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Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

U.S., Australian researchers say single H1N1 vaccine dose protects adults against virus

The results of clinical trials have shown one dose of the H1N1 (swine) flu vaccine is enough to offer adults protection against the virus, U.S. and Australian researchers said Thursday, the Associated Press reports (Neergaard, 9/11).

11 Sep 2009

Stem Cell Therapy International to merge with Histostem Korea

Stem Cell Therapy International Inc. (OTCBB: SCII) announced today that the Company has agreed to be a party to the settlement between Histostem, Incorporated, a Delaware Corporation ("Histostem USA") and Histostem Corporation, a Korean Corporation ("Histostem Korea"). The agreement is contingent upon the close of the SCII and Histostem Korea merger, and specifically, the agreement is contingent that at the close of the merger, SCII will acquire no less than 90% of the total fully diluted equity of Histostem Korea.

11 Sep 2009

Delcath Systems to continue Phase III clinical trial

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that the Data and Safety Monitoring Board ("DSMB") reviewed clinical data on 77 patients enrolled in its pivotal Phase III clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study.

11 Sep 2009

Pluristem begins enrollment following FDA approval for clinical trials of its PLX-PAD stem cell product

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

11 Sep 2009

First patient enrolled in Phase 2b RADAR clinical trial

Regado Biosciences, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, announced that on September 8, 2009 enrollment of the first patient in a Phase 2b, randomized, partially-blinded, multi-center, active-controlled, dose-ranging study of its lead product candidate, the REG1 anticoagulation system (REG1) was achieved.

11 Sep 2009

BioOhio and GCIC launch Ohio Bioscience Resource Directory

BioOhio and the Global Cardiovascular Innovation Center (GCIC) have launched an expanded and improved Ohio Bioscience Resource Directory, the most comprehensive online collection of Ohio companies, organizations, and research centers involved in the biosciences.

11 Sep 2009

Phase 3 trial results of LEVADEX orally inhaled migraine therapy to be presented

MAP Pharmaceuticals, Inc. announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

Positive results from Mpex' Phase 2b clinical trial with Aeroquin

Mpex Pharmaceuticals, Inc. today announced positive data from its Phase 2b clinical trial with Aeroquin((R)) (a novel aerosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF). Trial results showed that nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa (P. aeruginosa) in sputum after 28 days of dosing versus placebo.

11 Sep 2009

Phase 3 trial of ataluren commences

PTC Therapeutics, Inc. (PTC) today announced the initiation of a Phase 3 trial of ataluren (formerly PTC124(R)), an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis (nmCF).

11 Sep 2009

Phase II clinical trial of TAK-700 for treating advanced prostate cancer commences

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of the Phase II portion of a Phase I/II clinical trial of TAK-700 in patients with advanced prostate cancer.

11 Sep 2009

Children's Hospital to determine optimal duration of antimicrobial treatment for UTIs

In the largest study of its kind, pediatric researchers at The Children's Hospital of Philadelphia have received a federal contract for a project to determine the most beneficial method of using antibiotics to treat urinary tract infections (UTIs) in children.

11 Sep 2009

UBC acquires Cognitive Drug Research

United BioSource Corporation (UBC) today announced the acquisition of Cognitive Drug Research, Ltd. (CDR), the leader in computerized cognitive testing for clinical trials.

11 Sep 2009

Phase II human clinical trial of Exsulin commences

Exsulin Corporation today announced the start of a phase II human clinical trial of Exsulin, a peptide drug product aimed at restoring insulin production in people with diabetes mellitus. The randomized, controlled 12-week trial in patients with established Type 1 diabetes (T1DM) will be co-led by Mayo Clinic in Rochester, Minn., and McGill University Health Centre in Montreal, Canada.

10 Sep 2009

Phase 2b clinical trial results of TC-5214 to be presented at nAChR2009

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics, today confirmed plans to present data from its completed Phase 2b clinical trial of TC-5214 as an augmentation treatment for major depressive disorder at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009) in Lincolnshire, Illinois on October 15, 2009.

10 Sep 2009

Teva's COPAXONE holds promise for relapsing remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today presented data that demonstrated patients treated for 10 and 15 years with COPAXONE® (glatiramer acetate injection) had significant reduction in disease severity. These data, generated from the longest continuous prospective study of any disease modifying therapy in relapsing remitting multiple sclerosis (RRMS), were presented today at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

10 Sep 2009

Acceleron's Phase 1 trial of ACE-031 reveals its potential in treating neuromuscular diseases

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, and muscle, today announced preliminary results from the ACE-031 Phase 1 single dose clinical trial demonstrating that ACE-031 increased lean body mass and muscle volume. The results from this randomized, placebo-controlled study were presented at the 14th International Congress of the World Muscle Society in Geneva, Switzerland.

10 Sep 2009

Human neural stem cells to treat Pelizaeus-Merzbacher Disease

StemCells, Inc. (NASDAQ:STEM) announced today that it will soon initiate with the University of California, San Francisco (UCSF) Children’s Hospital a Phase I clinical trial to evaluate the therapeutic potential of StemCells’ proprietary HuCNS-SC® product candidate (purified human neural stem cells) to treat Pelizaeus-Merzbacher Disease (PMD), a myelination disorder that primarily affects infants and young children.

10 Sep 2009

FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Ascenta Therapeutics announced today that following the approval by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) Application for AT-406, an orally-active, small molecule, multi-IAP antagonist, the company will initiate a Phase I clinical trial in patients with advanced cancer during the fourth quarter of 2009.

10 Sep 2009