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Phase III trial results of Osiris Therapeutics' Prochymal for GvHD to be presented at BMT Tandem Meeting

Osiris Therapeutics, Inc. today announced that results from the Phase III trial evaluating Prochymal for the treatment of steroid-refractory acute graft vs. host disease (GvHD) will be presented by Paul Martin, M.D., of the Fred Hutchinson Cancer Research Center and Paul Szabolcs, M.D., of Duke University Medical Center at the 2010 BMT Tandem Meeting. The meeting is being held February 24-28 in Orlando, Florida.

24 Feb 2010

Idera Pharmaceuticals presents IMO-3100 TLR antagonist mechanism of action data at Keystone conference

Idera Pharmaceuticals, Inc. today presented data on the mechanism of action of IMO-3100, an antagonist of Toll-like Receptor (TLR) 7 and TLR9, in a preclinical primate model at the Keystone Symposia conference “Tolerance and Autoimmunity” being held February 21-26 in Taos, New Mexico. Idera is developing IMO-3100 for the treatment of autoimmune diseases. The presentation entitled “IMO-3100, a novel antagonist, suppresses TLR7- and TLR9-mediated immune responses in non-human primates” was made by Idera scientists.

24 Feb 2010

ViiV Healthcare highlights S/GSK1349572, SELZENTRY and EPZICOM for HIV/AIDS at 17th CROI

At the 17th Conference on Retroviruses and Opportunistic Infections (CROI), ViiV Healthcare presented new data across its broad range of investigational and current medicines for the treatment of HIV/AIDS. Highlighted data at the conference included an oral presentation on the investigational integrase inhibitor, S/GSK1349572, as well as data presentations on SELZENTRY® (maraviroc) and EPZICOM® (abacavir/lamivudine).

24 Feb 2010

Enrollment complete in Ocera Therapeutics' ASTUTE Phase 2B trial for mild hepatic encephalopathy

Ocera Therapeutics, Inc. announced today that the ASTUTE Study (AST-120 Used to Treat Hepatic Encephalopathy) has completed enrollment for its Phase 2B study ahead of schedule, with data expected mid 2010.

24 Feb 2010

Catalyst Pharmaceutical Partners, NIDA partner to conduct CPP-109 Phase II(b) clinical trial for cocaine addiction

Catalyst Pharmaceutical Partners, Inc. announced today that it has signed a non-binding Letter of Intent with the National Institute on Drug Abuse (NIDA) to conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst's formulation of vigabatrin, for the treatment of cocaine addiction. It is anticipated that NIDA, under their agreement with Veteran's Administration Cooperative Studies Program, will provide substantial resources for the trial and that Catalyst will contribute approximately $2.5 million in resources as part of the estimated $10 million trial cost.

23 Feb 2010

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Aradigm Corporation today announced that it dosed the first patient in the U.S. as part of its ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial, an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE) under a U.S. IND. This orphan disease indication is a chronic, severe respiratory disease and there are currently no approved treatments for this disease in the U.S.

23 Feb 2010

Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2009.

23 Feb 2010

TCAD therapy active and synergistic against drug resistant influenza virus strains

Adamas Pharmaceuticals, Inc., a privately held company, reported today on the publication of results from a preclinical study that demonstrated the synergistic effects of triple combination antiviral drug (TCAD) therapy against multiple strains of seasonal, pandemic, and avian influenza A (H1N1, H3N2 and H5N1) virus, including three strains of amantadine resistant pandemic H1N1 and two strains of oseltamivir resistant seasonal H1N1.

23 Feb 2010

Genentech's Avastin combination Phase III study in advanced stomach cancer does not meet primary endpoint

Genentech, Inc., a wholly owned member of the Roche Group, today announced that a Phase III study (AVAGAST) did not meet its primary endpoint of showing Avastin® (bevacizumab) plus Xeloda® (capecitabine) or 5-FU and cisplatin chemotherapy extended the lives of people with inoperable or advanced stomach (gastric) cancer, compared to chemotherapy alone.

23 Feb 2010

GlycoVaxyn initiates Phase I clinical study of GVXN SD133 vaccine candidate against Shigella dysenteriae

GlycoVaxyn, a pioneer in the development of innovative bioconjugate vaccines, has commenced a Phase I clinical study with its vaccine candidate (GVXN SD133) against Shigella dysenteriae, a cause of serious intestinal infections. This is the first product from the company to enter clinical evaluation.

23 Feb 2010

Viamet Pharmaceuticals, Novartis Option Fund partner to develop novel inhibitors against key metalloenzyme target

Viamet Pharmaceuticals, Inc. announced today that it has entered into a licensing option agreement with the Novartis Option Fund. Under terms of the agreement, Viamet will utilize its proprietary Metallophile™ Technology to discover and develop novel metalloenzyme inhibitors against a specific metalloenzyme of high interest to Novartis. The agreement includes an upfront fee and potential milestones totaling over $200 million as well as product royalties.

23 Feb 2010

Heartware completes patient enrollment for ADVANCE clinical trial

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced the conclusion of patient enrollment under its "ADVANCE" clinical trial.

23 Feb 2010

Merrimack Pharmaceuticals commences dosing in MM-121/Tarceva combination Phase 1/2 study for NSCLC

Merrimack Pharmaceuticals, Inc. announced today that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with non-small cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121.

23 Feb 2010

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

23 Feb 2010

Enzymerx completes enrollment for clinical trial of pegsitacase

EnzymeRx, LLC, a clinical-stage biotechnology company, announced completion of the enrollment of its first clinical trial of pegsitacase (formerly called Uricase-PEG 20), and the recent launch of a second clinical study. Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

22 Feb 2010

FDA grants Fast Track designation for Curemark's CM-AT autism treatment

Curemark LLC, a drug research and development company focused on the treatment of neurological diseases, announced that its CM-AT autism treatment, now in Phase III clinical trials, has been designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA).

22 Feb 2010

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. RSV infection in lung transplant patients represents an important unmet medical need; the condition is associated with significant morbidity, including the development of acute lung transplant rejection in 10% to 20% of infected patients.

22 Feb 2010

Emory School of Medicine to enroll nearly 1,140 people for Phase III clinical trial of progesterone for TBI

Researchers at 17 medical centers across the country soon will begin using the hormone progesterone to treat patients who experience traumatic brain injury (TBI). The treatment is part of a randomized, double-blind Phase III clinical trial that will enroll approximately 1,140 people over a three- to six-year period beginning in March, 2010. The trial is funded by a grant to Emory University from the National Institutes of Health.

20 Feb 2010

Polyphor discovers new class of antibiotics effective against multi-drug resistant Gram-negative bacteria

Today, Polyphor Ltd published the discovery of a new class of antibiotics with a novel mode of action (Science, VOL 327, ISSUE 5968). This proprietary new class of antibiotics is effective against multi-drug resistant Gram-negative bacteria, opening up new treatment options for serious and often life-threatening infections. The most advanced drug candidate in this new class, POL7080, selectively kills the dangerous bacteria Pseudomonas aeruginosa.

19 Feb 2010

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

BioCrossroads' Indiana Seed Fund has invested in Bioscience Vaccines, Inc. to accelerate the development of biologic materials, which may boost the effectiveness of a wide range of life-saving vaccines.

19 Feb 2010

Drug Trial News

Phase III trial results of Osiris Therapeutics' Prochymal for GvHD to be presented at BMT Tandem Meeting

Idera Pharmaceuticals presents IMO-3100 TLR antagonist mechanism of action data at Keystone conference

ViiV Healthcare highlights S/GSK1349572, SELZENTRY and EPZICOM for HIV/AIDS at 17th CROI

Enrollment complete in Ocera Therapeutics' ASTUTE Phase 2B trial for mild hepatic encephalopathy

Catalyst Pharmaceutical Partners, NIDA partner to conduct CPP-109 Phase II(b) clinical trial for cocaine addiction

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

TCAD therapy active and synergistic against drug resistant influenza virus strains

Genentech's Avastin combination Phase III study in advanced stomach cancer does not meet primary endpoint

GlycoVaxyn initiates Phase I clinical study of GVXN SD133 vaccine candidate against Shigella dysenteriae

Viamet Pharmaceuticals, Novartis Option Fund partner to develop novel inhibitors against key metalloenzyme target

Heartware completes patient enrollment for ADVANCE clinical trial

Merrimack Pharmaceuticals commences dosing in MM-121/Tarceva combination Phase 1/2 study for NSCLC

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Enzymerx completes enrollment for clinical trial of pegsitacase

FDA grants Fast Track designation for Curemark's CM-AT autism treatment

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Emory School of Medicine to enroll nearly 1,140 people for Phase III clinical trial of progesterone for TBI

Polyphor discovers new class of antibiotics effective against multi-drug resistant Gram-negative bacteria

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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