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Montreal Heart Institute and Cerenis commence CER-001 Phase 2 study in acute coronary syndrome

The Montreal Heart Institute today announced the start of the Phase 2 CHI-SQUARE (Can HDL Infusions Significantly QUicken Atherosclerosis REgression?) study of CER-001 in patients with acute coronary syndrome (ACS), in collaboration with Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and metabolic diseases.

16 Mar 2011

Plexxikon selects Clinipace to manage 4 clinical trials for RA treatment

Clinipace Worldwide, a global digital clinical research organization, announced today that Plexxikon Inc., a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease, has selected Clinipace to manage all aspects of four clinical trials comprising a Phase 1 healthy volunteer study, a Phase 1b rheumatoid arthritis study, and two phase 2 oncology studies.

16 Mar 2011

AstraZeneca commences NKTR-118 Phase III clinical programme for opioid-induced constipation

AstraZeneca today announced enrolment of the first patient in the Phase III clinical programme for NKTR-118, an oral peripherally-acting opioid antagonist being investigated for the treatment of opioid-induced constipation (OIC).

16 Mar 2011

Unigene initiates oral PTH Phase 2 study in postmenopausal women with osteoporosis

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today the dosing of the first subject in a Phase 2 study with an experimental oral parathyroid hormone analog for the treatment of osteoporosis in postmenopausal women.

16 Mar 2011

iTherX commences ITX-5061 Phase 1b study in patients with HCV

iTherX, a pharmaceutical company dedicated to discovering and developing a new class of therapies for hepatitis C, today announced that it has commenced patient recruitment in an open-label, proof-of-concept Phase 1b study of its lead compound ITX-5061 in liver transplant patients with hepatitis C virus infection.

16 Mar 2011

Apeiron in antitumor substances deal with Cleveland Clinic

APEIRON Biologics AG announced that it has entered into an exclusive option to license from the Cleveland Clinic a number of novel compounds. These compounds are currently in development at Cleveland Clinic as drug candidates for treatment of various cancers, designed to fight cancer based on stimulation of the immune system. In preclinical models, they have shown anti-cancer activity and a favourable toxicity profile as orally available agents.

15 Mar 2011

Anavex to commence phase I clinical trial in Alzheimer’s disease

Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) has announced that its clinical trial application (CTA) for ANAVEX 2-73, the company’s lead compound for Alzheimer’s disease, has been approved by the German regulatory health authority, BfArM. The Phase I trial of ANAVEX 2-73, which includes testing in healthy human volunteers, will commence immediately. In this Phase I program Anavex will assess the safety, maximally tolerated dose, pharmacokinetics and pharmacodynamics of ANAVEX 2-73.

15 Mar 2011

Additional research needed for oral PrEP to treat HIV

The first human studies of an oral drug regimen to prevent HIV infection in high-risk individuals yielded a promising near 50% reduction in HIV incidence, but a number of issues require additional research before oral pre-exposure prophylaxis can be implemented on a large scale, according to an article in AIDS Patient Care and STDs, a peer-reviewed journal published by Mary Ann Liebert, Inc.

15 Mar 2011

CLL patients receive Biothera's new combination therapy in Phase I/II clinical trial

Patients with earlier stage high-risk Chronic Lymphocytic Leukemia recently began receiving a new combination treatment in a Phase I/II clinical trial that researchers believe could result in a more effective therapy for this disease, Biothera announced today.

15 Mar 2011

Incyte’s ruxolitinib COMFORT-II Phase III trial in MF meets primary endpoint

COMFORT-II, the second pivotal Phase III trial of Incyte Corporation's investigational Janus kinase inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis, when compared to best available therapy.

15 Mar 2011

Oxford Biomedica’s TroVax(R) TRIST Phase III study results to be published in Cancer Immunology, Immunotherapy

Oxford BioMedica plc, a leading gene therapy company, today announces that further analyses of the TroVax Renal Immunotherapy Survival Trial, a randomised, double-blind, placebo-controlled Phase III study, have been accepted for publication in Cancer Immunology, Immunotherapy, the official journal of the Association for Cancer Immunotherapy.

15 Mar 2011

Cerenis commences CER-001 Phase 2 CHI-SQUARE study in patients with ACS

Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein therapies to treat cardiovascular and metabolic diseases, today announced the start of the Phase 2 CHI-SQUARE study of CER-001 in patients with acute coronary syndrome.

15 Mar 2011

Positive top-line results from IPX066 Phase III study in patients with PD

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., today announced statistically significant, positive, top-line results of the ADVANCE-Parkinson's Disease Phase III clinical study of the safety and efficacy of IPX066 versus immediate-release carbidopa-levodopa in advanced PD patients experiencing motor fluctuations.

15 Mar 2011

Repligen reports positive results from RG1068 Phase 3 study to improve MRI of the pancreas

Repligen Corporation reported today positive top-line results from a Phase 3 study to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with pancreatic disease using endoscopy (ERCP) as a diagnostic reference.

14 Mar 2011

Euthymics Bioscience initiates EB-1010 phase 2b/3a TRIADE clinical trial for major depressive disorder

Euthymics Bioscience, Inc. today announced the initiation of an advanced clinical study of its lead product candidate EB-1010 for the treatment of major depressive disorder (MDD). The TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects) trial is a phase 2b/3a clinical trial designed to assess the safety and efficacy of EB-1010, a novel serotonin-preferring triple reuptake inhibitor.

14 Mar 2011

Positive results from azide drug-loaded Emulsiphan preclinical toxicity study

Cornerstone Pharmaceuticals, Inc., a leader in cancer metabolism-based therapeutics, today announced encouraging results of a preclinical toxicity study of azide drug-loaded Emulsiphan nano emulsions conducted with the National Cancer Institute (NCI) under a Collaboration Agreement. Emulsiphan is Cornerstone's proprietary nanoparticle drug delivery system.

14 Mar 2011

Biodel selects BIOD-105, BIOD-107 recombinant human insulin formulations for clinical testing, development

Biodel Inc. announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.

14 Mar 2011

KAI initiates enrollment in KAI-4169 Phase 2 study for secondary hyperparathyroidism

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced enrollment of the first patients in a Phase 2 study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism (SHPT), which is a frequent and serious complication of end-stage renal disease (ESRD).

14 Mar 2011

Transcept initiates enrollment in TO-2061 Phase 2 study for treatment resistant obsessive compulsive disorder

Transcept Pharmaceuticals, Inc. today announced the first patient has been enrolled in a Phase 2 clinical study to evaluate TO-2061 as an adjunctive treatment for obsessive compulsive disorder (OCD) in patients who have responded inadequately to currently approved treatments. OCD affects 1 to 2 percent of the United States adult population and can significantly impair the lives of patients and their families.

14 Mar 2011

Omthera commences dosing in pivotal Epanova Phase III EVOLVE trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been dosed in its pivotal Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega-3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

14 Mar 2011

Drug Trial News

Montreal Heart Institute and Cerenis commence CER-001 Phase 2 study in acute coronary syndrome

Plexxikon selects Clinipace to manage 4 clinical trials for RA treatment

AstraZeneca commences NKTR-118 Phase III clinical programme for opioid-induced constipation

Unigene initiates oral PTH Phase 2 study in postmenopausal women with osteoporosis

iTherX commences ITX-5061 Phase 1b study in patients with HCV

Apeiron in antitumor substances deal with Cleveland Clinic

Anavex to commence phase I clinical trial in Alzheimer’s disease

Additional research needed for oral PrEP to treat HIV

CLL patients receive Biothera's new combination therapy in Phase I/II clinical trial

Incyte’s ruxolitinib COMFORT-II Phase III trial in MF meets primary endpoint

Oxford Biomedica’s TroVax(R) TRIST Phase III study results to be published in Cancer Immunology, Immunotherapy

Cerenis commences CER-001 Phase 2 CHI-SQUARE study in patients with ACS

Positive top-line results from IPX066 Phase III study in patients with PD

Repligen reports positive results from RG1068 Phase 3 study to improve MRI of the pancreas

Euthymics Bioscience initiates EB-1010 phase 2b/3a TRIADE clinical trial for major depressive disorder

Positive results from azide drug-loaded Emulsiphan preclinical toxicity study

Biodel selects BIOD-105, BIOD-107 recombinant human insulin formulations for clinical testing, development

KAI initiates enrollment in KAI-4169 Phase 2 study for secondary hyperparathyroidism

Transcept initiates enrollment in TO-2061 Phase 2 study for treatment resistant obsessive compulsive disorder

Omthera commences dosing in pivotal Epanova Phase III EVOLVE trial in patients with very high triglycerides

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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