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Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

RegeneRx Biopharmaceuticals, Inc. announced today that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease. The double-blind, placebo-controlled, investigator-sponsored trial is expected to enroll a total of 20 patients over the next several months, with data reported later in 2011. RGN-259 is a sterile, preservative-free topical eye drop formulation of the novel therapeutic peptide Thymosin beta 4, or Tβ4.

23 Dec 2010

Abbott, AstraZeneca discontinue CERTRIAD development collaboration

Abbott announced today that Abbott and AstraZeneca will discontinue their joint collaboration for the development of CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules.

23 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010

New era for anticoagulant therapy

In a Guest Editorial published in the new publication Clinical Investigation, Dr Jeffrey Weitz and Dr John Eikelboom of McMaster University in Hamilton, Canada highlight the importance of the approval in October by the FDA of dabigatran etexilate (Pradaxa®; Boehringer Ingelheim). This new oral thrombin inhibitor provides an alternative to warfarin for long-term stroke prevention in patients with non-valvular atrial fibrillation.

22 Dec 2010

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

BioCryst Pharmaceuticals, Inc. announced the initiation of a Phase 2b study of BCX4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone.

22 Dec 2010

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Vertex Pharmaceuticals Incorporated today announced a modification of its Phase 2 clinical trial evaluating 12-week, response-guided regimens of its lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

22 Dec 2010

Amorcyte reports AMR-001 phase I trial results in heart attack patients

The American Heart Journal today reported results of a clinical trial evaluating Amorcyte, lead product candidate, AMR-001 for the treatment of damaged heart muscle following acute myocardial infarction.

22 Dec 2010

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Anavex Life Sciences Corp. announced today that it has filed the regulatory submission for ANAVEX 2-73 with the German Health Authority, BfArM, and the local Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.

21 Dec 2010

Isis commences ISIS-APOCIIIRx Phase 1 trial in hypertriglyceridemia

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 1 study of ISIS-APOCIIIRx, an antisense drug designed to lower triglycerides to treat a variety of diseases associated with elevated triglycerides. Hypertriglyceridemia, a condition characterized by elevated levels of triglycerides, is an independent risk factor for cardiovascular disease and is a component of numerous cardiovascular and metabolic diseases, including metabolic syndrome.

21 Dec 2010

Biovest issues FAQ update on BiovaxID personalized cancer vaccine

Biovest International, Inc. today issued the following update in the form of a "Frequently Asked Questions" report in response to the high volume of inquiries received following the Company's recent presentation at the 2010 American Society of Hematology Annual Meeting (ASH 2010) in Orlando, Florida.

21 Dec 2010

Emisphere, Novo Nordisk partner to develop and commercialize oral formulations of insulins

Emisphere Technologies, Inc. and Novo Nordisk A/S today announced that they have entered into an exclusive Development and License Agreement to develop and commercialize oral formulations of Novo Nordisk's insulins, which have the potential of treating diabetes, using Emisphere's Eligen® Technology. This is the second license agreement between the two companies. The first agreement, for the development of oral formulations of GLP-1 receptor agonists, was signed in June 2008, with a potential drug currently in a Phase I clinical trial.

21 Dec 2010

Amylin submits metreleptin rolling submission BLA for treatment of rare forms of lipodystrophy

Amylin Pharmaceuticals, Inc. today announced that it has submitted the initial sections of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of lipodystrophy.

21 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Ambit Biosciences, today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.

20 Dec 2010

VistaGen reports successful completion of AV-101 Phase 1 safety study for neuropathic pain

VistaGen Therapeutics, Inc., a stem cell technology company focused on drug discovery and development, today announced the successful completion of its initial Phase 1 safety study of AV-101, the Company's novel orally available prodrug candidate for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S.

20 Dec 2010

Bristol-Myers Squibb, Oncolys complete license agreement for festinavir

Bristol-Myers Squibb Company and Oncolys BioPharma Inc., a privately held biotechnology company based in Japan, announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire exclusive worldwide rights to manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV.

20 Dec 2010

Rexahn granted Japanese patent for preclinical compound RX-0047

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it was awarded patent 4,546,454 entitled, "Antisense Oligonucleotides that Inhibit Expression of HIF-1," by the Japanese Patent Office.

20 Dec 2010

Oncothyreon commences combination PX-866/cetuximab Phase 1/2 trial in cancers

Oncothyreon Inc. today announced enrollment of the first patient in a Phase 1/2 trial of PX-866 in combination with the chimeric monoclonal antibody cetuximab (Erbitux®). PX-866 is a small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.

20 Dec 2010

Idera reports positive data from IMO-2125/ribavirin combination Phase 1 trial in null-responder HCV patients

Idera Pharmaceuticals, Inc. announced today preliminary data from a 4-week dose-ranging Phase 1 clinical trial of IMO-2125 in combination with ribavirin in 60 treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. In the trial, treatment with IMO-2125 in combination with ribavirin was well tolerated and achieved substantial decline in virus levels at two days after the first dose of IMO-2125 and after four weeks of treatment.

20 Dec 2010

Drug Trial News

Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

Abbott, AstraZeneca discontinue CERTRIAD development collaboration

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

New era for anticoagulant therapy

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Amorcyte reports AMR-001 phase I trial results in heart attack patients

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Isis commences ISIS-APOCIIIRx Phase 1 trial in hypertriglyceridemia

Biovest issues FAQ update on BiovaxID personalized cancer vaccine

Emisphere, Novo Nordisk partner to develop and commercialize oral formulations of insulins

Amylin submits metreleptin rolling submission BLA for treatment of rare forms of lipodystrophy

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

VistaGen reports successful completion of AV-101 Phase 1 safety study for neuropathic pain

Bristol-Myers Squibb, Oncolys complete license agreement for festinavir

Rexahn granted Japanese patent for preclinical compound RX-0047

Oncothyreon commences combination PX-866/cetuximab Phase 1/2 trial in cancers

Idera reports positive data from IMO-2125/ribavirin combination Phase 1 trial in null-responder HCV patients

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

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