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The Lancet Neurology publishes Neurologix NLX-P101 Phase 2 trial results against PD

Neurologix, Inc., announced today that the results of the Company's Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease were published in an online-first edition of The Lancet Neurology.

17 Mar 2011

Fibrocell Science submits azficel-T final study report to FDA

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted a final study report to the U.S. Food & Drug Administration (FDA) for a completed, six-month histological study examining skin after injections of azficel-T.

16 Mar 2011

RegeneRx RGN-352 Phase 2 trial in acute myocardial infarction placed on clinical hold

RegeneRx Biopharmaceuticals, Inc. announced that it has received a notice from the U.S. Food and Drug Administration (FDA) indicating that, due to non-compliance with FDA's current Good Manufacturing Practice (cGMP) regulations by its contract manufacturer, the Company's Phase 2 clinical trial of RGN-352, its injectable formulation of Thymosin beta 4 for the treatment of acute myocardial infarction (AMI), has been placed on clinical hold.

16 Mar 2011

Cortex enters agreement with Biovail to regain AMPAKINE assets and rights

Cortex Pharmaceuticals, Inc. announced that it has entered into an agreement with Biovail Laboratories International SRL, a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc., to regain the AMPAKINE® assets and rights related to respiratory depression.

16 Mar 2011

NIH awards TriLink $100,000 Phase I SBIR Grant to develop Hot Start approach for Ligase Chain Reaction

TriLink BioTechnologies, Inc. was recently awarded a Phase I SBIR Grant of approximately $100,000 by the National Institutes of Health to develop a Hot Start approach for Ligase Chain Reaction (LCR). Hot Start LCR will employ chemically modified ligation components containing thermolabile protecting groups to eliminate common performance problems seen in LCR, such as false-positive signals and non-specificity.

16 Mar 2011

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

Drug Trial News

The Lancet Neurology publishes Neurologix NLX-P101 Phase 2 trial results against PD

Fibrocell Science submits azficel-T final study report to FDA

RegeneRx RGN-352 Phase 2 trial in acute myocardial infarction placed on clinical hold

Cortex enters agreement with Biovail to regain AMPAKINE assets and rights

NIH awards TriLink $100,000 Phase I SBIR Grant to develop Hot Start approach for Ligase Chain Reaction

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

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