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.

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

BIND Biosciences announces $12.4 million Series C-1 financing

BIND Biosciences, Inc. (BIND), a privately held biopharmaceutical company developing best in class therapeutics based on its proprietary targeted nanotechnology platform, announced today that it has secured a $12.4 Million Series C-1 financing. This financing included all of BIND's current investors (including Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension and DHK Investments) as well as a new venture investor, Endeavour Vision, and private investors.

29 Jun 2010

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Daiichi Sankyo, Inc. and Eli Lilly and Company appreciate the availability of a "Clinical Alert" from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) in response to the FDA's Boxed Warning about Plavix® (clopidogrel), and commend the leading cardiovascular medical societies for providing perspective on the importance of genetic make-up and the variability in response of certain oral anti-platelet (OAP) therapy for patients with acute coronary syndrome (ACS) who are managed with angioplasty and stenting (known as PCI).

29 Jun 2010

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Astellas Pharma Inc. announced that the company presented results from a Japanese Phase 2 study conducted with ASP1941, a selective SGLT2 inhibitor, at the 70th Scientific Sessions of the American Diabetes Association (ADA) on June 26, 2010 (EST). ASP1941 is designed to block the re-absorption of glucose in the kidney and excrete glucose in the urine.

29 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Halozyme presents new data from Ultrafast Insulin development program at 70th ADA

Halozyme Therapeutics, Inc. today announced Phase 2 results demonstrating that the subcutaneous coinjection of rHuPH20 (recombinant human hyaluronidase, PH20) with lispro significantly improves postprandial hyperglycemia, reduces hypoglycemia, and accelerates the absorption of mealtime insulin in patients with type 2 diabetes.

28 Jun 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

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

Pharmacokinetics News and Research

Further Reading

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

BIND Biosciences announces $12.4 million Series C-1 financing

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Halozyme presents new data from Ultrafast Insulin development program at 70th ADA

Merck challenges New York jury decision in federal FOSAMAX retrial

FDA grants orphan drug designation for Chiasma's Octreolin

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

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