Pharmacodynamics News and Research

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CSL Behring commences C1-INH phase I/II study in hereditary angioedema

CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema.

4 May 2012

Generon commences F-627 Phase II trial in breast cancer

Generon Corporation Ltd. today announced the initiation of a Phase II clinical trial for F-627 after US FDA regulatory clearance. The current study is a Phase II, randomized, multicenter, open-label, active-controlled trial of F-627 in women with breast cancer receiving myelotoxic chemotherapy.

4 May 2012

Topline, interim results from Celldex Phase 2b EMERGE study of CDX-011 for advanced breast cancer

Celldex Therapeutics, Inc. today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast Cancer Research Program at Weill Cornell Medical College and the lead investigator of the EMERGE study, will join Celldex on the webcast to discuss data from the study.

2 May 2012

Simulations Plus launches new version of GastroPlus simulation software

Simulations Plus, Inc., a leading provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, announced today the release of Version 8.0 of its flagship GastroPlus simulation software with significantly expanded functionality and user convenience.

27 Apr 2012

Positive results from Repligen's RG3039 Phase 1 study for spinal muscular atrophy

Repligen Corporation today announced positive results from a Phase 1 study to evaluate the pharmacokinetic (PK) and safety profile of RG3039, a novel small molecule drug candidate for the potential treatment of spinal muscular atrophy (SMA).

25 Apr 2012

Palatin, AstraZeneca initiate second AZD2820 phase I trial in obesity

Palatin Technologies, Inc. today announced that a second phase I clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist under development for the treatment of obesity, has commenced.

20 Apr 2012

Stealth announces results from three Bendavia Phase I clinical trials for mitochondrial dysfunction

Stealth Peptides Inc., a privately held biopharmaceutical company developing innovative therapies for diseases with unmet medical needs, announced today the results from three Phase I clinical trials of Bendavia, a novel compound that targets the mitochondrion to treat mitochondrial dysfunction, including ischemia reperfusion and microvascular injury.

9 Apr 2012

Positive results from Nile's cenderitide Phase 1 trial on chronic heart failure

Nile Therapeutics, Inc., a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced results from its recently completed Phase 1 clinical trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure.

29 Mar 2012

DNDi commences Oxaborole SCYX-7158 Phase I clinical trial for sleeping sickness

The Drugs for Neglected Diseases initiative (DNDi) has commenced a Phase I clinical trial in healthy adults in Paris, France, to determine the safety and tolerability of a promising oral drug candidate Oxaborole SCYX-7158, to treat human African trypanosomiasis (HAT, or sleeping sickness) for stage 1 and stage 2 of the disease.

12 Mar 2012

BioLineRx granted Israeli approval for BL-7040 Phase II clinical trial for IBD

BioLineRx a biopharmaceutical development company, announced today that it has received approval from the Israeli Ministry of Health for commencing a Phase II clinical trial of BL-7040, an orally available molecule for treating Inflammatory Bowel Disease (IBD).

5 Mar 2012

Kowa announces data of LIVALO vs. Crestor on pharmacodynamics of warfarin

Kowa Pharmaceuticals America, Inc. today announced data assessing the effect of LIVALO (pitavastatin) compared with Crestor (rosuvastatin) on steady-state pharmacodynamics (PD) of warfarin by measuring international normalized ratio (INR) in healthy adult subjects.

14 Feb 2012

Trevena commences TRV130 Phase I clinical trial for severe post-operative pain

Trevena, Inc., the leader in discovery and development of G-protein coupled receptor (GPCR) biased ligands, announced today the initiation of a Phase I clinical trial of TRV130, a novel candidate designed for the intravenous treatment of moderate-to-severe post-operative pain.

13 Feb 2012

Aggrenox not affected by co-administration of omeprazole: Study

Boehringer Ingelheim presented results of a drug interaction study that found Aggrenox (aspirin/extended-release dipyridamole), an antiplatelet medication, is not affected by the co-administration of omeprazole, a proton pump inhibitor (PPI), frequently used to treat several gastrointestinal conditions. These data were presented at the International Stroke Conference (ISC) in New Orleans.

3 Feb 2012

Emergent commences Phase 2 combination trial of TRUw-016 with bendamustine in relapsed CLL

Emergent BioSolutions Inc. today announced the initiation of a Phase 2 study (protocol 16201) of TRU-016 in combination with bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL).

29 Dec 2011

Idera regains global rights to IMO-2055 from Merck KGaA for treatment of cancer

Idera Pharmaceuticals, Inc. today announced that it has regained global rights to IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as part of an agreed-upon termination of its oncology collaboration with Merck KGaA, Darmstadt, Germany.

1 Dec 2011

Alnylam announces new data from ALN-TTR01 Phase I trial on TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it will present new data from its ALN-TTR program at the VIIIth International Symposium on Familial Amyloidotic Polyneuropathy being held in Kumamoto, Japan from November 20-22, 2011.

15 Nov 2011

Nile Therapeutics third quarter net loss decreases to $1.1 million

Nile Therapeutics, Inc., a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced its third quarter financial results for 2011.

14 Nov 2011

Infinity third quarter total revenue increases marginally to $23.3 million

Infinity Pharmaceuticals, Inc. today highlighted its recent clinical and business progress and announced its third quarter 2011 financial results.

9 Nov 2011

Initiation of two IPI-145 Phase 1 clinical trials triggers $4M milestone payment to Intellikine

Intellikine, Inc., a company focused on the discovery and development of innovative, small molecule drugs targeting the PI3K/mTOR pathway, announced today that it has earned $4 million in milestone payments upon the initiation of two Phase 1 clinical trials of IPI-145.

31 Oct 2011

Infinity commences two IPI-145 Phase 1 clinical trials for hematologic malignancies

Infinity Pharmaceuticals, Inc. today announced that it has initiated two Phase 1 clinical trials of IPI-145, a potent, orally available inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma. These two enzymes are implicated in hematologic cancers as well as a broad range of inflammatory conditions, which are the areas of focus within Infinity's PI3K clinical development program.

31 Oct 2011