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of therapeutic antibody candidate VX15/2503 in cancer patients with advanced solid tumors.

5 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.

28 Dec 2010

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Transition Therapeutics Inc. today announced that the Company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.

27 Dec 2010

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Clinical Data, Inc., today announced that Santen Pharmaceutical Co., Ltd., has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data's highly selective adenosine A2A agonist, ATL313, for the indication of primary open angle glaucoma and ocular hypertension.

From Santen Pharmaceutical Co., Ltd. 23 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Anavex Life Sciences Corp. announced today that it has filed the regulatory submission for ANAVEX 2-73 with the German Health Authority, BfArM, and the local Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.

21 Dec 2010

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Ambit Biosciences, today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.

20 Dec 2010

VistaGen reports successful completion of AV-101 Phase 1 safety study for neuropathic pain

VistaGen Therapeutics, Inc., a stem cell technology company focused on drug discovery and development, today announced the successful completion of its initial Phase 1 safety study of AV-101, the Company's novel orally available prodrug candidate for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S.

20 Dec 2010

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

Icagen, Inc. today provided an update on its sodium channel program for pain and related disorders, which is being conducted in collaboration with Pfizer. As previously reported, the companies recently selected a candidate compound to advance into further clinical studies. Dosing of this candidate compound has now been initiated in a Phase I study in healthy volunteers.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

Alnylam Pharmaceuticals progress in delivery and translation of RNAi therapeutics

Alnylam Pharmaceuticals, a leading RNAi therapeutics company, presented new data at the 2010 International Chemical Congress of Pacific Basin Societies, being held in Honolulu, Hawaii, December 15-20.

17 Dec 2010

Pharmacokinetics News and Research

Further Reading

Pharmasset reports positive data from PSI-7977 and PSI-938 HCV clinical programs

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Nippon Kayaku begins apaziquone Phase 1 bladder cancer study in Japan

MacroGenics commences MGAH22 Phase I trail for patients with HER2-positive cancer

Positive topline results from ZGN-433 Phase 1b study in obesity patients

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

SuperGen initiates enrollment in first human trial of SGI-110 in MDS and AML

Alnylam presents ALN-VSP Phase I trial results for liver cancer

Vaccinex receives FDA clearance to initiate VX15/2503 Phase 1 clinical trial in advanced solid tumors

FDA approves 200 mg formulation of INTELENCE for HIV-1

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

VistaGen reports successful completion of AV-101 Phase 1 safety study for neuropathic pain

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

Alnylam Pharmaceuticals progress in delivery and translation of RNAi therapeutics

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