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.

Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

Halozyme Therapeutics, Inc. today announced the commencement of a Phase 1 clinical study that will assess the effects of three approved prandial (mealtime) insulin analogs administered with its proprietary rHuPH20 (PH20) hyaluronidase enzyme compared to each of the analogs alone. This randomized, three-way cross-over design, euglycemic clamp study will compare the postprandial pharmacokinetics (PK) and glucodynamics (GD) of the insulin analogs.

28 Sep 2009

MicroDose initiates Phase 1 clinical trial investigating the pharmacokinetics of atropine inhalation

MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has initiated a Phase I study at the University of Pittsburgh Medical Center with atropine sulfate delivered from the MicroDose proprietary dry powder inhaler (DPI). The study is a further step in the development program for an atropine inhaler to treat nerve agent poisoning in military and civil defense applications.

24 Sep 2009

Obesity can increase cancer incidence in leukemic children

Obesity is an important factor contributing to chemotherapy resistance and increasing relapse rates among children with leukemia, according to recent findings published online first in Cancer Research, a journal of the American Association for Cancer Research.

23 Sep 2009

BioMarin commences PEG-PAL Phase 2 clinical trial for phenylketonuria

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the first patient has initiated treatment in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Initial top-line results are expected in mid-2010.

23 Sep 2009

Vitae Pharmaceuticals initiates Phase 1 clinical trial of its novel cardiovascular agent

Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has initiated a Phase 1 clinical trial of its novel cardiovascular agent, VTP-27999.

21 Sep 2009

Provectus' Phase 2 clinical trial of PV-10 for metastatic melanoma complete

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical trial of PV-10 for metastatic melanoma. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma.

21 Sep 2009

Enzo Biochem and NEI join to conduct a human clinical trial of Enzo’s chronic autoimmune uveitis therapeutic

Enzo Biochem, Inc. (NYSE: ENZ), announced today that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Eye Institute, part of the National Institute of Health, to conduct a human clinical trial of Optiquel™, Enzo’s oral, proprietary therapeutic for chronic autoimmune uveitis.

21 Sep 2009

Anavex completes manufacturing of Alzheimer's disease drug ANAVEX 2-73 for its clinical trials

Anavex Life Sciences Corp., ("ANAVEX") (OTCBB: AVXL) today announced the completion of scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.

21 Sep 2009

PROLOR Biotech initiates Phase I clinical trial of its human growth hormone drug candidate

PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH) formerly Modigene Inc., today announced the initiation of a Phase I clinical trial of its long-acting human growth hormone drug candidate hGH-CTP.

21 Sep 2009

Lantheus commences Phase 1 study evaluating novel LMI1195 heart failure imaging agent

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced the initiation of a Phase 1 clinical study to assess the safety, dosimetry and tolerability of LMI1195, a novel F-18 small molecule tracer for imaging cardiac neuronal function, in healthy subjects, undergoing positron emission tomography (PET) imaging.

17 Sep 2009

KemPharm announces nomination of its second pipeline candidate

KemPharm, Inc. today announced the nomination of its second pipeline candidate, KP201, based on its proprietary ligand activated therapy (LAT) platform. KP201 is a new chemical entity (NCE) for the treatment of pain with the possibility of reduced abuse potential. KP201 joins lead candidate KP106, which is a novel prodrug candidate in development for ADHD.

16 Sep 2009

LEAD Therapeutics' LT-29 antibiotic effective against most common antibiotic resistant bacteria

LEAD Therapeutics, a privately held drug discovery company, announced the discovery of a novel antibiotic with potent activity against many of the most common antibiotic resistant bacteria.

16 Sep 2009

Optimer's North American phase 3 Fidaxomicin study results presented at the 49th ICAAC

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that new data highlighting fidaxomicin's (OPT-80) lower CDI recurrence rates and reduced risk of vancomycin-resistant enterococci (VRE) acquisition from Optimer's North American phase 3 study were presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.

16 Sep 2009

Pre-clinical studies of ID-12 orally-bioavailable inhibitor completes

ChemDiv Inc. of San Diego, and iDialog (Intellektualniy Dialog) of Yaroslavl, Russia, announced today the successful completion of a pre-clinical development and the subsequent nomination of ID-12 as lead clinical development candidate for the treatment of chronic hepatitis C. This novel small molecule orally-bioavailable inhibitor of hepatitis C virus (HCV) blocks early stage of viral infection.

16 Sep 2009

Lexicon initiates Phase 2 clinical trial of LX4211 in patients with type 2 diabetes mellitus

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced today that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus.

15 Sep 2009

Phase I results of Tobira's TBR-652 CCR5 antagonist for the treatment of HIV

Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced pharmacokinetic data and results from a double-blind, placebo-controlled, multiple-dose randomized study of TBR-652 in sixty healthy volunteers.

15 Sep 2009

Biotie Therapies commences clinical trial with its phosphodiesterase 4 inhibitor ELB353

Biotie has started a clinical trial with its phosphodiesterase 4 (PDE4) inhibitor ELB353, having received the prerequisite regulatory and ethical clearances for the clinical trial application.

14 Sep 2009

Phase 1 trial results of Achaogen's ACHN-490 announced at ICAAC meeting

Achaogen, a clinical stage biopharmaceutical company addressing the issue of multi-drug resistant bacterial infections through the discovery and development of innovative, broad-spectrum antibiotics, today announced the results of a Phase 1 trial and preclinical data on its lead drug candidate ACHN-490 at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting in San Francisco, CA.

14 Sep 2009

Altair announces positive Phase I results for AIR645 in treating asthma

Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced positive results from a phase I multiple dose safety and pharmacokinetic study of its lead product, once-weekly inhaled AIR645 in healthy adults and mild asthmatics.

14 Sep 2009

Phase 1 results of CTP-347 presented

Concert Pharmaceuticals, Inc. announced today the presentation of Phase 1 data on CTP-347, a deuterium-modified analog of paroxetine for the treatment of hot flashes. Concert presented the results during a poster session at the American College of Clinical Pharmacology’s 38th Annual Meeting.

14 Sep 2009

Pharmacokinetics News and Research

Further Reading

Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

MicroDose initiates Phase 1 clinical trial investigating the pharmacokinetics of atropine inhalation

Obesity can increase cancer incidence in leukemic children

BioMarin commences PEG-PAL Phase 2 clinical trial for phenylketonuria

Vitae Pharmaceuticals initiates Phase 1 clinical trial of its novel cardiovascular agent

Provectus' Phase 2 clinical trial of PV-10 for metastatic melanoma complete

Enzo Biochem and NEI join to conduct a human clinical trial of Enzo’s chronic autoimmune uveitis therapeutic

Anavex completes manufacturing of Alzheimer's disease drug ANAVEX 2-73 for its clinical trials

PROLOR Biotech initiates Phase I clinical trial of its human growth hormone drug candidate

Lantheus commences Phase 1 study evaluating novel LMI1195 heart failure imaging agent

KemPharm announces nomination of its second pipeline candidate

LEAD Therapeutics' LT-29 antibiotic effective against most common antibiotic resistant bacteria

Optimer's North American phase 3 Fidaxomicin study results presented at the 49th ICAAC

Pre-clinical studies of ID-12 orally-bioavailable inhibitor completes

Lexicon initiates Phase 2 clinical trial of LX4211 in patients with type 2 diabetes mellitus

Phase I results of Tobira's TBR-652 CCR5 antagonist for the treatment of HIV

Biotie Therapies commences clinical trial with its phosphodiesterase 4 inhibitor ELB353

Phase 1 trial results of Achaogen's ACHN-490 announced at ICAAC meeting

Altair announces positive Phase I results for AIR645 in treating asthma

Phase 1 results of CTP-347 presented

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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