Pharmacodynamics News and Research

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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

ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

ViroPharma Incorporated and Halozyme Therapeutics announced today that ViroPharma has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze in combination with Halozyme's Enhanze technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme, in subjects with hereditary angioedema.

14 Sep 2011

Acceleron commences ACE-536 Phase 1 clinical trial in anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases today announced that it has initiated a Phase 1 clinical study of ACE-536.

14 Sep 2011

Emergent commences TRU-016 Phase 1b/2 combination trial in relapsed indolent NHL

Emergent BioSolutions Inc. today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab and bendamustine for patients with relapsed indolent non-Hodgkin's B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

17 Aug 2011

FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).

2 Aug 2011