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BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 Feb 2010

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Optimer Pharmaceuticals, Inc. today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI). This study was conducted in approximately 100 clinical sites throughout North America and Europe. The Company plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

5 Feb 2010

BioMarin announces update on BMN 110 Phase I/II trial for Morquio A Syndrome

BioMarin Pharmaceutical Inc. today announced an update on the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. Preliminary clinical data from the first 24 weeks of the study (12 weeks at 0.1mg/kg and 12 weeks at 1.0 mg/kg) have been evaluated, and BioMarin plans to announce top-line results for the full 36-week study after completion of dosing at 2.0 mg/kg in the second quarter of 2010.

5 Feb 2010

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Protalix Biotherapeutics, Inc. today announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, February 10-12, 2010 in Miami, Florida.

5 Feb 2010

Paloma Pharmaceuticals receives FDA approval to enter Phase I studies with P529

Paloma Pharmaceuticals, Inc. announced today that it has received acceptance of its IND to enter Phase I studies with Palomid 529 (P529) in patients with age-related macular degeneration (AMD).

5 Feb 2010

Data analysis of Delcath Systems' Phase III trial of melphalan to be commenced

Delcath Systems, Inc., a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial. The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.

4 Feb 2010

Results from three phase two studies show the effectiveness of Tanezumab

Tanezumab, a humanized monoclonal antibody that targets nerve-growth factor, reduced pain in three common pain conditions, according to the results from three phase two studies presented today in a single poster at the American Academy of Pain Medicine's 26th Annual Meeting.

4 Feb 2010

Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

Shire plc, the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida.

4 Feb 2010

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Seattle Genetics, Inc. and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma.

4 Feb 2010

Recent clinical trials in patients with ALBP show that SOMA 250 mg reduces disability

A recent analysis of two pivotal clinical trials in patients with acute low back pain (ALBP) who were treated with SOMA® (carisoprodol) 250 mg showed significantly improved functionality and reduced disability after three days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ).

4 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

Daiichi Sankyo Company, Limited, announced today that it has initiated a new large-scale pivotal Phase III trial for edoxaban, its investigational oral Factor Xa inhibitor. This new study, called HOKUSAI (pronounced hoe·koo·sigh) VTE, is evaluating the safety and efficacy of edoxaban in reducing recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

3 Feb 2010

MV vaccine prevents TB in people with HIV infection

Results from clinical trials conducted in Tanzania show that a new vaccine against tuberculosis, Mycobacterium vaccae (MV), is effective in preventing tuberculosis in people with HIV infection. Findings from the trials, which were conducted by investigators from Dartmouth Medical School in the United States, will be published in the next issue of AIDS, the leading journal in the field of HIV and AIDS research. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

3 Feb 2010

Promising results from Soligenix' RiVax vaccine trials against ricin toxin

Soligenix, Inc., a late-stage biotechnology company, announced today the publication of an article in the February 2010 edition of Vaccine, which describes preclinical formulations of RiVax™, its ricin toxin vaccine, with heightened stability. The article was authored by the Company's collaborators at the University of Texas Southwestern Medical Center at Dallas (UT Southwestern) where the vaccine originated. RiVax™ is currently being evaluated in Phase 1 human safety and immunogenicity trials, as well as non-human primate trials for efficacy.

3 Feb 2010

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Repros Therapeutics Inc. today announced that the Company has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency that the Company may initiate its Investigational New Drug Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial.

3 Feb 2010

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term treatment option for age-related and HIV lipoatrophy patients.

3 Feb 2010

GenSpera’s G-115 anti-cancer drug awarded US patent

GenSpera, Inc. announced that its patent application, entitled “Tumor Activated Prodrugs,” has been issued by the United States Patent and Trademark Office (USPTO) as US Patent 7,635,682. The patent covers the composition and potential uses of G-115, GenSpera’s second anti-cancer drug in development.

2 Feb 2010

Vantia Therapeutics initiates Phase IIb trial of VA106483 for nocturia

Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, today announces it has begun its planned Phase IIb trial of its lead development compound VA106483 for nocturia.

2 Feb 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Drug Trial News

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

BioMarin announces update on BMN 110 Phase I/II trial for Morquio A Syndrome

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Paloma Pharmaceuticals receives FDA approval to enter Phase I studies with P529

Data analysis of Delcath Systems' Phase III trial of melphalan to be commenced

Results from three phase two studies show the effectiveness of Tanezumab

Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Recent clinical trials in patients with ALBP show that SOMA 250 mg reduces disability

Phase 2a clinical trial results of VX-809 in patients with CF announced

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

MV vaccine prevents TB in people with HIV infection

Promising results from Soligenix' RiVax vaccine trials against ricin toxin

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

GenSpera’s G-115 anti-cancer drug awarded US patent

Vantia Therapeutics initiates Phase IIb trial of VA106483 for nocturia

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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