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LigoCyte to enroll 98 subjects in first clinical trial for bivalent IM norovirus vaccine

LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company focused on the development of innovative vaccine products, announced today that it has initiated the first clinical trial for its bivalent intramuscular (IM) norovirus vaccine candidate, marking the fourth human clinical trial in the Company's norovirus virus-like particle (VLP) vaccine program.

17 Sep 2010

FDA grants AGTC $1M for Phase II human clinical trial in alpha-1 antitrypsin deficiency

Applied Genetic Technologies Corporation, a privately-held, clinical stage biotechnology company developing novel systems to deliver human therapeutics, announces that it has received a grant of $1 million from the Food and Drug Administration (FDA Orphan Drugs Program) to fund a Phase II Human Clinical Trial evaluating the safety and efficacy of a treatment for Alpha 1 Antitrypsin Deficiency (AAT), a genetic disease known to result in serious lung and/or liver disease.

17 Sep 2010

ISTA Pharmaceuticals initiates REMURA Phase 3 clinical program for dry eye disease

ISTA Pharmaceuticals, Inc., today announced that it has initiated a Phase 3 clinical program of ISTA's proprietary formulation of REMURA (bromfenac ophthalmic solution for dry eye) for alleviating the signs and symptoms of dry eye disease. The Phase 3 efficacy studies are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).

16 Sep 2010

BioCryst Pharmaceuticals announces BCX4208 compound results for treating gout

BioCryst Pharmaceuticals, Inc. announced positive top-line results from its randomized, double-blind, multi-center, placebo-controlled Phase 2 study designed to evaluate the urate-lowering activity and safety of several doses of BCX4208 alone and in combination with selected doses of allopurinol administered once-daily.

16 Sep 2010

Incyte Corporation publishes clinical trial data of INCB18424 drug for myelofibrosis treatment

Incyte Corporation, Results from a Phase I/II study of Incyte's janus kinase (JAK) inhibitor with the investigational name INCB18424 (also known as INCB018424 and INC424) were published today in The New England Journal of Medicine, demonstrating marked and durable clinical benefits in patients with myelofibrosis.

16 Sep 2010

Chimerix presents promising clinical data for CMX001 in late-breaker poster session at 50th ICAAC

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today presented promising clinical data for CMX001 in a late-breaker poster session at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy.

16 Sep 2010

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

ViroPharma Incorporated today announced the presentation of data from its Phase 1 study of VP20621 (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections, a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications.

16 Sep 2010

Relypsa announces positive results from Phase 2 clinical trial of RLY5016

Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced positive results from the company's PEARL-HF study, a Phase 2 clinical trial of the company's lead compound, RLY5016. These data were presented by Dr. Bertram Pitt, Professor of Medicine Emeritus, Division of Medicine at the University of Michigan School of Medicine, during the Late-Breaking Clinical Trials Session in an oral presentation titled "The PEARL-HF (Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Dose To Evaluate the Effects of RLY5016 in Heart Failure Patients) Trial" at the 14th Annual Scientific Meeting of the Heart Failure Society of America held in San Diego, CA September 13-15, 2010.

16 Sep 2010

Spirogen, Celtic Therapeutics announces initiation of Phase II ovarian cancer trial with SG2000

Spirogen Limited and Celtic Therapeutics Holdings LP announced today the commencement of a Phase II clinical trial of SG2000 in ovarian cancer. The trial is being sponsored by the National Cancer Institute of the USA, and is now actively recruiting patients for treatment.

16 Sep 2010

BioCryst reports results from forodesine studies for CTCL and CLL

BioCryst Pharmaceuticals, Inc. announced preliminary top-line results from its multinational, open-label, single-arm trial evaluating 200 mg once-daily oral forodesine in the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), as well as interim results from the Company's exploratory Phase 2 study to investigate the efficacy and safety of 200 mg twice-daily oral forodesine as monotherapy for chronic lymphocytic leukemia (CLL).

15 Sep 2010

Abstract on ACH-1625 accepted as late breaking poster presentation at The Liver Meeting 2010

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced that its abstract titled "ACH-1625 Demonstrates Sustained Viral Suppression in Presence of Uncommon Drug Resistant HCV Variants: Pharmacokinetic, Pharmacodynamic and Clinical Virology Analysis of Phase I Study" has been accepted as a late breaking poster presentation at the 61st Annual Meeting of the American Association for the Study of Liver Disease The Liver Meeting 2010 being held October 29-November 2, 2010 in Boston.

15 Sep 2010

Phase II clinical trial shows GTx-758 reduces serum free testosterone

GTx, Inc. today announced that in a Phase II, open label, pharmacokinetic-pharmacodynamic clinical trial, GTx-758, an oral selective estrogen receptor alpha agonist being developed to treat advanced prostate cancer, suppressed serum total testosterone to castrate levels, increased serum SHBG (sex hormone binding globulin), and markedly reduced serum free testosterone in healthy male volunteers.

15 Sep 2010

COTI selected for Canadian life sciences partnering mission

Critical Outcome Technologies Inc. announced today that the Company was selected by the Consulate General of Canada and BIOTECanada to attend a life sciences partnering mission in Boston, MA. This initiative is being held in conjunction with the BioPharm America conference taking place September 15-17, 2010.

15 Sep 2010

ADVENTRX announces Exelbine 12-month stability test results

ADVENTRX Pharmaceuticals, Inc. today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company's intended commercial manufacturing site.

15 Sep 2010

AVANIR's AVP-923 Phase III STAR trial results published in 'Annals of Neurology' website

AVANIR Pharmaceuticals, Inc. today announced the electronic publication of the results of the pivotal Phase III STAR trial of its investigational drug AVP-923 (dextromethorphan/quinidine) in the Annals of Neurology. The publication entitled "Dextromethorphan Plus Ultra-Low-Dose Quinidine Reduces Pseudobulbar Affect" evaluated two low dose formulations compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).

15 Sep 2010

ITS commences treatment in synthetic universal influenza vaccine Phase I trial

Immune Targeting Systems (ITS) Limited, one of the leading developers of synthetic vaccines for mutating viruses, today announced the first patient has been treated in its Phase-I trial with its synthetic universal influenza vaccine (FP-01). Commencement of trials follows receipt of UK Regulatory Authority (MHRA) approval. Over the same period the company brought in £500,000 new investment from Esperante Ventures (UK).

15 Sep 2010

AMRI selects compound for advanced preclinical testing in treatment of IBS

AMRI today announced the selection of a compound from its proprietary research program for the treatment of irritable bowel syndrome (IBS) for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2011.

15 Sep 2010

Harbor BioSciences releases Apoptone clinical trial data for castration resistant prostate cancer

Harbor BioSciences, Inc. a biopharmaceutical company developing novel therapeutics for the treatment of cancer, metabolic and inflammatory diseases, today released new positive data from its ongoing Phase I/IIa clinical trial with Apoptone(HE3235) for castration resistant prostate cancer (CRPC) – also referred to as hormone resistant prostate cancer.

15 Sep 2010

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Optimer Pharmaceuticals, Inc. announced the presentation of new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.

15 Sep 2010

Neurocrine Biosciences announces GSK561679 antagonist's efficacy in major depressive disorder

Neurocrine Biosciences, Inc. today announced top-line efficacy and safety results from a Phase II clinical trial utilizing Corticotropin Releasing Factor (CRF1) receptor antagonist GSK561679 in patients currently experiencing a major depressive episode.

15 Sep 2010

Drug Trial News

LigoCyte to enroll 98 subjects in first clinical trial for bivalent IM norovirus vaccine

FDA grants AGTC $1M for Phase II human clinical trial in alpha-1 antitrypsin deficiency

ISTA Pharmaceuticals initiates REMURA Phase 3 clinical program for dry eye disease

BioCryst Pharmaceuticals announces BCX4208 compound results for treating gout

Incyte Corporation publishes clinical trial data of INCB18424 drug for myelofibrosis treatment

Chimerix presents promising clinical data for CMX001 in late-breaker poster session at 50th ICAAC

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

Relypsa announces positive results from Phase 2 clinical trial of RLY5016

Spirogen, Celtic Therapeutics announces initiation of Phase II ovarian cancer trial with SG2000

BioCryst reports results from forodesine studies for CTCL and CLL

Abstract on ACH-1625 accepted as late breaking poster presentation at The Liver Meeting 2010

Phase II clinical trial shows GTx-758 reduces serum free testosterone

COTI selected for Canadian life sciences partnering mission

ADVENTRX announces Exelbine 12-month stability test results

AVANIR's AVP-923 Phase III STAR trial results published in 'Annals of Neurology' website

ITS commences treatment in synthetic universal influenza vaccine Phase I trial

AMRI selects compound for advanced preclinical testing in treatment of IBS

Harbor BioSciences releases Apoptone clinical trial data for castration resistant prostate cancer

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Neurocrine Biosciences announces GSK561679 antagonist's efficacy in major depressive disorder

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