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.

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease initiated

GlycoMimetics, Inc., a clinical-stage biotechnology company developing a new class of glycobiology-based therapies for a broad range of indications, today announced the commencement of a Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease. The company also announced that GMI-1070 has received Fast Track designation from the U.S. Food and Drug Administration.

25 Jun 2010

Nektar commences dosing in Phase 1 study of NKTR-102 in combination with 5-FU/leucovorin

Nektar Therapeutics announced today that the first patients have been dosed in a new Phase 1 dose-escalation clinical study to evaluate NKTR-102, the company's lead oncology compound, in combination with 5-fluorouracil (5-FU)/leucovorin in refractory solid tumor cancers. The study is being conducted at University Hospitals Case Medical Center of the Case Comprehensive Cancer Center in Cleveland, Ohio.

24 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

$Phase 1 clinical trial of XMT-1107 initiated in patients with refractory advanced solid tumors$

Phase 1 clinical trial of XMT-1107 initiated in patients with refractory advanced solid tumors

Mersana Therapeutics, a platform-based cancer therapeutics company, today announced that it has initiated a Phase 1 clinical trial to study the safety and pharmacokinetics of XMT-1107 in patients with refractory advanced solid tumors. XMT-1107 is a novel anti-angiogenic fumagillin analog that employs Mersana's Fleximer platform. Mersana's XMT-1001, a conjugate of Fleximer and camptothecin, is currently completing a Phase 1 study.

23 Jun 2010

Enobia reports positive interim data from ENB-0040 enzyme replacement therapy study for children with HPP

Enobia Pharma today announced positive interim data from a clinical study of ENB-0040, a bone targeted enzyme replacement therapy, under investigation for the treatment of hypophosphatasia (HPP). After 12 weeks of treatment with ENB-0040, children with HPP showed marked improvements in bone mineralization and function including increases in strength, endurance and mobility and reduction in pain. These findings were presented by Dr. Michael Whyte at ENDO 2010, the 92nd Annual Meeting of The Endocrine Society.

22 Jun 2010

Celator announces expansion of research agreement with Cephalon

Celator Pharmaceuticals today announced that it has expanded its research agreement with Cephalon, Inc.. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

22 Jun 2010

Sinapis initiates dosing in Phase I trial of intravenous infusion of methamphetamine

Sinapis Pharma, Inc. announces that its first patients were dosed in a Phase I clinical trial study on June 14, 2010. This study, in human volunteers, is designed to evaluate the safety, pharmacokinetics, and absolute bioavailability of an intravenous infusion of methamphetamine. The first cohort, investigating shorter infusion times, went well. Future cohorts will evaluate longer infusion times and higher drug doses.

21 Jun 2010

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Ardea Biosciences, Inc. announced that additional positive data from its Phase 2 program for RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, are being presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy. RDEA594, a first-in-class selective inhibitor of the URAT1 transporter, treats the underlying cause of gout by increasing the excretion of uric acid in order to bring the body's levels of uric acid into a normal range.

18 Jun 2010

First patient dosed in AR-42 Phase I/IIa clinical study at OSUCCC-James in adult patients with blood cancer

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in an investigator sponsored Phase I/IIa clinical study of AR-42 (formerly OSU-HDAC42) at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) in adult patients with relapsed or refractory multiple myeloma (MM), chronic lymphocytic leukemia (CLL) or lymphoma.

18 Jun 2010

FerroKin BioSciences announces closing of $12M financing

FerroKin BioSciences, a biotechnology company developing a new therapy for the treatment of iron overload, today announced the closing of a $12 million financing. Participants in the financing include current investors Burrill & Company, Celgene Corporation, Clarus Ventures and MP Healthcare Venture Management, Inc., with Healthcap Ventures of Stockholm participating as a new investor.

18 Jun 2010

Positive results from Phase I clinical trial of GLYX-13 presented at NCDEU meeting

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, today reported that it presented data at the NCDEU 50th Anniversary Meeting showing that its novel mechanism compound GLYX-13 appeared safe in a Phase I trial. GLYX-13 is a glycine site functional partial agonist selective modulator of the NMDA receptor that is being developed initially for use in depression as adjunctive therapy.

17 Jun 2010

Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on novel, anti-inflammatory drugs, announced today the results from its ICH compliant Phase II study of MRX-4>th EAACI Congress in London. The study's principal investigators were Drs. Eric Bateman, Mary Bateman and Paul Potter.

16 Jun 2010

Immunomedics initiates dosing in milatuzumab-doxorubicin conjugate Phase I/II trial for relapsed multiple myeloma

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the dosing of the first patient in a Phase I/II clinical trial of the doxorubicin conjugate of milatuzumab for the treatment of patients with relapsed multiple myeloma.

16 Jun 2010

Anacor's AN3365 novel systemic antibiotic achieves proof of concept

Anacor Pharmaceuticals today announced that a Joint Research Committee, composed of both GlaxoSmithKline (GSK) and Anacor employees, has determined that AN3365, a novel systemic antibiotic derived from Anacor's boron chemistry platform, has achieved proof of concept as defined under the collaboration agreement between GSK and Anacor.

15 Jun 2010

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Micromet, Inc. today announced the presentation of updated results from a Phase 1 trial of the Company's lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin's lymphoma. A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing.

14 Jun 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Biodel Inc. announced today that the following oral and poster presentations describing results from studies of the company's product candidates will be presented during the 70th Scientific Sessions of the American Diabetes Association this month in Orlando, Florida:

14 Jun 2010

Abstract on Phase I/II DIGNITY trial of ThermoDox in RCW Breast Cancer accepted at ASTRO 2010

Celsion Corporation announced today that an abstract on the Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall Breast Cancer has been accepted for a poster session at the 52nd American Society for Radiation Oncology Annual Meeting. The abstract will provide updated clinical results, as well as the rationale and design of the DIGNITY study, which is evaluating ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer.

14 Jun 2010

Pharmacokinetics News and Research

Further Reading

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease initiated

Nektar commences dosing in Phase 1 study of NKTR-102 in combination with 5-FU/leucovorin

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Phase 1 clinical trial of XMT-1107 initiated in patients with refractory advanced solid tumors

Enobia reports positive interim data from ENB-0040 enzyme replacement therapy study for children with HPP

Celator announces expansion of research agreement with Cephalon

Sinapis initiates dosing in Phase I trial of intravenous infusion of methamphetamine

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

First patient dosed in AR-42 Phase I/IIa clinical study at OSUCCC-James in adult patients with blood cancer

FerroKin BioSciences announces closing of $12M financing

Positive results from Phase I clinical trial of GLYX-13 presented at NCDEU meeting

Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Immunomedics initiates dosing in milatuzumab-doxorubicin conjugate Phase I/II trial for relapsed multiple myeloma

Anacor's AN3365 novel systemic antibiotic achieves proof of concept

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Abstract on Phase I/II DIGNITY trial of ThermoDox in RCW Breast Cancer accepted at ASTRO 2010

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